Clindamycin Gel

Pronunciation: KLIN-da-MYE-sin
Generic Name: Clindamycin
Brand Name: Examples include Cleocin T and Clindamax

Clindamycin Gel is used for:

Treating severe acne. It may also be used for other conditions as determined by your doctor.

Clindamycin Gel is a topical lincomycin antibiotic. It works by killing sensitive bacteria that cause acne and reducing the amount of free fatty acids that irritate the skin surface.

Do NOT use Clindamycin Gel if:

• you are allergic to any ingredient in Clindamycin Gel or to lincomycin


• you have Crohn disease, antibiotic-associated colitis, or ulcerative colitis

Contact your doctor or health care provider right away if any of these apply to you.

Before using Clindamycin Gel:

Some medical conditions may interact with Clindamycin Gel. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have a gastrointestinal (bowel) disease or diarrhea

Some MEDICINES MAY INTERACT with Clindamycin Gel. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Nondepolarizing muscle relaxants (eg, vecuronium) or succinylcholine because their actions and the risk of their side effects may be increased by Clindamycin Gel


• Erythromycin because it may decrease Clindamycin Gel's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if Clindamycin Gel may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Clindamycin Gel:

Use Clindamycin Gel as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Clindamycin Gel is for topical use on the skin only.


• Clean and dry the affected area. Cover the affected and surrounding area with a thin film of medicine.


• Clindamycin Gel works best if it is used at the same time each day.


• Continue to use Clindamycin Gel even if your condition improves. Do not miss any doses.


• If you miss a dose of Clindamycin Gel, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Clindamycin Gel.

Important safety information:

• Clindamycin Gel may cause harm if it is swallowed. If you may have taken it by mouth, contact your poison control center or emergency room right away.


• Several weeks may pass before you see improvement in your acne. Continue using Clindamycin Gel for the full time recommended by your doctor.


• Be sure to use Clindamycin Gel for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.


• Do not get Clindamycin Gel in your eyes or on the inside of your nose or mouth. If you accidentally get the medicine in your eye, immediately flush with a large amount of cool tap water.


• If severe diarrhea, stomach pain or cramping, or bloody stools develop during treatment or within several months after treatment with Clindamycin Gel, check with your doctor or pharmacist right away. Do not treat it without first checking with your doctor.


• Talk with your doctor before you use any other medicines or cleansers on your skin.


• Clindamycin Gel should not be used in CHILDREN younger than 12 years old; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Clindamycin Gel while you are pregnant. It is not known if Clindamycin Gel is found in breast milk. Do not breast-feed while taking Clindamycin Gel.

Possible side effects of Clindamycin Gel:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dryness; itching; oiliness or oily skin.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood or mucus in stools; bloody or severe diarrhea; stomach cramps or pain; swelling, redness, burning, or peeling of your skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Clindamycin Gel may be harmful if swallowed.

Proper storage of Clindamycin Gel:

Store Clindamycin Gel at room temperature, between 68 and 77 degrees F (20 and 25 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Protect from freezing. Keep Clindamycin Gel out of the reach of children and away from pets.

General information:

• If you have any questions about Clindamycin Gel, please talk with your doctor, pharmacist, or other health care provider.


• Clindamycin Gel is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Clindamycin Gel. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Clindamycin resources

• Clindamycin Use in Pregnancy & Breastfeeding
• Clindamycin Drug Interactions
• Clindamycin Support Group
• 20 Reviews for Clindamycin - Add your own review/rating

Compare Clindamycin with other medications

• Acne
• Bacterial Vaginitis
• Perioral Dermatitis

cholecystokinin Injection

koe-lee-sis-toh-KYE-nin

Uses For cholecystokinin

Cholecystokinin belongs to the group of medicines known as diagnostic aids. Diagnostic aids are used to help diagnose certain medical problems. Cholecystokinin is given by injection before tests are done to see if the gallbladder and pancreas are working the way they should. It is also used to help with other tests of the stomach and intestines.

Cholecystokinin makes the gallbladder contract (squeeze together). It also makes the pancreas produce enzymes, which are some of the juices needed for the digestion of food. In addition, cholecystokinin increases the movements or contractions of the stomach and intestines. The doctor will know if there is anything wrong with these organs if cholecystokinin does not work in the usual way.

The doses of cholecystokinin will be different for different patients and depend on the weight of the patient and on the type of test.

Cholecystokinin is used only under the supervision of a doctor.

Before Using cholecystokinin

In deciding to use a diagnostic test, any risks of the test must be weighed against the good it will do. This is a decision you and your doctor will make. Also, other things may affect test results. For this test, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to cholecystokinin or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies on cholecystokinin have been done only in adult patients, and there is no specific information comparing use of cholecystokinin in children with use in other age groups.

Geriatric

cholecystokinin has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this diagnostic test. Make sure you tell your doctor if you have any other medical problems, especially:

• Blockage of the intestines—The use of cholecystokinin may make this problem worse

Proper Use of cholecystokinin

Dosing

The dose of cholecystokinin will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of cholecystokinin. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

cholecystokinin Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Abdominal or stomach pain, cramps, or discomfort


• flushing or redness of skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

Intelence

Generic Name: Etravirine
Class: Nonnucleoside Reverse Transcriptase Inhibitors
VA Class: AM800
Chemical Name: 4-{[6-amino-5-bromo-2-((4-cyanophenyl)amino)-4-pyrimidinyl]oxy}-3,5-dimethylbenzonitrile
Molecular Formula: C₂₀H₁₅BrN₆O
CAS Number: 269055-15-4

Introduction

Antiretroviral; nonnucleoside reverse transcriptase inhibitor (NNRTI).^{1 2 3 5}

Uses for Intelence

Treatment of HIV Infection

Treatment of HIV-1 infection in conjunction with other antiretrovirals.¹

Used only in treatment-experienced (previously treated) adults with evidence of HIV-1 replication and HIV-1 strains resistant to an NNRTI and other antiretroviral agents.^{1 2 3}

Selection of etravirine for use in antiretroviral regimens should be guided by viral resistance testing (when available) and the individual’s prior antiretroviral treatment.¹

Concomitant use of etravirine and another NNRTI (e.g., delavirdine, efavirenz, nevirapine) is not recommended.^{1 5}

A regimen that includes etravirine and nucleoside and nucleotide reverse transcriptase inhibitors (NRTIs) as the only antiretroviral agents is not recommended in adults who experienced virologic failure while receiving a previous NNRTI-containing regimen.¹ There is some evidence that such regimens may be less effective in these patients than regimens that include HIV protease inhibitors (PIs).⁵

Do not use in initial antiretroviral regimens.^{5 9} Risks versus benefits not established in treatment-naive adults^{1 5} or in pediatric patients.¹

Intelence Dosage and Administration

Administration

Oral Administration

Administer orally after a meal.¹ Food enhances bioavailability of etravirine.^{1 11} (See Food under Pharmacokinetics.)

Swallow tablets whole; do not chew.

For patients unable to swallow tablets, the tablets may be administered as a dispersion in water.¹ To prepare a dispersion containing 200 mg, place two 100-mg tablets in a glass containing water and stir until a uniform dispersion occurs.¹ Consume the dispersion promptly; rinse the glass with water several times and swallow each rinse to ensure consumption of the entire dose.¹

Dosage

Must be given in conjunction with other antiretrovirals.¹

Adults

Treatment of HIV Infection

Oral

200 mg twice daily.^{1 5}

Special Populations

Hepatic Impairment

Dosage adjustment not necessary in patients with mild or moderate hepatic impairment (Child-Pugh class A or B);^{1 5 12} data not available in patients with severe hepatic impairment (Child-Pugh class C).^{1 5} (See Special Populations under Pharmacokinetics.)

Dosage adjustment not necessary in HIV-infected patients coinfected with hepatitis B virus (HBV) and/or hepatitis C virus (HCV).¹ (See Special Populations under Pharmacokinetics.)

Renal Impairment

Dosage adjustment not necessary.^{1 5} (See Special Populations under Pharmacokinetics.)

Geriatric Patients

Select dosage with caution because of age-related decreases in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy.¹

Cautions for Intelence

Contraindications

• 
  

  Manufacturer states none known.¹

  
  

Warnings/Precautions

Sensitivity Reactions

Dermatologic and Hypersensitivity Reactions

Severe, potentially life-threatening and fatal skin reactions reported.¹ Reactions include Stevens-Johnson syndrome, toxic epidermal necrolysis, and erythema multiforme.¹ Hypersensitivity reactions with rash and systemic symptoms also reported.¹

If severe hypersensitivity reactions (e.g., severe rash or rash with fever, malaise, fatigue, muscle or joint pain, blisters, oral lesions, conjunctivitis, facial edema, hepatitis, eosinophilia, angioedema) occur, immediately discontinue etravirine and initiate appropriate therapy.¹ Monitor clinical status and liver transaminase concentrations.¹

Rash of mild to moderate intensity also reported;^{1 2 3} generally occurs within first few weeks of therapy and resolves with continued therapy (median duration 12–16 days).^{1 2 3}

Manufacturer states that history of rash while receiving other NNRTIs does not appear to increase the risk for etravirine-related rash.¹

Adipogenic Effects

Possible redistribution or accumulation of body fat, including central obesity, dorsocervical fat enlargement (“buffalo hump”), peripheral wasting, facial wasting, breast enlargement, and general cushingoid appearance.¹

Immune Reconstitution Syndrome

During initial treatment, patients who respond to antiretroviral therapy may develop an inflammatory response to indolent or residual opportunistic infections (e.g., Mycobacterium avium complex [MAC], M. tuberculosis, cytomegalovirus [CMV], Pneumocystis jiroveci [formerly P. carinii]); this may necessitate further evaluation and treatment.¹

Specific Populations

Pregnancy

Category B.¹

Antiretroviral Pregnancy Registry at 800-258-4263.¹

Some experts state safety and pharmacokinetic data insufficient to recommend etravirine in pregnant women.⁷

Lactation

Not known whether distributed into human milk.¹

Instruct HIV-infected women not to breast-feed because of risk of HIV transmission and risk of adverse effects in the infant.^{1 7}

Pediatric Use

Safety and efficacy not established in pediatric patients.¹

Geriatric Use

Insufficient experience in patients ≥65 years of age to determine whether they respond differently than younger adults.¹

Common Adverse Effects

Rash, peripheral neuropathy.¹

Interactions for Intelence

Metabolized by CYP isoenzymes 3A, 2C9, and 2C19.^{1 5} Induces CYP3A;¹ inhibits 2C9 and 2C19.¹ Inhibits P-glycoprotein.¹

Drugs Affecting or Metabolized by Hepatic Microsomal Enzymes

Potential pharmacokinetic interactions with drugs that induce or inhibit CYP isoenzymes 3A, 2C9, or 2C19 with possible altered metabolism of etravirine.^{1 5}

Potential pharmacokinetic interaction with drugs that are substrates for CYP isoenzymes 3A, 2C9, or 2C19 with possible altered metabolism of the substrate.^{1 5}

Drugs Affected by P-glycoprotein Transport

Potential pharmacokinetic interaction with drugs that are substrates for P-glycoprotein.¹

Specific Drugs

Drug	Interaction	Comments
Abacavir	No in vitro evidence of antagonistic antiretroviral effects 1
Antiarrhythmics (amiodarone, disopyramide, flecainide, systemic lidocaine, mexiletine, propafenone, quinidine)	Possible decreased antiarrhythmic agent concentrations1	Use caution; monitor concentrations of the antiarrhythmic agent1 5
Anticoagulants, oral	Possible increased warfarin concentrations1 5	Monitor INR; adjust warfarin dosage if needed1 5
Anticonvulsants (carbamazepine, phenobarbital, phenytoin)	Possible decreased etravirine concentrations and decreased antiretroviral efficacy1 5	Concomitant use not recommended;1 5 consider alternative anticonvulsants5
Antifungals, azoles (fluconazole, itraconazole, ketoconazole, posaconazole, voriconazole)	Fluconazole: Substantially increased etravirine concentrations; no change in fluconazole concentrations1 5 Itraconazole: Possible increased etravirine concentrations and decreased itraconazole concentrations1 5 Ketoconazole: Possible increased etravirine concentrations and decreased ketoconazole concentrations1 5 Posaconazole: Possible increased etravirine concentrations; no change in posaconazole concentrations1 5 Voriconazole: Increased etravirine and voriconazole concentrations 1 5	Fluconazole: Dosage adjustment not needed for either drug; use caution because of limited safety data regarding increased etravirine concentrations1 5 Itraconazole: Dosage adjustment of itraconazole may be needed depending on other concomitantly administered drugs;1 5 consider monitoring itraconazole concentrations5 Ketoconazole: Dosage adjustment of ketoconazole may be needed depending on other concomitantly administered drugs1 5 Posaconazole: Dosage adjustment of posaconazole may be needed depending on other concomitantly administered drugs1 Voriconazole: Use caution because of limited safety data regarding increased etravirine concentrations; manufacturer of etravirine states that dosage adjustment not needed for either drug;1 some experts state that dosage adjustment of voriconazole may be needed depending on other concomitantly administered drugs and that consideration should be given to monitoring voriconazole concentrations5
Antimycobacterials (rifabutin, rifampin, rifapentine)	Rifabutin: Decreased concentrations of etravirine and rifabutin1 5 Rifampin: Substantially decreased etravirine concentrations possible1 5 Rifapentine: Substantially decreased etravirine concentrations possible1 5	Rifabutin: Recommended dosage of rifabutin is 300 mg daily in patients receiving etravirine in a regimen that does not include a ritonavir-boosted PI;1 5 rifabutin not recommended in patients receiving etravirine in a regimen that includes ritonavir-boosted darunavir, ritonavir-boosted lopinavir, or ritonavir-boosted saquinavir1 5 Rifampin: Concomitant use not recommended1 5 Rifapentine: Concomitant use not recommended1 5
Atazanavir	Atazanavir or ritonavir-boosted atazanavir: Increased etravirine concentrations; decreased atazanavir concentrations and possible decreased antiretroviral efficacy1 5 No in vitro evidence of antagonistic antiretroviral effects1	Concomitant use of atazanavir (with or without low-dose ritonavir) not recommended1 5
Benzodiazepines (alprazolam, diazepam)	Alprazolam: Data not available5 Diazepam: Possible increased diazepam concentrations1 5	Alprazolam: Monitor for therapeutic effects of alprazolam if used concomitantly5 Diazepam: Consider need to decrease diazepam dosage1 5
Clarithromycin	Increased etravirine concentrations; decreased clarithromycin concentrations and increased concentrations of the major metabolite (14-hydroxyclarithromycin)1 5	Consider an alternative to clarithromycin (e.g., azithromycin) for treatment of MAC; 14-hydroxyclarithromycin has reduced activity against MAC1 5
Clopidogrel	Possible decreased concentrations of the active metabolite of clopidogrel1	Consider alternatives to clopidogrel1
Corticosteroids (dexamethasone)	Dexamethasone: Possible decreased etravirine concentrations and decreased antiretroviral efficacy1 5	Caution; consider alternatives to dexamethasone, especially when long-term corticosteroid use anticipated1 5
Darunavir	Ritonavir-boosted darunavir: Decreased etravirine AUC; no change in darunavir concentrations 1 2 3 5 Safety and efficacy of ritonavir-boosted darunavir and etravirine established in phase 3 clinical studies1 2 3 5 No in vitro evidence of antagonistic antiretroviral effects1	Ritonavir-boosted darunavir: Dosage adjustment not needed1 5
Delavirdine	Possible increased etravirine concentrations1	Concomitant use not recommended1 5
Didanosine	No in vitro evidence of antagonistic antiretroviral effects1
Digoxin	Possible increased digoxin concentrations; no change in etravirine concentrations1	If digoxin and etravirine are initiated at the same time, initiate digoxin at the lowest dosage1 If etravirine is initiated in a patient already receiving digoxin, dosage adjustment of either drug not needed1 Monitor serum digoxin concentrations and adjust digoxin dosage to achieve desired clinical effect1
Efavirenz	Decreased etravirine concentrations1 5 and loss of antiretroviral efficacy1	Concomitant use not recommended1 5
Emtricitabine	No in vitro evidence of antagonistic antiretroviral effects1
Enfuvirtide	No in vitro evidence of antagonistic antiretroviral effects1	Dosage adjustment not needed1
Estrogens or progestins	Hormonal contraceptives: Slight increase in ethinyl estradiol concentrations; no change in norethindrone concentrations1 5	Dosage adjustment not needed with oral contraceptives containing ethinyl estradiol and norethindrone1 5
Fosamprenavir	Fosamprenavir or ritonavir-boosted fosamprenavir: Substantial increase in amprenavir concentrations1 5 No in vitro evidence of antagonistic antiretroviral effects with amprenavir1	Concomitant use of fosamprenavir (with or without low-dose ritonavir) not recommended1 5
Histamine H2-receptor antagonists	Ranitidine: Decreased etravirine concentrations1	Ranitidine: Dosage adjustment not needed1
HMG-CoA reductase inhibitors (atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin)	Atorvastatin: Decreased atorvastatin concentrations; no change in etravirine concentrations1 5 Fluvastatin: Possible increased fluvastatin concentrations; no change in etravirine concentrations1 5 Lovastatin: Possible decreased lovastatin concentrations1 5 Pravastatin: Pharmacokinetic interaction not expected1 5 Rosuvastatin: Pharmacokinetic interaction not expected1 5 Simvastatin: Possible decreased simvastatin concentrations1 5	Atorvastatin: Usual dosages of etravirine and atorvastatin can be used; however, may need to adjust atorvastatin dosage based on clinical response1 5 (do not exceed maximum recommended dosage)5 Fluvastatin: May need to adjust fluvastatin dosage1 5 Lovastatin: May need to adjust lovastatin dosage based on clinical response1 5 (do not exceed maximum recommended dosage);5 if a ritonavir-boosted PI is included in the regimen, some experts recommend that lovastatin not be used5 Pravastatin: No dosage adjustment needed5 Rosuvastatin: No dosage adjustment needed5 Simvastatin: May need to adjust simvastatin dosage based on clinical response1 5 (do not exceed maximum recommended dosage);5 if a ritonavir-boosted PI is included in the regimen, some experts recommend that simvastatin not be used5
Immunosuppressive agents (cyclosporine, sirolimus, tacrolimus)	Potential for decreased immunosuppressive agent concentrations1	Use with caution1
Indinavir	Indinavir (without low-dose ritonavir): Decreased indinavir concentrations1 No in vitro evidence of antagonistic antiretroviral effects1	Concomitant use of indinavir (without low-dose ritonavir) not recommended1 5
Lamivudine	No in vitro evidence of antagonistic antiretroviral effects 1
Lopinavir	Lopinavir/ritonavir: Decreased etravirine AUC and decreased lopinavir concentrations1 5 No in vitro evidence of antagonistic antiretroviral effects1	Because decrease in etravirine systemic exposure in patients receiving concomitant lopinavir/ritonavir is similar to that in patients receiving etravirine and concomitant ritonavir-boosted darunavir (a combination found to be safe and effective), manufacturer and some experts state that dosage adjustments not needed for either drug1 5
Maraviroc	Decreased maraviroc concentrations; no change in etravirine concentrations1 5 Maraviroc and ritonavir-boosted darunavir: Increased maraviroc concentrations5 No in vitro evidence of antagonistic antiretroviral effects1	Regimens that include maraviroc without a potent CYP3A inhibitor (e.g., ritonavir-boosted PI): Recommended dosage of maraviroc is 600 mg twice daily; dosage adjustment of etravirine not needed1 5 Regimens that include maraviroc and a potent CYP3A inhibitor (e.g., ritonavir-boosted PI): Recommended dosage of maraviroc is 150 mg twice daily; dosage adjustment of etravirine not needed1 5
Methadone	No change in methadone or etravirine concentrations1 5 8	Dosage adjustment not needed1 5 8
Nelfinavir	Nelfinavir (without low-dose ritonavir): Increased nelfinavir concentrations1 No in vitro evidence of antagonistic antiretroviral effects1	Concomitant use of nelfinavir (without low-dose ritonavir) not recommended1 5
Nevirapine	Decreased etravirine concentrations1 5 and loss of antiretroviral efficacy1	Concomitant use not recommended1 5
Paroxetine	No change in etravirine or paroxetine concentrations1	Dosage adjustment not needed1
Proton pump inhibitors	Omeprazole: Increased etravirine concentrations1	Omeprazole: Dosage adjustment not needed1
Raltegravir	No change in etravirine concentrations; slight decrease in raltegravir AUC and plasma concentrations1 10 No in vitro evidence of antagonistic antiretroviral effects1	Dosage adjustment not needed for either drug1 5 10
Ritonavir	Full-dose ritonavir: Substantial decrease in etravirine concentrations and possible loss of antiretroviral efficacy1 No in vitro evidence of antagonistic antiretroviral effects 1	Full-dose ritonavir (600 mg twice daily): Concomitant use not recommended1 5 Low-dose ritonavir (usually 100 mg once or twice daily): Etravirine may be used concomitantly with certain ritonavir-boosted PI regimens (i.e., ritonavir-boosted darunavir, lopinavir/ritonavir, ritonavir-boosted saquinavir);1 concomitant use with ritonavir-boosted atazanavir, ritonavir-boosted fosamprenavir, or ritonavir-boosted tipranavir not recommended1 5
Saquinavir	Ritonavir-boosted saquinavir (saquinavir 1 g twice daily and ritonavir 100 mg twice daily): Decrease in etravirine AUC; no change in saquinavir plasma concentrations1 5 No in vitro evidence of antagonistic antiretroviral effects1	Because decrease in etravirine systemic exposure in patients receiving concomitant saquinavir is similar to that in patients receiving etravirine concomitantly with ritonavir-boosted darunavir (a combination found to be safe and effective), manufacturer and some experts state that dosage adjustments not needed for either drug1 5
Sildenafil	Decreased sildenafil concentrations1 5	Usual dosages of etravirine and sildenafil can be used; however, may need to alter dosage of sildenafil based on clinical effect1 5
Stavudine	No in vitro evidence of antagonistic antiretroviral effects1
St. John’s wort (Hypericum perforatum)	Possible substantially decreased etravirine concentrations and loss of antiretroviral efficacy1	Concomitant use not recommended1 5
Tenofovir	Decreased etravirine concentrations; no change in tenofovir concentrations1 No in vitro evidence of antagonistic antiretroviral effects1	Dosage adjustment not needed1
Tipranavir	Ritonavir-boosted tipranavir: Decreased etravirine concentrations and possible decreased antiretroviral efficacy; increased tipranavir concentrations1 5 No in vitro evidence of antagonistic antiretroviral effects1	Concomitant use of ritonavir-boosted tipranavir not recommended1 5
Zidovudine	No in vitro evidence of antagonistic antiretroviral effects1

Intelence Pharmacokinetics

Absorption

Bioavailability

Absolute oral bioavailability is unknown.¹

Following oral administration, peak plasma concentrations attained within approximately 2.5–4 hours.^{1 11}

Food

Systemic exposure is decreased by about 50% if etravirine is administered under fasting conditions compared with administration after a meal.^{1 11}

Effect of food on etravirine bioavailability was studied using various meals (standard, light, enhanced-fiber, high-fat);¹¹ magnitude of the food effect is similar with all meal types.^{1 11}

Distribution

Extent

Not known whether etravirine is distributed into human milk.¹

Distribution into compartments other than plasma (e.g., CSF, genital tract secretions) not evaluated.¹

Plasma Protein Binding

99.9%, principally albumin and alpha 1-acid glycoprotein.¹

Elimination

Metabolism

Metabolized principally in the liver by CYP isoenzymes 3A, 2C9, and 2C19.¹

In cell culture, the major metabolites are at least 90% less active than etravirine against wild-type HIV.¹

Elimination Route

Following oral administration of a single dose, the majority (93.7%) is eliminated in feces as unchanged etravirine (81.2–86.4%).¹ Up to 1.2% of the dose is eliminated in urine as metabolites.¹

Unlikely to be removed by hemodialysis or peritoneal dialysis.¹

Half-life

Mean terminal elimination half-life is about 41 hours.¹

Special Populations

Renal impairment: Pharmacokinetics not studied; alterations not expected because renal clearance is minimal.¹

Hepatic impairment: Pharmacokinetics not altered in patients with mild or moderate hepatic impairment (Child-Pugh class A or B);^{1 12} not studied in patients with severe hepatic impairment (Child-Pugh class C).¹

HIV-infected individuals coinfected with HBV and/or HCV: Reduced clearance reported.¹

Geriatric individuals: Studies in those up to 77 years of age indicate no substantial differences in pharmacokinetics relative to younger adults.¹

Pediatric patients: Pharmacokinetics not studied.¹

Pregnant patients: Pharmacokinetics not studied.¹

Stability

Storage

Oral

Tablets

25°C (may be exposed to 15–30°C).¹ Tight container; protect from moisture.¹ Dispense and store in original container; the desiccant should remain in the original bottle.¹

Actions and SpectrumActions

• 
  

  Inhibits replication of HIV-1 by interfering with viral RNA- and DNA-directed polymerase activities of reverse transcriptase.^{1 4}

  
  


• 
  

  Highly active against wild-type HIV-1; active against some clinical isolates resistant to other NNRTIs (delavirdine, efavirenz, nevirapine).^{1 3 4 5}

  
  


• 
  

  Different resistance profile than other NNRTIs; single mutations that result in class resistance to other NNRTIs do not necessarily result in resistance to etravirine.^{2 3 4 5}

  
  


• 
  

  Cross-resistance may occur between etravirine and other commercially available NNRTIs^{1 4 5} and is expected in patients who have virologic failure while receiving a regimen that contains etravirine.¹

  
  

Advice to Patients

• 
  

  Critical nature of compliance with HIV therapy.¹ Used in conjunction with other antiretrovirals; do not use for monotherapy.¹

  
  


• 
  

  Antiretroviral therapy is not a cure for HIV infection, and opportunistic infections still may occur.¹ HIV transmission via sexual contact or sharing needles is not prevented by antiretrovirals.¹

  
  


• 
  

  Importance of reading patient information provided by the manufacturer.¹

  
  


• 
  

  Advise patients to take etravirine as prescribed and not to alter or discontinue therapy without consulting their clinician.¹

  
  


• 
  

  Importance of taking etravirine twice daily after a meal.¹ Food enhances absorption of the drug;^{1 11} magnitude of the food effect is similar with all meal types (standard, light, enhanced-fiber, high-fat).^{1 11}

  
  


• 
  

  Advise patients to swallow the tablets whole with liquid (e.g., water).¹ Alternatively, disperse tablets in a glass of water and drink the liquid containing the dispersed etravirine tablets immediately, then rinse the glass with water several times and drink the rinse.¹

  
  


• 
  

  If a missed dose is remembered within 6 hours of the usually scheduled time, it should be taken after a meal as soon as possible and the next dose taken at the regularly scheduled time.¹ If missed dose is remembered >6 hours after the scheduled time, the dose should be omitted and the next dose taken at the regularly scheduled time.¹

  
  


• 
  

  Advise patients that severe and potentially life-threatening rash has occurred (usually within the first few weeks of etravirine therapy).¹ Importance of immediately contacting clinician if rash occurs.¹ Importance of immediately discontinuing etravirine and seeking medical care if rash associated with systemic symptoms (e.g., fever, generally ill feeling, extreme tiredness, muscle or joint aches, blisters, oral lesions, eye inflammation, swelling of the face, eyes, lips, or mouth, breathing difficulties, yellowing of the eyes or skin, dark or tea colored urine, pale colored stools, nausea, vomiting, loss of appetite, or right upper quadrant tenderness/pain) occurs.¹

  
  


• 
  

  Advise patients that redistribution/accumulation of body fat may occur with antiretroviral therapy, with as yet unknown long-term health effects.¹

  
  


• 
  

  Advise patients to contact their clinician if signs or symptoms of an infection occur.¹

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and herbal products (e.g., St. John’s wort), and any concomitant illnesses.¹

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.¹

  
  


• 
  

  Importance of advising patients of other important precautionary information.¹ (See Cautions.)

  
  

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Etravirine

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Tablets	100 mg	Intelence	Tibotec

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Intelence 100MG Tablets (CENTOCOR ORTHO BIOTECH PRODUCT): 120/$865.97 or 360/$2490.86

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions November 2010. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

1. Tibotec Therapeutics. Intelence (etravirine) tablets prescribing information. Raritan, NJ; 2010 Feb.

2. Madruga JV, Cahn P, Grinsztejn B et al. Efficacy and safety of TMC125 (etravirine) in treatment-experienced HIV-1 infected patients in DUET-1: 24-week results from a randomised, double-blind, placebo-controlled trial. Lancet. 2007; 370:29-38. [PubMed 17617270]

3. Lazzarin A, Campbell T, Clotet B et al. Efficacy and safety of TMC125 (etravirine) in treatment-experienced HIV-1 infected patients in DUET-2: 24-week results from a randomised, double-blind, placebo-controlled trial. Lancet. 2007; 370:39-48. [PubMed 17617271]

4. Vingerhoets J, Azijn H, Fransen E et al. TMC125 displays a high genetic barrier to the development of resistance: evidence from in vitro selection experiments. J Virol. 2005; 79:12773-82. [PubMed 16188980]

5. US Department of Health and Human Services (HHS) Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. December 1, 2009. Updates available at the HHS HIV/AIDS Information Services (AIDSinfo) website.

6. Tibotec Therapeutics, Bridgewater, NJ: Personal communication.

7. US Department of Health and Human Services (HHS) Panel on Treatment of HIV-infected Pregnant Women and Prevention of Perinatal Transmission. Recommendations for use of antiretroviral drugs in pregnant HIV-1-infected women for maternal health and interventions to reduce perinatal HIV transmission in the United States. May 24, 2010. Updates available at the HHS HIV/AIDS Information Services (AIDSinfo) website.

8. Schöller-Gyüre M, van den Brink W, Kakuda TN et al. Pharmacokinetic and pharmacodynamic study of the concomitant administration of methadone and TMC125 in HIV-negative volunteers. J Clin Pharmacol. 2008; 48:322-9.

9. Working Group on Antiretroviral Therapy and Medical Management of HIV-infected Children convened by the National Resource Center at the François-Xavier Bagnoud Center; UMDN, the Health Resources and Services Administration (HRSA), and the National Institutes of Health (NIH). Guidelines for the use of antiretroviral agents in pediatric HIV infection. February 23, 2009. Updates available at the US Department of Health and Human Services HIV/AIDS Information Services (AIDSinfo) website.

10. Anderson MS, Kakuda TN, Hanley W et al. Minimal pharmacokinetic interaction between the human immunodeficiency virus nonnucleoside reverse transcriptase inhibitor etravirine and the integrase inhibitor raltegravir in healthy subjects. Antimicrob Agents Chemother. 2008; 52:4228-32. [PubMed 18838586]

11. Schöller-Gyüre M, Boffito M, Pozniak AL et al. Effects of different meal compositions and fasted state on the oral bioavailability of etravirine. Pharmacotherapy. 2008; 28:1215-22. [PubMed 18823217]

12. Schöller-Gyüre M, Kakuda TN, De Smedt G et al. Effects of hepatic impairment on the steady-state pharmacokinetics of etravirine 200 mg BID: an open-label, multiple-dose, controlled Phase I study in adults. Clin Ther. 2010; 32:328-37. [PubMed 20206790]

More Intelence resources

• Intelence Side Effects (in more detail)
• Intelence Dosage
• Intelence Use in Pregnancy & Breastfeeding
• Intelence Drug Interactions
• Intelence Support Group
• 0 Reviews for Intelence - Add your own review/rating

• Intelence Prescribing Information (FDA)


• Intelence Consumer Overview


• Intelence Advanced Consumer (Micromedex) - Includes Dosage Information


• Intelence MedFacts Consumer Leaflet (Wolters Kluwer)


• Etravirine Professional Patient Advice (Wolters Kluwer)

Compare Intelence with other medications

• HIV Infection

imipenem and cilastatin Intravenous, Intramuscular

im-i-PEN-em, sye-la-STAT-in SOE-dee-um

Commonly used brand name(s)

In the U.S.

• Primaxin IM


• Primaxin IV

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Antibiotic

Pharmacologic Class: Beta-Lactam

Chemical Class: Carbapenem

Uses For imipenem and cilastatin

Imipenem and cilastatin combination is used in the treatment of infections caused by bacteria. It works by killing bacteria or preventing their growth. imipenem and cilastatin will not work for colds, flu, or other virus infections.

Imipenem and cilastatin combination is used to treat infections in many different parts of the body. It is sometimes given with other antibiotics.

imipenem and cilastatin is available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, imipenem and cilastatin combination is used in certain patients with the following medical conditions:

• Febrile neutropenia (treatment)


• Melioidosis (treatment)

Before Using imipenem and cilastatin

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For imipenem and cilastatin, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to imipenem and cilastatin or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

imipenem and cilastatin has been tested in a limited number of children 12 years of age and older and, in effective doses, has not been reported to cause different side effects or problems in children than it does in adults.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of imipenem and cilastatin in the elderly with use in other age groups, imipenem and cilastatin is not expected to cause different side effects or problems in older people than it does in younger adults.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving imipenem and cilastatin, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using imipenem and cilastatin with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Ganciclovir


• Theophylline


• Valganciclovir


• Valproic Acid

Using imipenem and cilastatin with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Cyclosporine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of imipenem and cilastatin. Make sure you tell your doctor if you have any other medical problems, especially:

• Central nervous system (CNS) disorders (for example, brain disease or history of seizures)—Patients with nervous system disorders, including seizures, may be more likely to have side effects

• Kidney disease—Patients with kidney disease may be more likely to have side effects

Proper Use of imipenem and cilastatin

To help clear up your infection completely, imipenem and cilastatin combination must be given for the full time of treatment, even if you begin to feel better after a few days. Also, imipenem and cilastatin works best when there is a constant amount in the blood or urine. To help keep the amount constant, it must be given on a regular schedule.

Dosing

The dose of imipenem and cilastatin will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of imipenem and cilastatin. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage form:
  
  • For bacterial infections:
    
    • Adults and children 12 years of age and over—250 milligrams (mg) to 1 gram injected into a vein every six to eight hours; or 500 to 750 mg injected into a muscle every twelve hours, depending on how severe your infection is.
    
    
    • Children up to 12 years of age—Use and dose must be determined by your doctor.
    
    
  
  

Precautions While Using imipenem and cilastatin

Some patients may develop tremors or seizures while receiving imipenem and cilastatin. If you already have a history of seizures and you are taking anticonvulsants, you should continue to take them unless otherwise directed by your doctor.

In some patients, imipenem and cilastatin combination may cause diarrhea.

• Severe diarrhea may be a sign of a serious side effect. Do not take any diarrhea medicine without first checking with your doctor . Diarrhea medicines may make your diarrhea worse or make it last longer.


• For mild diarrhea, diarrhea medicine containing kaolin (e.g., Kaopectate liquid) or attapulgite (e.g., Kaopectate tablets, Diasorb) may be taken. However, other kinds of diarrhea medicine should not be taken. They may make your diarrhea worse or make it last longer.


• If you have any questions about this or if mild diarrhea continues or gets worse, check with your health care professional.

imipenem and cilastatin Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Confusion


• convulsions (seizures)


• dizziness


• pain at place of injection


• skin rash, hives, itching, fever, or wheezing


• tremors

Less common

• Dizziness


• increased sweating


• nausea or vomiting


• unusual tiredness or weakness

Rare

• Fever


• severe abdominal or stomach cramps and pain


• watery and severe diarrhea, which may also be bloody (these side effects may also occur up to several weeks after you stop receiving imipenem and cilastatin)

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Diarrhea


• nausea and vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More imipenem and cilastatin Intravenous, Intramuscular resources

• Imipenem and cilastatin Intravenous, Intramuscular Use in Pregnancy & Breastfeeding
• Imipenem and cilastatin Intravenous, Intramuscular Drug Interactions
• Imipenem and cilastatin Intravenous, Intramuscular Support Group
• 0 Reviews for Imipenem and cilastatin Intravenous, Intramuscular - Add your own review/rating

Compare imipenem and cilastatin Intravenous, Intramuscular with other medications

• Aspiration Pneumonia
• Bacteremia
• Bacterial Infection
• Bone infection
• Bronchitis
• Deep Neck Infection
• Endocarditis
• Endometritis
• Febrile Neutropenia
• Intraabdominal Infection
• Joint Infection
• Kidney Infections
• Meningitis
• Nosocomial Pneumonia
• Pelvic Infections
• Peritonitis
• Pneumonia
• Pneumonia with Cystic Fibrosis
• Septicemia
• Skin and Structure Infection
• Skin Infection
• Urinary Tract Infection

Aranesp Albumin Free

Generic Name: darbepoetin alfa (DAR be POE e tin AL fa)

Brand Names: Aranesp, Aranesp Albumin Free, Aranesp SureClick

What is Aranesp Albumin Free (darbepoetin alfa)?

Darbepoetin alfa is a man-made form of a protein that helps your body produce red blood cells. The amount of this protein in your body may be reduced when you have kidney failure or use certain medications. When fewer red blood cells are produced, you can develop a condition called anemia.

Darbepoetin alfa is used to treat anemia (a lack of red blood cells in the body).

Darbepoetin alfa may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Aranesp Albumin Free (darbepoetin alfa)?

You should not use this medication if you have untreated or uncontrolled high blood pressure, if you are allergic to darbepoetin alfa or epoetin alfa (Epogen or Procrit), or if you have ever had pure red cell aplasia (PRCA, a type of anemia) caused by using either of these two drugs.

Before using darbepoetin alfa, tell your doctor if you have heart disease, congestive heart failure, high blood pressure, kidney disease, a blood cell or clotting disorder, cancer, a seizure disorder, a latex allergy, or a history of stroke, heart attack, or blood clots.

This medicine can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. This risk will increase the longer you use epoetin alfa. Darbepoetin alfa may also shorten remission time or survival time in some people with certain types of cancer. Talk with your doctor about the risks and benefits of using darbepoetin alfa.

Seek emergency medical help if you have symptoms of heart or circulation problems, such as chest pain or heavy feeling, pain spreading to the arm or shoulder, shortness of breath, slurred speech, or problems with vision or balance.

To be sure this medication is helping your condition, your blood may need to be tested often. Your blood pressure will also need to be checked. Visit your doctor regularly.

Contact your doctor if you feel light-headed or unusually weak or tired. These may be signs that your body has stopped responding to darbepoetin alfa. Some women using darbepoetin alfa have started having menstrual periods, even after not having a period for a long time due to a medical condition. You may be able to get pregnant if your periods restart. Talk with your doctor about the need for birth control.

What should I discuss with my healthcare provider before using Aranesp Albumin Free (darbepoetin alfa)?

You should not use this medication if you are allergic to darbepoetin alfa or epoetin alfa (Epogen or Procrit), or if you have:

• 
  

  untreated or uncontrolled high blood pressure; or

  
  


• 
  

  if you have ever had pure red cell aplasia (PRCA, a type of anemia) caused by using darbepoetin alfa or epoetin alfa.

  
  

To make sure you can safely take darbepoetin alfa, tell your doctor if you have any of these other conditions:

• 
  

  heart disease, congestive heart failure, high blood pressure;

  
  


• 
  

  kidney disease (or if you are on dialysis);

  
  


• 
  

  a history of stroke, heart attack, or blood clots;

  
  


• 
  

  a blood cell or clotting disorder, such as sickle cell anemia or hemophilia;

  
  


• 
  

  cancer;

  
  


• 
  

  a seizure disorder; or

  
  


• 
  

  if you are allergic to latex.

  
  

FDA pregnancy category C. It is not known whether darbepoetin alfa will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether darbepoetin alfa passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Some women using darbepoetin alfa have started having menstrual periods, even after not having a period for a long time due to a medical condition. You may be able to get pregnant if your periods restart. Talk with your doctor about the need to use birth control while you are using darbepoetin alfa.

Darbepoetin alfa may shorten remission time in some people with head and neck cancer who are also being treated with radiation. Darbepoetin alfa may also shorten survival time in certain people with breast cancer, non-small cell lung cancer, head and neck cancer, cervical cancer, or lymphoid cancer. Talk with your doctor about your individual risk.

How should I use Aranesp Albumin Free (darbepoetin alfa)?

Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Your doctor may occasionally change your dose to make sure you get the best results.

Darbepoetin alfa is injected under the skin or into a vein. You may be shown how to use an IV at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles, IV tubing, and other items used to inject the medicine.

Do not shake the medication bottle or you may ruin the medicine. Prepare your dose in a syringe only when you are ready to give yourself an injection. Do not use the medication if it has changed colors or has particles in it. Call your doctor for a new prescription.

Use a disposable needle only once. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

To be sure this medication is helping your condition, your blood may need to be tested often. Your blood pressure will also need to be checked. Visit your doctor regularly.

If you need surgery, tell the surgeon ahead of time that you are using darbepoetin alfa. Store in the refrigerator and protect from light. Do not freeze darbepoetin alfa, and throw away the medication if it has become frozen.

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose of darbepoetin alfa.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include some of the serious side effects listed in this medication guide.

What should I avoid while using Aranesp Albumin Free (darbepoetin alfa)?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Aranesp Albumin Free (darbepoetin alfa) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Contact your doctor if you feel light-headed or unusually weak or tired. These may be signs that your body has stopped responding to darbepoetin alfa.

Darbepoetin alfa can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. This risk will increase the longer you use darbepoetin alfa. Seek emergency medical help if you have symptoms of heart or circulation problems, such as:

• 
  

  chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;

  
  


• 
  

  feeling short of breath, even with mild exertion;

  
  


• 
  

  swelling, rapid weight gain;

  
  


• 
  

  sudden numbness or weakness, especially on one side of the body;

  
  


• 
  

  sudden severe headache, confusion, problems with vision, speech, or balance; or

  
  


• 
  

  pain, swelling, warmth, or redness in one or both legs.

  
  

Stop using darbepoetin alfa and call your doctor at once if you have other serious side effects such as:

• 
  

  fever, chills, body aches, flu symptoms;

  
  


• 
  

  feeling like you might pass out;

  
  


• 
  

  easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

  
  


• 
  

  seizure (black-out or convulsions); or

  
  


• 
  

  dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).

  
  

Less serious side effects may include:

• 
  

  stomach pain;

  
  


• 
  

  mild cough;

  
  


• 
  

  mild skin rash or redness; or

  
  


• 
  

  pain, bruising, swelling, warmth, redness, oozing, or bleeding where the IV needle is placed.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Aranesp Albumin Free (darbepoetin alfa)?

There may be other drugs that can interact with darbepoetin alfa. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Aranesp Albumin Free resources

• Aranesp Albumin Free Side Effects (in more detail)
• Aranesp Albumin Free Use in Pregnancy & Breastfeeding
• Aranesp Albumin Free Drug Interactions
• Aranesp Albumin Free Support Group
• 1 Review for Aranesp Albumin Free - Add your own review/rating

• Darbepoetin Alfa Professional Patient Advice (Wolters Kluwer)


• Aranesp Prescribing Information (FDA)


• Aranesp Monograph (AHFS DI)


• Aranesp Advanced Consumer (Micromedex) - Includes Dosage Information


• Aranesp MedFacts Consumer Leaflet (Wolters Kluwer)


• Aranesp Consumer Overview

Compare Aranesp Albumin Free with other medications

• Anemia Associated with Chronic Renal Failure
• Anemia, Chemotherapy Induced

Where can I get more information?

• Your pharmacist can provide more information about darbepoetin alfa.

See also: Aranesp Albumin Free side effects (in more detail)

Antagon

Generic Name: ganirelix (Subcutaneous route)

ga-ni-REL-ix

Commonly used brand name(s)

In the U.S.

• Antagon

Available Dosage Forms:

• Solution

Therapeutic Class: Endocrine-Metabolic Agent

Pharmacologic Class: Luteinizing Hormone Releasing Hormone Antagonist

Uses For Antagon

Ganirelixis used as a fertility medicine to prevent premature luteinizing hormone (LH) surges in women undergoing the fertility procedure of controlled ovarian hyperstimulation. LH is involved in ovulation, which is the development of eggs in the ovaries. Ganirelix may help reduce the need for follicle-stimulating hormone (FSH) , which is also involved in ovulation.

Ganirelix is available only with your doctor's prescription.

Before Using Antagon

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	X	Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of ganirelix. Make sure you tell your doctor if you have any other medical problems.

Proper Use of Antagon

To make using ganirelix as safe and reliable as possible, you should understand how and when to use this medicine and what effects may be expected. A paper with information for the patient will be given to you with your filled prescription and will provide many details concerning the use of ganirelix. Read this paper carefully and ask your health care professional for any additional information or explanation.

Sometimes ganirelix can be given by injection at home. If you are using this medicine at home:

• Understand and use the proper method of safely preparing the medicine if you are going to prepare your own medicine.


• Wash your hands with soap and water and use a clean work area to prepare your injection.


• Make sure you clearly understand and carefully follow your doctor's instructions on how to give yourself an injection, including using the proper needle and syringe.


• Do not inject more or less of the medicine than your doctor ordered.


• Remember to move the site of injection to different areas to prevent skin problems from developing.


• Throw away needles, syringes, bottles, and unused medicine after the injection in a safe manner.


• Tell your doctor when you use your last dose of ganirelix. Your doctor will give you another medicine called human chorionic gonadotrophin (hCG) or arrange for you to get this medicine at the right time.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage form:
  
  • For treatment of female infertility:
    
    • Adults—After receiving FSH treatment on Day 2 or 3 of your menstrual cycle, 250 micrograms (mcg) of ganirelix is injected under the skin once a day during the early to midfollicular phase (about Day 7 or Day 8 of your menstrual cycle).
    
    
  
  

Missed Dose

Call your doctor or pharmacist for instructions.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Antagon

It is very important that your doctor check your progress often at regular visits to make sure that the medicine is working properly and to check for unwanted effects. Your doctor will probably want to follow the developing eggs inside the ovaries by doing an ultrasound examination and measuring hormones in your blood stream.

If your doctor has asked you to record your basal body temperatures (BBTs) daily, make sure that you do this every day. Using a BBT record or some other method, your doctor will help you decide when you are most fertile and when ovulation occurs. It is important that sexual intercourse take place around the time when you are most fertile to give you the best chance of becoming pregnant. Follow your doctor's directions carefully.

If severe abdominal pain occurs with use of ganirelix, discontinue treatment and report the problem to your doctor immediately. Do not receive the injection of human chorionic gonadotropin (hCG) and avoid sexual intercourse.

Antagon Side Effects

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Stop taking this medicine and get emergency help immediately if any of the following effects occur:

Less common

• Abdominal pain (severe)


• nausea and vomiting


• weight gain (rapid)

Check with your doctor as soon as possible if any of the following side effects occur:

Less common

• Nausea


• vaginal bleeding

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

• Headache


• redness, pain or swelling at injection site

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Antagon side effects (in more detail)

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More Antagon resources

• Antagon Side Effects (in more detail)
• Antagon Use in Pregnancy & Breastfeeding
• Antagon Drug Interactions
• Antagon Support Group
• 0 Reviews for Antagon - Add your own review/rating

• Antagon Concise Consumer Information (Cerner Multum)


• Ganirelix MedFacts Consumer Leaflet (Wolters Kluwer)


• Ganirelix Prescribing Information (FDA)


• Ganirelix Acetate Monograph (AHFS DI)

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