Isentress

Generic Name: raltegravir (Oral route)

ral-TEG-ra-vir

Commonly used brand name(s)

In the U.S.

• Isentress

Available Dosage Forms:

• Tablet, Chewable


• Tablet

Therapeutic Class: Antiretroviral Agent

Pharmacologic Class: Integrase Inhibitor

Uses For Isentress

Raltegravir is used together with other medicines to treat human immunodeficiency virus (HIV) infection. HIV is the virus that causes acquired immune deficiency syndrome (AIDS). This medicine is usually given to patients who have already received HIV medicines in the past.

Raltegravir will not cure or prevent HIV infection or AIDS. It helps keep HIV from reproducing and appears to slow down the destruction of the immune system. This may help delay problems that are usually related to AIDS or HIV disease from occurring. Raltegravir will not keep you from spreading HIV to other people. People who receive this medicine may continue to have other problems usually related to AIDS or HIV disease.

This medicine is available only with your doctor's prescription.

Before Using Isentress

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.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of raltegravir in children younger than 2 years of age. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of raltegravir in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving raltegravir.

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 taking this medicine, 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 this medicine 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.

• Fosamprenavir

Using this medicine 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.

• Etravirine


• Omeprazole


• Rifampin

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 medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Infections—May decrease your body's ability to fight infection.

• Liver disease, severe—Use with caution. This medicine has not been studied in patients with severe liver problems.

• Phenylketonuria (PKU)—The chewable tablet contains phenylalanine, which can make this condition worse.

Proper Use of Isentress

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine comes with a patient package insert. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

It is important to take this medicine together with other medicines for HIV. Be sure to take all of the medicines your doctor ordered, and to take them at the right times.

You may take this medicine with or without food.

You may chew or swallow the chewable tablets whole. However, the film-coated tablets must be swallowed whole.

Do not substitute the chewable tablets with the film-coated tablets. Ask your doctor or pharmacist if you have any questions.

Do not change or stop using this medicine without checking first with your doctor. When your supply of this medicine is running low, contact your doctor or pharmacist ahead of time. Do not allow yourself to run out of this medicine.

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 treatment of HIV infection:
  
  • For oral dosage form (chewable tablets):
    
    • Children 6 to less than 12 years of age and weighing at least 25 kilograms (kg)—Dose is based on body weight and must be determined by your doctor. The dose is usually 150 milligrams (mg) two times a day. However, the dose is usually not more than 300 mg two times a day.
    
    
    • Children 6 to less than 12 years of age and weighing less than 25 kg—Dose is based on body weight and must be determined by your doctor. The dose is usually 75 to 150 mg two times a day. However, the dose is usually not more than 300 mg two times a day.
    
    
    • Children 2 to less than 6 years of age and weighing at least 10 kg—Dose is based on body weight and must be determined by your doctor. The dose is usually 75 mg two times a day. However, the dose is usually not more than 300 mg two times a day.
    
    
    • Children younger than 2 years of age—Use and dose must be determined by your doctor.
    
    
  
  
  • For oral dosage form (film-coated tablets):
    
    • Adults, teenagers, and children 12 years of age and older—400 milligrams (mg) two times a day.
    
    
    • Children 6 to less than 12 years of age and weighing at least 25 kilograms (kg)—400 mg two times a day.
    
    
    • Children 6 to less than 12 years of age and weighing less than 25 kg—Use of chewable tablets recommended.
    
    
    • Children 2 to less than 6 years of age and weighing at least 10 kg—Use of chewable tablets recommended.
    
    
    • Children younger than 2 years of age—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

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.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Isentress

It is very important that your doctor check your or your child's progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Serious skin and allergic reactions can occur with this medicine. These could be life-threatening and require immediate medical attention. Stop using this medicine and check with your doctor right away if you have a severe rash; blistering, peeling, or loosening of the skin; fever or chills; muscle or joint pain; sores or ulcers on the skin; swelling of the face, lips, tongue, or throat; unusual tiredness or weakness; or yellowing of the eyes or skin while you or your child are using this medicine.

When you start taking HIV medicines, your immune system may get stronger. If you or your child have infections that are hidden in your body, such as pneumonia or tuberculosis, you may notice new symptoms when your body tries to fight them. If this occurs, tell your doctor immediately.

This medicine will not keep you from giving HIV to your partner during sex. Make sure you understand this and practice safe sex, even if your partner also has HIV, by using a latex condom or other barrier method. This medicine will also not keep you from giving HIV to other people if they are exposed to your blood. Do not re-use or share needles with anyone.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Isentress 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:

Less common or rare

• Blood in the urine


• burning or stinging of the skin


• dark urine


• decreased frequency or amount of urine


• fast heartbeat


• fever


• general tiredness and weakness


• hives


• hoarseness


• increased blood pressure


• increased thirst


• irritation


• itching


• joint pain, stiffness, or swelling


• light-colored stools


• loss of appetite


• lower back or side pain


• nausea and vomiting


• pain in the groin or genitals


• painful blisters on the trunk of the body


• painful cold sores or blisters on the lips, nose, eyes, or genitals


• rash


• redness of the skin


• sharp back pain just below the ribs


• shortness of breath


• swelling of the eyelids, face, lips, hands, lower legs, or feet


• tightness in the chest


• troubled breathing or swallowing


• unusual tiredness or weakness


• upper right abdominal or stomach pain


• weight gain


• wheezing


• yellow eyes and skin

Incidence not known

• Black, tarry stools


• bleeding gums


• headache


• muscle cramps or spasms


• muscle pain or stiffness


• pinpoint red spots on the skin


• stomach pain, continuing


• unusual bleeding or bruising

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

• Sleeplessness


• trouble with sleeping


• unable to sleep

Less common or rare

• Acid or sour stomach


• belching


• depression


• dizziness


• heartburn


• indigestion


• lack or loss of strength


• stomach discomfort, upset, or pain


• tenderness in the stomach area


• thoughts of killing oneself or changes in behavior

Incidence not known

• Delusions of persecution, mistrust, suspiciousness, and/or combativeness


• diarrhea


• fear or nervousness

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: Isentress side effects (in more detail)

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More Isentress resources

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

• Isentress Prescribing Information (FDA)


• Isentress Consumer Overview


• Isentress Monograph (AHFS DI)


• Isentress MedFacts Consumer Leaflet (Wolters Kluwer)


• Raltegravir Professional Patient Advice (Wolters Kluwer)

Compare Isentress with other medications

• HIV Infection