belimumab Intravenous

be-LIM-ue-mab

Commonly used brand name(s)

In the U.S.

• Benlysta

Available Dosage Forms:

• Powder for Solution

Pharmacologic Class: Monoclonal Antibody

Uses For belimumab

Belimumab injection is used to treat systemic lupus erythematosus (SLE or lupus) in adults who are also receiving other therapy. It is a monoclonal antibody that changes the immune system to help control lupus symptoms.

belimumab is to be administered only by or under the immediate supervision of your doctor.

Before Using belimumab

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 belimumab, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to belimumab 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 belimumab injection in children. 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 belimumab injection in the elderly.

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

• Depression, history of or


• Mental illness, history of—Use with caution. May make these conditions worse.

• Infection or


• Weak immune system (eg, history of cancer or steroid use)—May decrease your body's ability to fight infection.

Proper Use of belimumab

A nurse or other trained health professional will give you belimumab. belimumab is given through a needle placed in one of your veins.

belimumab must be given slowly, so the needle will remain in place for at least one hour. You may also receive medicines to help prevent possible allergic reactions to the injection.

belimumab comes with a Medication Guide. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

Precautions While Using belimumab

It is very important that your doctor check your progress at regular visits to make sure that belimumab is working properly. Blood tests may be needed to check for unwanted effects.

You should not receive belimumab if you are also using cyclophosphamide (Cytoxan®).

Tell your doctor if you are pregnant or if you plan to become pregnant. Women who could potentially get pregnant while receiving belimumab must use an effective form of birth control during therapy and for at least 4 months after the last dose. If you become pregnant while receiving belimumab, your doctor may want you to join a registry for pregnant patients.

belimumab may increase your risk of developing infections. Avoid being near people who are sick while you are receiving belimumab. Wash your hands often. Tell your doctor if you have any kind of infection before you receive the medicine. Also tell your doctor if you have ever had an infection that would not go away or an infection that kept coming back.

Call your doctor right away if you have blurred vision; a cough that won't go away; fever, chills, or flu-like symptoms, such as a runny or stuffy nose; a headache; night sweats; or weight loss. These may be signs that you have an infection.

Belimumab may cause an infustion reaction while you are receiving it or right after the infusion ends. Check with your doctor or nurse right away if you have a headache; itching; dizziness, fainting, or lightheadedness; nausea; muscle or joint pain; or a rash.

belimumab may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have chest pain; hives; itching; a rash; swelling of the face, tongue, and throat; or trouble breathing after you receive the medicine.

belimumab may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you or your caregiver notice any of these unwanted effects, tell your doctor right away.

While you are being treated with belimumab, and after you stop treatment with it, do not have any immunizations (vaccines) without your doctor's approval. Belimumab may lower your body's resistance and the vaccine may not work as well or you might get the infection the vaccine is meant to prevent. In addition, you should not be around other persons living in your household who receive live virus vaccines because there is a chance they could pass the virus on to you. Some examples of live vaccines include measles, mumps, influenza (nasal flu vaccine), poliovirus (oral form), rotavirus, and rubella. Do not get close to them and do not stay in the same room with them for very long. If you have questions about this, talk to your doctor.

belimumab 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 or nurse immediately if any of the following side effects occur:

More common

• Bladder pain


• bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the site of injection


• bloody or cloudy urine


• body aches or pain


• chest congestion


• chills


• cough


• cough-producing mucus


• diarrhea


• difficult, burning, or painful urination


• difficulty with breathing or swallowing


• dizziness


• ear congestion


• facial swelling


• fever


• frequent urge to urinate


• general feeling of discomfort or illness


• headache


• hives


• itching, pain, redness, swelling, tenderness, or warmth on the skin


• joint pain


• loss of appetite


• lower back or side pain


• muscle aches and pains


• nasal congestion


• nausea or vomiting


• pain or tenderness around the eyes and cheekbones


• reddening of the skin, especially around the ears


• swelling of the eyes, face, or inside of the nose


• shivering


• shortness of breath or troubled breathing


• skin rash


• sneezing


• sore throat


• stuffy or runny nose


• sweating


• tightness in the chest


• trouble sleeping


• unusual tiredness or weakness


• wheezing

Less common

• Black, tarry stools


• fast heartbeat


• hoarseness


• sores, ulcers, or white spots on the lips or in the mouth


• swollen glands


• tender, swollen glands in the neck


• unusual bleeding or bruising


• voice changes

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

• Arm or leg pain


• sleeplessness


• unable to sleep

Less common

• Abdominal or stomach pain


• depression


• fear or nervousness


• headache, severe and throbbing


• weakness

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: belimumab Intravenous side effects (in more detail)

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More belimumab Intravenous resources

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

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