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US Brand Names

Description

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.

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

This product is available in the following dosage forms:

• Powder for Solution

Before Using

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 belimumab injection in children. Safety and efficacy have not been established.

Geriatric

Appropriate studies on the relationship of age to the effects of belimumab have not been performed in the geriatric population. However, no geriatric-specific problems have been documented to date.

Pregnancy

Breastfeeding

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.

Drug Interactions

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.

Other Interactions

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:

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

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

• Multiple drug allergy, history of—May increase the risk of having an allergic reaction to belimumab.

Proper Use

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

This medicine 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.

This medicine 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

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to decide if you should continue to take it.

You should not receive this medicine if you are also using other biologic therapies or cyclophosphamide (Cytoxan®).

Tell your doctor if you are pregnant or if you plan to become pregnant. Women who could potentially get pregnant while receiving this medicine must use an effective form of birth control during therapy and for at least 4 months after the last dose.

This medicine may increase your risk of developing infections. Avoid being near people who are sick while you are receiving this medicine. 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.

Using this medicine may increase your risk of getting cancer. Talk to your doctor if you have concerns about this risk.

Belimumab may cause an infusion 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, lightheadedness, nausea, muscle or joint pain, or a rash.

This medicine 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.

This medicine 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 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 get any immunizations (vaccines) without your doctor's approval. In addition, you should not be around other persons living in your household who receive live virus vaccines. Some examples of live virus vaccines include measles, mumps, influenza (nasal flu vaccine), poliovirus (oral form), rotavirus, and rubella. If you have questions about this, talk to your doctor.

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:

• Bleeding, blistering, burning, coldness, skin discoloration, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
• Body aches or pain
• Chest congestion
• Chills
• Cough
• Diarrhea
• Difficulty with breathing or swallowing
• Dizziness
• Ear congestion
• Fever
• Headache
• Hives
• Itching, pain, redness, swelling, tenderness, or warmth of the skin
• Joint pain
• Loss of appetite
• Lower back or side pain
• Muscle aches and pains
• Nausea or vomiting
• Pain or tenderness around the eyes and cheekbones
• Swelling of the eyes, face, or inside of the nose
• Shortness of breath or trouble breathing
• Sneezing
• Sore throat
• Stuffy or runny nose
• Sweating
• Tightness in the chest
• Unusual tiredness or weakness

• Black, tarry stools
• Bloody or cloudy urine
• Depression
• Difficult, burning, or painful urination
• Fast heartbeat
• Frequent urge to urinate
• 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:

• Arm or leg pain
• Headache, severe and throbbing
• Unable to sleep

• Abdominal or stomach pain
• 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.

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