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Belimumab

Generic Name: belimumab (be-LIM-ue-mab)
Brand Name: Benlysta

Belimumab is used for:

Treating certain patients with systemic lupus erythematosus (SLE). It is used along with other medicines. It may also be used for other conditions as determined by your doctor.

Belimumab is a B-lymphocyte stimulator (BLyS)-specific inhibitor. Patients with lupus often have high levels of a certain protein in their blood. Belimumab works by limiting the activity of that protein.

Do NOT use belimumab if:

  • you are allergic to any ingredient in belimumab
  • you have severe, active central nervous system lupus
  • you have certain severe kidney problems associated with lupus (severe, active lupus nephritis)
  • you are using another biologic medicine (eg, etanercept, infliximab, immune globulin)
  • you are receiving cyclophosphamide as an injection into your vein (intravenous [IV])

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

Before using belimumab:

Some medical conditions may interact with belimumab. 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 history of a long-term infection, an infection that keeps coming back, tuberculosis (TB) infection or a positive TB skin test, or hepatitis B infection
  • if you have an infection, open cuts or sores on your body, or flu-like symptoms or other signs of infection (eg, fever; chills; cough; warm, red, or painful skin), or you are using medicine to treat an infection
  • if you have a history of cancer or heart problems
  • if you have a history of mental or mood problems (eg, depression), or suicidal thoughts or actions
  • if you have recently received a vaccine or are scheduled to receive a vaccine

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

  • Other biologic medicines (eg, etanercept, infliximab, immune globulin), IV cyclophosphamide, or monoclonal antibodies (eg, certolizumab, denosumab) because the risk of their side effects may be increased by belimumab

This may not be a complete list of all interactions that may occur. Ask your health care provider if belimumab 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 belimumab:

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

  • Belimumab comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get belimumab refilled.
  • Belimumab is usually given as an injection into the vein at your doctor's office, hospital, or clinic.
  • You may receive another medicine before each treatment with belimumab to decrease the chance of an allergic reaction. Discuss any questions with your doctor.
  • Belimumab is colorless to pale yellow. Do not use belimumab if it contains particles, is cloudy or discolored, or if the syringe or pen is cracked or damaged.
  • Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
  • If you miss a dose of belimumab, contact your doctor right away.

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

Important safety information:

  • Do NOT use more than the recommended dose or use for longer than prescribed without checking with your doctor.
  • Belimumab may lower the ability of your body to fight infection and may increase the risk of severe or fatal infection. Avoid contact with people who have colds, flu, shingles, or other infections. Tell your doctor right away if you notice signs of infection like fever, sore throat, rash, or chills.
  • A severe brain infection called progressive multifocal leukoencephalopathy (PML) has happened with use of belimumab. It may cause disability or death. Discuss any questions or concerns with your doctor. Tell your doctor at once if you notice new or worsening symptoms such as confusion; memory problems; difficulty talking or walking; changes in mood or behavior; or changes in thinking, eyesight, balance, or strength.
  • Treatment with medicines similar to belimumab may increase in the risk of developing cancer. It is possible that treatment with belimumab may also increase this risk. Discuss any questions or concerns with your doctor.
  • Some patients using belimumab reported mental or mood changes (eg, anxiety, depression) and suicidal thoughts or actions. The majority of these patients had a history of depression or other serious mental or mood problems. It is unknown if belimumab is associated with an increased risk of these events. Tell your doctor right away if you develop anxiety, depression, severe or persistent trouble sleeping, suicidal thoughts or actions, or any other mental or mood changes.
  • Infusion reactions, as well as serious and sometimes fatal allergic reactions, have been reported on the day of or the day after patients have received belimumab. The risk of allergic reactions may be increased if you have a history of multiple drug allergies. Your health care provider will monitor you while you receive belimumab and for a period of time afterwards. Tell your health care provider right away if you experience difficulty breathing or shortness of breath; fainting; itching; muscle pain; rash; headache; nausea; severe dizziness or light-headedness; slow heartbeat; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness; unusual tiredness; or wheezing.
  • Tell your doctor or dentist that you take belimumab before you receive any medical or dental care, emergency care, or surgery.
  • Do not receive a live vaccine (eg, measles, mumps) while you are using belimumab or for 30 days before you begin using it. Talk with your doctor before you receive any vaccine.
  • Belimumab may not work as well in black patients. Contact your doctor if your symptoms do not improve or if they become worse.
  • Women who may become pregnant should use effective birth control while using belimumab and for 4 months after the last treatment. Check with your doctor if you have questions about effective birth control.
  • Belimumab should be used with extreme caution in the ELDERLY and in CHILDREN; safety and effectiveness in these patients 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 belimumab while you are pregnant. It is not known if this medicine is found in breast milk. Do not breast-feed while using belimumab.

Possible side effects of belimumab:

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:

Diarrhea; headache; nausea; pain in the arm or leg; sinus inflammation; stomach pain; stuffy or runny nose; trouble sleeping; vomiting.

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, throat, or tongue; wheezing; unusual hoarseness); muscle pain or weakness; new or worsening mental or mood changes (eg, anxiety, depression); severe or persistent headache; severe or persistent trouble sleeping; suicidal thoughts or actions; symptoms of heart problems (eg, pain or discomfort in the chest or other areas of the upper body, shortness of breath, slow heartbeat, dizziness, cold sweats, unusual nausea); symptoms of infection (eg, fever, chills, or persistent sore throat; persistent cough; coughing up mucus; bloody diarrhea; flu-like symptoms; warm, red, or painful skin; open sore that does not heal; burning, increased, or painful urination); unusual lumps or skin growths.

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.

Proper storage of belimumab:

Belimumab is usually handled and stored by a health care provider. If you are using belimumab at home, store belimumab as directed by your pharmacist or health care provider. Keep belimumab out of the reach of children and away from pets.

General information:

  • If you have any questions about belimumab, please talk with your doctor, pharmacist, or other health care provider.
  • Belimumab 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 should not be used to decide whether or not to take belimumab or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about belimumab. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to belimumab. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using belimumab.

Review Date: November 3, 2016

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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