(be LIM ue mab) Brand: Benlysta
• You must not use belimumab if you are allergic to it.
• Till you receive belimumab, speak your doctor if you have an active or chronic infection, a history of cancer, or a history of depression or mental illness.
• Serious and sometimes fatal infections may occur during treatment with belimumab. Call your doctor right away if you have signs of infection such as fever, chills, flu symptoms, night sweats, pain or burning when you urinate, cough with mucus, stabbing chest pain, feeling short of breath, bloody diarrhea, or swelling, pain, tenderness, or redness anywhere on your body.
• Belimumab can lower blood cells that help your body fight infections. Your blood may need to be tested often. Avoid being around people who are sick or have infections.
• Avoid being around people who have colds, the flu, or another contagious illnesses. Contact your doctor at once if you develop signs of infection. Do not receive a "live" vaccine within 30 days till or after you are treated with belimumab.
• You may have thoughts about suicide while receiving belimumab, especially if you have a history of suicidal thoughts or actions. Message any new or worsening symptoms to your doctor, such as: depression, anxiety, mood or behavior changes, trouble sleeping, or thoughts about hurting yourself or others.
• Belimumab is a monoclonal antibody that affects the actions of the body's immune system. Monoclonal antibodies are made to target and destroy only determined cells in the body. This may help to protect healthy cells from damage.
• Belimumab is used in to treat active systemic lupus erythematosus (SLE) in adults.
• Belimumab is not for use in people who have severe kidney problems caused by SLE, or have active SLE that affects the central nervous system (brain, nerves, and spinal cord).
• Belimumab may also be used for another purposes not listed in this medicine guide.
• You must not use belimumab if you are allergic to it.
• To create certain you can safely receive belimumab, speak your doctor if you have any of these another conditions:
· an active or chronic infection;
· a history of cancer; or
· a history of depression or mental illness.
• You may have thoughts about suicide while receiving belimumab, especially if you have a history of suicidal thoughts or actions.
• FDA pregnancy category C. It is not known whether belimumab will harm an unborn child. Speak your doctor if you are pregnant or plan to become pregnant while using this medication.
• If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to estimate any effects of belimumab on the baby.
• It is not known whether belimumab passes into breast milk or if it could harm a nursing child. You must not breast-feed while you are using belimumab.
• Belimumab is injected into a vein through an IV. You will receive this injection in a clinic or hospital setting. Belimumab should be given slowly, and the IV infusion can take about an hour to complete.
• The first 3 doses of belimumab are given 2 weeks separately. Then the injections are given each 4 weeks. Your dosing schedule may be various. Follow your doctor's instructions.
• You may be given another medications to prevent determined side effects of belimumab.
• Contact your doctor if you miss an appointment for your belimumab injection.
• Search abnormal medical attention or call the Poison Help line at 1-800-222-1222.
• Avoid being around people who have colds, the flu, or another contagious illnesses.
• Do not receive a "live" vaccine while you are being treated with belimumab. The vaccine may not work as well during this time, and may not fully protect you from malady. Live vaccines include measles, mumps, rubella (MMR), Bacillus Calmette-Guérin (BCG), oral polio, rotavirus, smallpox, typhoid, yellow fever, varicella (chickenpox), H1N1 influenza, and nasal flu vaccine.
• Some people receiving a belimumab injection have had a reaction to the infusion (when the medication is injected into the vein). Speak your caregiver right away if you feel nauseated, light-headed, itchy, or have muscle pain, severe headache, or slow heartbeats.
• Get abnormal medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your person, lips, tongue, or throat.
• Call your doctor at once if you have a serious side effect such as:
· new or worsening depression, anxiety, mood or behavior changes, trouble sleeping, or thoughts about hurting yourself or others;
· chest pain or hard feeling, pain spreading to the hand or shoulder, nausea, sweating, common ill feeling.
· wheezing, chest tightness, trouble breathing; or
• Serious and sometimes fatal infections may occur during treatment with belimumab. Call your doctor right away if you have signs of infection such as:
· fever, chills, flu symptoms, night sweats, weight loss;
· heighten urination, pain or burning when you urinate;
· cough with yellow or green mucus, stabbing chest pain, feeling short of breath;
· swelling, pain, tenderness, or redness anywhere on your body; or
· bloody diarrhea.
• Smaller serious side effects may include:
· nausea, diarrhea, stomach pain;
· mild pain in your arms or legs; or
· mild cool symptoms such as stuffy nose, sneezing, sore throat.
• This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may message side effects to FDA at 1-800-FDA-1088.
• Speak your doctor about all another medicines you use, especially:
· cyclophosphamide (Cytoxan); or
· drugs that weaken your immune system such as cancer medication, steroids, and medicines to prevent rejection of a transplanted organ.
• This list is not complete and another drugs may interact with belimumab. Speak your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal commodity. Do not start a new medicine without telling your doctor.
• Your doctor or pharmacist can provide more information about belimumab.
Remember, hold this and all another medicines out of the reach of children, never share your medicines with others, and use this medicine only for the indication prescribed.
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