Belimumab

Belimumab is injected into a vein through an IV. You will receive this injection in a clinic or hospital setting. Belimumab must be given slowly, and the IV infusion can take about an hour to complete.

The first 3 doses of belimumab are given 2 weeks apart. Then the injections are given every 4 weeks. Your dosing schedule may be different. Follow your doctor's instructions.

You may be given other medicines to prevent certain side effects of belimumab.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Contact your doctor if you miss an appointment for your belimumab injection.

Drug interactions have not been studied. Since belimumab reduces the activity of the immune system it may interfere with the response to immunizations. Live vaccines should not be administered concurrently with belimumab or at least 30 days before administration of belimumab.

Belimumab is a prescription medicine that is used with other medicines to treat lupus. Belimumab is in a class of medications called monoclonal antibodies and works by affecting the immune system by blocking the activity of a certain protein in people with lupus. 

Common side effects include nausea, diarrhea, and fever.

Belimumab may be found in some form under the following brand names:

• Benlysta

Belimumab is part of the drug class:

• Selective immunosuppressants

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category C. Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known if belimumab will harm your unborn baby. Tell your healthcare provider if you become pregnant during your treatment with belimumab. 

• If you become pregnant while receiving belimumab, talk to your healthcare provider about enrolling in the belimumab pregnancy registry. You can enroll in this registry by calling 1-877-681-6296. The purpose of this registry is to monitor the health of you and your baby.

• Store autoinjectors and prefilled syringes in the refrigerator at 36°F to 46°F (2°C to 8°C). Do not freeze.
• Keep belimumab and all other medications out of the reach of children. 
• Keep belimumab autoinjectors and prefilled syringes in the original package until time of use to protect from light.
• Do not shake. Keep away from heat.
• Do not use and do not place back in the refrigerator if left out at room temperature for more than 12 hours.
• Safely throw away medicine that is out of date or no longer needed.

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with belimumab, especially:

• cyclophosphamide (Cytoxan); or

• drugs that weaken your immune system such as cancer medicine, steroids, and medicines to prevent rejection of a transplanted organ.

This list is not complete. Other drugs may interact with belimumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

• It is used to treat lupus.

Systemic lupus erythematosus: Treatment of adult patients with active, autoantibody-positive systemic lupus erythematosus (SLE) who are receiving standard therapy.

Limitations of use: Use is not recommended in patients with severe active lupus nephritis, severe active CNS lupus, or in combination with other biologics, including B-cell targeted therapies or intravenous (IV) cyclophosphamide.

Systemic lupus erythematosus (SLE):

IV: Initial: 10 mg/kg every 2 weeks for 3 doses; Maintenance: 10 mg/kg every 4 weeks

SubQ: 200 mg once weekly

Switching from IV therapy: Administer the first SubQ dose 1 to 4 weeks after the last IV dose.

Missed dose: If a dose is missed, administer the dose as soon as possible and then resume the original schedule on the usual day of administration or start a new weekly schedule based on the date that the missed dose was administered.

IV: Administer IV over 1 hour through a dedicated IV line. Do NOT administer as an IV push or bolus. Discontinue infusion for severe hypersensitivity reaction (eg, anaphylaxis, angioedema). The infusion may be slowed or temporarily interrupted for minor reactions. Consider premedicating with an antihistamine and antipyretic for prophylaxis against hypersensitivity or infusion reactions.

SubQ: Allow prefilled syringe and autoinjector to warm to room temperature for 30 minutes prior to administration; do not warm product in any other way. Administer SubQ using a different injection site on the same day each week; do not administer into tender, bruised, red, or hard skin. Initial use is recommended under supervision of physician; self-injection may occur after proper training.

Abatacept: May enhance the adverse/toxic effect of Belimumab. Avoid combination

BCG (Intravesical): Immunosuppressants may diminish the therapeutic effect of BCG (Intravesical). Avoid combination

Belatacept: May enhance the adverse/toxic effect of Belimumab. Avoid combination

Coccidioides immitis Skin Test: Immunosuppressants may diminish the diagnostic effect of Coccidioides immitis Skin Test. Monitor therapy

Cyclophosphamide: Belimumab may enhance the adverse/toxic effect of Cyclophosphamide. Avoid combination

Echinacea: May diminish the therapeutic effect of Immunosuppressants. Consider therapy modification

Etanercept: May enhance the adverse/toxic effect of Belimumab. Avoid combination

Fingolimod: Immunosuppressants may enhance the immunosuppressive effect of Fingolimod. Management: Avoid the concomitant use of fingolimod and other immunosuppressants when possible. If combined, monitor patients closely for additive immunosuppressant effects (eg, infections). Consider therapy modification

Leflunomide: Immunosuppressants may enhance the adverse/toxic effect of Leflunomide. Specifically, the risk for hematologic toxicity such as pancytopenia, agranulocytosis, and/or thrombocytopenia may be increased. Management: Consider not using a leflunomide loading dose in patients receiving other immunosuppressants. Patients receiving both leflunomide and another immunosuppressant should be monitored for bone marrow suppression at least monthly. Consider therapy modification

Monoclonal Antibodies: May enhance the adverse/toxic effect of Belimumab. Avoid combination

Natalizumab: Immunosuppressants may enhance the adverse/toxic effect of Natalizumab. Specifically, the risk of concurrent infection may be increased. Avoid combination

Pimecrolimus: May enhance the adverse/toxic effect of Immunosuppressants. Avoid combination

Roflumilast: May enhance the immunosuppressive effect of Immunosuppressants. Consider therapy modification

Sipuleucel-T: Immunosuppressants may diminish the therapeutic effect of Sipuleucel-T. Monitor therapy

Tacrolimus (Topical): May enhance the adverse/toxic effect of Immunosuppressants. Avoid combination

Tertomotide: Immunosuppressants may diminish the therapeutic effect of Tertomotide. Monitor therapy

Tofacitinib: Immunosuppressants may enhance the immunosuppressive effect of Tofacitinib. Management: Concurrent use with antirheumatic doses of methotrexate or nonbiologic disease modifying antirheumatic drugs (DMARDs) is permitted, and this warning seems particularly focused on more potent immunosuppressants. Consider therapy modification

Vaccines (Inactivated): Belimumab may diminish the therapeutic effect of Vaccines (Inactivated). Management: Patients should receive inactivated vaccines prior to initiation of belimumab therapy whenever possible, due to the risk for an impaired response to the vaccine during belimumab therapy. Consider therapy modification

Vaccines (Live): Belimumab may enhance the adverse/toxic effect of Vaccines (Live). Avoid combination