Adult Dosing
Active, autoantibody-positive SLE
- 10 mg/kg IV infusion over a period of 1 hr
- Administer at 2-wk intervals for the first 3 doses and at 4-wk intervals thereafter
Notes:- Reconstitute, dilute and administer as an IV infusion only; do not administer as an IV push or bolus
- Rate of infusion may be slowed or interrupted if the patient develops an infusion reaction
- Administer premedication for prophylaxis against infusion reactions and hypersensitivity reactions
- Do not infuse concomitantly in the same IV line with other agents
Pediatric Dosing
- Safety and effectiveness in pediatric patients have not been established
[Outline]
See Supplemental Patient Information
- Efficacy of belimumab has not been studied in patients with severe active lupus nephritis or severe active CNS lupus; use not recommended. Also, belimumab has not been evaluated in combination with other biologics or IV cyclophosphamide
- Therapy has been associated with more incidences of mortality than placebo during the controlled period of clinical trials
- Serious, and sometimes fatal, infections may occur in patients receiving immunosuppressive agents, including belimumab. Use with caution in patients with chronic infections. Suspend therapy if patients develop a new infection during treatment
- Belimumab may increase the risk for the development of malignancies
- Serious hypersensitivity reactions, including anaphylaxis may occur during therapy. Hence, belimumab should be administered under direct supervision of healthcare providers prepared to manage anaphylaxis. Carefully monitor patients during and for an appropriate period of time after administration
- Monitor patients receiving belimumab for infusion reactions; suicidal thoughts, worsening of depression, or other mood changes
- Do not give live vaccines for 30 days before or concurrently with belimumab therapy, as it may interfere with the response to immunizations
Cautions: Use cautiously in
- Chronic or recurrent infections
- Elderly patients
- African-American/black patients
Supplemental Patient Information
- Instruct patients to contact their healthcare provider if they experience new or worsening depression, suicidal thoughts or other mood changes
- Advise patients that belimumab may decrease their ability to fight infections
- Inform patients not to receive live vaccines during belimumab therapy
Pregnancy Category:C
Breastfeeding: Safety unknown. Because maternal antibodies are excreted in human milk, a decision should be made whether to discontinue nursing or to discontinue the drug, analyzing the importance of the drug to the mother.
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