Benlysta 400 lyophilized powder for injectable solution

Benlysta (Human Genome Sciences), manufactured drug form of Belimumab, 400mg/5mL belimumab lyophilized powder for injectable solution, NDC 49401-102

Available in:

NDC Product ID:

  • 49401-102

Manufacturer:

Manufactured drug form

Manufactured form of:

Generic drug:

  • No

Label date:

  • Mar 10, 2011

Label link:

Label sections:

Section name Section URI Prominent warning Highlight text Section LOINC code
  • 1 Indications And Usage
  • No
  • BENLYSTA is a B-lymphocyte stimulator (BLyS)-specific inhibitor indicated for the treatment of adult patients with active, autoantibody-positive, systemic lupus erythematosus who are receiving standard therapy. ( 1, 14) Limitations of Use: The efficacy of BENLYSTA has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus ( 1). BENLYSTA has not been studied in combination with other biologics or intravenous cyclophosphamide (1). Use of BENLYSTA is not recommended in these situations.
  • 34067-9
  • 2 Dosage And Administration
  • No
  • Recommended dosage regimen is 10 mg/kg at 2-week intervals for the first 3 doses and at 4-week intervals thereafter. Reconstitute, dilute and administer as an intravenous infusion only, over a period of 1 hour. (2.1) Consider administering premedication for prophylaxis against infusion reactions and hypersensitivity reactions (2.2)
  • 34068-7
  • 3 Dosage Forms And Strengths
  • No
  • Single-use vials of belimumab lyophilized powder: 120 mg per vial (3) 400 mg per vial (3)
  • 43678-2
  • 4 Contraindications
  • No
  • Previous anaphylaxis to belimumab. ( 4)
  • 34070-3
  • 5 Warnings And Precautions
  • No
  • Mortality: There were more deaths reported with BENLYSTA than with placebo during the controlled period of clinical trials. (5.1) Serious Infections: Serious and sometimes fatal infections have been reported in patients receiving immunosuppressive agents, including BENLYSTA. Use with caution in patients with chronic infections. Consider interrupting BENLYSTA therapy if patients develop a new infection during BENLYSTA treatment. (5.2) Hypersensitivity Reactions, Including Anaphylaxis: Serious reactions have been reported. BENLYSTA should be administered by healthcare providers prepared to manage anaphylaxis. Monitor patients during and for an appropriate period of time after administration of BENLYSTA. (2.2, 5.4) Depression: Depression and suicidality have been reported in BENLYSTA studies. Patients should be instructed to contact their healthcare provider if they experience new or worsening depression, suicidal thoughts or other mood changes. (5.6) Immunization: Live vaccines should not be given concurrently with BENLYSTA. (5.7)
  • 43685-7
  • 6 Adverse Reactions
  • No
  • Common adverse reactions (≥5%) in clinical trials were: nausea, diarrhea, pyrexia, nasopharyngitis, bronchitis, insomnia, pain in extremity, depression, migraine, and pharyngitis. ( 6.1) To report SUSPECTED ADVERSE REACTIONS, contact Human Genome Sciences, Inc. at 1-877-423-6597 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
  • 34084-4
  • 7 Drug Interactions
  • No
  • 34073-7
  • 8 Use In Specific Populations
  • No
  • Pregnancy: Registry available. (8.1)
  • 43684-0
  • 10 Overdosage
  • No
  • 34088-5
  • 11 Description
  • No
  • 34089-3
View entire collection »

Discontinued:

  • No

Marketing start date:

  • Mar 10, 2011

FDA application number:

  • BLA125370
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