Belimumab

بلیموماب

⚠ Unverified

🎗️ Antineoplastic And Immunomodulating AgentsAnti-BLyS antibody

Market / country: 🇺🇸 USA

Benlysta (US)

🧮 Dose calculator

Lupus erythematosus · Regimen source: FDA Benlysta · 2.2

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🛡️ Safety & information

Contraindications

Warnings

  • • Serious infections; hypersensitivity and anaphylaxis (sometimes delayed); SJS/TEN; depression and suicidality; malignancy; no live vaccines. FDA Benlysta · 5

Formulations

👥 Special populations

  • 🤰 PregnancyUse with caution

    Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Benlysta · 8.1

    “Risk Summary Available data on use of BENLYSTA in pregnant women, from observational studies, published case reports, and postmarketing surveillance, are insufficient to determine whether there is a drug-associated risk for major birth defects or miscarriage.”
  • 🤱 BreastfeedingUse with caution

    Label: use with caution while breastfeeding; see the label text. FDA Benlysta · 8.2

    “Risk Summary No information is available on the presence of belimumab in human milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production.”
  • 👶 ChildrenUse with caution

    The label has conditions, age limits or notes for children; the label sentence is quoted below. FDA Benlysta · 8.4

    “The safety and effectiveness of BENLYSTA have been established for the treatment of active SLE and active lupus nephritis in pediatric patients 5 years of age and older who are receiving standard therapy.”
  • 👴 Older adultsUse with caution

    Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Benlysta · 8.5

    “Use with caution in geriatric patients.”
  • ⚥ Females & males of reproductive potentialUse with caution

    Label has advice on pregnancy testing, contraception or fertility for females and males. FDA Benlysta · 8.3

    “Contraception Following an assessment of benefit versus risk, if prevention of pregnancy is warranted, females of reproductive potential should use effective contraception during treatment and for at least 4 months after the final treatment.”

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