Ofatumumab

اوفاتوموماب

⚠ Unverified

🎗️ Antineoplastic And Immunomodulating AgentsAnti-CD20 antibody (SC)

Market / country: 🇺🇸 USA

Kesimpta (US)

🧮 Dose calculator

Multiple sclerosis (relapsing) · Regimen source: FDA Kesimpta · 2.2

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🛡️ Safety & information

Contraindications

  • ⛔ Active HBV infection; prior hypersensitivity or life-threatening injection reaction. FDA Kesimpta · 4

Warnings

  • • Infections (screen HBV first); PML; reduced immunoglobulins; liver injury. FDA Kesimpta · 5
  • • Injection-related reactions; fetal risk (contraception for 6 months). FDA Kesimpta · 5

Formulations

👥 Special populations

  • 🤰 PregnancyUse with caution

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

    “Risk Summary There are no adequate data on the developmental risk associated with the use of KESIMPTA in pregnant women.”
  • 🤱 BreastfeedingUse with caution

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

    “Risk Summary There are no data on the presence of ofatumumab in human milk, the effects on the breastfed infant, or the effects of the drug on milk production.”
  • 👶 ChildrenSafety not established

    Label: safety and effectiveness in children have not been established. FDA Kesimpta · 8.4

    “Safety and effectiveness in pediatric patients have not been established.”
  • 👴 Older adultsUse with caution

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

    “Clinical studies of KESIMPTA did not include sufficient numbers of geriatric patients to determine whether they respond differently from younger subjects.”
  • ⚥ Females & males of reproductive potentialUse with caution

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

    “Contraception Females of childbearing potential should use effective contraception while receiving KESIMPTA and for 6 months after the last treatment of KESIMPTA.”

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