Natalizumab

ناتالیزوماب

⚠ Unverified

🎗️ Antineoplastic And Immunomodulating AgentsAnti-α4 integrin antibody

Market / country: 🇺🇸 USA

Tysabri (US)

🧮 Dose calculator

Multiple sclerosis (relapsing) · Regimen source: FDA Tysabri · 2.1

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🛡️ Safety & information

Contraindications

Warnings

  • • Boxed warning: progressive multifocal leukoencephalopathy (PML) — risk rises with anti-JCV antibodies, treatment duration and prior immunosuppressants. FDA Tysabri · Boxed Warning
  • • Herpes infections (encephalitis, retinitis); hepatotoxicity; hypersensitivity. FDA Tysabri · 5

Formulations

  • 300 mg/15 mL (20 mg/mL) vial for IV infusion — injection 🇺🇸 USA FDA Tysabri · 3

👥 Special populations

  • 🤰 PregnancyUse with caution

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

    “Risk Summary There are no adequate data on the risk of major birth defects, miscarriage, or other adverse maternal outcomes associated with the use of TYSABRI in pregnant women.”
  • 🤱 BreastfeedingUse with caution

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

    “Risk Summary Natalizumab has been detected in human milk.”
  • 👶 ChildrenSafety not established

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

    “Safety and effectiveness in pediatric patients with multiple sclerosis or Crohn's disease below the age of 18 years 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 Tysabri · 8.5

    “Clinical studies of TYSABRI did not include sufficient numbers of patients aged 65 years and over to determine whether they respond differently than younger patients.”
  • ⚥ Females & males of reproductive potentialNo data

    The source for this drug has no section for this group.

📚 Reference status for this drug

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