Emicizumab

امیسیزوماب

⚠ Unverified

🩸 Blood And Blood Forming OrgansBispecific antibody (factor VIII mimetic)

Market / country: 🇺🇸 USA

Hemlibra (US)

🧮 Dose calculator

Haemophilia A · Regimen source: FDA Hemlibra · 2.1

  • • Stop prophylactic bypassing agents the day before starting; prophylactic factor VIII may continue in week 1. FDA Hemlibra · 2.1

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🛡️ Safety & information

Warnings

Formulations

👥 Special populations

  • 🤰 PregnancyUse with caution

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

    “Risk Summary There are no available data on HEMLIBRA use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage.”
  • 🤱 BreastfeedingUse with caution

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

    “Risk Summary There is no information regarding the presence of emicizumab-kxwh in human milk, the effects on the breastfed child, or the effects on milk production.”
  • 👶 ChildrenUse with caution

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

    “The safety and efficacy of HEMLIBRA have been established in pediatric patients.”
  • 👴 Older adultsUse with caution

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

    “Clinical studies of HEMLIBRA did not include a sufficient number of patients aged 65 and over to determine whether they respond differently from younger patients.”
  • ⚥ Females & males of reproductive potentialUse with caution

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

    “Contraception Women of childbearing potential should use contraception while receiving HEMLIBRA.”

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