Macitentan

ماسیتنتان

⚠ Unverified

❤️ Cardiovascular SystemEndothelin receptor antagonist

Market / country: 🇺🇸 USA

Opsumit (US)

🧮 Dose calculator

Pulmonary arterial hypertension (PAH) · Regimen source: FDA Opsumit · 2.1

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🛡️ Safety & information

Contraindications

Warnings

  • • Boxed warning: embryo-fetal toxicity — contraindicated in pregnancy; pregnancy test before and monthly, effective contraception until 1 month after stopping (REMS). FDA Opsumit · Boxed Warning
  • • Hepatotoxicity; fluid retention; haemoglobin decrease; pulmonary oedema with veno-occlusive disease; decreased sperm counts. FDA Opsumit · 5

Formulations

👥 Special populations

  • 🤰 PregnancyContraindicated

    Label: contraindicated in pregnancy. FDA Opsumit · 4

    “OPSUMIT is contraindicated in females who are pregnant.”
  • 🤱 BreastfeedingDangerous / avoid

    Label: breastfeeding not recommended, or choose between the drug and breastfeeding. FDA Opsumit · 8.2

    “Because of the potential for serious adverse reactions in breastfed infants from OPSUMIT advise women not to breastfeed during treatment with OPSUMIT.”
  • 👶 ChildrenSafety not established

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

    “The safety and effectiveness of OPSUMIT in pediatric patients have not been established for the treatment of PAH.”
  • 👴 Older adultsNo specific problem stated

    Label: no specific difference or dose adjustment stated for older adults. FDA Opsumit · 8.5

    “No overall differences in safety or effectiveness were observed between these subjects and younger subjects.”
  • ⚥ Females & males of reproductive potentialUse with caution

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

    “Contraception Patients who can become pregnant who are using OPSUMIT should use an effective method of contraception prior to initiation of treatment, during treatment, and for one month after discontinuation of treatment with OPSUMIT to prevent pregnancy [see Warnings and Precautions (5.1) ] .”

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