Macitentan
ماسیتنتان
❤️ Cardiovascular SystemEndothelin receptor antagonist
Market / country: 🇺🇸 USA
Opsumit (US)
🧮 Dose calculator
Pulmonary arterial hypertension (PAH) · Regimen source: FDA Opsumit · 2.1
- • Doses above 10 mg have not been studied and are not recommended. FDA Opsumit · 2.1
Enter age (weight is optional for this regimen).
🛡️ Safety & information
Contraindications
- ⛔ Pregnancy. FDA Opsumit · 4.1
- ⛔ Hypersensitivity to macitentan. FDA Opsumit · 4.2
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
- 10 mg tablet — tablet 🇺🇸 USA FDA Opsumit · 3
👥 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) ] .”
🔗 Reference links
- FDA (approval record)NDA204410
- DailyMed (FDA label)FDA Opsumit
- MedlinePlus (NIH)Macitentan
- WHO ATC/DDDC02KX04
- Darooyab (Iran)Macitentan
🇮🇷 Registered in Iran Darooyab · G-5425/Macitentan
Dosage forms with Iranian generic codes, per Darooyab.
- 52255 · MACITENTAN ORAL 10 mg TABLET · قرص ماسیتنتان ۱۰ میلیگرم
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Opsumit · 3FDA Opsumit · 2.1FDA Opsumit · 4.1FDA Opsumit · 4.2FDA Opsumit · Boxed WarningFDA Opsumit · 5FDA Opsumit · SPL approval / marketing categoryFDA Opsumit · 4FDA Opsumit · 8.2FDA Opsumit · 8.4FDA Opsumit · 8.5FDA Opsumit · 8.3
- UK SmPC (eMC / MHRA)❌ Not present
- Published guideline❌ Not present
- Licensed reference (medical school)❌ Not present
- Iranian leaflet (IFDA)❌ Not present
- Pharmacy website (secondary, unreliable)✅ PresentDarooyab · G-5425/Macitentan
- Clinical review⚠ Unverified