Ambrisentan
آمبریسنتان
❤️ Cardiovascular SystemEndothelin receptor antagonist
Market / country: 🇺🇸 USA
Letairis (US)
🧮 Dose calculator
Pulmonary arterial hypertension (PAH) · Regimen source: FDA Letairis · 2.1
- • Titrate at 4-week intervals. Do not split, crush or chew. FDA Letairis · 2.1
Enter age (weight is optional for this regimen).
🛡️ Safety & information
Contraindications
- ⛔ Pregnancy. FDA Letairis · 4.1
- ⛔ Idiopathic pulmonary fibrosis (including WHO group 3 pulmonary hypertension). FDA Letairis · 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 Letairis · Boxed Warning
- • Fluid retention; pulmonary oedema with veno-occlusive disease; decreased sperm counts; haemoglobin decrease. FDA Letairis · 5
Formulations
- 5 mg tablet (do not split) — tablet 🇺🇸 USA FDA Letairis · 3
- 10 mg tablet — tablet 🇺🇸 USA FDA Letairis · 3
👥 Special populations
- 🤰 PregnancyContraindicated
Label: contraindicated in pregnancy. FDA Letairis · 4
“Letairis is contraindicated in females who are pregnant.”
- 🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Letairis · 8.2
“Because many drugs are present in human milk and because of the potential for serious adverse reactions in breastfed infants from Letairis, a decision should be made whether to discontinue breastfeeding or discontinue Letairis, taking into account the importance of the drug to the mother.”
- 👶 ChildrenSafety not established
Label: safety and effectiveness in children have not been established. FDA Letairis · 8.4
“Safety and effectiveness of Letairis 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 Letairis · 8.5
“The elderly (age ≥65 years) showed less improvement in walk distances with Letairis than younger patients did, but the results of such subgroup analyses must be interpreted cautiously.”
- ⚥ Females & males of reproductive potentialUse with caution
Label has advice on pregnancy testing, contraception or fertility for females and males. FDA Letairis · 8.3
“Contraception Patients who can become pregnant who are using ambrisentan should use effective contraception prior to initiation of treatment, during treatment, and for one month after discontinuation of treatment with ambrisentan to prevent pregnancy [see Warnings and Precautions (5.1) ] .”
🔗 Reference links
- FDA (approval record)NDA022081
- DailyMed (FDA label)FDA Letairis
- MedlinePlus (NIH)Ambrisentan
- WHO ATC/DDDC02KX02
- Darooyab (Iran)Ambrisentan
🇮🇷 Not found in Iran list Darooyab · G-4906/Ambrisentan
Darooyab lists no registered dosage form or brand for this drug. This does not prove it is unavailable.
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Letairis · 3FDA Letairis · 2.1FDA Letairis · 4.1FDA Letairis · 4.2FDA Letairis · Boxed WarningFDA Letairis · 5FDA Letairis · 4FDA Letairis · 8.2FDA Letairis · 8.4FDA Letairis · 8.5FDA Letairis · 8.3FDA Letairis · SPL approval / marketing category
- 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-4906/Ambrisentan
- Clinical review⚠ Unverified