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Ambrisentan Prescribing Information
Ambrisentan is contraindicated for use during pregnancy because it may cause major birth defects if used by pregnant patients, based on studies in animals
Therefore, for females of reproductive potential, exclude pregnancy before the initiation of treatment with ambrisentan. Advise use of effective contraception before initiation, during treatment, and for one month after treatment with ambrisentan
[see Contraindications (4.1), Warnings and Precautions (5.1), and Use in Specific Populations (8.1)]
. Therefore, for females of reproductive potential, exclude pregnancy before the initiation of treatment with ambrisentan. Advise use of effective contraception before initiation, during treatment, and for one month after treatment with ambrisentan
[see Dosage and Administration (2.2) Contraindications (4.1), Warnings and Precautions (5.1), and Use in Specific Populations (8.1, 8.3)]
. When pregnancy is detected, discontinue ambrisentan as soon as possible (5.1).- Box Warning 4/2025
- Indications and Usage (1) 4/2025
- Dosage and Administration, Pregnancy Testing in Females of Reproductive Potential (2.2) 4/2025
- Warnings and Precautions for Use Embryo-fetal Toxicity (5.1) 4/2025
- Ambrisentan Risk Evaluation and Mitigation Strategy (REMS) (5.2) (removed)4/2025
Ambrisentan is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) in adult patients:
• To improve exercise ability and delay clinical worsening.
Studies establishing effectiveness included predominantly patients with WHO Functional Class II–III symptoms and etiologies of idiopathic or heritable PAH (60%) or PAH associated with connective tissue diseases (34%).
• Initiate treatment at 5 mg once daily (2.1).
• Titrate at 4-week intervals as needed and tolerated (2.1).
• Do not split, crush, or chew tablets (2.1).
5 mg and 10 mg film
-
coated tablets for oral administration- Each 5 mg tablet is pale pink colored, round shape, biconvex beveled edge film-coated tablet debossed with “236” on one side and plain on the other side.
- Each 10 mg tablet is deep pink colored, oval shape, biconvex film-coated tablet debossed with “237” on one side and plain on the other side.
• Breastfeeding: Choose ambrisentan or breastfeeding (8.2).
• Not recommended in patients with moderate or severe hepatic impairment (8.7).
We receive information directly from the FDA and PrescriberPoint is updated as frequently as changes are made available