Ambrisentan Tablets
Dosage form: tablet, film coated
Drug class:Agents for pulmonary hypertension
Medically reviewed by Drugs.com. Last updated on May 1, 2022.
On This Page
- Boxed Warning
- Indications and Usage
- Dosage and Administration
- Dosage Forms and Strengths
- Contraindications
- Warnings and Precautions
- Adverse Reactions/Side Effects
- Drug Interactions
- Use In Specific Populations
- Overdosage
- Description
- Clinical Pharmacology
- Nonclinical Toxicology
- Clinical Studies
- How Supplied/Storage and Handling
- Patient Counseling Information
- Medication Guide
Do not administer Ambrisentan Tablets to a pregnant female because it may cause fetal harm. Ambrisentan Tablets are very likely to produce serious birth defects if used by pregnant females, as this effect has been seen consistently when it is administered to animals [see Contraindications (4.1), Warnings and Precautions (5.1), and Use in Specific Populations (8.1)].
Exclude pregnancy before the initiation of treatment with Ambrisentan Tablets. Females of reproductive potential must use acceptable methods of contraception during treatment with Ambrisentan Tablets and for one month after treatment. Obtain monthly pregnancy tests during treatment and 1 month after discontinuation of treatment [see Dosage and Administration (2.2) and Use in Specific Populations (8.3)].
Because of the risk of embryo-fetal toxicity, for all female patients, Ambrisentan Tablets are only available through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Ambrisentan REMS [see Warnings and Precautions(5.2)].
Indications and Usage for Ambrisentan Tablets
Ambrisentan Tablets are indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1):
- 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...
