at no cost [1%:15% have been observed in some patients. Measure hemoglobin prior to initiating therapy, at 1 month, and periodically thereafter. Significant decreases in hemoglobin in the absence of other causes may warrant the discontinuation of therapy. Use not recommended in patients with clinically significant anemia. Hepatic effects: Increases in serum liver aminotransferases have been reported during postmarketing use; however, in the majority of the cases, alternative causes of hepatotoxicity could be identified. Perform liver enzyme testing when clinically indicated. Discontinue therapy if signs/symptoms of hepatic injury appear, if serum liver aminotransferases >5 times ULN (US labeling) or >3 times ULN (Canadian labeling) are observed, or if aminotransferases are increased in the presence of bilirubin >2 times ULN. Hepatotoxicity has been reported with other endothelin receptor antagonists (eg, bosentan); however, ambrisentan may be tried in patients that have experienced asymptomatic increases in liver enzymes caused by another endothelin receptor antagonist after the liver enzymes have returned to normal. Spermatogenesis: Sperm count may be reduced in men during treatment (as observed with bosentan). No changes in sperm function or hormone levels have been noted. Fertility issues may require discussion with patient. Disease-related concerns: Hepatic impairment: Use caution in patients with mild hepatic impairment; ambrisentan exposure may be increased. The US labeling does not recommend use in patients with moderate or severe impairment. The Canadian labeling recommends use with caution in moderate impairment with monthly monitoring of ALT/AST during therapy and contraindicates use in severe hepatic impairment (with or without cirrhosis) and in patients with ALT or AST >3 times ULN at baseline. Pulmonary veno-occlusive disease (PVOD): Discontinue in any patient with pulmonary edema suggestive of PVOD. Special populations: Pregnancy: [US Boxed Warning]: May cause birth defects; use in pregnancy is contraindicated. Exclude pregnancy prior to initiation of therapy and obtain pregnancy tests monthly during treatment and for 1 month after therapy is complete. Reliable contraception must be used during therapy and for 1 month after stopping treatment. Two reliable methods of contraception (eg, hormone method with a barrier method or two barrier methods) must be used throughout treatment and for one month after stopping treatment. Patients who have undergone a tubal ligation or the insertion of a contraceptive implant or intrauterine device (Copper T 380A or LNg 20) do not require additional contraceptive measures. A missed menses or suspected pregnancy should be reported to a healthcare provider and prompt immediate pregnancy testing. Women should also be educated on the appropriate use of emergency contraception if failure of contraceptive is known or suspected or in the event of unprotected sex. Concurrent drug therapy issues: Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information. Other warnings/precautions: Letairis REMS Program: [US Boxed Warning]: Because of the high likelihood of teratogenic effects, ambrisentan is only available through the Letairis REMS restricted distribution program. Female patients (regardless of reproductive potential), prescribers, and pharmacies must be registered with and meet conditions of the program. Call 1-866-664-5327 or visit www.letairisrems.com for more information. Monitoring Parameters Monitor for significant peripheral edema and evaluate etiology if it occurs; hepatic enzyme testing when clinically appropriate. The Canadian labeling recommends hepatic function testing at baseline then as clinically indicated (all patients) and monthly during therapy (patients with moderate impairment or other risk factors [eg, significant right heart failure, preexisting hepatic disease or previously elevated transaminases, concurrent medications known to increase transaminases]). A woman of childbearing potential must have a negative pregnancy test prior to the initiation of therapy, monthly during treatment, and 1 month after stopping treatment. Hemoglobin and hematocrit should be measured at baseline, at 1 month, and periodically thereafter (generally stabilizes after the first few weeks of treatment). Pregnancy Risk Factor X Pregnancy Considerations [US Boxed Warning]: May cause birth defects; use in pregnancy is contraindicated. Exclude pregnancy prior to initiation of therapy and obtain pregnancy tests monthly during treatment and for 1 month after therapy is complete. Reliable contraception must be used during therapy and for 1 month after stopping treatment. Based on animal studies, ambrisentan is likely to produce major birth defects if used by pregnant women. Two reliable methods of contraception (eg, hormone method with a barrier method or 2 barrier methods) must be used throughout treatment and for 1 month after stopping treatment. Patients who have undergone a tubal ligation or the insertion of a contraceptive implant or intrauterine device (Copper T 380A or LNg 20) do not require additional contraceptive measures. A missed menses or suspected pregnancy should be reported to a healthcare provider and prompt immediate pregnancy testing. Sperm counts may be reduced in men during treatment (as observed with bosentan). Women with pulmonary arterial hypertension are encouraged to avoid pregnancy (McLaughlin 2009; Taichman 2014). Patient Education Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?) Patient may experience headache, flushing, cough, or rhinorrhea. Have patient report immediately to prescriber signs of liver problems (dark urine, fatigue, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or jaundice), shortness of breath, excessive weight gain, swelling of arm or leg, or loss of strength and energy (HCAHPS). Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions. Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients. Next Interactions Print this page Add to My Med List More about ambrisentan Side Effects During Pregnancy Dosage Information Drug Interactions Support Group En Español 10 Reviews Add your own review/rating Drug class: agents for pulmonary hypertension Consumer resources Ambrisentan Ambrisentan (Advanced Reading) Professional resources Ambrisentan (AHFS Monograph) Other brands: Letairis Related treatment guides Pulmonary Hypertension] Drug Status Rx Availability Prescription only X Pregnancy Category Not for use in pregnancy N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Ambrisentan Rating 10 User Reviews 8.0 /10 10 User Reviews 8.0 Rate it! Drug Class Agents for pulmonary hypertension Related Drugs agents for pulmonary hypertension sildenafil , tadalafil , Revatio , Adcirca , Letairis , Opsumit Pulmonary Hypertension sildenafil , tadalafil , Revatio , Adcirca , Letairis , Opsumit , Tracleer , Adempas , bosentan , macitentan , Tyvaso , iloprost , Flolan , Remodulin , Uptravi , treprostinil , riociguat , epoprostenol , Orenitram , Veletri , Ventavis , selexipag , More... adequately subtle
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