Ambrisentan Dosage
This dosage information may not include all the information needed to use Ambrisentan safely and effectively. See additional information for Ambrisentan.
The information at Drugs.com is not a substitute for medical advice. ALWAYS consult your doctor or pharmacist.
Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Pulmonary Hypertension
pulmonary arterial hypertension in patients with WHO class II or III symptoms to improve exercise capacity and delay clinical worsening:
5 mg orally once a day with or without food
Renal Dose Adjustments
There was no significant impact of ambrisentan exposure in PAH patients with mild or moderate renal impairment (creatinine clearances ranging between 20 and 150 mL/min). There is no information on the exposure to ambrisentan in patients with severe renal impairment.
Liver Dose Adjustments
Dosage adjustments are necessary in patients developing aminotransferase abnormalities. Liver chemistries must be measured prior to initiation of ambrisentan and at least every month thereafter. If there are aminotransferase elevations greater than 3 times the ULN and less than or equal to 5 times the ULN, they should be re-measured. If the confirmed level is greater than 3 times the ULN and less than or equal to 5 times the ULN, reduce the daily dose or interrupt treatment and continue to monitor every two weeks until the levels are less than 3 times the ULN. If there are aminotransferase elevations more than 5 times the ULN and equal to or less than 8 times the ULN, ambrisentan should be discontinued and monitoring should continue until the levels are less than 3 times the ULN. Ambrisentan can then be re initiated with more frequent measurement of aminotransferase levels. If there are aminotransferase elevations greater than 8 times the ULN, treatment should be stopped and re initiation should not be considered.
Ambrisentan is not recommended in patients with elevated aminotransferases (greater than 3 times the ULN) at baseline because monitoring liver injury may be more difficult. If aminotransferase elevations are accompanied by clinical symptoms of liver injury (such as anorexia, nausea, vomiting, fever, malaise, fatigue, right upper quadrant abdominal discomfort, itching, or jaundice) or increases in bilirubin greater than 2 times the ULN, ambrisentan treatment should be stopped.
Dose Adjustments
The dose may be increased to 10 mg orally once daily if 5 mg is tolerated.
Precautions
Safety and effectiveness have not been established in pediatric patients (less than 18 years of age).
Dialysis
Data not available
Other Comments
The US FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for ambrisentan. It includes a Medication Guide, elements to assure safe use, and implementation system. Additional information is available at www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111350.htm.
