Potential risk of developing hepatic injury. Elevated serum aminotransferase (AST/ALT) concentrations to at least 3 times the upper limit of normal (ULN) reported. A class effect of endothelin-receptor antagonists; during postmarketing experience, unexplained hepatic cirrhosis and liver failure reported rarely after prolonged therapy (>12 months) with another endothelin-receptor antagonist (bosentan).
Serum aminotransferases and bilirubin (if aminotransferase concentrations are elevated) must be measured prior to initiation of therapy and monthly thereafter. (See Hepatic Effects under Cautions.)
In patients with adverse hepatic effects, dosage reduction, interruption of therapy, or discontinuance of the drug may be necessary. (See Patients with Adverse Hepatic Effects under Dosage and Administration.)
Ambrisentan generally should be avoided in patients with elevated aminotransferases (>3 × ULN) at baseline (because monitoring for liver injury may be more difficult).
Fetotoxicity
May cause fetal harm; contraindicated in pregnant women. Pregnancy must be excluded before start of treatment and prevented thereafter by use of 2 acceptable methods of contraception during and for one month following treatment unless patient has undergone tubal sterilization or chooses to use a Copper T380A or LNg 20 IUD, in which case no additional contraceptive method is required. (See Fetal/Neonatal Morbidity and Mortality under Cautions and also see Advice to Patients.)
REMS:
FDA approved a REMS for ambrisentan to ensure that the benefits of a drug outweigh the risks. The REMS may apply to one or more preparations of ambrisentan and consists of the following: medication guide, elements to assure safe use, and implementation system. See the FDA REMS page ([Web]) or the ASHP REMS Resource Center ([Web]).
Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. You can take this medicine with or without food. Do not cut, crush or chew this medicine. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice.
A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.
Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.
Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.
What if I miss a dose?
If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.
This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
What should I watch for while using this medicine?
Visit your doctor for regular check ups. Tell your doctor or healthcare professional if your symptoms do not start to get better or if they get worse. You will need to have important blood work done while you are taking this medicine.
This medicine can cause birth defects. Do not get pregnant while taking this drug. Females with child-bearing potential will need to have a negative pregnancy test before starting this medicine and every month while taking this medicine. Use 2 reliable forms of birth control together while you are taking this medicine and for 1 month after you stop taking this medicine. If you think that you might be pregnant talk to your doctor right away.
Because of the risks of liver injury and birth defects, this medicine is available only through a special program. Doctors, pharmacies, and patients must meet all of the conditions of the program. Your health care provider will help you get signed up with the program if you need this medicine.
What side effects may I notice from receiving this medicine?
Side effects that you should report to your doctor or health care professional as soon as possible:
This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Where should I keep my medicine?
Keep out of the reach of children.
Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.
NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.
Remember, keep this and all other medicines out of the reach of children,
never share your medicines with others, and use this medication only for the indication prescribed.
