Ambrisentan Frequently Asked Questions

WHAT IS THE MOST IMPORTANT INFORMATION I NEED TO KNOW ABOUT AMBRISENTAN?

  • Serious birth defects. Ambrisentan tablets can cause serious birth defects if taken during pregnancy.
  • Females must not be pregnant when they start taking Ambrisentan tablets or become pregnant during treatment with Ambrisentan tablets.
  • Do not have unprotected sex. Talk to your doctor or pharmacist right away if you have unprotected sex or if you think your birth control has failed. Your doctor may tell you to use emergency birth control.
  • Tell your doctor right away if you miss a menstrual period or think you may be pregnant for any reason.
  • Females who are able to get pregnant must use two acceptable forms of birth control during treatment with Ambrisentan tablets, and for one month after stopping Ambrisentan tablets because the medicine may still be in the body.
  • For a list of warnings and precautions see the attached Prescribing Information

 

AMBRISENTAN RISK EVALUATION & MITIGATION STRATEGY (REMS) PROGRAM

  • All females, regardless of reproductive potential must enroll in the Ambrisentan Risk Evaluation & Mitigation Strategy (REMS) Program and agree to all of the instructions including compliance with the pregnancy testing and contraception requirements of the program.
  • Male patients are not enrolled in the REMS
  • For complete information on the Ambrisentan REMS Program, or for complete Prescribing Information about ambrisentan, visit https://www.ambrisentanrems.us.com/

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Ambrisentan Tablets from Sun Pharma

Report suspect of adverse drug reactions to FDA
You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch , or call 1-800-FDA-1088.