Questions about generics?
Your PAH Specialist is the best resource to answer questions about your treatment, but you can find answers to some common questions about generics here.
What is a generic?
According to the United States Food & Drug Administration (FDA), a generic is a drug product that is created to be the same as an already marketed brand-name drug in dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use.
Manufacturers of generic drugs are not required to repeat animal and clinical studies that are required of branded medicines to demonstrate safety and effectiveness.
Who provides generic forms of Letairis?
It is likely that more than one manufacturer will produce generic forms of ambrisentan, the active ingredient in Letairis. Gilead Sciences, the manufacturer of Letairis, does not produce or sell a generic version of ambrisentan.
How will I know if I am getting Letairis or a generic form?
A generic may appear different from Letairis in characteristics such as pill shape, size, imprint, and color. In addition, if multiple generic versions of ambrisentan are available, pill appearance may vary from refill to refill, depending on which generic the pharmacy has in stock.
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Will my PAH Specialist be notified if I am switched to a generic?
Once generic versions of Letairis are available, your Certified Pharmacy may switch your medication from branded Letairis to a generic version. In some states this can occur without notifying you or your prescribing physician.
Will my insurance company require me to switch to a generic?
Some insurance plans may request that you switch to a generic version. In many cases, it is left to the prescribing physician and patient to choose to stay on a branded version. Talk to your PAH Specialist. For information about how to stay on branded Letairis, click here.
What is my out-of-pocket cost for generics versus branded Letairis?
Your medication costs can vary based on a variety of factors, such as insurance coverage and benefit design, and the costs set by the manufacturer. The cost-sharing programs in place for branded Letairis, including the Letairis Co-Pay Coupon Program, are not available for generic forms of ambrisentan. In addition, depending on other medications you may take, your costs may vary each month. LEAP is available to help you better understand your insurance benefits and your monthly out-of-pocket costs. Learn more here.
Can the Letairis Co-Pay Coupon Program cover the cost of generic ambrisentan?
The Letairis Co-Pay Coupon Program and LEAP financial assistance are available only to patients who take branded Letairis. Learn more about financial assistance available to Letairis patients here.
What about the Letairis REMS Program? Will I still need to have a monthly pregnancy test if I am switched to a generic?
Because of the risk of serious birth defects associated with endothelin receptor antagonists (ERAs) such as Letairis/ambrisentan, the FDA requires that all females be enrolled into a REMS Program to ensure females are aware of the risks associated with the drug. Prescribers must also be enrolled into the program to ensure they are aware of and will appropriately educate female patients about the risks associated with ambrisentan.
This means that all females taking either branded Letairis or generic ambrisentan will be required to enroll in a REMS Program. Females who are able to get pregnant will continue to receive education about acceptable methods of birth control through the REMS Program and will also be required to have a negative monthly pregnancy test prior to receiving their monthly shipment. The Certified Pharmacy will call each month to ensure this test has occurred. Talk to your physician or pharmacist if you have questions.