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Frequently Asked Questions About WINREVAIR

About Pulmonary Arterial Hypertension (PAH)

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What is PAH?

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What are the symptoms of PAH?

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How does PAH affect the heart and lungs?

About WINREVAIR

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What is WINREVAIR?

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Is WINREVAIR approved by the FDA?

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Does WINREVAIR have side effects?

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Can I add WINREVAIR to my current PAH medications?

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Is WINREVAIR effective and safe for adult patients with PAH?

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Where can I report exposure during pregnancy or breastfeeding?

How WINREVAIR works

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How does WINREVAIR work?

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Which treatment pathway does WINREVAIR work on?

Taking WINREVAIR

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I have been trained by a healthcare provider on how to inject the medicine. Can I find additional information on your website?

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Where can I find my prescribed dose? 

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What should I do if I am bleeding at the injection site? 

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Is there a chance my dose could change?

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What should I do if I accidentally get some medicine on my skin or my work surface?  

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What should I do if I am not sure I administered my prescribed dose correctly?

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What should I do if the plunger of my dosing syringe moves automatically when I try to withdraw medicine from the vial?

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What should I do if my kit parts are damaged or are discolored, cloudy, or have particles?

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What should I do if my medicine does not turn clear after mixing and swirling?

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What should I do if the sterile water will not come out of the prefilled syringe?

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What should I do if I dropped my kit components?

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Can I use my kit that has been left out of the refrigerator? 

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Do I need to use the mixed medicine right away?  

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How can I get help preparing and giving my injection? 

While taking WINREVAIR

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How should WINREVAIR be stored? 

Learn about The Merck Access Program.

Watch step-by-step instructions on how to take WINREVAIR.

Report exposure during pregnancy or breastfeeding to the Merck Sharp & Dohme, LLC Adverse Event reporting line at 1-877-888-4231.

What is WINREVAIR?

WINREVAIR is a prescription medicine for adults with pulmonary arterial hypertension (PAH). PAH is a type of high blood pressure in the arteries of your lungs.

WINREVAIR can improve your ability to exercise, improve your ability to perform normal activities with fewer symptoms, and reduce the risk of your physical condition and symptoms worsening.

Important Safety Information

Before taking WINREVAIR and during treatment, tell your healthcare provider:

  • About all of your medical conditions and all of the medicines you take, including prescriptions, over-the-counter medicines, vitamins, and herbal supplements.
  • If you are pregnant, planning to get pregnant, become pregnant, or think you may be pregnant. If you are able to get pregnant, your healthcare provider should do a pregnancy test before you start taking WINREVAIR.
  • If you are breastfeeding or plan to breastfeed.

If you are able to get pregnant, you should use effective birth control during treatment with WINREVAIR and for at least 4 months after your final dose. WINREVAIR may harm your unborn baby. Do not breastfeed during treatment and for 4 months after your final dose.

 

WINREVAIR may cause serious side effects including:

  • High level of hemoglobin in your blood. Hemoglobin is a protein in red blood cells that carries oxygen. High levels of hemoglobin can increase your risk for blood clots.
  • Severely low number of platelets in your blood. Platelets are blood cells that help blood clot. Tell your healthcare provider if you develop easy bruising or bleeding, bleeding that does not stop, or nosebleeds.
  • Serious bleeding. Tell your healthcare provider if you develop any signs or symptoms of bleeding, including: vomiting blood or your vomit looks like coffee-grounds, pink or brown urine, red or black stools that look like tar, coughing up blood or blood clots, persistent headaches, nausea, dizziness or feeling weak, persistent abdominal cramps, severe back pain, abnormally heavy menstrual bleeding.
  • Decreased fertility: WINREVAIR may affect female and male fertility, which may affect your ability to have children. Talk to your healthcare provider if this is a concern for you.

Your healthcare provider will do a blood test before your first 5 doses of WINREVAIR, longer if needed, and then from time to time to check your levels of hemoglobin and platelets.

 

The most common side effects of WINREVAIR include headache, nose bleeds, rash, tiny blood vessels that look like pink or red lines on the skin (spider veins), diarrhea, dizziness, and redness.

 

These are not all the possible side effects of WINREVAIR. Call your doctor for medical advice about side effects.

 

Taking WINREVAIR:

  • If your healthcare provider decides that you or a caregiver can give WINREVAIR at home, do not try to inject WINREVAIR until you or a caregiver have received training from your healthcare provider on the right way to prepare and inject the medicine.
  • Your healthcare provider may delay treatment or change your dose if needed, based on the results of your blood tests to check your hemoglobin and platelet levels.
  • See the detailed “Instructions for Use” booklet that comes with WINREVAIR for information on how to prepare and inject a dose of WINREVAIR.

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.

 

Please read the accompanying Patient Information and Instructions for Use (1-vial kit, 2-vial kit) for WINREVAIR, and discuss them with your doctor. The physician Prescribing Information also is available.

 

What is WINREVAIR?
Important Safety Information

WINREVAIR is a prescription medicine for adults with pulmonary arterial hypertension (PAH). PAH is a type of high blood pressure in the arteries of your lungs.

WINREVAIR can improve your ability to exercise, improve your ability to perform normal activities with fewer symptoms, and reduce the risk of your physical condition and symptoms worsening.

Important Safety Information

Before taking WINREVAIR and during treatment, tell your healthcare provider:

  • About all of your medical conditions and all of the medicines you take, including prescriptions, over-the-counter medicines, vitamins, and herbal supplements.
  • If you are pregnant, planning to get pregnant, become pregnant, or think you may be pregnant. If you are able to get pregnant, your healthcare provider should do a pregnancy test before you start taking WINREVAIR.
  • If you are breastfeeding or plan to breastfeed.

If you are able to get pregnant, you should use effective birth control during treatment with WINREVAIR and for at least 4 months after your final dose. WINREVAIR may harm your unborn baby. Do not breastfeed during treatment and for 4 months after your final dose.

 

WINREVAIR may cause serious side effects including:

  • High level of hemoglobin in your blood. Hemoglobin is a protein in red blood cells that carries oxygen. High levels of hemoglobin can increase your risk for blood clots.
  • Severely low number of platelets in your blood. Platelets are blood cells that help blood clot. Tell your healthcare provider if you develop easy bruising or bleeding, bleeding that does not stop, or nosebleeds.
  • Serious bleeding. Tell your healthcare provider if you develop any signs or symptoms of bleeding, including: vomiting blood or your vomit looks like coffee-grounds, pink or brown urine, red or black stools that look like tar, coughing up blood or blood clots, persistent headaches, nausea, dizziness or feeling weak, persistent abdominal cramps, severe back pain, abnormally heavy menstrual bleeding.
  • Decreased fertility: WINREVAIR may affect female and male fertility, which may affect your ability to have children. Talk to your healthcare provider if this is a concern for you.

Your healthcare provider will do a blood test before your first 5 doses of WINREVAIR, longer if needed, and then from time to time to check your levels of hemoglobin and platelets.

 

The most common side effects of WINREVAIR include headache, nose bleeds, rash, tiny blood vessels that look like pink or red lines on the skin (spider veins), diarrhea, dizziness, and redness.

 

These are not all the possible side effects of WINREVAIR. Call your doctor for medical advice about side effects.

 

Taking WINREVAIR:

  • If your healthcare provider decides that you or a caregiver can give WINREVAIR at home, do not try to inject WINREVAIR until you or a caregiver have received training from your healthcare provider on the right way to prepare and inject the medicine.
  • Your healthcare provider may delay treatment or change your dose if needed, based on the results of your blood tests to check your hemoglobin and platelet levels.
  • See the detailed “Instructions for Use” booklet that comes with WINREVAIR for information on how to prepare and inject a dose of WINREVAIR.

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.

 

Please read the accompanying Patient Information and Instructions for Use (1-vial kit, 2-vial kit) for WINREVAIR, and discuss them with your doctor. The physician Prescribing Information also is available.