What is WINREVAIR?
What is WINREVAIR?
What is WINREVAIR?
Important Safety Information
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 and perform normal activities with fewer symptoms, and reduce the risk of your physical condition and symptoms worsening, including lowering your risk of hospitalization for PAH, lung transplant, and death.
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 and perform normal activities with fewer symptoms, and reduce the risk of your physical condition and symptoms worsening, including lowering your risk of hospitalization for PAH, lung transplant, and death.
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 and perform normal activities with fewer symptoms, and reduce the risk of your physical condition and symptoms worsening, including lowering your risk of hospitalization for PAH, lung transplant, and death.
Important Safety Information
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 and over-the-counter medicines, vitamins, or 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 planning 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 are common with WINREVAIR and can be severe and increase your risk for blood clots.
- Severely low number of platelets in your blood. Platelets are blood cells that help blood clot. Low platelet counts are common with WINREVAIR and can be severe and increase your risk of bleeding. Tell your healthcare provider if you develop easy bruising or bleeding, bleeding that does not stop, or nosebleeds.
- Serious bleeding. You are more likely to have serious bleeding if you have low platelet counts, take prostacyclin medicines to treat PAH, or take medicines to help keep blood clots from forming. 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 infections, headache, nosebleeds, rash, tiny blood vessels that look like pink or red lines on the skin (spider veins), diarrhea, dizziness, redness, and bleeding gums.
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.
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.
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 and over-the-counter medicines, vitamins, or 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 planning to breastfeed.
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 and perform normal activities with fewer symptoms, and reduce the risk of your physical condition and symptoms worsening, including lowering your risk of hospitalization for PAH, lung transplant, and death.
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 and perform normal activities with fewer symptoms, and reduce the risk of your physical condition and symptoms worsening, including lowering your risk of hospitalization for PAH, lung transplant, and death.
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 and perform normal activities with fewer symptoms, and reduce the risk of your physical condition and symptoms worsening, including lowering your risk of hospitalization for PAH, lung transplant, and death.
Important Safety Information 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 and over-the-counter medicines, vitamins, or 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 planning 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 are common with WINREVAIR and can be severe and increase your risk for blood clots.
- Severely low number of platelets in your blood. Platelets are blood cells that help blood clot. Low platelet counts are common with WINREVAIR and can be severe and increase your risk of bleeding. Tell your healthcare provider if you develop easy bruising or bleeding, bleeding that does not stop, or nosebleeds.
- Serious bleeding. You are more likely to have serious bleeding if you have low platelet counts, take prostacyclin medicines to treat PAH, or take medicines to help keep blood clots from forming. 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 infections, headache, nosebleeds, rash, tiny blood vessels that look like pink or red lines on the skin (spider veins), diarrhea, dizziness, redness, and bleeding gums.
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.
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.
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 and over-the-counter medicines, vitamins, or 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 planning to breastfeed.