Clinical Trial Results

WINREVAIR was studied in a 6-month clinical trial called STELLAR.

In STELLAR, 323 adults with PAH (WHO Group 1, functional class II or III) added either WINREVAIR or placebo to the PAH medicines they were already taking.

163 patients added WINREVAIR.

160 patients added placebo.

WHO = World Health Organization.

WINREVAIR and placebo were given as injections under the skin (subcutaneously) once every 3 weeks.

Almost all patients in the trial (96%) were already taking 2 or 3 PAH medicines before adding WINREVAIR or placebo.

With WINREVAIR, you could improve your ability to exercise.

In STELLAR, adults with PAH who added WINREVAIR increased their 6-minute walk distance (6MWD) by approximately 134 feet (41 meters) compared to their 6-minute walk distance at the start of the study.^a

6-minute walk distance:

^aMeasured at 24 weeks and adjusted by the 6MWD of patients who added placebo to their current PAH medicines.

“We took the longer way home.  
That’s my win.”

WINREVAIR could keep your PAH from getting worse.

Adding WINREVAIR to current medicines reduced the risk of death or a PAH worsening event^b by 84% compared to current PAH medicines plus placebo.

84% Lower Risk of Death or PAH Worsening

In STELLAR, 9 out of 163 WINREVAIR patients (5.5%) experienced a PAH worsening event^b or death, compared to 42 out of 160 patients (26.3%) taking their current medicines plus placebo. These events were recorded over a median period of 33.6 weeks.

^bPAH worsening was defined as being listed for a lung and/or heart transplant; needing PAH rescue therapy or an increase in the dose of prostacyclin infusion therapy of 10% or more; needing an atrial septostomy (a procedure to manage right heart failure); hospitalization for PAH of 24 hours or more; or the combination of a worsening of functional class and a decrease in 6MWD of 15% or more, confirmed by two 6MWD tests at least 4 hours apart but no more than 1 week.

What could your days be like if you had fewer PAH symptoms?

With WINREVAIR, you could improve your ability to do normal activities with fewer PAH symptoms.

2x More WINREVAIR Patients Improved In Functional Class

In STELLAR, at 24 weeks, 29% of the adults with PAH who added WINREVAIR improved by at least 1 functional class, compared to 14% of patients who added placebo to their current PAH medicines.

At the start, all STELLAR patients were in functional class II (49%) or III (51%), meaning that their PAH symptoms caused minor (for class II) or major (for class III) limitations to ordinary physical activity.

Improvement in functional class means being physically active with fewer limitations from PAH symptoms, including:

Shortness of breath

Feeling tired

Feeling lightheaded

Chest pain

PVR and NT-proBNP are important measures of heart health and function that help your healthcare provider monitor your PAH.

In STELLAR, adults with PAH who added WINREVAIR experienced a greater decrease from the start of the study in pulmonary vascular resistance (PVR)^c and N-terminal pro-B-type natriuretic peptide (NT-proBNP)^d levels.

PVR Is Defined as the Amount of Resistance to Blood Flow in the Lungs, Measured by a Right-Sided Heart Catheterization Test; NT-ProBNP Is a Protein That Helps Check for Stress on the Heart, Measured by a Blood Test

Your PAH care team may evaluate PVR and NT-proBNP along with other tests to get a more complete picture of your heart health and function.

^cAdding WINREVAIR reduced PVR by 235 dynes*sec/cm⁵ (units of resistance) compared to current PAH medicines plus placebo.

^dAdding WINREVAIR reduced levels of NT-proBNP by 442 pg/mL compared to current PAH medicines plus placebo.

What are the possible side effects of WINREVAIR?

Possible Side Effects

How to take
WINREVAIR.

Taking 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 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

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.

What is WINREVAIR? What is WINREVAIR?

Important Safety Information Important Safety Information