Question 1

What is Winrevair?

Accepted Answer

Winrevair is a biologic medication known as an activin signaling inhibitor. It works by helping to restore the balance between cellular signals that regulate the growth and narrowing of blood vessels in the lungs.

By targeting these specific pathways, the medication helps to manage the underlying structural changes in the pulmonary arteries that lead to increased blood pressure.

Question 2

What is Winrevair used for?

Accepted Answer

Winrevair is used to treat pulmonary arterial hypertension (WHO Group 1).

Question 3

How does Winrevair work?

Accepted Answer

Restoring Signaling Balance

In people with pulmonary arterial hypertension (PAH), the blood vessels in the lungs become thick and narrow. This happens because of an imbalance in the signals that control how cells in the blood vessel walls grow and multiply. Specifically, there is often too much signaling that promotes cell growth and not enough signaling that limits it.

Winrevair works by targeting this imbalance. It is a fusion protein that binds to certain proteins, such as activins, that contribute to the overgrowth of cells in the lung's blood vessels.

Improving Blood Flow

By binding to these proteins, Winrevair helps to:

Reduce vessel wall thickening: It limits the excessive growth of cells that cause the pulmonary arteries to narrow.

Improve vascular health: It helps restore a more normal environment within the blood vessels.

Lower blood pressure in the lungs: As the vessels become less constricted, blood can flow more easily from the heart to the lungs.

This mechanism is different from many other PAH treatments, which primarily focus on widening the blood vessels. Winrevair aims to address the underlying structural changes in the vessels themselves.

Question 4

What are the active ingredients in Winrevair?

Accepted Answer

The active ingredient in Winrevair is sotatercept .

Question 5

What are the side effects of Winrevair?

Accepted Answer

Common side effects of Winrevair may include:

Headache

Fatigue

Diarrhea

Always consult with a healthcare professional about potential side effects.

Question 6

What drug class is Winrevair?

Accepted Answer

Winrevair belongs to the long-acting beta2-agonist and corticosteroid combination drug class.

Question 7

What is the dosage of Winrevair and how do I take it?

Accepted Answer

Administration

Winrevair is given as a subcutaneous injection, which means it is injected into the fatty tissue just under the skin. It is typically administered once every three weeks.

A healthcare provider may give the injection in a clinical setting. Alternatively, you or a caregiver may be trained to prepare and inject the medication at home. Do not attempt to self-inject until you have been properly instructed on how to prepare the dose and perform the injection.

Injection Sites

Common areas for injection include:

The abdomen (at least two inches away from the belly button).

The front of the thighs.

The back of the upper arms (if administered by a caregiver).

It is important to rotate the injection site with each dose. Do not inject into skin that is tender, bruised, red, or hard.

Preparation

Winrevair comes as a powder in a vial that must be mixed with a specific liquid before use. The medication should be taken out of the refrigerator and allowed to reach room temperature before mixing. Once the powder is dissolved, the solution should be clear and colorless. If the liquid is cloudy or contains particles, it should not be used.

Missed Dose

If you miss a dose of Winrevair, contact your healthcare provider for instructions. Generally, the missed dose should be administered as soon as possible. If the next scheduled dose is very close, your doctor may advise you to skip the missed dose and return to your regular schedule. Do not take two doses at the same time to make up for a missed one.

Question 8

Is Winrevair safe during pregnancy and breastfeeding?

Accepted Answer

Pregnancy

There is limited information regarding the use of Winrevair in pregnant women. Based on animal studies, this medication may cause harm to a developing fetus. Healthcare providers typically recommend that the drug only be used during pregnancy if the potential benefit outweighs the potential risk.

Females of reproductive potential are advised to use effective contraception during treatment and for at least 4 months after the final dose. If you become pregnant or suspect you are pregnant while using this medication, notify your healthcare provider immediately.

Breastfeeding

It is currently unknown whether Winrevair passes into human breast milk or if it affects a nursing infant or milk production. Due to the potential for serious side effects in a breastfed child, it is generally recommended to avoid breastfeeding during treatment and for 4 months following the last dose.

Fertility

Animal studies suggest that Winrevair may impair both female and male fertility. It is not yet known how this medication affects human fertility. Individuals planning to have children should discuss these risks with their doctor before beginning treatment.

Question 9

What forms and strengths does Winrevair come in?

Accepted Answer

Dosage Forms

Winrevair is supplied as a sterile powder in a single-dose vial. It does not contain preservatives. Before administration, the powder must be dissolved using a specific liquid provided in the medication kit.

Administration Route

This medication is given by subcutaneous injection. This involves injecting the liquid into the layer of fat directly under the skin.

Packaging

Winrevair is distributed in kits designed for single-use. These kits generally include vials containing the medication powder and prefilled syringes containing sterile water for injection, which is used to dissolve the powder. The kits also include components for mixing and administration, such as vial adapters and needles.

The medication is available in kits that contain a single vial or kits that contain multiple vials.

Question 10

What is the FDA approval status of Winrevair?

Accepted Answer

FDA Approval and Indications

The U.S. Food and Drug Administration (FDA) approved Winrevair in March 2024. It is indicated for the treatment of adults with pulmonary arterial hypertension (PAH), specifically those in World Health Organization (WHO) Group 1. The medication is used to increase exercise capacity, improve WHO functional class, and reduce the risk of clinical worsening events.

Regulatory Designations

The FDA granted Winrevair Breakthrough Therapy and Orphan Drug designations during its development. These designations are intended to expedite the review of drugs for serious conditions and encourage the development of treatments for rare diseases.

Safety Monitoring

There are no boxed warnings or Risk Evaluation and Mitigation Strategy (REMS) requirements for this medication. However, the FDA requires healthcare providers to monitor hemoglobin and platelet levels before each of the first five doses and periodically thereafter to manage potential side effects like erythrocytosis (increased red blood cells) or thrombocytopenia (decreased platelets).

Question 11

What should I know about Winrevair and cost?

Accepted Answer

Estimated List Price

The manufacturer's list price for Winrevair is approximately $14,000 per vial. Most patients require one vial every three weeks, though the total cost can vary depending on the specific dose prescribed by a healthcare provider.

Insurance and Coverage

The amount a patient pays out-of-pocket is largely determined by their insurance plan. Coverage details may include:

Commercial Insurance: Many private plans cover Winrevair, but patients may be responsible for deductibles, co-pays, or coinsurance.

Medicare and Medicaid: Coverage is generally available through government programs, though the specific costs depend on the individual's plan and phase of coverage.

Specialty Pharmacy: Winrevair is a specialty medication and is typically distributed through specialty pharmacies rather than standard retail locations.

Financial Assistance Programs

Because of the high cost of treatment, financial support options may be available to help eligible patients:

Co-pay Assistance: Patients with commercial insurance may be eligible for co-pay cards or coupons provided by the manufacturer to lower their out-of-pocket expenses.

Patient Assistance Programs: For individuals who are uninsured or have limited insurance coverage, the manufacturer may offer programs that provide the medication at no cost or a significantly reduced rate based on financial need.

Patients should consult with their insurance provider or a specialty pharmacy coordinator to understand their specific coverage and potential costs.

Winrevair

Medication Quick Facts

📋Overview

What It's Used For

How It Works

Side Effects

Warnings & Precautions

Dosage & How to Take

Pregnancy & Breastfeeding

Forms & Strengths

FDA / Regulatory Status

Price Information

FAQ

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