Comming Soon Opsumit (Macitentan) Copay Assistance Program |QuickRx

Without insurance or copay assistance, Opsumit (macitentan) can be very expensive. As a specialty medication for pulmonary arterial hypertension, Opsumit requires ongoing daily treatment which can result in significant monthly costs.

Factors That Affect Opsumit Cost:

• No generic available: Opsumit is currently only available as a brand-name medication
• Insurance coverage: Many plans cover Opsumit with varying copay or coinsurance amounts
• Pharmacy pricing: Prices may vary between specialty pharmacies
• Copay assistance: Eligible patients may significantly reduce their out-of-pocket costs through assistance programs

Contact QuickRx at (917) 830-2525 to explore copay assistance options that may help reduce your Opsumit costs.

Several copay assistance programs may help reduce Opsumit (macitentan) costs depending on your insurance status and financial situation.

Available Opsumit Copay Assistance Options:

• Manufacturer copay cards: For commercially insured patients
• Patient assistance programs: For uninsured or underinsured patients meeting income requirements
• Independent foundation grants: Pulmonary hypertension-focused financial support organizations
• State pharmaceutical assistance programs: Varies by state

QuickRx can help determine which programs you qualify for and assist with enrollment at no cost to you.

Medicare patients cannot use manufacturer copay cards due to federal regulations. However, other assistance options may be available for Medicare beneficiaries.

Medicare Patient Options:

• Independent foundation grants: Some foundations provide assistance regardless of insurance type
• State pharmaceutical assistance programs: Many states offer additional help for Medicare patients
• Medicare Extra Help: Low-Income Subsidy program for prescription costs
• Medicare Part D coverage: Review your plan’s formulary and coverage for Opsumit

QuickRx can help Medicare patients explore all available options for reducing Opsumit costs. Call (800) 496-6111 to speak with a patient navigator.

No, QuickRx provides completely FREE copay assistance services for all patients. Our patient navigators help you find and enroll in Opsumit copay assistance programs at no charge.

What QuickRx Does For Free:

• Reviews your insurance coverage and identifies available programs
• Completes copay card and patient assistance applications
• Coordinates with your healthcare provider for required documentation
• Manages ongoing renewals and insurance changes
• Provides continuous support throughout your PAH treatment

Our goal is to help you access the Opsumit you need at the lowest possible cost.

No, there is currently no generic version of Opsumit (macitentan) available. Opsumit is only available as a brand-name medication manufactured by Actelion Pharmaceuticals (a Janssen company).

Because no generic alternative exists, copay assistance programs are especially important for helping patients afford their Opsumit treatment. QuickRx can help you explore all available financial assistance options.

Opsumit (macitentan) is a prescription medication used to treat pulmonary arterial hypertension (PAH). It belongs to a class of medications called endothelin receptor antagonists.

About Opsumit:

• Drug class: Endothelin Receptor Antagonist, Vasodilator
• Mechanism: Blocks endothelin (ET)-1 from binding to endothelin receptors on blood vessel walls, helping to reduce blood pressure in the lungs
• FDA approved: October 18, 2013
• Manufacturer: Actelion Pharmaceuticals US Inc (Janssen)
• Available form: 10 mg tablets

Opsumit helps reduce the risks of disease progression and hospitalization in patients with pulmonary arterial hypertension.

Opsumit is FDA-approved for the treatment of pulmonary arterial hypertension (PAH), also known as WHO Group I pulmonary hypertension.

About Pulmonary Arterial Hypertension:

• What is PAH: A type of high blood pressure that affects the arteries in the lungs and the right side of the heart
• Treatment goal: Opsumit helps reduce the risks of disease progression and hospitalization for PAH patients
• Specialist care: PAH treatment decisions should be made in consultation with a pulmonary arterial hypertension specialist

Treatment choice depends on the etiology of PAH, risk stratification, and other cardiopulmonary conditions.

The recommended dose of Opsumit is 10 mg taken orally once daily.

Dosing Information:

• Standard dose: 10 mg once daily
• Maximum dose: 10 mg per day
• Administration: Swallow tablet whole; do not split, crush, or chew
• Food: May be taken with or without food

Your healthcare provider will determine if Opsumit is appropriate for your condition. Always take Opsumit exactly as prescribed.

Like all medications, Opsumit can cause side effects. Common side effects reported in clinical trials include respiratory symptoms and anemia.

Most Common Side Effects (occurring in more than 10% of patients):

• Anemia: Low red blood cell count (13%)
• Headache: (14%)
• Bronchitis: (12%)
• Nasopharyngitis: Inflammation of nose and throat (up to 20%)
• Pharyngitis: Sore throat (up to 20%)

Less Common Side Effects (1-10% of patients):

• Urinary tract infection: (9%)
• Influenza: Flu-like symptoms (6%)
• Increased liver enzymes: (2%)

Tell your doctor about any side effects you experience. Some side effects may require monitoring or treatment adjustment.

Contact your doctor immediately if you experience any serious side effects while taking Opsumit.

Serious Side Effects Requiring Medical Attention:

• Liver problems: Dark urine, fatigue, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, yellowing of skin or eyes (jaundice)
• Severe anemia: Unusual tiredness, weakness, shortness of breath, pale skin
• Fluid retention: Excessive weight gain, swelling of arms or legs
• Low blood pressure: Dizziness, fainting, lightheadedness
• Urinary tract infection: Blood in urine, burning or painful urination, fever, lower abdominal pain
• Allergic reactions: Rash, hives, itching, swelling of face, lips, tongue, or throat, trouble breathing (angioedema)
• Pulmonary edema: New or worsening shortness of breath, which may indicate pulmonary veno-occlusive disease

Hepatic injury, including fulminant hepatitis and liver failure, has been reported with Opsumit.

Certain patients should not take Opsumit or should use extreme caution.

Opsumit is Contraindicated In:

• Pregnancy: Opsumit may cause fetal harm and is contraindicated during pregnancy
• Hypersensitivity: Patients with known allergy to macitentan or any component of the formulation

Use Caution If You Have:

• Severe anemia: Use is not recommended
• Severe chronic heart failure: Use with caution due to risk of fluid retention
• Moderate to severe liver impairment: Canadian labeling recommends against use
• Elevated liver enzymes: Initiation not recommended if ALT or AST greater than 3 times the upper limit of normal

Important Warning – Pregnancy:

BOXED WARNING: Opsumit may cause fetal harm based on animal data. For females of reproductive potential, pregnancy must be excluded before starting treatment, during treatment, and for 1 month after stopping treatment. Use effective contraception. If pregnancy is detected, discontinue Opsumit as soon as possible.

Opsumit can interact with several medications. Always tell your doctor about all medications you take.

Medications to AVOID with Opsumit:

• Strong CYP3A4 inducers: May decrease Opsumit levels significantly (examples: rifampin, phenytoin, carbamazepine, St. John’s Wort)
• Strong CYP3A4 inhibitors: May increase Opsumit levels significantly (examples: ketoconazole, itraconazole, ritonavir)
• Fluconazole: May increase Opsumit levels
• Sparsentan: May increase adverse effects of endothelin receptor antagonists

Medications Requiring Monitoring:

• Moderate CYP3A4 inducers or inhibitors: Monitor for effectiveness or side effects
• Amiodarone: May increase Opsumit levels
• Grapefruit juice: May increase Opsumit levels

Your healthcare provider should review all your medications before starting Opsumit.

Yes, Opsumit may be taken with or without food.

Administration Instructions:

• Swallow tablet whole with water
• Do not split, crush, or chew tablets
• Take at the same time each day for best results
• May be taken with or without food

Note: Avoid grapefruit juice while taking Opsumit, as it may increase drug levels in your body.

Regular monitoring is important during Opsumit treatment.

Required Monitoring:

• Liver function tests: Monitor liver enzymes (ALT, AST) prior to initiation and repeat as clinically appropriate; Canadian labeling recommends monthly monitoring during the first year
• Hemoglobin/hematocrit: Prior to initiation and repeat as clinically appropriate (Canadian labeling recommends after first month and then as appropriate)
• Pregnancy testing: Exclude pregnancy before starting treatment in patients who could become pregnant
• Peripheral edema: Monitor for significant swelling and evaluate the cause if it occurs
• Signs of liver injury: Watch for anorexia, dark urine, fatigue, fever, itching, jaundice, nausea, right upper quadrant pain, vomiting

Your healthcare provider will determine the appropriate monitoring schedule for your situation.

The REMS (Risk Evaluation and Mitigation Strategy) program for Opsumit was discontinued as of April 2, 2025.

What Changed:

• Prior requirements: Previously, prescribers, pharmacies, and patients had to be specially certified or enrolled in the REMS program
• Current status: The FDA determined that a REMS is no longer necessary; product labeling is sufficient to convey safety information about embryo-fetal toxicity risk
• No special certification needed: Prescribers, pharmacies, and patients no longer need to enroll or certify in a REMS program

Important Safety Information Remains:

• The boxed warning about embryo-fetal toxicity still applies
• Pregnancy must still be excluded before treatment and effective contraception is required
• All prescribing precautions regarding pregnancy should continue to be followed

The discontinuation of the REMS program may make it easier to access Opsumit, but all safety precautions remain important.

Treatment duration with Opsumit depends on your response to therapy and your healthcare provider’s recommendations.

General Treatment Approach:

• PAH is typically a chronic condition requiring ongoing treatment
• Your pulmonary hypertension specialist will monitor your response to Opsumit
• Treatment may be adjusted based on disease progression, side effects, or other factors
• Do not stop taking Opsumit without consulting your healthcare provider

Continue taking Opsumit exactly as prescribed. If you have questions about your treatment duration, discuss them with your PAH specialist.

Questions about your Opsumit copay assistance? Contact QuickRx at (917) 830-2525 or (800) 496-6111.