LuciMaci___LUCIUS PHARMACEUTICALS

Lucius Macitentan Patient Information Leaflet

Brand Name: Opsumit®
Generic Name: Macitentan (ma-si-TEN-tan)
Manufacturer: Lucius Pharmaceuticals
Therapeutic Class: Endothelin Receptor Antagonist (ERA)
Dosage: This leaflet covers the 10 mg tablet strength.

1. What is Lucius Macitentan and what is it used for?

Lucius Macitentan is a prescription medicine used to treat Pulmonary Arterial Hypertension (PAH), which is high blood pressure in the arteries of your lungs.

It is used to delay disease progression and reduce the risk of hospitalization for PAH.
It works by blocking a substance in your body called endothelin. Endothelin causes blood vessels to narrow. By blocking endothelin, macitentan helps the blood vessels in your lungs relax and widen, making it easier for your heart to pump blood through your lungs and improving your ability to exercise.

It is approved for use in adults and in children aged 5 years and older.

2. Before you take Lucius Macitentan

Do NOT take this medicine if you:

Are allergic to macitentan or any of the other ingredients in this medicine.
Are pregnant, think you might be pregnant, or are planning to become pregnant. Macitentan is very likely to cause serious birth defects. See "Pregnancy Program" below.
Have liver problems, including cirrhosis.

Warnings and Precautions:
Talk to your doctor before taking Lucius Macitentan if you have or have had:

Liver Problems: Your doctor will perform blood tests to check your liver function before you start and during your treatment.
Low Red Blood Cell Count (Anemia): Macitentan can cause a decrease in hemoglobin and red blood cells. Your doctor will perform blood tests to check this.
Fluid Retention (Edema): Macitentan can cause your body to hold onto fluid, leading to swelling in your hands, legs, or ankles, and possibly weight gain. This could be a sign of heart failure.
Decreased Sperm Count: This medication may affect fertility in males.

Pregnancy Program (REMS Program):

Macitentan must never be used during pregnancy.
Due to the high risk of birth defects, this drug is only available through a special restricted distribution program called the Macitentan REMS Program.
Prescribers and pharmacies must be certified in this program.
Female patients must be tested for pregnancy before starting, monthly during treatment, and 1 month after stopping treatment. They must use acceptable forms of contraception.

Other Medicines and Supplements:
Tell your doctor about ALL the medicines you take. This is extremely important for:

Strong CYP3A Inducers: Rifampin, carbamazepine, St. John's Wort, etc. These may make macitentan less effective and should be avoided.
Hormonal Contraceptives (Birth Control Pills): Macitentan may make some hormonal birth control less effective. Discuss non-hormonal methods (like condoms or an IUD) with your doctor.

3. How to take Lucius Macitentan

Dosage: The typical dose for adults and children weighing 40 kg or more is 10 mg taken once daily.
Administration:
- Take the tablet by mouth with a full glass of water.
- You can take it with or without food.
- Swallow the tablet whole; do not crush, chew, or split it.
Timing: Try to take your dose at approximately the same time every day.
Missed Dose:
- Take it as soon as you remember.
- If it is almost time for your next dose, skip the missed dose and take your next dose at the regular time.
- Do not take a double dose to make up for a missed one.
Overdose: In case of overdose, contact your doctor or go to the nearest emergency room immediately. Symptoms may include headache, nausea, and vomiting.

4. Possible Side Effects

Common Side Effects:

Anemia (low red blood cell count)
Sore throat and nasal congestion (sinusitis)
Bronchitis
Headache
Flu-like symptoms
Bladder infection (urinary tract infection)

Serious Side Effects (Contact your doctor immediately if you experience any of these):

Signs of Liver Problems: Nausea, vomiting, right upper stomach pain, fatigue, loss of appetite, dark urine, yellowing of your skin or eyes (jaundice).
Signs of Fluid Retention: Unusual swelling of your ankles, legs, hands, or feet; sudden, unexplained weight gain; increased shortness of breath; feeling unusually tired.
Signs of Anemia: Severe tiredness, pale skin, shortness of breath, fast heartbeat.

5. How to Store Lucius Macitentan

Store at room temperature in the original container.
Keep out of reach of children and pets.
Do not use this medicine after the expiration date printed on the pack.

6. Contents of the Pack and Other Information

Active Ingredient: Macitentan (10 mg per tablet).
Inactive Ingredients: Includes lactose, maize starch, and other tablet-forming agents.

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