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Drug class: agents for pulmonary hypertension

Generic name: Macitentan.

What is Opsumit?

Opsumit helps your heart pump more blood by lowering blood pressure.Opsumit treats hypertension pulmonary arterial (PAH). It increases your ability to exercise and helps prevent your condition from worsening.

Women can only get Opsumit through a pharmacy that is certified. You must register in the programme, and you must understand the risks and advantages of taking this medicine.


Opsumit should not be used if pregnant. Inform your doctor immediately if you think you might have become pregnant while on treatment. Use highly effective birth-control methods to avoid pregnancy during treatment and for 30 days following the end of your treatment.

Before you begin taking Opsumit, you will need a negative pregnancy result. You will be tested every month throughout your treatment and one month after stopping this medication.

Before you take this drug

Opsumit should not be used if you have an allergy to macitentan, are pregnant, or may become pregnant while taking the medication.

Tell your doctor about any of the following to ensure that this medicine will be safe for you:

  • Liver disease
  • Heart disease
  • Anaemia (low red cell count)

This medication may harm a developing baby or cause a birth defect. Opsumit should not be used if you are pregnant or suspect you may be pregnant. Inform your doctor immediately if you think you have missed a period or if it appears that you became pregnant while taking Opsumit.

Before starting the treatment, you will need a negative pregnancy result. Every month, you will be tested during treatment and one month after stopping the medicine.

Even if you don't plan to get pregnant, if:

  • You have reached puberty, even if your period has not yet begun.
  • You have not had a hysterectomy or your ovaries taken out.
  • You have not experienced menopause.

During the 30 days following your last Opsumit dose and while taking Opsumit, you should use two highly effective methods of birth control or a combination.

  • Tubal ligation is the only effective method of birth control.
  • A birth control method that is effective on its own includes the intrauterine device or implant.
  • You must always use a barrier birth control method as a backup if you are using birth control pills or injections. Use a spermicide insert or gel in conjunction with a barrier birth control method.
  • You must have a backup barrier method if you only use one. Use a cervical cap or diaphragm in addition to the condom and spermicide gel.
  • You must use a second form of birth control if your partner has undergone a vasectomy. This can be a hormonal method (birth control pills or injections) or a barrier method (skin patches, vaginal rings, or skin patches).

Opsumit includes patient instructions on acceptable birth control methods to use when taking this medication. Please follow the instructions carefully. If you have questions, ask your doctor or pharmacist.

Even if your child has not started menstruating, if you are a parent or carer and you notice signs of puberty in a girl (such as breast development or pubic hair), you should speak to her doctor.Macitentan may decrease sperm counts and affect male fertility (your ability to have children).Breastfeeding women must not use this medicine.

How to take Opsumit?

Follow the instructions on your prescription label. Please follow all the instructions on the prescription label. Take this medication only as prescribed. Do not exceed the recommended dosage or take it for a longer time.This medicine can be taken with or without food.

Do not chew, crush, or break Opsumit tablets.You may need to have frequent blood tests while using Opsumit.Store away from heat and moisture at room temperature.

Details on dosage

Adult dose for pulmonary hypertension:

Dosage: 10 mg once daily orally

Approved indications: To delay the progression of pulmonary arterial hypertension (PAH) in WHO Group I.

What happens if I miss the dose?

As soon as you recall a missed dose, take it immediately. If it is almost time for your next scheduled dosage, skip it altogether. Do not double up on additional medicine just because of one missed dose.

What happens if I overdose?

Call 1-800-222-1222 for poison help or seek immediate medical attention.

What should be avoided?

Avoid unprotected sexual activity while taking Opsumit. You must use birth control to prevent pregnancy while taking Opsumit and for 30 days following its discontinuation.

Side effects of Opsumit

If you experience any of the following symptoms of an allergic reaction: hives, difficulty breathing, swelling of your lips, face, tongue, or throat,

If you experience any of the following symptoms, stop using Opsumit immediately and contact your doctor.

  • Pain or burning after urinating;
  • Rapid weight gain and swelling
  • Liver problems: nausea, upper abdominal pain, itching and fatigue, loss of appetite, dark urine, clay-coloured stools, or jaundice
  • New lung problems Anxiety, sweating, and pale skin Severe shortness of breath, wheezing or gasping, coughing up foamy mucus

Side effects of Opsumit include:

  • Sore throat, stuffy nose, and sinus pain
  • A bladder infection
  • Headache
  • Flu symptoms (fever, chills, and body aches)

There may be other side effects. For medical advice on side effects, call your doctor. Contact the FDA by dialing 1-800-FDA-1088 in order to report side effects.

Interaction with other drug

Macitentan may interact with other drugs, such as prescription and over-the-counter medicines, herbal products, vitamins, and herbal supplements. Inform your healthcare providers of all the medicines you are taking and those you plan to take.



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