How Effective is Opsumit (macitentan) ?
Opsumit (macitentan) effectively lowers blood pressure in the lungs, helping the heart to pump blood easily and more efficiently. This medicine is used in treating pulmonary arterial hypertension (PAH). Opsumit improves an individual’s ability to exercise. If you have PAH, Opsumit will prevent your condition from worsening.
It is available only to women under a special program and you can only get it from a certified pharmacy. Unless you understand all the benefits and risks of using Opsumit, and you are registered in the program, you cannot take it.
One should not take Opsumit if they are pregnant. You must inform your doctor at once if you think you have become pregnant while on this medication. Be sure to use an effective birth control method so that you do not become pregnant when you are using Opsumit, and for at least a month after you have stopped using it.
Before you start using this medication, you will be required to have a negative pregnancy test. You will also undergo the pregnancy tests every 30 days during your treatment. You will be re-tested again 30 days after you have stopped taking Opsumit.
One should not take this medication if they are pregnant, allergic to Opsumit (macitentan), or if you may become pregnant while on treatment.
To ensure that Opsumit is safe for you, you must inform your physician if you have:
Opsumit (macitentan) can harm an unborn baby. It can also cause serious birth defects. You should never use this medication during pregnancy, or if you suspect you might be pregnant. You should inform your doctor at once if you suspect you have become pregnant.
Before taking Opsumit, you must have a negative pregnancy test. You will also be re-tested after every one month during treatment, and after a month when you have stopped taking it.
You are normally considered able to get pregnant if:
- You have not gone a whole year without a menstrual period (Menopause);
- You have already reached puberty stage even if you haven’t had your first periods yet; or
- You have never had your ovaries removed
- While taking Opsumit, use a very effective form of birth control. You can even take two methods of birth control together.
If you are using birth control vaginal rings, skin patches, injections, or pills, you should also use some back-up barrier form of birth control like a cervical cap, diaphragm or condom. You should not fail to use a spermicide gel, or insert alongside a barrier form of birth control.
A tubal ligation alone is a highly effective method of preventing pregnancy.
If you choose to use a barrier method, you should also use an additional barrier method to act as a back-up. For instance, use a cervical cap or a diaphragm in addition to a condom. You can also use an insert or a spermicide gel.
Birth control implant or an intrauterine device (IUD) alone is also highly effective birth control methods.
In case you sexual partner or husband has had a vasectomy, you should still use another method of birth control such as a hormonal form or a barrier form.
Opsumit comes with clear instructions about all acceptable forms of birth control methods to use while using it. You should follow all the instructions carefully. You can always ask your pharmacist or doctor if you need any clarification.
If you are the caregiver or parent of a young girl taking this Opsumit, you should contact the doctor right away if you detect or see any sign of puberty such as pubic hair and breast development. You don’t have to wait until menstrual periods begin.
The use of Opsumit can decrease sperm count in men and it can also affect their fertility negatively.
It has not been proven whether Opsumit can pass into breast milk/if it can actually harm a new born baby. Do not breast-feed while taking this Opsumit.
What is the Recommended Dosage of Opsumit?
For Pulmonary Hypertension:
- Adults should take 10 mg orally once per day
- Approved indication. Opsumit has been approved as the treatment of pulmonary arterial hypertension. It delays disease progression.
- Avoid having unprotected sex while on this medication. You must a highly effective birth control so that you don’t become pregnant while on treatment, and for at least a month after stopping using this medicine.
What are the Side Effects of Opsumit?
Contact your doctor at once if you notice any signs of allergic reaction to this medication: difficult breathing; hives, swelling of your throat, tongue, lips, or face.
Stop using this medication and contact your doctor immediately if you have these severe side effects of Opsumit:
- Burning or pain when urinating;
- New lung problems – sweating, anxiety, wheezing, pale skin, life-threatening shortness of breath, uneven heart rate, chest pain, cough with foamy mucus, gasping for breath;
- Rapid weight gain;
- Swelling; or
- Liver problems – itching, upper stomach pain, dark urine, nausea, tired feeling, clay-colored stools, and loss of appetite, jaundice (yellowing of the eyes or skin.)
Common Side Effects of Opsumit may include:
- Flu symptoms such as fever, body aches, and chills;
- Stuffy nose, sore throat, sinus pain; or