Opsumit
Generic name:macitentan [ MA-si-TEN-tan ]
Drug class:Agents for pulmonary hypertension
What is Opsumit?
Opsumit lowers blood pressure in your lungs, helping your heart pump blood more efficiently.
Opsumit is used to treat pulmonary arterial hypertension (PAH). It improves your ability to exercise and prevents your condition from getting worse.
Opsumit is available to women only under a special program from a certified pharmacy. You must be registered in the program and understand the risks and benefits of taking this medication.
Warnings
Do not use Opsumit if you are pregnant. Tell your doctor right away if you miss a menstrual period or think you may have become pregnant during treatment. You must use highly effective birth control methods to prevent pregnancy while you are using this medication and for at least 30 days after your treatment ends.
You will need to have a negative pregnancy test before you start taking Opsumit. You will also be re-tested every month during your treatment, and 1 month after you stop taking this medicine.
Before taking this medicine
You should not use Opsumit if you are allergic to macitentan, or if you are pregnant or might become pregnant during treatment.
To make sure this medicine is safe for you, tell your doctor if you have ever had:
liver disease;
heart disease; or
anemia (low red blood cells).
This medication can harm an unborn baby or cause birth defects. Do not use Opsumit if you are pregnant or think you might be pregnant. Tell your doctor right away if you miss a menstrual period or think you may have become pregnant during treatment.
You will need to have a negative pregnancy test before starting this treatment. You will be re-tested every month during your treatment, and 1 month after you stop taking this medicine.
Even if you are not planning a pregnancy, you are considered able to become pregnant if:
you have entered puberty (even if you have not yet started having periods);
you have never had a hysterectomy or had your ovaries removed; or
you have not gone through menopause (you have never gone 12 months in a row without a menstrual period).
While taking Opsumit and for 30 days after your last dose, you must use a highly effective form of birth control, or two methods together.
A tubal ligation alone is an effective birth control method.
An intrauterine device (IUD) or birth control implant alone are also effective birth control methods.
If you use birth control pills, injections, skin patches, or vaginal rings, you must use a back-up barrier form of birth control, such as a condom or diaphragm or cervical cap. Always use a spermicide gel or insert together with a barrier form of birth control.
If you...
