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 use only a barrier method, you must use a second barrier method as a back-up. For example, use a diaphragm or cervical cap in addition to a condom, plus a spermicide gel or insert.
• If your sexual partner has had a vasectomy, you must still use a second method of birth control–either a barrier method or a hormonal form (birth control pills, injections, skin patch, or vaginal ring).

Opsumit comes with patient instructions about acceptable forms of birth control to use while taking this medicine. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

If you are the parent or caregiver of a female child taking this medication, talk to the child’s doctor once you notice any signs of puberty (breast development or pubic hair), even if menstrual periods have not yet begun.

Macitentan can decrease sperm count and may affect fertility in men (your ability to have children).

You should not breast-feed while using this medicine.

How should I take Opsumit?

Take Opsumit exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

You may take this medicine with or without food.

Swallow the Opsumit tablet whole and do not crush, chew, or break the tablet.

While using Opsumit, you may need frequent blood tests.

Store at room temperature away from moisture and heat.

Dosing information

Usual Adult Dose for Pulmonary Hypertension:

Recommended dose: 10 mg orally once a day

Approved indication: For the treatment of pulmonary arterial hypertension (PAH, WHO Group I) to delay disease progression.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What to avoid

Do not have unprotected sex while taking Opsumit. You must use birth control to prevent pregnancy during treatment and for at least 30 days after you stop taking this medicine.

Opsumit side effects

Get emergency medical help if you have any signs of an allergic reaction to Opsumit: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using Opsumit and call your doctor at once if you have:

• pain or burning when you urinate;
• swelling, rapid weight gain;
• liver problems – nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
• new lung problems – anxiety, sweating, pale skin, severe shortness of breath, wheezing, gasping for breath, cough with foamy mucus, chest pain, fast or uneven heart rate.

Common Opsumit side effects may include:

• stuffy nose, sinus pain, sore throat;
• a bladder infection;
• headache; or
• flu symptoms (fever, chills, body aches).

What is tadalafil?

Tadalafil relaxes muscles of the blood vessels and increases blood flow to particular areas of the body.

Tadalafil under the name of Cialis is used to treat erectile dysfunction (impotence) and symptoms of benign prostatic hypertrophy (enlarged prostate). Another brand of tadalafil is Adcirca, which is used to treat pulmonary arterial hypertension and improve exercise capacity in men and women.

Warnings

Do not take tadalafil if you are also using a nitrate drug for chest pain or heart problems, including nitroglycerin, isosorbide dinitrate, isosorbide mononitrate, and some recreational drugs such as “poppers”. Taking tadalafil with a nitrate medicine can cause a sudden and serious decrease in blood pressure.

Some medicines can cause unwanted or dangerous effects when used with tadalafil. Tell your doctor about all your current medicines, especially riociguat (Adempas).

Contact your doctor or seek emergency medical attention if your erection is painful or lasts longer than 4 hours. A prolonged erection (priapism) can damage the penis.

Get medical help at once if you have nausea, chest pain, or dizziness during sex.

Stop using tadalafil and get emergency medical help if you have sudden vision loss.

Before taking this medicine

You should not take tadalafil if you are allergic to it.

Taking tadalafil with certain other medicines can cause a sudden and serious decrease in blood pressure. Do not take this medicine if you also use:

• riociguat (to treat pulmonary arterial hypertension); or
• a nitrate drug (for chest pain or heart problems) such as nitroglycerin, isosorbide dinitrate, isosorbide mononitrate, or recreational drugs such as amyl nitrate or nitrite “poppers”.

Some tadalafil can remain in your bloodstream for 2 or more days after each dose you take (longer if you have liver or kidney disease). Avoid nitrate use during this time.

To make sure this medicine is safe for you, tell your doctor if you have ever had:

• heart disease or heart rhythm problems;
• a heart attack or stroke;
• angina (chest pain), high or low blood pressure;
• pulmonary hypertension (unless you are taking tadalafil for this);
• a condition called pulmonary veno-occlusive disease (narrowing of the veins that carry blood from the lungs to the heart);
• liver or kidney disease (or if you are on dialysis);
• vision loss, or retinitis pigmentosa (an inherited condition of the eye);
• a bleeding disorder;
• a blood cell disorder such as sickle cell anemia, multiple myeloma, or leukemia;
• a physical deformity of the penis (such as Peyronie’s disease), or an erection lasting longer than 4 hours;
• a stomach ulcer; or
• health problems that make sexual activity unsafe.

Sudden vision loss has occurred in a small number of people taking medicines like tadalafil (Viagra or others). Most of these people already had certain eye problems or risk factors for blood vessel disorders (heart disease, diabetes, high blood pressure, high cholesterol, coronary artery disease, smoking, or being over 50 years old). It is not clear whether the medicine was the actual cause of vision loss. Sudden hearing loss has also been reported with tadalafil. Stop tadalafil and call your doctor immediately for any hearing loss, decrease in hearing, or ringing in the ears.

Do not start or stop taking tadalafil during pregnancy without your doctor’s advice. Having pulmonary arterial hypertension (PAH) during pregnancy may cause heart failure, stroke, or other medical problems in both mother and baby. Tell your doctor right away if you become pregnant.

It may not be safe to breastfeed while using tadalafil. Ask your doctor about any risk.

Cialis is not for use in women.

Tadalafil is not approved for use by anyone younger than 18 years old.

How should I take tadalafil?

Tadalafil is usually taken only once per day. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Tadalafil can be taken with or without food.

Do not break or split a Cialis tablet. Swallow it whole.

For erectile dysfunction, take Cialis just before sexual activity but not more than once per day. It can be used up to 36 hours before sexual activity. Cialis can help achieve an erection when sexual stimulation occurs. An erection will not occur just by taking a pill. Follow your doctor’s instructions.

Do not take Cialis for erectile dysfunction if you are taking Adcirca for pulmonary arterial hypertension.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

If tadalafil is used as needed, you are not likely to be on a dosing schedule.

If you take tadalafil every day and you miss a dose, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What to avoid

Drinking alcohol with this medicine can cause a drop in blood pressure, leading to dizziness or fainting.

Grapefruit and grapefruit juice may interact with tadalafil and lead to unwanted side effects. Avoid the use of grapefruit products while taking this medicine.

Tadalafil side effects

Get emergency medical help if you have signs of an allergic reaction to tadalafil: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop and get medical help at once if you have nausea, chest pain, or dizziness during sex. You could be having a life-threatening side effect.

Stop using tadalafil and call your doctor at once if you have:

• a light-headed feeling, like you might pass out;
• an erection is painful or lasts longer than 4 hours (prolonged erection can damage the penis);
• vision changes or sudden vision loss;
• ringing in your ears or sudden hearing loss; or
• heart attack symptoms – chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating.

Common tadalafil side effects may include:

• headache;
• flushing (warmth, redness, or tingly feeling);
• nausea, upset stomach;
• stuffy nose; or
• muscle pain, back pain, pain in your arms, legs, or back.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect tadalafil?

Tell your doctor about all your current medicines and any you start or stop using, especially:

• medicines to treat erectile dysfunction or pulmonary arterial hypertension;
• an antibiotic or antifungal medicine;
• antiviral medicine to treat hepatitis C or HIV/AIDS;
• drugs to treat high blood pressure or a prostate disorder; or
• seizure medicine.

This list is not complete. Other drugs may interact with tadalafil, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.