adempas

Adempas (riociguat) lowers blood pressure in your lungs, helping your heart pump blood more efficiently.

Adempas is used to treat chronic thromboembolic pulmonary hypertension (CTEPH) in people who cannot be treated with surgery, or in people who have undergone surgery but still have symptoms. Adempas can treat certain symptoms of CTEPH and can improve your ability to exercise.

Adempas is used to treat pulmonary arterial hypertension (PAH). It can improve your ability to exercise and help prevent PAH from getting worse.

Riociguat 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.

Important information

Do not use Adempas 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 starting taking Adempas. You will also be re-tested every month during your treatment, and 1 month after you stop taking this medicine.

Adempas is available to women only under a special program from a certified pharmacy.

Before taking this medicine

You should not use Adempas if you are allergic to riociguat, or if you are pregnant or might become pregnant during treatment.

Some medicines can interact with riociguat and should not be used at the same time. Your doctor may need to change your treatment plan if you use any of the following drugs:

• dipyridamole;

• theophylline;

• erectile dysfunction medicine such as sildenafil, tadalafil, or vardenafil;

• a nitrate drug for chest pain or heart problems (amyl nitrite, nitroglycerin, and others); or

• other medicines to treat PAH (Adcirca or Revatio).

To make sure Adempas is safe for you, tell your doctor if you have:

• heart disease;

• blood circulation problems;

• low blood pressure;

• a condition called pulmonary veno-occlusive disease (PVOD);

• a recent history of coughing up blood or bleeding from your lung;

• liver disease;

• kidney disease (or if you are on dialysis);

• if you smoke; or

• if you are dehydrated.

FDA pregnancy category X. This medication can harm an unborn baby or cause birth defects. Do not use Adempas if you are pregnant. Tell your doctor right away if you miss a menstrual period or think you may have become pregnant during treatment.

See also: Pregnancy and breastfeeding warnings (in more detail)

You will need to have a negative pregnancy test before starting this treatment. You will also 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 Adempas 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).

Adempas 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.

It is not known whether riociguat passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

How should I take Adempas?

Take Adempas exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Adempas is usually taken 3 times per day. Space your doses 6 to 8 hours apart.

You may take this medicine with or without food.

You may need frequent medical tests to help your doctor determine how long to treat you with Adempas.

Store at room temperature away from moisture and heat.

Adempas dosing information

Usual Adult Dose for Pulmonary Hypertension:

Initial dose: 1 mg orally 3 times a day
Maximum dose: 2.5 mg orally 3 times a day

Comments:
-For patients who cannot tolerate the hypotensive effect, consider a starting dose of 0.5 mg orally 3 times a day. If systolic blood pressure remains greater than 95 mmHg and the patient has no signs of hypotension, the dose may be titrated up by 0.5 mg orally 3 times a day.
-Dose increases should be no more frequent than every 2 weeks.

Use(s):
-Persistent/recurrent chronic thromboembolic pulmonary hypertension (CTEPH) (WHO group 4) after surgical treatment or inoperable CTEPH to improve exercise capacity and WHO functional class.
-As monotherapy or in combination with endothelin receptor antagonists or prostanoids to treat pulmonary arterial hypertension (PAH) (WHO group 1) to improve exercise capacity, improve WHO functional class and to delay clinical worsening.

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.

Call your doctor if you miss your doses for 3 days in a row or longer.

What happens if I overdose?

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

What should I avoid while taking Adempas?

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

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Smoking can make Adempas less effective. Tell your doctor if you start or stop smoking while you are taking this medicine. Your dose needs may need to be changed

Avoid taking an antacid within 1 hour before or after you take Adempas. Some antacids can make it harder for your body to absorb riociguat.

Adempas side effects

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

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

• a light-headed feeling, like you might pass out;

• vomiting or coughing up bright red blood, or vomit that looks like coffee grounds; 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 Adempas side effects may include:

• mild dizziness;

• headache;

• upset stomach, vomiting, diarrhea; or

• swelling in your hands, legs, or feet.

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.

See also: Side effects (in more detail)

What other drugs will affect Adempas?

Other drugs may interact with riociguat, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.