Adempas

Name: Adempas

What Is Adempas?

Riociguat lowers blood pressure in your lungs, helping your heart pump blood more efficiently.

Riociguat 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. Riociguat can treat certain symptoms of CTEPH and can improve your ability to exercise.

Riociguat is used to treat pulmonary arterial hypertension (PAH). Riociguat 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.

Riociguat may also be used for purposes not listed in this medication guide.

Do not use riociguat if you are pregnant. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 1 month after your treatment ends.

You will need to have a negative pregnancy test before starting taking riociguat. You will also be re-tested every month during your treatment, and 1 month after you stop taking this medicine.

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

You should not use riociguat if you are allergic to it, 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 riociguat 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.

Do not use riociguat if you are pregnant. It could harm the unborn baby or cause birth defects. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 1 month after your treatment ends. 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 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 riociguat 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).

Riociguat 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.

Other uses for this medicine

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

How should I take riociguat?

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.

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

You may take riociguat with or without food.

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

Store at room temperature away from moisture and heat.

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.

Introduction

Vasodilator; a soluble guanylate cyclase (sGC) stimulator.1 6 7 10

Proper Use of Adempas

Take this medicine as exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

You may take this medicine with or without food.

If you have trouble swallowing the tablet, you may crush it and mix with water or soft foods (eg, applesauce) and take it immediately.

If you are using an antacid that contains aluminum or magnesium, take it 1 hour after taking riociguat.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (tablets):
    • For chronic thromboembolic pulmonary hypertension and pulmonary arterial hypertension:
      • Adults—At first, 1 milligram (mg) 3 times a day. Other patients may start at 0.5 mg 3 times a day. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 2.5 mg 3 times a day.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you missed taking this medicine for 3 days, call your doctor right away.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Administration

Oral Administration

Antacids (eg, aluminum hydroxide/magnesium hydroxide) decrease riociguat absorption and should not be taken within 1 hr of taking riociguat

If a dose is missed, continue with next regularly scheduled dose

If dosage interrupted for >3 days, retitrate dose

Adempas side effects

Get emergency medical help if you have 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;

  • abnormal vaginal bleeding, or any other unusual bleeding;

  • vomiting or coughing up bright red blood, or vomit that looks like coffee grounds;

  • low red blood cells (anemia) - pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating; 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:

  • dizziness;

  • headache;

  • indigestion, nausea, vomiting;

  • diarrhea, constipation; 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.

Liver Dose Adjustments

Severe liver dysfunction (Child-Pugh C): Safety and efficacy have not been established.

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