Adempas Side Effects Center

Last updated on RxList: 8/19/2020
Adempas Side Effects Center

What Is Adempas?

Adempas (riociguat) is a soluble guanylate cyclase stimulator used to treat adults with two forms of pulmonary hypertension.

What Are Side Effects of Adempas?

Common side effects of Adempas include:

Dosage for Adempas

The recommended starting dosage of Adempas is 1 mg taken 3 times a day.

What Drugs, Substances, or Supplements Interact with Adempas?

Adempas may interact with:

  • nitrates,
  • sildenafil,
  • tadalafil,
  • vardenafil,
  • dipyridamole,
  • theophylline,
  • azole antifungals,
  • HIV protease inhibitors,
  • rifampin,
  • phenytoin,
  • carbamazepine,
  • phenobarbital,
  • St. John's Wort, or
  • antacids

Tell your doctor all medications and supplements you use.

Adempas During Pregnancy and Breastfeeding

Adempas is not recommended for use during pregnancy. It may harm a fetus. For women, Adempas is only available through the Adempas REMS Program and women must comply with pregnancy testing and contraception requirements. Consult your doctor for details. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Adempas (riociguat) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

QUESTION

COPD (chronic obstructive pulmonary disease) is the same as adult-onset asthma. See Answer
Adempas Consumer Information

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

Stop using riociguat 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, unusual tiredness, feeling light-headed or short of breath, cold hands and feet; or
  • build-up of fluid in your lungs--anxiety, sweating, pale skin, severe shortness of breath, wheezing, gasping for breath, cough with foamy mucus, chest pain, fast or uneven heart rate.

Common side effects may include:

  • headache, dizziness;
  • indigestion, nausea, 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.

Read the entire detailed patient monograph for Adempas (Riociguat Tablets)

SLIDESHOW

COPD Foods to Boost Your Health - COPD Diet Tips See Slideshow
Adempas Professional Information

SIDE EFFECTS

The following serious adverse reactions are discussed elsewhere in the labeling:

  • Embryo-Fetal Toxicity [see WARNINGS AND PRECAUTIONS]
  • Hypotension [see WARNINGS AND PRECAUTIONS]
  • Bleeding [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety data described below reflect exposure to Adempas in two, randomized, double blind, placebo-controlled trials in patients with inoperable or recurrent/persistent CTEPH (CHEST-1) and treatment naive or pre-treated PAH patients (PATENT-1). The population (Adempas: n = 490; Placebo: n = 214) was between the age of 18 and 80 years [see Clinical Studies].

The safety profile of Adempas in patients with inoperable or recurrent/persistent CTEPH (CHEST-1) and treatment naive or pre-treated PAH (PATENT-1) were similar. Therefore, adverse drug reactions (ADRs) identified from the 12 and 16 week placebo-controlled trials for PAH and CTEPH respectively were pooled, and those occurring more frequently on Adempas than placebo (≥3%) are displayed in Table 1 below. Most adverse reactions in Table 1 can be ascribed to the vasodilatory mechanism of action of Adempas.

The overall rates of discontinuation due to an adverse event in the pivotal placebo-controlled trials were 2.9% for Adempas and 5.1% for placebo (pooled data).

Table 1: Adverse Reactions Occurring More Frequently (≥3%) on Adempas than Placebo (Pooled from CHEST-1 and PATENT-1)

Adverse Reactions Adempas %
(n=490)
Placebo %
(n=214)
Headache 27 18
Dyspepsia and Gastritis 21 8
Dizziness 20 13
Nausea 14 11
Diarrhea 12 8
Hypotension 10 4
Vomiting 10 7
Anemia (including laboratory parameters) 7 2
Gastroesophageal reflux disease 5 2
Constipation 5 1

Other events that were seen more frequently in Adempas compared to placebo and potentially related to treatment were: palpitations, nasal congestion, epistaxis, dysphagia, abdominal distension and peripheral edema. With longer observation in uncontrolled long-term extension studies the safety profile was similar to that observed in the placebo controlled phase 3 trials.

DRUG INTERACTIONS

Pharmacodynamic Interactions With Adempas

Other Soluble Guanylate Cyclase Stimulators

Co-administration of Adempas is contraindicated in patients with use of other soluble guanylate cyclase (sGC) stimulators [see CONTRAINDICATIONS].

Nitrates

Co-administration of Adempas with nitrates or nitric oxide donors (such as amyl nitrite) in any form is contraindicated because of hypotension [see CONTRAINDICATIONS and CLINICAL PHARMACOLOGY].

PDE Inhibitors

Co-administration of Adempas with specific PDE-5 inhibitors (such as sildenafil, tadalafil, or vardenafil) and nonspecific PDE inhibitors (such as dipyridamole or theophylline), is contraindicated because of hypotension. Do not administer within 24 hours of sildenafil. Do not administer 24 hours before or within 48 hours after tadalafil [see DOSAGE AND ADMINISTRATION]. Clinical experience with co-administration of Adempas and other phosphodiesterase inhibitors (for example, milrinone, cilostazole, roflumilast) is limited.

Pharmacokinetic Interactions With Adempas

Smoking

Plasma concentrations in smokers are reduced by 50% to 60% compared to nonsmokers. Based on pharmacokinetic modeling, for patients who are smokers, doses higher than 2.5 mg three times a day may be considered in order to match exposure seen in nonsmoking patients. Safety and effectiveness of Adempas doses higher than 2.5 mg three times a day have not been established. A dose reduction should be considered in patients who stop smoking [see DOSAGE AND ADMINISTRATION and CLINICAL PHARMACOLOGY].

Strong CYP And P-gp/BCRP Inhibitors

Concomitant use of riociguat with strong cytochrome CYP inhibitors and Pgp/BCRP inhibitors such as azole antimycotics (for example, ketoconazole, itraconazole) or HIV protease inhibitors (such as ritonavir) increase riociguat exposure and may result in hypotension. Consider a starting dose of 0.5 mg 3 times a day when initiating Adempas in patients receiving strong CYP and P-gp/BCRP inhibitors. Monitor for signs and symptoms of hypotension on initiation and on treatment with strong CYP and P-gp/BCRP inhibitors. A dose reduction should be considered in patients who may not tolerate the hypotensive effect of riociguat [see DOSAGE AND ADMINISTRATION, WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY].

Strong CYP3A Inducers

Strong inducers of CYP3A (for example, rifampin, phenytoin, carbamazepine, phenobarbital or St. John’s Wort) may significantly reduce riociguat exposure. Data are not available to guide dosing of riociguat when strong CYP3A inducers are co-administered [see CLINICAL PHARMACOLOGY].

Antacids

Antacids such as aluminum hydroxide/magnesium hydroxide decrease riociguat absorption and should not be taken within 1 hour of taking Adempas [see CLINICAL PHARMACOLOGY].

Read the entire FDA prescribing information for Adempas (Riociguat Tablets)

© Adempas Patient Information is supplied by Cerner Multum, Inc. and Adempas Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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