"The U.S. Food and Drug Administration today approved Opsumit (macitentan), a new drug to treat adults with pulmonary arterial hypertension (PAH), a chronic, progressive and debilitating disease that can lead to death or the need for lung transpla"...
Chronic-Thromboembolic Pulmonary Hypertension
Adempas is indicated for the treatment of adults with persistent/recurrent chronic thromboembolic pulmonary hypertension (CTEPH), (WHO Group 4) after surgical treatment, or inoperable CTEPH, to improve exercise capacity and WHO functional class [see Clinical Studies].
Pulmonary Arterial Hypertension
Adempas is indicated for the treatment of adults with pulmonary arterial hypertension (PAH), (WHO Group 1), to improve exercise capacity, WHO functional class and to delay clinical worsening.
Efficacy was shown in patients on Adempas monotherapy or in combination with endothelin receptor antagonists or prostanoids. Studies establishing effectiveness included predominately patients with WHO functional class II–III and etiologies of idiopathic or heritable PAH (61%) or PAH associated with connective tissue diseases (25%) [see Clinical Studies].
DOSAGE AND ADMINISTRATION
Recommended Dosage In Adult Patients
The recommended starting dosage is 1 mg taken 3 times a day. For patients who may not tolerate the hypotensive effect of Adempas, consider a starting dose of 0.5 mg taken three times a day. If systolic blood pressure remains greater than 95 mmHg and the patient has no signs or symptoms of hypotension, up-titrate the dose by 0.5 mg taken three times a day. Dose increases should be no sooner than 2 weeks apart. The dose can be increased to the highest tolerated dosage, up to a maximum of 2.5 mg taken three times a day. If at any time, the patient has symptoms of hypotension, decrease the dosage by 0.5 mg taken three times a day.
If a dose is missed, advise patients to continue with the next regularly scheduled dose. In case Adempas is interrupted for 3 days or more, re-titrate Adempas.
Pregnancy Testing In Females Of Reproductive Potential
Obtain pregnancy tests prior to initiation and monthly during treatment [see Use in Specific Populations].
Use In Patients Who Smoke
Consider titrating to dosages higher than 2.5 mg three times a day, if tolerated, in patients who smoke. A dose decrease may be required in patients who stop smoking [see DRUG INTERACTIONS and CLINICAL PHARMACOLOGY].
Strong CYP And P-gp/BCRP inhibitors
Consider a starting dose of 0.5 mg, three times a day when initiating Adempas in patients receiving strong cytochrome P450 (CYP) and P-glycoprotein/breast cancer resistance protein (P-gp/BCRP) inhibitors such as azole antimycotics (for example, ketoconazole, itraconazole) or HIV protease inhibitors (for example, ritonavir). Monitor for signs and symptoms of hypotension on initiation and on treatment with strong CYP and P-gp/BCRP inhibitors [see WARNINGS AND PRECAUTIONS, DRUG INTERACTIONS and CLINICAL PHARMACOLOGY].
Dosage Forms And Strengths
Tablets: film-coated, round, bi-convex:
- 0.5 mg, white, with “BAYER” cross on one side and “0.5” and “R” on the other side
- 1 mg, pale-yellow, with “BAYER” cross on one side and “1” and “R” on the other side
- 1.5 mg, yellow-orange, with “BAYER” cross on one side and “1.5” and “R” on the other side
- 2 mg, pale orange, with “BAYER” cross on one side and “2” and “R” on the other side
- 2.5 mg, red-orange, with “BAYER” cross on one side and “2.5” and “R” on the other side
Storage And Handling
Adempas (riociguat) tablets are film-coated, round, and debossed with the “Bayer cross” on one side.
|Color||Debossing Side 2||NDC 50419-xxx-xx|
|Bottle of 90||Blister of 42|
|0.5 mg||White||0.5 R||250-01||250-03|
|1 mg||Pale yellow||1 R||251-01||251-03|
|15 mg||Yellow-orange||1.5 R||252-01||252-03|
|2 mg||Pale orange||2 R||253-01||253-03|
|2.5 mg||Red-orange||2.5 R||254-01||254-03|
Store at 25°C (77°F); excursions are permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 5/27/2014
Additional Adempas Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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