Adempas

ADEMPAS- riociguat tablet, film coated
Bayer HealthCare Pharmaceuticals Inc.

WARNING: EMBRYO-FETAL TOXICITY

Do not administer Adempas to a pregnant female because it may cause fetal harm [see Contraindications (4.1), Warnings and Precautions (5.1) and Use in Specific Populations (8.1)].

Females of reproductive potential: Exclude pregnancy before the start of treatment, monthly during treatment, and 1 month after stopping treatment. To prevent pregnancy, females of reproductive potential must use effective forms of contraception during treatment and for one month after [see Dosage and Administration (2.3), Warnings and Precautions (5.1, 5.2),and Use in Specific Populations (8.3)].

For all female patients, Adempas is available only through a restricted program called the Adempas Risk Evaluation and Mitigation Strategy (REMS) Program [see Warnings and Precautions (5.1, 5.2)].

1 INDICATIONS AND USAGE

1.1 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 (14.1)].

1.2 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 (14.2)].

2 DOSAGE AND ADMINISTRATION

2.1 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.

Crushed Tablets

For patients who are unable to swallow whole tablets, Adempas may be crushed and mixed with water or soft foods (such as applesauce) immediately before administration [see Clinical Pharmacology (12.3)].

2.2 Dosage Interruption

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.

2.3 Pregnancy Testing in Females of Reproductive Potential

Obtain pregnancy tests prior to start of treatment and monthly during treatment [see Use in Specific Populations (8.3)].

2.4 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 (7.2) and Clinical Pharmacology (12.3)].

2.5 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 (5.3), Drug Interactions (7.2) and Clinical Pharmacology (12.3)].

2.6 Transitioning to and from Adempas

Discontinue sildenafil at least 24 hours prior to administering Adempas [see Contraindications (4.3) and Drug Interactions (7)].
Discontinue tadalafil at least 48 hours prior to administering Adempas [see Contraindications (4.3) and Drug Interactions (7)]. Consider initiating Adempas at a starting dose of 0.5 mg in patients at risk of hypotension [see Dosage and Administration (2.1)]. Monitor for signs and symptoms of hypotension on initiation.
Discontinue Adempas at least 24 hours prior to administering a PDE5-inhibitor [see Dosage and Administration (2.1), Contraindications (4.3), and Drug Interactions (7)]. Monitor for signs and symptoms of hypotension on initiation.

3 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

4 CONTRAINDICATIONS

4.1 Pregnancy

Based on data from animal reproduction studies, Adempas may cause fetal harm when administered to a pregnant woman and is contraindicated in females who are pregnant. Adempas was consistently shown to have teratogenic effects when administered to animals. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus [see Use in Specific Populations (8.1)].

4.2 Nitrates and Nitric Oxide Donors

Co-administration of Adempas with nitrates or nitric oxide donors (such as amyl nitrite) in any form is contraindicated [see Drug Interactions (7.1) and Clinical Pharmacology (12.2)].

4.3 Phosphodiesterase Inhibitors

Concomitant administration of Adempas with specific PDE-5 inhibitors (such as sildenafil, tadalafil, or vardenafil) or nonspecific PDE 5 inhibitors (such as dipyridamole or theophylline) is contraindicated [see Dosage and Administration (2.6), Drug Interactions (7.1) and Clinical Pharmacology (12.2)]. Do not administer within 24 hours of sildenafil. Do not administer 24 hours before or within 48 hours after tadalafil.

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