Adefmipus Tablets 1.5 mg (Riociguat)

Adult dose

Initial dose The initial dose is 1.0 mg per dose, 3 times daily for 2 weeks. This medicine should be taken 3 times daily at approximately 6-8-hour intervals, regardless of food intake. To minimize the potential for hypotension, the initial dose may be started at 0.5mg 3 times daily. Dose titration If systolic blood pressure is 95 mmHg or higher and there are no signs or symptoms of hypotension, increase the dose by 0.5 mg per dose up to a maximum of 2.5 mg; dose titration should be performed at 2-week intervals. If systolic blood pressure is less than 95 mmHg and there are no signs or symptoms of hypotension, maintain the dose. If systolic blood pressure is less than 95 mmHg and signs or symptoms of hypotension are observed, withhold the next 3 doses at any time and, after 24 hours, if clinically acceptable, resume treatment at a dose reduced by 0.5 mg per dose. Maintenance dose The individualized maintenance dose established for each patient should be maintained provided that no signs or symptoms of hypotension occur. The maximum daily dose of this medicine is 7.5 mg. If a dose is missed, continue with the next scheduled dose. If tolerability is poor, dose reduction may be considered at any time. Interruption of treatment If treatment must be interrupted for 3 days or more, restart at the initial dose, administered 3 times daily for 2 weeks, and then continue treatment according to the dose titration method described above. For patients who cannot swallow tablets, this medicine may be crushed immediately before use, mixed with water or soft food such as applesauce, and administered orally. Elderly patients Exposure to this medicine is increased in elderly patients aged 65 years or older; therefore, special care is needed when individually titrating the dose. Patients with hepatic impairment Exposure to this medicine is increased in patients with moderate hepatic impairment (Child Pugh B); therefore, special care is needed when individually titrating the dose. This medicine has not been studied in patients with severe hepatic impairment (Child Pugh C) and should not be administered to them. Patients with renal impairment Exposure to this medicine is increased in patients with mild, moderate, or severe renal impairment (creatinine clearance 15-80 mL/min); therefore, special care is needed when individually titrating the dose. This medicine has not been studied in patients with a creatinine clearance of 15 mL/min or in patients on dialysis and should not be administered to them. Patients taking strong dual or multiple pathway CYP and P-gp (P-glycoprotein) / BCRP (Breast cancer resistance protein) inhibitors When initiating this medicine in patients taking a stable dose of strong dual or multiple pathway CYP and P-gp/BCRP inhibitors [e.g., azole antifungals (ketoconazole, itraconazole, etc.), HIV protease inhibitors (e.g., ritonavir, etc.)], consider a starting dose of 0.5mg 3 times daily to reduce the risk of hypotension. Monitor for signs and symptoms of hypotension at the start of treatment and during treatment (see section ‘3. Patients for whom administration requires caution’ under Precautions for Use). Smokers Smoking cessation is recommended for smokers. Blood concentrations of this medicine were lower in smokers than in nonsmokers. Dose adjustment of this medicine may be necessary in patients who stop smoking or start smoking during treatment. Switching medications Discontinue sildenafil at least 24 hours before starting this medicine. Discontinue tadalafil at least 48 hours before starting this medicine. For patients at risk of hypotension, consider starting this medicine at an initial dose of 0.5mg. When switching medications, observation for signs or symptoms of hypotension is recommended initially. Discontinue this medicine at least 24 hours before administering a PDE-5 inhibitor. When switching medications, observation for signs or symptoms of hypotension is recommended initially.

This medication should not be used in pregnant women as it may harm the fetus. Women of childbearing potential must confirm pregnancy status before taking this medication and should use appropriate contraception continuously during and after treatment. This medication should be avoided in certain patients. For example, patients with allergies to the active ingredients, pregnant or nursing women, those with specific low blood pressure circumstances, severe liver or kidney dysfunction, or those taking specific other medications should not use it. Patients with special conditions related to pulmonary vascular diseases or at high risk of respiratory bleeding should use this medication cautiously, and patients at risk of hypotension should closely monitor blood pressure. Dosage adjustment and caution are necessary for patients with impaired liver or kidney function and elderly patients. This medication may interact with other drugs, so inform the doctor or pharmacist about any other medications being taken. Especially, taking it with other vasodilators can be risky. During treatment, side effects such as headache, dizziness, dyspepsia, nausea, diarrhea, vomiting, peripheral edema may occur; and in rare cases, severe bleeding may happen, so immediate consultation with a healthcare professional is necessary if unusual symptoms appear. There are no special interactions with food, but smoking may reduce the effectiveness, so quitting smoking is recommended. Dizziness may occur while taking this medication, so caution is required when driving or operating machinery. In case of overdose, severe hypotension may occur, requiring immediate medical attention. This medication is not recommended for children as safety and effectiveness have not been established. Lastly, it should be stored out of reach of children and not transferred to other containers.

• Headache
• dizziness
• indigestion
• peripheral edema
• nausea
• diarrhea
• vomiting
• anemia
• palpitations
• low blood pressure

Store this medication in a tightly sealed container to avoid exposure to air or moisture. The recommended storage temperature is room temperature between 1 to 30 degrees Celsius.

Appearance

Round, yellow-orange, film-coated tablet with both sides convex; one side is engraved with '1.5' above 'R', and the other side features the Bayer cross.

Package unit

42 tablets (21 tablets/PTP packaging x 2)