Ruianto ? Cinacalcet Hydrochloride Tablets

Selected in the fifth round of National Volume-Based Procurement organized

by the National Essential Drugs, Category B under Medical Insurance

[Drug Name]

Generic Name: Cinacalcet Hydrochloride Tablets

[Indications]

This product is used for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease (CKD) receiving maintenance dialysis.

[Dosage and Administration]

This product is for oral use. The initial adult dose is 25 mg once daily. It should be taken with food or shortly after a meal. Tablets must be swallowed whole and should not be split before use. Based on adequate monitoring of intact parathyroid hormone (iPTH), serum calcium, and serum phosphorus levels, the dose may be gradually increased from 25 mg to 75 mg once daily. If hyperparathyroidism is not adequately controlled, the maximum daily dose is 100 mg. Dose increments should be in steps of 25 mg at intervals of no less than 3 weeks.

[Warnings]

Contraindicated in patients with hypersensitivity to this product or any of its components. For detailed information on adverse reactions and precautions, please refer to the Chinese package insert.

[Contraindications]

25 mg (calculated as C22H22F3N)

[Shelf Life]

36 months

[Approval Number]

National Medical Products Administration Approval Number: H20213175