Procysbi Delayed Release

Generic name:cysteamine bitartrate
Dosage form: capsule, delayed release pellets
Drug class:Miscellaneous uncategorized agents

Medically reviewed by Drugs.com. Last updated on Feb 1, 2022.

Indications and Usage for Procysbi Delayed Release

PROCYSBI is indicated for the treatment of nephropathic cystinosis in adults and pediatric patients 1 year of age and older.

Procysbi Delayed Release Dosage and Administration

Important Dosing Instructions

• Initiate cysteamine treatment immediately after diagnosis of nephropathic cystinosis.
• Cysteamine-naïve Patients: Start PROCYSBI at a fraction of the maintenance dosage.
  • Patients 1 year to less than 6 years: Gradually increase the dosage, allowing a minimum of 2 weeks between adjustments [see Dosage and Administration (2.2)].
  • Patients 6 years of age and older: Gradually increase the dosage over 4 to 6 weeks until the maintenance dosage is achieved.
• Patients switching from immediate-release cysteamine: Start the total daily dosage of PROCYSBI at a dosage equal to the previous total daily dosage of immediate-release cysteamine [see Dosage and Administration (2.3)].
• If adverse reactions occur, decrease the PROCYSBI dosage.
• After the maintenance dosage of PROCYSBI is achieved: The dosage may need to be further increased to achieve a therapeutic target WBC cystine concentration. The maximum dosage of PROCYSBI is 1.95 grams/m2 of body surface area per day [see Dosage and Administration (2.4, 2.5)].
• Round dose calculations to the nearest incremental dosage that can be administered using the available strengths of PROCYSBI delayed-release capsules or packets of oral granules. Only use whole capsules or entire contents of the packets.