Source: FDA, National Drug Code (US) Revision Year: 2020
PROCYSBI, for oral administration, is a cystine-depleting agent that lowers the cystine content of cells in patients with nephropathic cystinosis, an inherited defect of lysosomal transport.
PROCYSBI contains the bitartrate salt of cysteamine. The chemical name for cysteamine bitartrate is ethanethiol, 2-amino, (2R,3R)-2,3-dihydroxybutanedioate (1:1) (salt). Cysteamine bitartrate is a highly water soluble white powder with a molecular weight of 227.24 and the molecular formula C2H7NS∙C4H6O6.
It has the following chemical structure:
Each PROCYSBI delayed-release capsule contains either 25 mg cysteamine (equivalent to 74 mg cysteamine bitartrate) or 75 mg cysteamine (equivalent to 221 mg cysteamine bitartrate).
Each packet of PROCYSBI delayed-release oral granules contains either 75 mg cysteamine (equivalent to 221 mg cysteamine bitartrate) or 300 mg cysteamine (equivalent to 884 mg cysteamine bitartrate).
PROCYSBI delayed release granules contain the following inactive ingredients: Eudragit L 30 D-55, hypromellose, microcrystalline cellulose, purified water, sodium lauryl sulfate, talc, and triethyl citrate. Additionally the capsule shell contains the following inactive ingredients: gelatin, ink (blue and white), and titanium dioxide.
| Dosage Forms and Strengths |
|---|
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PROCYSBI delayed-release capsules:
PROCYSBI delayed-release oral granules:
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| How Supplied |
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PROCYSBI (cysteamine bitartrate) delayed-release capsules25 mg cysteamine: A hard gelatin capsule with light blue opaque cap imprinted with “PRO” in white ink and light blue opaque body imprinted with “25 mg” in white ink, supplied as bottle of 60 capsules (NDC 75987-100-04). Each bottle contains one desiccant canister and one oxygen absorber canister. 75 mg cysteamine: A hard gelatin capsule with dark blue opaque cap imprinted with “PRO” in white ink and light blue opaque body imprinted with “75 mg” in white ink, supplied as bottle of 250 capsules (NDC 75987-101-08). Each bottle contains one desiccant canister and two oxygen absorber canisters. PROCYSBI (cysteamine bitartrate) delayed-release oral granules75 mg cysteamine: Single-use packets containing white to off-white granules, supplied as 60 packets in a carton (NDC 75987-140-13). 75 mg cysteamine: Single-use packets containing white to off-white granules, supplied as 120 packets in a carton (NDC 75987-140-14). 300 mg cysteamine: Single-use packets containing white to off-white granules, supplied as 60 packets in a carton (NDC 75987-145-13). 300 mg cysteamine: Single-use packets containing white to off-white granules, supplied as 120 packets in a carton (NDC 75987-145-14). Distributed by: Horizon Therapeutics USA, Inc., Lake Forest, IL 60045 |
| Drug | Countries | |
|---|---|---|
| PROCYSBI | Austria, Canada, Estonia, Spain, Finland, France, Croatia, Ireland, Italy, Lithuania, Poland, Romania, United Kingdom, United States |
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