PROCYSBI- cysteamine bitartrate capsule, delayed release pellets PROCYSBI- cysteamine bitartrate granule, delayed release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CYSTEAMINE BITARTRATE (UNII: QO84GZ3TST) (CYSTEAMINE - UNII:5UX2SD1KE2)

Available from:

Horizon Therapeutics USA, Inc.

INN (International Name):

Cysteamine bitartrate

Composition:

Cysteamine 25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

PROCYSBI is indicated for the treatment of nephropathic cystinosis in adults and pediatric patients 1 year of age and older. The use of PROCYSBI is contraindicated in patients with a serious hypersensitivity reaction, including anaphylaxis, to penicillamine or cysteamine. Risk Summary There are no available data on PROCYSBI use in pregnant women to inform any drug-associated risks for birth defects or miscarriage [see Data] . Cysteamine (administered as cysteamine bitartrate) was teratogenic and fetotoxic in rats at doses less than the recommended human maintenance dose. The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Advise pregnant women of the potential risk to a fetus. Data Animal Data Embryo-fetal development studies were conducted in rats using oral administration of cysteamine

Product summary:

How Supplied PROCYSBI (cysteamine bitartrate) delayed-release capsules PROCYSBI (cysteamine bitartrate) delayed-release oral granules Storage and Handling Instructions for the Patient

Authorization status:

New Drug Application

Summary of Product characteristics

PROCYSBI- CYSTEAMINE BITARTRATE CAPSULE, DELAYED RELEASE PELLETS
PROCYSBI- CYSTEAMINE BITARTRATE GRANULE, DELAYED RELEASE
HORIZON THERAPEUTICS USA, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PROCYSBI SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR PROCYSBI.
PROCYSBI (CYSTEAMINE BITARTRATE) DELAYED-RELEASE CAPSULES, FOR ORAL USE
PROCYSBI (CYSTEAMINE BITARTRATE) DELAYED-RELEASE ORAL GRANULES
INITIAL U.S. APPROVAL: 1994
RECENT MAJOR CHANGES
Warnings and Precautions, Fibrosing Colonopathy (5.4)
02/2022
INDICATIONS AND USAGE
PROCYSBI is a cystine-depleting agent indicated for the treatment of
nephropathic cystinosis in adults and
pediatric patients 1 year of age and older. (1)
DOSAGE AND ADMINISTRATION
Recommended Dosage in Cysteamine-Naïve Patients
See full prescribing information for weight-based dosing tables for
the starting and maintenance
dosage. (2.2)
For initial intolerance, temporarily discontinue and then re-start
PROCYSBI at a lower dosage and
gradually increase to the maintenance dosage. (2.2)
Switching from Immediate-release Cysteamine to PROCYSBI
Start with a total daily dose of PROCYSBI equal to the previous total
daily dose of immediate-release
cysteamine bitartrate. (2.3)
Dose Titration
Adjust dose to achieve a therapeutic target white blood cell (WBC)
cystine concentration. (2.4, 2.5)
If a dose adjustment is required, increase the dosage by 10%. The
maximum dosage is 1.95 grams/m
per day. (2.4)
If adverse reactions occur, decrease the dosage. Some patients may be
unable to achieve their
therapeutic target. (2.4)
Preparation and Administration (2.6)
_Capsules_: Swallow whole; do not crush or chew capsules or capsule
contents. Take the capsules with
fruit juice (except grapefruit juice) or water.
_Oral Granules:_ Do not crush or chew the granules. Sprinkle and mix
the granules in applesauce, berry
jelly or fruit juice (except grapefruit juice).
For patients who cannot swallow the capsules or with gastrostomy
tube