Cystadrops® (Cysteamine Ophthalmic Solution) Dosing and Administration

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FOR U.S. PATIENTS

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HOW TO DOSE CYSTADROPS^1,2

CYSTADROPS IS A VISCOUS SOLUTION WITH PRACTICAL 4X/DAY DOSING

Instill one drop of CYSTADROPS in each eye, 4 times a day during waking hours.
Do not touch dropper tip to the eyelids, surrounding areas, or any surface, as this may contaminate the solution.
In case of concomitant therapy with other topical ocular products, an interval of 10 minutes should be allowed between successive applications. Eye ointments should be administered last.
If the patient misses an instillation, the patient should be told to administer a dose as soon as feasible and then continue the treatment with the next scheduled instillation. Discard bottle 7 days after first opening.
Remove contact lenses prior to application. Lenses may be reinserted 15 minutes following administration.

CYSTADROPS Dropper Assembly & Administration Guide

Cystine eye drops dosing

HOW CYSTADROPS IS SUPPLIED¹

5 mL sterile viscous solution in an amber glass bottle.
Each mL contains 3.8 mg/mL of cysteamine (0.37%) equivalent to 5.6 mg/mL of cysteamine hydrochloride (0.55%).
A PVC* dropper applicator with HDPE** closure is packed separately and included in each carton.
The bottle and dropper must be assembled before first use.
Patients will receive 4 bottles (1-month supply) or 12 bottles (3-months supply) at a time.

*PVC (polyvinyl chloride)
**HDPE (high density polyethylene)

Cystadrops how to store

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Clinical Data & Safety

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Indications and Usage

CYSTADROPS^® (cysteamine ophthalmic solution) 0.37% is a cystine-depleting agent indicated for the treatment of corneal cystine crystal deposits in adults and children with cystinosis.

Important Safety Information

Contamination of Tip and Solution: To minimize the risk of contamination, do not touch the dropper tip to any surface. Keep bottle tightly closed when not in use.
Benign Intracranial Hypertension: Benign intracranial hypertension (or pseudotumor cerebri) associated with oral cysteamine or ophthalmic use of cysteamine (with concurrent oral cysteamine) has been reported, which has resolved with diuretic therapy.
Contact Lens Use: Contains benzalkonium chloride. Contact with soft contact lenses should be avoided. Remove contact lenses prior to application. Lenses may be reinserted 15 minutes following administration.
The most common adverse reactions (≥ 10%) are eye pain, vision blurred, eye irritation, ocular hyperaemia, instillation site discomfort, eye pruritus, lacrimation increased, and ocular deposits.
To report SUSPECTED ADVERSE REACTIONS, contact Recordati Rare Diseases Inc. at 1-888-575-8344, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

CYSTADROPS^® (cysteamine ophthalmic solution), for topical ophthalmic use, is available as 3.8 mg/mL of cysteamine (0.37%) in 5 mL bottles.

INDICATIONS AND IMPORTANT SAFETY INFORMATION

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Important Safety Information

Contamination of Tip and Solution: To minimize the risk of contamination, do not touch the dropper tip to any surface. Keep bottle tightly closed when not in use.

References

CYSTADROPS [Package Insert]. Lebanon, NJ: Recordati Rare Diseases; 2020
CYSTADROPS [Instructions For Use]. Lebanon, NJ: Recordati Rare Diseases; 2020