CYSTARAN 6.5 mg/mL

cysteamine hydrochloride · SOLUTION · Leadiant Biosciences, Inc.

No Recall History

Plain English

Cystaran is a prescription eye drop solution containing cysteamine hydrochloride used to treat corneal cystine crystal accumulation in patients with cystinosis. It works by reducing cystine levels in the cornea to help improve vision and reduce eye discomfort.

Key Facts

Brand Name: CYSTARAN
Generic Name: cysteamine hydrochloride
NDC Code (Product): 54482-035
Manufacturer: Leadiant Biosciences, Inc.
Strength: 6.5 mg/mL
Dosage Form: SOLUTION
Route: OPHTHALMIC
Marketing Status
Application #: NDA200740
Marketing Start: 12/30/2012

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

eye irritation140 reports

eye pain59 reports

ocular hyperaemia54 reports

photophobia36 reports

product dose omission issue19 reports

headache18 reports

nausea16 reports

vomiting16 reports

intentional product misuse13 reports

vision blurred13 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE CYSTARAN ® is a cystine-depleting agent indicated for the treatment of corneal cystine crystal accumulation in patients with cystinosis. CYSTARAN is a cystine-depleting agent indicated for the treatment of corneal cystine crystal accumulation in patients with cystinosis. ( 1 )

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Instill one drop of CYSTARAN in each eye, every waking hour. Do not touch dropper tip to any surface, as this may contaminate the solution. Discard after 1 week of use. Instill one drop of CYSTARAN in each eye, every waking hour. ( 2 )

Contraindications

4 CONTRAINDICATIONS None. None. ( 4 )

Adverse Reactions

6 ADVERSE REACTIONS The most common adverse reactions (incidence approximately 10% or greater) are sensitivity to light, redness, eye pain/irritation, headache and visual field defects. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Leadiant Biosciences, Inc. at 1-888-393-4584 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety data described below reflect exposure in controlled clinical trials of six months to 19 years duration in approximately 300 patients. The most frequently reported ocular adverse reactions occurring in ≥10% of patients were sensitivity to light, redness, and eye pain/irritation, headache and visual field defects.