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Prescribing Information

 

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CYSTARAN Reduces Corneal Cystine Crystals1,2

Cystine crystals are an ocular effect of cystinosis. Corneal cystine crystal accumulation may lead to painful and debilitating complications in patients with cystinosis, including2-4:

  • Photophobia
  • Eye pain
  • Squinting
  • Band keratopathy
  • Foreign body sensation
  • Corneal haziness
  • Blepharospasm
  • Corneal abrasion

Only ophthalmic cysteamine therapy has been proven to reduce corneal cystine crystals. Oral cysteamine therapy is ineffective in reducing the ocular effects of cystinosis.1-3

For information about CYSTARAN, or to place an order, please call: 1‑877‑534‑9627.
For medical information about CYSTARAN, please call: 1‑866‑634‑2765.

References: 1. CYSTARAN [prescribing information]. Gaithersburg, MD: Sigma-Tau Pharmaceuticals, Inc; 2012. 2. Gahl WA, Kuehl EM, Iwata F, Lindblad A, Kaiser-Kupfer MI. Corneal crystals in nephropathic cystinosis: natural history and treatment with cysteamine eyedrops. Mol Genet Metab. 2000;71:100-120. 3. Kaiser-Kupfer MI, Fujikawa L, Kuwabara T, Jain S, Gahl WA. Removal of corneal crystals by topical cysteamine in nephropathic cystinosis. N Engl J Med. 1987;316:775-779. 4. Tsilou E, Zhou M, Gahl W, Sieving PC, Chan CC. Ophthalmic manifestations and histopathology of infantile nephropathic cystinosis: report of a case and review of the literature. Surv Ophthalmol. 2007;52:97-105.

Indication:

CYSTARAN (CYSTEAMINE OPHTHALMIC SOLUTION) 0.44% STERILE is a cystine-depleting agent indicated for the treatment of corneal cystine crystal accumulation in patients with cystinosis.

Important Safety Information:

To minimize contaminating the dropper tip and solution, care should be taken not to touch the eyelids or surrounding areas with the dropper tip of the bottle. Keep bottle tightly closed when not in use.

There have been reports of benign intracranial hypertension (or pseudotumor cerebri) associated with oral cysteamine treatment that has resolved with the addition of diuretic therapy. There have also been reports associated with ophthalmic use of cysteamine; however, all of these patients were on concurrent oral cysteamine.

CYSTARAN contains benzalkonium chloride, which may be absorbed by soft contact lenses. Contact lenses should be removed prior to application of solution and may be reinserted 15 minutes following its administration.

CYSTARAN is for topical ophthalmic use only.

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.