Cysteamine Hydrochloride

Brand names: Cystaran
Drug class: Antineoplastic Agents , Antineoplastic Agents

Usage of Cysteamine Hydrochloride

Corneal Cystine Crystal Accumulation

Treatment of corneal cystine crystal accumulation in patients with cystinosis (designated an orphan drug by FDA for this use).

Because oral cysteamine does not reverse corneal cystine crystal accumulation in cystinosis patients, concurrent ophthalmic cysteamine is necessary.

Temporarily reduces formation of corneal cystine crystals in patients with cystinosis; strict compliance and continued use are necessary for sustained efficacy.

Commercially available in US as a 0.44% (of cysteamine) ophthalmic solution that contains the preservative benzalkonium chloride (Cystaran). Various other ophthalmic formulations (e.g., 0.11%, 0.55%, preservative-free) were studied during the clinical trial program in the US.

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How to use Cysteamine Hydrochloride

General

Available only through a specialty pharmacy. Call the Cystaran Hotline at 800-440-0473 or visit [Web] for specific information.

Administration

Ophthalmic Administration

Apply topically to each eye as an ophthalmic solution; the solution is for topical ophthalmic use only.

To minimize risk of contamination, avoid touching the eyelids, surrounding areas of the eye, or any other surface with the dropper tip of the bottle. Keep the bottle tightly closed when not in use. (See Advice to Patients.)

Remove contact lenses prior to each dose (since the benzalkonium chloride preservative may be absorbed by soft lenses); may reinsert lenses 15 minutes following administration.

For proper storage information, see Storage under Stability and also see Advice to Patients.

Dosage

Available as cysteamine hydrochloride; dosage is expressed in terms of cysteamine.

Each 6.5 mg of cysteamine hydrochloride is equivalent to 4.4 mg of cysteamine.

Pediatric Patients

Corneal Cystine Crystal Accumulation Ophthalmic

1 drop of a 0.44% solution in each eye every waking hour.

Continued therapy is necessary since corneal cystine crystals accumulate when therapy is discontinued.

Adults

Corneal Cystine Crystal Accumulation Ophthalmic

1 drop of a 0.44% solution in each eye every waking hour.

Continued therapy is necessary since corneal cystine crystals accumulate when therapy is discontinued.

Special Populations

No special population dosage recommendations at this time. (See Renal Impairment under Cautions.)

Warnings

Contraindications

  • Manufacturer states none known.

    • Warnings/Precautions

    Benign Intracranial Hypertension

    Benign intracranial hypertension (or pseudotumor cerebri) and/or papilledema reported with oral cysteamine bitartrate therapy. Benign intracranial hypertension also reported with ophthalmic cysteamine, but all patients were concurrently receiving oral cysteamine therapy.

    Specific Populations

    Pregnancy

    Category C.

    Lactation

    Not known whether oral cysteamine is distributed into human milk. Systemic exposure expected to be negligible following ophthalmic administration. Discontinue nursing or the drug.

    Pediatric Use

    Safety and efficacy established in pediatric patients; the drug is approved for use in such patients. The majority of patients in the ophthalmic cysteamine clinical trials were pediatric patients.

    Geriatric Use

    Not evaluated; the reduced life expectancy from cystinosis did not allow for inclusion of geriatric patients in the clinical study population.

    Renal Impairment

    Effect of renal impairment on the pharmacokinetics of cysteamine following ophthalmic administration not evaluated because ophthalmic exposure is negligible compared with systemic exposure. However, the majority of patients in the ophthalmic clinical studies were assumed to have had some degree of renal impairment due to their underlying disease. (See Special Populations under Dosage and Administration.)

    Common Adverse Effects

    Photophobia (sensitivity to light), ocular (including conjunctival) redness, ocular pain and/or irritation, headache, visual field defects.

    What other drugs will affect Cysteamine Hydrochloride

    No known drug interactions. Clinically important interactions with systemically-administered drugs unlikely because of cysteamine's negligible systemic exposure following topical ophthalmic application.

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