CMV Retinitis Treatments

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Brand Name

Zirgan

Generic Name

Ganciclovir

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FDA approval date: April 30, 2010

Classification: Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor

Form: Injection, Gel

What is Zirgan (Ganciclovir)?

ZIRGAN ®

Approved To Treat

CMV Retinitis

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Brand Information

ZIRGAN (ganciclovir)

1INDICATIONS AND USAGE

ZIRGAN is indicated for the treatment of acute herpetic keratitis (dendritic ulcers) in adults and pediatric patients aged 2 years and older.

2DOSAGE AND ADMINISTRATION

The recommended dosage is 1 drop in the affected eye 5 times per day (approximately every 3 hours while awake) until the corneal ulcer heals, and then 1 drop 3 times per day for 7 days.

3DOSAGE FORMS AND STRENGTHS

Ophthalmic gel: 0.15% ganciclovir.

4CONTRAINDICATIONS

None.

5ADVERSE REACTIONS

Most common adverse reactions reported in patients were blurred vision (60%), eye irritation (20%), punctate keratitis (5%), and conjunctival hyperemia (5%).

6DESCRIPTION

ZIRGAN (ganciclovir ophthalmic gel) 0.15% contains ganciclovir, a nucleoside analog antiviral. ZIRGAN is a sterile, preserved, clear, colorless, ophthalmic gel for topical ophthalmic use.

The chemical name is 9-[[2-hydroxy-1-(hydroxymethyl)ethoxy]methyl]guanine (CAS number 82410-32-0). Ganciclovir is represented by the following structural formula:

Ganciclovir has a molecular weight of 255.23, and the empirical formula is C

Each gram of gel contains: ACTIVE: ganciclovir 1.5 mg (0.15%). INACTIVES: carbomer homopolymer, water for injection, sodium hydroxide (to adjust the pH to 7.2-7.6), mannitol. PRESERVATIVE: benzalkonium chloride 0.075 mg (0.0075%).

7CLINICAL STUDIES

In one open-label, randomized, controlled, multicenter clinical trial which enrolled 164 patients with herpetic keratitis, ZIRGAN was non-inferior to acyclovir ophthalmic ointment, 3% in patients with dendritic ulcers. Clinical resolution (healed ulcers) at Day 7 was achieved in 77% (55/71) for ZIRGAN versus 72% (48/67) for acyclovir, 3% (difference 5.8%, 95% CI - 9.6%-18.3%). In three randomized, single-masked, controlled, multicenter clinical trials which enrolled 213 total patients, ZIRGAN was non-inferior to acyclovir ophthalmic ointment, 3% in patients with dendritic ulcers. Clinical resolution at Day 7 was achieved in 72% (41/57) for ZIRGAN versus 69% (34/49) for acyclovir (difference 2.5%, 95% CI - 15.6%-20.9%).

8HOW SUPPLIED/STORAGE AND HANDLING

ZIRGAN (ganciclovir ophthalmic gel) 0.15% is supplied as 5 grams of a sterile, preserved, clear, colorless, topical ophthalmic gel containing 0.15% of ganciclovir in a polycoated aluminum tube with a white polyethylene tip and cap and protective band (NDC 24208-535-35).

Storage

Store at 15°C to 25°C (59°F to 77°F). Do not freeze.

9PATIENT COUNSELING INFORMATION

When to Consult a Physician

Advise patients to consult a physician if pain develops, or if redness, itching, or inflammation becomes aggravated.

Risk of Contamination

ZIRGAN is sterile when packaged. Advise patients to not allow the dropper tip to touch any surface, as this may contaminate the gel.

Avoidance of Contact Lenses

Advise patients to not wear contact lenses when using ZIRGAN.

Distributed by:

Bausch & Lomb Americas Inc.

Bridgewater, NJ 08807 USA

Manufactured by:

Bausch & Lomb Incorporated

Tampa, FL 33637 USA

Zirgan is a trademark of Laboratoires Théa Corporation used under license.

9224806 (Folded)

9224706 (Flat)

10PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

NDC24208-535-35

BAUSCH + LOMB

Zirgan

(ganciclovir

ophthalmic gel)

0.15%

Sterile

FOR TOPICAL

OPHTHALMIC

USE ONLY

Rx only

5 g

AB48835

9691901