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CYTOVENE IV- ganciclovir sodium injection, powder, lyophilized, for solution


Patient Information

Hematologic Toxicity

Inform patients that CYTOVENE-IV may cause hematologic toxicity, including granulocytopenia (neutropenia), anemia, and thrombocytopenia. Inform patients that their blood counts and platelet counts should be closely monitored while on treatment[seeWarnings and Precautions (5.1)].

Impairment of Renal Function

Inform patients that CYTOVENE-IV has been associated with decreased renal function and that serum creatinine or creatinine clearance should be monitored while on treatment to allow for dosage adjustment in patients with renal impairment[seeWarnings and Precautions (5.2)].

Impairment of Fertility

Inform patients that CYTOVENE-IV may cause temporary or permanent infertility in humans[seeWarnings and Precautions (5.3),Use in Specific Populations (8.3)].

Pregnancy and Contraception

Advise female patients to use effective contraception during and for at least 30 days following treatment with CYTOVENE-IV. Similarly, advise men to practice barrier contraception during and for at least 90 days following treatment with CYTOVENE-IV[seeWarnings and Precautions (5.4),Use in Specific Populations (8.1,8.3)].

Carcinogenicity

Inform patients that CYTOVENE-IV should be considered a potential carcinogen[seeWarnings and Precautions (5.5)].

Drug Interactions

Inform patients that CYTOVENE-IV may interact with other drugs. Advise patients to report to their healthcare provider the use of any other medication[seeDrug Interactions (7)].

Impairment of Cognitive Ability

Based on the adverse reaction profile, ganciclovir may affect cognitive abilities, including the ability to drive and operate machinery, as seizures, dizziness, and/or confusion have been reported with the use of CYTOVENE-IV[seeAdverse Reaction (6.1)].

Ophthalmological Examination in Patients with CMV Retinitis

Inform patients that CYTOVENE-IV is not a cure for CMV retinitis, and they may continue to experience progression of retinitis during or following treatment. Advise patients to have frequent ophthalmological follow-up examinations while being treated with CYTOVENE-IV. Some patients may require more frequent ophthalmological follow-up[seeDosage and Administration (2.2),Adverse Reactions (6.1)].

Lactation

Advise nursing mothers not to breastfeed if they are receiving CYTOVENE-IV because of the potential for serious adverse events in nursing infants and because HIV can be passed to the baby in breast milk[seeUse in Specific Populations (8.2)].

Distributed by:
Genentech USA, Inc.
A Member of the Roche Group
1 DNA Way
South San Francisco, CA 94080-4990

CYTOVENE-IV is a registered trademark of Hoffmann-La Roche Inc.

2018 Genentech, Inc. All rights reserved.

Representative sample of labeling (see theHOW SUPPLIEDsection for complete listing):



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