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GANCICLOVIR- ganciclovir sodium injection, powder, lyophilized, for solution


Patient Information

Hematologic Toxicity

Inform patients that ganciclovir 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[see Warnings and Precautions (5.1)].

Impairment of Renal Function

Inform patients that ganciclovir 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[see Warnings and Precautions (5.2)].

Impairment of Fertility

Inform patients that ganciclovir may cause temporary or permanent infertility in humans[see Warnings 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 ganciclovir for injection. Similarly, advise men to practice barrier contraception during and for at least 90 days following treatment with ganciclovir for injection[see Warnings and Precautions (5.4),Use in Specific Populations (8.1,8.3)].

Carcinogenicity

Inform patients that ganciclovir should be considered a potential carcinogen[see Warnings and Precautions (5.5)].

Drug Interactions

Inform patients that ganciclovir for injection may interact with other drugs. Advise patients to report to their healthcare provider the use of any other medication[see Drug Interactions (7)].

Impairment of Cognitive Ability

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

Ophthalmological Examination in Patients with CMV Retinitis

Inform patients that ganciclovir 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 ganciclovir for injection. Some patients may require more frequent ophthalmological follow-up[see Dosage and Administration (2.2), Adverse Reactions (6.1)].

Lactation

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

Rx Only

Manufactured by:
Hainan Poly Pharm. Co., Ltd.,
Guilinyang Economic Development Area, Haikou, Hainan Province, China 571127

Distributed by:
Slate Run Pharmaceuticals, LLC,
Columbus, Ohio 43215

10000138/01

Revised: 09/2018



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