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GANCICLOVIR injection, solution

  1. Patient Information
  2. Manufactured And Distributed By:

Patient Information 

Hematologic Toxicity
Inform patients of the potential for hematologic toxicity associated with the use of GANCICLOVIR INJECTION including granulocytopenia (neutropenia), anemia and thrombocytopenia. Inform patients that their blood counts will be closely monitored while on therapy
[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 will be monitored carefully to allow for dosage adjustment in patients with renal impairment
[see Dosage and Administration (2.5), Warnings and Precautions (5.2)].

Impairment of Fertility
Inform patients that ganciclovir has caused decreased fertility in animals and may cause temporary or permanent infertility in humans
[see Warnings and Precautions (5.3), Use in Specific Populations (8.3)].

Pregnancy and Contraception
Inform women of childbearing potential that ganciclovir causes birth defects in animals. Advise female patients to use effective contraception during treatment and for at least 30 days following treatment with GANCICLOVIR INJECTION. Similarly, advise men to practice barrier contraception during and for at least 90 days following treatment with GANCICLOVIR INJECTION
[see Warnings and Precautions (5.3), Use in Specific Populations (8.1, 8.3)].

Inform patients that ganciclovir causes tumors in animals. Although there is no information from human studies, ganciclovir should be considered a potential carcinogen
[see Warnings and Precautions (5.5)].

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

Ophthalmological Examination in Patients with CMV Retinitis
Advise patients with CMV retinitis to have frequent ophthalmological examinations while being treated with GANCICLOVIR INJECTION to monitor disease status and for other retinal abnormalities. More frequent ophthalmological follow-up may be needed in some cases
[see Dosage and Administration (2.2), Adverse Reactions (6.1)].

Advise nursing mothers that breastfeeding is not recommended during treatment with GANCICLOVIR 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)].

Manufactured And Distributed By: 

Exela Pharma Sciences

Lenoir, NC 28645

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