ganciclovir ganciclovir sodium
Refer to the “Also Known As” section to reference different products that include the same medication as ganciclovir.
Brand Name: ganciclovir
Generic Name: GANCICLOVIR SODIUM
Drug Type: HUMAN PRESCRIPTION DRUG
Dosage Form: INJECTION, SOLUTION
Data Current As Of: 2019-11-18
indications & usage
Ganciclovir Injection is a deoxynucleoside analogue cytomegalovirus (CMV) DNA polymerase inhibitor indicated for the:
treatment of cmv retinitis
Ganciclovir Injection is indicated for the treatment of cytomegalovirus (CMV) retinitis in immunocompromised adult patients, including patients with acquired immunodeficiency syndrome (AIDS) [see Clinical Studies (14.1)].
prevention of cmv disease in transplant recipients
Ganciclovir Injection is indicated for the prevention of CMV disease in adult transplant recipients at risk for CMV disease [see Clinical Studies (14.2)].
patient counseling information
Inform patients that Ganciclovir Injection 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 Injection 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
Pregnancy and Contraception
Advise female patients to use effective contraception during 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 (5.4), Use in Specific Populations (8.1, 8.3)].
Inform patients that Ganciclovir Injection should be considered a potential carcinogen [see Warnings and Precautions (5.5)].
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)].
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 Ganciclovir Injection [see Adverse Reaction (6.1)].
Ophthalmological Examination in Patients with CMV Retinitis
Inform patients that Ganciclovir Injection 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 Injection. Some patients may require more frequent ophthalmological follow-up [see Dosage and Administration (2.2), Adverse Reactions (6.1)].
Advise nursing mothers not to breastfeed if they are receiving 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)].
Mfd. for SAGENT Pharmaceuticals
Schaumburg, IL 60195 (USA)
Made in Canada
©2019 Sagent Pharmaceuticals, Inc.
Revised: August 2019
PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Vial Label
500 mg per 10 mL
(50 mg per mL)
CAUTION – Handle this product with great care because it is a potent cytotoxic agent and suspected carcinogen.
10 mL Single-Dose Vial
For Intravenous Infusion Only
Caution: Cytotoxic Agent