ganciclovir ganciclovir sodium

Get an overview of GANCICLOVIR (ganciclovir sodium injection, solution), including its generic name, formulation (i.e. pill, oral solution, injection, inhaled medicine) and why it’s used. The medication in ganciclovir can be sold under different names.

Refer to the “Also Known As” section to reference different products that include the same medication as ganciclovir.

Drug Basics

Brand Name: ganciclovir

Generic Name: GANCICLOVIR SODIUM

Drug Type: HUMAN PRESCRIPTION DRUG

Route: INTRAVENOUS

Dosage Form: INJECTION, SOLUTION

Data Current As Of: 2019-11-18

Boxed Warning 08/2018
Warnings and Precautions (5.3) 08/2018

indications & usage

Ganciclovir Injection is a deoxynucleoside analogue cytomegalovirus (CMV) DNA polymerase inhibitor indicated for the:

  • treatment of CMV retinitis in immunocompromised adult patients, including patients with acquired immunodeficiency syndrome (AIDS). (1.1)
  • prevention of CMV disease in adult transplant recipients at risk for CMV disease. (1.2)

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

Hematologic Toxicity

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

Inform patients that Ganciclovir Injection 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 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)].

Carcinogenicity

Inform patients that Ganciclovir Injection 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)].

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)].

Lactation

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)].

SAGENT®
Mfd. for SAGENT Pharmaceuticals
Schaumburg, IL 60195 (USA)
Made in Canada
©2019 Sagent Pharmaceuticals, Inc.

Revised: August 2019

SAGENT Pharmaceuticals®

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Vial Label

NDC 25021-185-10

Rx only

Ganciclovir Injection

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

This drug label information is as submitted to the Food and Drug Administration (FDA) and is intended for informational purposes only. If you think you may have a medical emergency, immediately call your doctor or dial 911. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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