Ganciclovir: Package Insert and Label Information (Page 6 of 6)

14.2 Prevention of CMV Disease in Transplant Recipients

Ganciclovir Injection was evaluated in three randomized, controlled trials of prevention of CMV disease in organ transplant recipients.

In a randomized, double-blind, placebo-controlled study of 149 heart transplant recipients at risk for CMV infection (CMV seropositive or a seronegative recipient of an organ from a CMV seropositive donor), there was a reduction in the overall incidence of CMV disease in patients treated with Ganciclovir Injection. Immediately post-transplant, patients received Ganciclovir Injection solution 5 mg/kg twice daily for 14 days followed by 6 mg/kg once daily for 5 days/week for an additional 14 days. Twelve of the 76 (16%) patients treated with Ganciclovir Injection vs 31 of the 73 (43%) placebo-treated patients developed CMV disease during the 120-day post-transplant observation period. No significant differences in hematologic toxicities were seen between the two treatment groups Trial ICM 1496: In a randomized, double-blind, placebo-controlled study of 149 heart transplant recipients at risk for CMV infection (CMV seropositive or a seronegative recipient of an organ from a CMV seropositive donor), there was a reduction in the overall incidence of CMV disease in patients treated with Ganciclovir Injection. Immediately post-transplant, patients received Ganciclovir Injection solution 5 mg/kg twice daily for 14 days followed by 6 mg/kg once daily for 5 days/week for an additional 14 days. Twelve of the 76 (16%) patients treated with Ganciclovir Injection vs 31 of the 73 (43%) placebo-treated patients developed CMV disease during the 120-day post-transplant observation period. No significant differences in hematologic toxicities were seen between the two treatment groups [see Adverse Reactions (6.1)] .

In a randomized, double-blind, placebo-controlled study of 72 bone marrow transplant recipients with asymptomatic CMV infection (CMV positive culture of urine, throat or blood) there was a reduction in the incidence of CMV disease in patients treated with Ganciclovir Injection following successful hematopoietic engraftment. Patients with virologic evidence of CMV infection received Ganciclovir Injection solution 5 mg/kg twice daily for 7 days followed by 5 mg/kg once daily through day 100 post-transplant. One of the 37 (3%) patients treated with Ganciclovir Injection vs 15 of the 35 (43%) placebo-treated patients developed CMV disease during the study. At 6 months post-transplant, there continued to be a reduction in the incidence of CMV disease in patients treated with Ganciclovir Injection. Six of 37 (16%) patients treated with Ganciclovir Injection vs 15 of the 35 (43%) placebo-treated patients developed disease through 6 months post-transplant. The overall rate of survival was higher in the group treated with Ganciclovir Injection, both at day 100 and day 180 post-transplant. Although the differences in hematologic toxicities were not statistically significant, the incidence of neutropenia was higher in the group treated with Ganciclovir Injection see Trial ICM 1689: In a randomized, double-blind, placebo-controlled study of 72 bone marrow transplant recipients with asymptomatic CMV infection (CMV positive culture of urine, throat or blood) there was a reduction in the incidence of CMV disease in patients treated with Ganciclovir Injection following successful hematopoietic engraftment. Patients with virologic evidence of CMV infection received Ganciclovir Injection solution 5 mg/kg twice daily for 7 days followed by 5 mg/kg once daily through day 100 post-transplant. One of the 37 (3%) patients treated with Ganciclovir Injection vs 15 of the 35 (43%) placebo-treated patients developed CMV disease during the study. At 6 months post-transplant, there continued to be a reduction in the incidence of CMV disease in patients treated with Ganciclovir Injection. Six of 37 (16%) patients treated with Ganciclovir Injection vs 15 of the 35 (43%) placebo-treated patients developed disease through 6 months post-transplant. The overall rate of survival was higher in the group treated with Ganciclovir Injection, both at day 100 and day 180 post-transplant. Although the differences in hematologic toxicities were not statistically significant, the incidence of neutropenia was higher in the group treated with Ganciclovir Injection [ see Adverse Reactions (6.1)] .

This was a randomized, unblinded study that evaluated 40 allogeneic bone marrow transplant recipients at risk for CMV disease. Patients underwent bronchoscopy and bronchoalveolar lavage (BAL) on day 35 post-transplant. Patients with histologic, immunologic or virologic evidence of CMV infection in the lung were then randomized to observation or treatment with Ganciclovir Injection solution (5 mg/kg twice daily for 14 days followed by 5 mg/kg once daily 5 days/week until day 120). Four of 20 (20%) patients treated with Ganciclovir Injection and 14 of 20 (70%) control patients developed interstitial pneumonia. The incidence of CMV disease was lower in the group treated with Ganciclovir Injection Trial ICM 1570: This was a randomized, unblinded study that evaluated 40 allogeneic bone marrow transplant recipients at risk for CMV disease. Patients underwent bronchoscopy and bronchoalveolar lavage (BAL) on day 35 post-transplant. Patients with histologic, immunologic or virologic evidence of CMV infection in the lung were then randomized to observation or treatment with Ganciclovir Injection solution (5 mg/kg twice daily for 14 days followed by 5 mg/kg once daily 5 days/week until day 120). Four of 20 (20%) patients treated with Ganciclovir Injection and 14 of 20 (70%) control patients developed interstitial pneumonia. The incidence of CMV disease was lower in the group treated with Ganciclovir Injection , consistent with the results observed in ICM 1689.

15 REFERENCES

1. “OSHA Hazardous Drugs.” OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html.

16 HOW SUPPLIED/STORAGE AND HANDLING

How Supplied

Ganciclovir Injection is supplied as follows:

NDC

Ganciclovir Injection (50 mg per mL)

Package Factor

51817-171- 01

500 mg per 10 ml Single-Dose Vial

25 vials per carton

51817-589-02

500 mg per 10 ml Single-Dose Vial

1 vial per carton

Ganciclovir Injection is a clear solution supplied in 10 mL sterile vials, each containing ganciclovir sodium equivalent to 500 mg of ganciclovir.

Storage

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Store diluted infusion solution under refrigeration at 2° to 8°C (36° to 46°F) for no longer than 24 hours. Do not freeze.

Discard unused portion.

17 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 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 on 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 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)].

Ganciclovir Injection (ganciclovir sodium)

Manufactured by:

Pharmascience Inc. Candiac Canada J5R 1J1

Pharmascience Inc. Material code: 36620-v2

Revised: October 2019

PACKAGE LABEL — PRINCIPAL DISPLAY — 500 mg Carton Label 25 x 10 mL

Rx only NDC 51817-171-01

Ganciclovir Injection

500mg/10mL (50 mg/mL)

FOR INTRAVENOUS INFUSION ONLY

CAUTION: Cytotoxic Agent

Handle this product with great care because it is a potent cytotoxic agent and suspected carcinogen

25 x 10 mL Single-dose vials

Ganciclovir Injection box label 25x10 mL
(click image for full-size original)

PACKAGE LABEL — PRINCIPAL DISPLAY — 500 mg Carton Label 1 x 10 mL

Rx only NDC 51817-589-02

Ganciclovir Injection

500mg/10mL (50 mg/mL)

FOR INTRAVENOUS INFUSION ONLY

CAUTION: Cytotoxic Agent

Handle this product with great care because it is a potent cytotoxic agent and suspected carcinogen

Sterile, Nonpyrogenic, Preservative-Free.

The container closure is not made with natural rubber latex.

1 x 10 mL Single-dose vial

Ganciclovir Injection box label 1x10 mL
(click image for full-size original)

PACKAGE LABEL — 10mL Vial Label

Rx only NDC 51817-171-01

Ganciclovir Injection

500mg/10mL (50 mg/mL)

Sterile solution equivalent to 500mg ganciclovir

Sterile, Nonpyrogenic, Preservative-Free.

The container closure is not made with natural rubber latex.

FOR INTRAVENOUS INFUSION ONLY.

10 mL Single-dose vial

CAUTION: Cytotoxic Agent

Handle this product with great care because it is a potent cytotoxic agent and suspected carcinogen

Usual dosage: See package insert

Store at 25°C (77°F): excursions permitted to 15°C-30°C (59°-86°F)

Ganciclovir Injection vial label 10 mL
(click image for full-size original)
GANCICLOVIR ganciclovir sodium injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51817-171
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GANCICLOVIR SODIUM (GANCICLOVIR) GANCICLOVIR 500 mg in 10 mL
Inactive Ingredients
Ingredient Name Strength
WATER
HYDROCHLORIC ACID
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51817-171-01 25 VIAL in 1 CARTON contains a VIAL
1 10 mL in 1 VIAL This package is contained within the CARTON (51817-171-01)
2 NDC:51817-171-02 1 VIAL in 1 CARTON contains a VIAL
2 10 mL in 1 VIAL This package is contained within the CARTON (51817-171-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207645 04/24/2018
Labeler — Pharmascience Inc. (244596946)
Registrant — Pharmascience Inc. (244596946)
Establishment
Name Address ID/FEI Operations
Pharmascience Inc. 202657094 manufacture (51817-171)

Revised: 01/2020 Pharmascience Inc.

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