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
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
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 ganciclovir sodium injection, solution | |||||||||||||||||||||||||
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| 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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