GANCICLOVIR (Page 6 of 6)

14.2 Prevention of CMV Disease in Transplant Recipients

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

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 intravenous ganciclovir. Immediately post-transplant, patients received intravenous ganciclovir 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 intravenous ganciclovir 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)].

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 intravenous ganciclovir following successful hematopoietic engraftment. Patients with virologic evidence of CMV infection received intravenous ganciclovir 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 intravenous ganciclovir 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 intravenous ganciclovir. Six of 37 (16%) patients treated with intravenous ganciclovir 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 intravenous ganciclovir, 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 intravenous ganciclovir [see Dosage and Administration (2.4), Adverse Reactions (6.1) ].

Trial ICM 1570

This was a randomized, unblinded trial which 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 intravenous ganciclovir (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 intravenous ganciclovir and 14 of 20 (70%) control patients developed interstitial pneumonia. The incidence of CMV disease was lower in the group treated with intravenous ganciclovir [see Dosage and Administration (2.4)].

15 REFERENCES

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

16 HOW SUPPLIED/STORAGE AND HANDLING

GANCICLOVIR INJECTION is supplied as a sterile, unpreserved, colorless solution in a single-dose polymeric bag containing 500 mg ganciclovir in 250 mL of solution (2 mg/mL) sealed with a Twist Off port from Technoflex, and oversealed in an aluminum pouch (NDC 51754-2500-1), in cases of 10 (NDC 51754-2500-3). Follow guidelines for handling and disposal for cytotoxic drugs.1

The premix flexible plastic container bag contains no preservative; any unused portion should be discarded [see Dosage and Administration (2.6)] .

Gently shaking should redissolve any crystals that may have formed during transportation and/or storage at temperatures lower than recommended. The solution must be clear at the time of use.

Storage

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

17 PATIENT COUNSELING 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)] .

Carcinogenicity
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)].

LactationAdvise 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

Principal Display Panel

NDC 51754-2500-1 250 mL

GANCICLOVIR INJECTION

500 mg per 250 mL (2 mg per mL)

0.8% sodium chloride solution

Single-dose for intravenous use only

Discard unused portion of drug

Container Label Bag
(click image for full-size original)

Bag Overwrap Label

Label Overwrap
(click image for full-size original)
GANCICLOVIR ganciclovir injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51754-2500
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GANCICLOVIR (GANCICLOVIR) GANCICLOVIR 2 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE 8 mg in 1 mL
SODIUM HYDROXIDE
HYDROCHLORIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51754-2500-1 250 mL in 1 BAG None
2 NDC:51754-2500-3 10 BAG in 1 POUCH contains a BAG
2 250 mL in 1 BAG This package is contained within the POUCH (51754-2500-3)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA209347 02/28/2017
Labeler — EXELA PHARMA SCIENCES, LLC (831274399)
Registrant — EXELA PHARMA SCIENCES, LLC (831274399)
Establishment
Name Address ID/FEI Operations
EXELA PHARMA SCIENCES, LLC 831274399 manufacture (51754-2500)

Revised: 10/2017 EXELA PHARMA SCIENCES, LLC

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