CYTOVENE-IV Solution for injection (2020)

Βιβλιογραφική αναφορά

Συγγραφείς

H2-Pharma, LLC

Λέξεις κλειδιά

61269-450

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BOXED WARNING SECTION

WARNING: HEMATOLOGIC TOXICITY, IMPAIRMENT OF FERTILITY, FETAL TOXICITY, MUTAGENESIS AND CARCINOGENESIS Hematologic Toxicity: Granulocytopenia, anemia, thrombocytopenia, and pancytopenia have ...

1. Indications and Usage

1.1 Treatment of CMV Retinitis CYTOVENE-IV is indicated for the treatment of cytomegalovirus (CMV) retinitis in immunocompromised adult patients, including patients with acquired immunodeficiency syndrome ...

2. Dosage and Administration

2.1 Important Dosing and Administration Information To avoid phlebitis/pain at the infusion site, CYTOVENE-IV must only be administered by intravenous infusion over 1 hour, preferably via plastic cannula, ...

3. Dosage Forms and Strengths

For injection: Single-dose vial containing 500 mg of ganciclovir as a sterile lyophilized white to off-white powder for reconstitution with 10 mL of preservative-free sterile water for injection, ...

4. Contraindications

CYTOVENE-IV is contraindicated in patients who have experienced a clinically significant hypersensitivity reaction (e.g., anaphylaxis) to ganciclovir, valganciclovir, or any component of the formulation. ...

5. Warnings and Precautions

5.1 Hematologic Toxicity Granulocytopenia (neutropenia), anemia, thrombocytopenia and pancytopenia have been observed in patients treated with CYTOVENE-IV. The frequency and severity of these events vary ...

6. Adverse Reactions

The following serious adverse reactions are discussed in greater detail in other sections of the labeling: Hematologic Toxicity [see Warnings and Precautions (5.1)] Renal Impairment [see Warnings ...

6.1. Clinical Trials Experience

6.1 Clinical Trial Experience in Adult Patients Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly ...

6.2. Postmarketing Experience

The following adverse reactions have been identified during post-approval use of CYTOVENE-IV or ganciclovir capsules. Because these reactions are reported voluntarily from a population of uncertain size, ...

7. Drug Interactions

Drug-drug interaction studies were conducted in patients with normal renal function. Patients with impaired renal function may have increased concentrations of ganciclovir and the coadministered drug following ...

8.1. Pregnancy

Risk Summary In animal studies, ganciclovir caused maternal and fetal toxicity and embryo-fetal mortality in pregnant mice and rabbits as well as teratogenicity in rabbits at exposures two times the exposure ...

8.2. Lactation

Risk Summary No data are available regarding the presence of ganciclovir in human milk, the effects on the breastfed infant, or the effects on milk production. When ganciclovir was administered to lactating ...

8.3. Females and Males of Reproductive Potential

Pregnancy Testing Females of reproductive potential should undergo pregnancy testing before initiation of treatment with CYTOVENE-IV [see Dosage and Administration (2.2), Use in Specific Populations ...

8.4. Pediatric Use

Safety and efficacy of CYTOVENE-IV have not been established in pediatric patients. A total of 120 pediatric patients with serious CMV infections participated in clinical trials. Granulocytopenia and thrombocytopenia ...

8.5. Geriatric Use

Clinical studies of CYTOVENE-IV did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly ...

8.6. Renal Impairment

Dose reduction is recommended when administering CYTOVENE-IV to patients with renal impairment [see Dosage and Administration (2.5), Warnings and Precautions (5.2)].

8.7. Hepatic Impairment

The safety and efficacy of CYTOVENE-IV have not been studied in patients with hepatic impairment.

10. Overdosage

Reports of adverse reactions after overdoses with CYTOVENE-IV, some with fatal outcomes, have been received from clinical trials and during postmarketing experience. One or more of the following adverse ...

11. Description

CYTOVENE-IV contains ganciclovir, in the form of the sodium salt for intravenous injection. Ganciclovir is a synthetic guanine derivative active against cytomegalovirus (CMV). Chemically, ganciclovir is ...

12.1. Mechanism of Action

Ganciclovir is an antiviral drug with activity against CMV [see Microbiology (12.4)].

12.3. Pharmacokinetics

Absorption At the end of a 1-hour intravenous infusion of 5 mg/kg ganciclovir, total AUC ranged between 22.1 ± 3.2 (n=16) and 26.8 ± 6.1 mcg∙hr/mL (n=16) and Cmax ranged between 8.27 ± 1.02 ...

12.4. Microbiology

Mechanism of Action Ganciclovir is a synthetic analogue of 2'-deoxyguanosine, which inhibits replication of human CMV in cell culture and in vivo. In CMV-infected cells, ganciclovir is initially phosphorylated ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis, Mutagenesis Ganciclovir was carcinogenic in mice at the same mean drug exposure in humans as at the RHD (5 mg/kg). At the dose of 1000 mg/kg/day (1.4 times the exposure at the RHD), there ...

14. Clinical Studies

14.1 Treatment of CMV Retinitis In a retrospective, non-randomized, single-center analysis of 41 patients with AIDS and CMV retinitis diagnosed by ophthalmologic examination between August 1983 and April ...

15. References

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

16.1. How Supplied

CYTOVENE-IV (ganciclovir) for injection is supplied in 10 mL sterile single-dose vials, each containing 543 mg ganciclovir sodium equivalent to 500 mg of ganciclovir as a white to off-white powder. The ...

16.2. Storage and Handling

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Store reconstituted solution in the vial at 25°C (77°F) for no longer than 12 hours. Do not ...

17. Patient Counseling Information

Hematologic Toxicity Inform patients that CYTOVENE-IV may cause hematologic toxicity, including granulocytopenia (neutropenia), anemia, and thrombocytopenia. Inform patients that their blood counts and ...