Clofarabine Injection

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Drink plenty of fluids every day during your treatment with clofarabine, especially if you vomit or have diarrhea.

This medication will be stored in the hospital.

Clofarabine Injection contains clofarabine, a purine nucleoside metabolic inhibitor. Clofarabine (1 mg/mL) is supplied in a 20 mL, single-dose vial. The 20 mL vial contains 20 mg clofarabine formulated in 20 mL unbuffered normal saline (comprised of Water for Injection, USP, and Sodium Chloride, USP). The pH range of the solution is 4.5 to 7.5. The solution is sterile, clear and practically colorless, and is preservative-free.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Clofarabine has not been tested for carcinogenic potential.

Clofarabine showed clastogenic activity in the in vitro mammalian cell chromosome aberration assay (CHO cells) and in the in vivo rat micronucleus assay. It did not show evidence of mutagenic activity in the bacterial mutation assay (Ames test).

Studies in mice, rats, and dogs have demonstrated dose-related adverse effects on male reproductive organs. Seminiferous tubule and testicular degeneration and atrophy were reported in male mice receiving intraperitoneal (IP) doses of 3 mg/kg/day (9 mg/m2/day, approximately 17% of clinical recommended dose on a mg/m2 basis). The testes of rats receiving 25 mg/kg/day (150 mg/m2/day, approximately 3 times the recommended clinical dose on a mg/m2 basis) in a 6-month IV study had bilateral degeneration of the seminiferous epithelium with retained spermatids and atrophy of interstitial cells. In a 6-month IV dog study, cell degeneration of the epididymis and degeneration of the seminiferous epithelium in the testes were observed in dogs receiving 0.375 mg/kg/day (7.5 mg/m2/day, approximately 14% of the clinical recommended dose on a mg/m2 basis). Ovarian atrophy or degeneration and uterine mucosal apoptosis were observed in female mice at 75 mg/kg/day (225 mg/m2/day, approximately 4-fold of recommended human dose on a mg/m2 basis), the only dose administered to female mice. The effect on human fertility is unknown.

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

Hematologic Toxicity: Advise patients to return for regular blood counts and to report any symptoms associated with hematologic toxicity (such as weakness, fatigue, pallor, shortness of breath, easy bruising, petechiae, purpura, fever) to their physician [see Warnings and Precautions (5.1), Adverse Reactions (6.1)].

Infection: Advise patients of the signs or symptoms of infection (e.g., fever) and report to the physician immediately if any occur [see Warnings and Precautions (5.3), Adverse Reactions (6.1)].

Hepatic and Renal Toxicity: Advise patients to avoid medications including over the counter and herbal medications, which may be hepatotoxic or nephrotoxic, during the 5 days of clofarabine administration. Also, advise patients of the possibility of developing liver function abnormalities and to immediately report signs or symptoms of jaundice. Advise patients of the signs or symptoms of renal failure/ acute renal failure [see Warnings and Precautions (5.7, 5.8)].

Systemic Inflammatory Response Syndrome (SIRS)/Capillary Leak Syndrome: Advise patients of the signs or symptoms of SIRS, such as fever, tachycardia, tachypnea, dyspnea and symptoms suggestive of hypotension [see Warnings and Precautions (5.5), Adverse Reactions (6.1)].

Pregnancy and Breastfeeding: Advise male and female patients with reproductive potential to use effective contraceptive measures to prevent pregnancy [see Warnings and Precautions (5.11), Use in Specific Populations (8.1)]. Advise female patients to avoid breastfeeding during clofarabine treatment [see Use in Specific Populations (8.3)].

Gastrointestinal Disorders: Advise patients that they may experience nausea, vomiting, and/or diarrhea with clofarabine. If these symptoms are significant, they should seek medical attention [see Warnings and Precautions (5.9)].

Rash: Advise patients that they may experience skin rash with clofarabine. If this symptom is significant, they should seek medical attention.

Manufactured by:
Teva Pharmachemie
Swensweg 5
Haarlem, The Netherlands

Manufactured for:
Winthrop U.S.,
a business of sanofi-aventis U.S. LLC
Bridgewater, NJ 08807
A SANOFI COMPANY

Distributed by:
sanofi-aventis U.S. LLC
Bridgewater, NJ 08807

©2016. sanofi-aventis U.S. LLC. All rights reserved.

Revised: 10/2016

Winthrop
A SANOFI COMPANY

NDC 0955-1746-01
Rx ONLY

Clofarabine
injection

20 mg/20 mL

Each vial contains
20 mg/20 mL (1 mg/mL)

Must Be Diluted Prior
To Intravenous Use

Contains 1 (20 mL)
Single-Use Vial

SANOFI