Brand Name
Clofarabine
View Brand InformationFDA approval date: May 10, 2017
Classification: Nucleoside Metabolic Inhibitor
Form: Injection
What is Clofarabine?
Clofarabine Injection is indicated for the treatment of pediatric patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia after at least two prior regimens. Clofarabine Injection is a nucleoside metabolic inhibitor indicated for the treatment of pediatric patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia after at least two prior regimens.
Approved To Treat
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Brand Information
CLOFARABINE (CLOFARABINE)
1INDICATIONS AND USAGE
Clofarabine injection is indicated for the treatment of pediatric patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia after at least two prior regimens.
2DOSAGE FORMS AND STRENGTHS
Injection: 20 mg/20 m L (1 mg/m L) clear colorless solution in single-dose vial
3CONTRAINDICATIONS
None.
4ADVERSE REACTIONS
The following clinically significant adverse reactions are discussed in greater detail in other sections of the label:
- Myelosuppression
- Hemorrhage
- Serious Infections
- Hyperuricemia (tumor lysis syndrome)
- Systemic Inflammatory Response Syndrome (SIRS) and Capillary Leak Syndrome
- Venous Occlusive Disease of the Liver
- Hepatotoxicity
- Renal Toxicity
- Enterocolitis
- Skin Reactions
4.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Table 1: Most Commonly Reported (≥ 5% Overall) Adverse Reactions by System Organ Class (N=115 pooled analysis)
¹ Patients with more than one adverse reaction (Med DRA preferred term) within a SOC are counted only once in the SOC totals. Patients with more thanone occurrence of the same adverse reaction (Med DRA preferred term) are counted only once within that reaction and at the highest severity grade.
The following adverse reactions were reported in <5% of the 115 pediatric patients with ALL or AML:
Gastrointestinal Disorders: cecitis, pancreatitis
Hepatobiliary Disorders: hyperbilirubinemia
Immune System Disorders: hypersensitivity
Infections and Infestations: bacterial infection, Enterococcal bacteremia, Escherichia bacteremia, Escherichia sepsis, fungal infection, fungal sepsis, gastroenteritis adenovirus, infection, influenza, parainfluenza virus infection, pneumonia fungal, pneumonia primary atypical, Respiratory syncytial virus infection, sinusitis, staphylococcal infection
Investigations: blood creatinine increased
Psychiatric Disorders: mental status change
Respiratory, Thoracic and Mediastinal Disorder: pulmonary edema
Table 2 lists the incidence of treatment-emergent laboratory abnormalities after clofarabine injection administration at 52 mg/m
Table 2: Incidence of Treatment-Emergent Laboratory Abnormalities after Clofarabine Injection Administration
4.2Postmarketing Experience
The following adverse reactions have been identified during post-approval use of clofarabine injection. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
- Gastrointestinal disorders: gastrointestinal hemorrhage including fatalities.
- Metabolism and nutrition disorders: hyponatremia
- Skin and subcutaneous tissue disorders: Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) (including fatal cases).
5OVERDOSAGE
There were no known overdoses of clofarabine injection. The highest daily dose administered to a human to date (on a mg/m
6DESCRIPTION
Clofarabine injection contains clofarabine, a purine nucleoside metabolic inhibitor.
The chemical name of clofarabine is 2-chloro-9-(2'-deoxy-2'-fluoro-β-D-arabinofuranosyl)-9H-purine-6-amine. Its molecular formula is C
The molecular structure of clofarabine is:
Clofarabine
Clofarabine injection (1 mg/m L) is supplied in a 20 m L, single-dose vial. The 20 m L vial contains 20 mg clofarabine formulated in 20 m L unbuffered normal saline (comprised of Water for Injection, USP, and Sodium Chloride, USP). The p H range of the solution is 4.5 to 7.5. The solution is sterile, clear and practically colorless, and is preservative-free.
7CLINICAL STUDIES
Seventy-eight (78) pediatric patients with ALL were exposed to clofarabine injection. Seventy (70) of the patients received the recommended pediatric dose of clofarabine injection 52 mg/m
Dose Escalation Study in Pediatric Patients with Hematologic Malignancies
The safety and efficacy of clofarabine injection were evaluated in pediatric patients with refractory or relapsed hematologic malignancies in an open-label, dose-escalation, noncomparative study (NCT00042341, A Phase II, Open Label Study of Clofarabine in Pediatric Patients With Refractory or Relapsed Acute Lymphoblastic Leukemia). The starting dose of clofarabine injection was 11.25 mg/m
Single-Arm Study in Pediatric ALL
Clofarabine injection was evaluated in an open-label, single-arm study (NCT00042341) of 61 pediatric patients with relapsed/refractory ALL. Patients received a dose of 52 mg/m
All patients had disease that had relapsed after and/or was refractory to two or more prior therapies. Most patients, 38/61 (62%), had received > 2 prior regimens and 18/61 (30%) of the patients had undergone at least 1 prior transplant. The median age of the treated patients was 12 years, 61% were male, 39% were female, 44% were White, 38% were Hispanic or Latino, 12% were Black or African-American, 2% were Asian and 5% were Other race.
The overall remission (OR) rate (Complete Remission [CR] + CR in the absence of total platelet recovery [CRp]) was evaluated. CR was defined as no evidence of circulating blasts or extramedullary disease, an M1 bone marrow (
Response rates for these studies were determined by an unblinded Independent Response Review Panel (IRRP).
Table 3 summarizes results for the pediatric ALL study. Responses were seen in both pre-B and T-cell immunophenotypes of ALL. The median cumulative dose was 530 mg (range 29-2815 mg) in 1 (41%), 2 (44%) or 3 or more (15%) cycles. The median number of cycles was 2 (range 1-12). The median time between cycles was 28 days with a range of 12 to 55 days.
Table 3: Results in Single-Arm Pediatric ALL
CR = Complete response
CRp = Complete response without platelet recovery
1 Does not include 4 patients who were transplanted (duration of response, including response after transplant, in these 4 patients was 28.6 to 107.7 weeks).
The median duration of CR, including patients who received transplantation, was 47.9 weeks (range 4.3 to 107.7+), where + indicates the patient was still in CR by the study end. Of 35 patients who were refractory to their immediately preceding induction regimen, 6 (17%) achieved a CR or CRp. Of 18 patients who had at least 1 prior hematopoietic stem cell transplant (HSCT), 5 (28%) achieved a CR or CRp.
Among the 12 patients who achieved at least a CRp, 6 patients achieved the best response after 1 cycle of clofarabine, 5 patients required 2 courses and 1 patient achieved a CR after 3 cycles of therapy.
8REFERENCES
1. OSHA Hazardous Drugs.
9HOW SUPPLIED/STORAGE AND HANDLING
Clofarabine injection is supplied in single-dose 20 m L clear tubular USP Type-I vials containing 20 mg of clofarabine in 20 m L of solution. Each box contains one clofarabine injection vial (NDC72205-394-01). The 20-m L tubular USP Type-I clear vials contain 20 m L (20 mg) of solution. The pH range of the solution is 4.5 to 7.5.
10PATIENT COUNSELING INFORMATION
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
Infection
Advise patients of the signs or symptoms of infection (e.g., fever) and report to the physician immediately if any occur
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 injection 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
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
Pregnancy
Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females to inform their healthcare provider of a known or suspected
Lactation
Advise females not to breastfeed during treatment with clofarabine injection and for 2 weeks after the last dose
Gastrointestinal Disorders
Advise patients that they may experience nausea, vomiting, and/or diarrhea with clofarabine injection. If these symptoms are significant, they should seek medical attention [
Rash
Advise patients that they may experience skin rash with clofarabine injection. If this symptom is significant, they should seek medical attention.
Manufactured by:
Telangana - 509 228,
INDIA
Telangana - 509 228,
INDIA
Distributed by:
Piscataway, NJ 06854-3714
Issued on: 05/2025
11PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Clofarabine Injection-20 mg/20 mL (1 mg/m L)-Carton Label
Clofarabine Injection- 20 mg/20 mL (1 mg/m L)-Vial Label
