Clofarabine

Clofarabine
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1];

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Overview

Clofarabine is a {{{drugClass}}} that is FDA approved for the treatment of {{{indication}}}. Common adverse reactions include .

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

There is limited information regarding Off-Label Guideline-Supported Use of Clofarabine in adult patients.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Condition1

• Developed by:

• Class of Recommendation:

There is limited information regarding Off-Label Guideline-Supported Use of Clofarabine in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Clofarabine in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

• Clolar® (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. This indication is based upon response rate. There are no trials verifying an improvement in disease-related symptoms or increased survival with Clolar.

Dosage

• Administer the recommended pediatric dose of 52 mg/m2 as an intravenous infusion over 2 hours daily for 5 consecutive days.

• Treatment cycles are repeated following recovery or return to baseline organ function, approximately every 2 to 6 weeks. The dosage is based on the patient's body surface area (BSA), calculated using the actual height and weight before the start of each cycle. To prevent drug incompatibilities, no other medications should be administered through the same intravenous line.

• Provide supportive care, such as intravenous fluids, antihyperuricemic treatment, and alkalinize urine throughout the 5 days of Clolar administration to reduce the effects of tumor lysis and other adverse events.

• Discontinue Clolar if hypotension develops during the 5 days of administration.

Monitor renal and hepatic function during the 5 days of Clolar administration.

• Monitor patients taking medications known to affect blood pressure. Monitor cardiac function during administration of Clolar.

• Reduce the dose by 50% in patients with creatinine clearance (CrCL) between 30 and 60 mL/min. There is insufficient information to make a dosage recommendation in patients with CrCL less than 30 mL/min.

Dose Modifications and Reinitiation of Therapy

Hematologic Toxicity

• Administer subsequent cycles no sooner than 14 days from the starting day of the previous cycle and provided the patient's ANC is ≥ 0.75 × 109/L.

• If a patient experiences a Grade 4 neutropenia (ANC <0.5 × 109/L) lasting ≥4 weeks, reduce dose by 25% for the next cycle.

Non-hematologic Toxicity

• Withhold Clolar if a patient develops a clinically significant infection, until the infection is controlled, then restart at the full dose.

• Withhold Clolar for a Grade 3 non-infectious non-hematologic toxicity (excluding transient elevations in serum transaminases and/or serum bilirubin and/or nausea/vomiting controlled by antiemetic therapy). Re-institute Clolar administration at a 25% dose reduction when resolution or return to baseline.

• Discontinue Clolar administration for a Grade 4 non-infectious non-hematologic toxicity.

• Discontinue Clolar administration if a patient shows early signs or symptoms of SIRS or capillary leak (e.g., hypotension, tachycardia, tachypnea, and pulmonary edema) occur and provide appropriate supportive measures.

• Discontinue Clolar administration if Grade 3 or higher increases in creatinine or bilirubin are noted. Re-institute Clolar with a 25% dose reduction, when the patient is stable and organ function has returned to baseline. If hyperuricemia is anticipated (tumor lysis), initiate measures to control uric acid.

Off-Label Use and Dosage (Pediatric)

Non–Guideline-Supported Use

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Clofarabine in pediatric patients.

Contraindications

• Condition1

Warnings

• Description

Precautions

• Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Clofarabine in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Clofarabine in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Drug Interactions

• Drug

• Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy Category

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Clofarabine in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Clofarabine during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Clofarabine with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Clofarabine with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Clofarabine with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Clofarabine with respect to specific gender populations.

Race

There is no FDA guidance on the use of Clofarabine with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Clofarabine in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Clofarabine in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Clofarabine in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Clofarabine in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral

• Intravenous

Monitoring

There is limited information regarding Monitoring of Clofarabine in the drug label.

• Description

IV Compatibility

There is limited information regarding IV Compatibility of Clofarabine in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

• Description

Management

• Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Clofarabine in the drug label.

Pharmacology

There is limited information regarding Clofarabine Pharmacology in the drug label.

Mechanism of Action

Structure

File:Clofarabine01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Clofarabine in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Clofarabine in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Clofarabine in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Clofarabine in the drug label.

How Supplied

Storage

There is limited information regarding Clofarabine Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Clofarabine in the drug label.

Precautions with Alcohol

• Alcohol-Clofarabine interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• ®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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