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clofarabine (Rx)Brand and Other Names:Clolar

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable solution

  • 1mg/mL (20mg vial)
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Refractory or Relapsed Acute Lymphoblastic Leukemia

<21 years: 52 mg/m² IV over 2 hr qDay for 5 consecutive days 

Treatment cycles repeated q2-6wk following recovery or return to baseline organ function

>21 years: Not indicated for this age group

Acute Myelogenous Leukemia (Orphan)

Orphan indication sponsor

  • Genzyme Corporation; 4545 Horizon Hill Blvd; San Antonio, TX 78229-2263

Dosage Modifications

Discontinue if hypotension develops during 5 days of treatment

Hepatic impairment: Not studied

Renal impairment

  • CrCl 30-60 mL/min: Decrease dose by 50%
  • CrCl <30 mL/min: Insufficient data to make recommendation

Monitor

Respiratory status & BP during infusion

Renal & hepatic function during administration

Hematologic status

Dosage Forms & Strengths

injectable solution

  • 1mg/mL (20mg vial)
more...

Refractory or Relapsed Acute Lymphoblastic Leukemia

52 mg/m² IV over 2 hr daily for 5 consecutive days 

Treatment cycles repeated q2-6wk following recovery or return to baseline organ function

Dosage Modifications

Discontinue if hypotension develops during 5 days of treatment

Hepatic impairment: Not studied

Renal impairment

  • CrCl 30-60 mL/min: Decrease dose by 50%
  • CrCl <30 mL/min: Insufficient data to make recommendation

Monitor

Respiratory status & BP during infusion

Renal & hepatic function during administration

Hematologic status

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Interactions

Interaction Checker

clofarabine and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

            Sort by :  
             activity indicator 
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            Adverse Effects

            >10%

            Infection: bacterial, viral, & fungal (83%)

            Vomiting (83%)

            Nausea (75%)

            Anemia (83%)

            Leukopenia (88%)

            Lymphopenia (82%)

            Febrile neutropenia (57%)

            Thrombocytopenia (81%)

            Diarrhea (53%)

            Abdominal pain (8-35%)

            Anorexia (30%)

            Dermatitis

            Pruritus (43%)

            Fatigue (34%)

            Headache (43%)

            Pyrexia (39%)

            Edema (12%)

            Flushing (19%)

            HTN (13%)

            Hypotension (29%)

            Anxiety (21%)

            Pain (15%)

            Erythema (11%)

            Petechiae (26%)

            Palmar-plantar erythrodysesthesia syndrome (16%)

            Gingival bleeding (14%)

            Mucositis (16%)

            Oral candidiasis (11%)

            Cough

            Dyspnea (13%)

            Pleural effusion (12%)

            Hepatobiliary disorder

            Hematuria (13%)

            Limb pain (30%)

            Myalgia (14%)

            Contusion

            Injection site pain

            Transfusion reaction

            1-10%

            Back pain (10%)

            Bacteremia (10%)

            Herpes simplex infections (10%)

            Sepsis (10%)

            Irritability (10%)

            Lethargy (10%)

            Somnolence (10%)

            Cellulitis (8%)

            Agitation (5%)

            Postmarketing Reports

            Gastrointestinal disorders: Gastrointestinal hemorrhage including fatalities

            Skin and subcutaneous tissue disorders: Occurrences of Stevens-Johnson Syndrome and toxic epidermal necrolysis

            Metabolism and nutrition disorders: Hyponatremia

            Hepatitis and hepatic failure

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            Warnings

            Contraindications

            Hypersensitivity

            Cautions

            Expect typical chemotherapeutic adverse events (diarrhea, nausea/vomiting, bone marrow suppression, risk of tumor lysis syndrome)

            Discontinue immediately if clinically significant systemic inflammatory response synd or capillary leak synd develops (may be prevented with prophylactic steroids)

            Myelosuppression may be severe and prolonged; monitor complete blood and platelet counts

            Serious and fatal cerebral, gastrointestinal and pulmonary hemorrhage; monitor platelets and coagulation parameters and treat accordingly

            Monitor for signs and symptoms of infection; severe and fatal sepsis as a result of bone marrow suppression; discontinue therapy promptly if infection occur

            Monitor for and discontinue promptly if systemic inflammatory response or capillary leak syndrome suspected

            Anticipate and monitor for signs and symptoms of tumor lysis syndrome occur; treat promptly

            Monitor for and discontinue if venous occlusive disease of the liver suspected

            Monitor liver enzymes and discontinue therapy at first signs of severe hepatotoxicity; discontinue therapy, immediately, for Grade 3 or greater liver enzyme and/or bilirubin elevations; fatal hepatotoxicity may occur

            Monitor renal function and interrupt or discontinue if creatinine levels increase or acute renal failure occur

            Monitor for signs and symptoms of enterocolitis and treat promptly

            Discontinue therapy if exfoliative or bullous rash suspected or if Stevens-Johnson syndrome or toxic epidermal necrolysis suspected

            Avoid pregnancy

            Hepatitis and hepatic failure reported

            Renal impairment

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            Pregnancy & Lactation

            Pregnancy Category: D

            Lactation: excretion in milk unknown/not recommended

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

            more...
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            Pharmacology

            Half-Life: 5.2 hr

            Protein Bound: 47%

            Vd: 172 L/sq.meter

            Metabolism: metabolized intracellularly to active triphosphate derivative by kinases & phosphokinases

            Clearance: 28.8 L/h/sq.meter

            Excretion: urine 49-60%

            Mechanism of Action

            Purine nucleoside analog, inhibits ribonucleotide reductase & DNA polymerases

            May also promote mitochondria-mediated apoptosis

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            Administration

            IV Preparation

            Filter through 0.2 micron syringe filter

            Dilute in D5W or NS

            May store at room temp for <24 hr

            IV Administration

            Infuse over 2 hr

            Do not administer other drugs in same IV line

            Continuous IV fluids are recommended during the 5 days of Tx to reduce effects of tumor lysis syndrome

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            Images

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            Formulary

            FormularyPatient Discounts

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
            • Manage and view all your plans together – even plans in different states.
            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
            Add or Remove Plans
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            Select a class to view formulary status for similar drugs

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