cladribine (Rx)

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Brand and Other Names:Leustatin

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable solution

  • 1mg/mL
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Hairy Cell Leukemia

0.09 mg/kg/day IV for 7 days continuous infusion; may repeat q28-35Days 

Monitor: CBC, chemistries

Orphan Indications

Multiple Sclerosis

Non-Hodgkin Lymphoma

Acute Myeloid Leukemia

Chronic Lymphocytic Leukemia

Orphan indications sponsor

  • Orphan indication sponsor: Ortho Biotech Oncology Research & Development, Unit of J & J Pharmaceutical Research & Dev., LLC; 920 Route 202 South, P.O. Box 300; Raritan, NJ 08869-0602

Other Indications & Uses

Off-label: Cutaneous T-cell lymphoma, AML, CLL, NHL, autoimmune hemolytic anemia, mycosis fungoides, Sezary syndrome

Safety and efficacy not established

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Interactions

Interaction Checker

and cladribine

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

            All Interactions Sort By:
             activity indicator 

            >10%

            Fever (69%)

            Fatigue (45%)

            Nausea (28%)

            Rash (27%)

            HA (22%)

            Appetite decreased (17%)

            Vomiting (13%)

            1-10%

            Diarrhea (10%)

            Purpura (10%)

            Asthenia (9%)

            Chills (9%)

            Constipation (9%)

            Dizziness (9%)

            Petechiae (8%)

            Insomnia (7%)

            Malaise (7%)

            SOB (7%)

            Abdominal pain (6%)

            Edema (6%)

            Erythema (6%)

            Pruritis (6%)

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            Warnings

            Black Box Warnings

            The drug should be administered under the supervision of an experienced cancer chemotherapy physician

            Bone marrow suppression may occur but is usually reversible and appears to be dose dependent

            Continuous infusion of high doses of 4 to 9 times the recommended dose for hairy cell leukemia has been associated with serious acute nephrotoxicity and neurological toxicity resulting in irreversible paraparesis and quadraparesis. Standard cladribine dosing regimens have also been associated with severe neurological toxicity

            Contraindications

            Hypersensitivity

            Cautions

            Hepatic/renal impairment

            Allopurinol and IV hydration recommended for patients with high tumor burden to prevent tumor lysis syndrome

            Avoid pregnancy

            May impair fertility; shown to suppress rapidly generating cells, including testicular cells

            Do not administer live virus vaccines; risk of infection in setting of immunosuppression

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            Pregnancy & Lactation

            Pregnancy Category: D

            Lactation: not known if excreted in breast milk, do not nurse

            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.

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            Pharmacology

            Mechanism of Action

            Purine analog, impairs DNA repair

            Pharmacokinetics

            Half-Life: 5.4 hr

            Protein bound: 20%

            Vd: 4.5 L/kg

            Clearance: 978 mL/hr/kg

            Excretion: urine

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            Administration

            IV Incompatibilities

            Solution: D5W

            Y-site: none reported

            IV Compatibilities

            Y-site (partial list): carboplatin, cisplatin, cyclophosphamide, cytarabine, diphenhydramine, dopamine, etoposide, heparin, lorazepam, metoclopramide, morphine, ondansetron, paclitaxel, KCl, prochlorperazine, promethazine, NaHCO3, teniposide, vincristine

            IV Preparation

            Single-use vials

            Prepare with bacteriostatic NS

            Both cladribine and diluent should be passed through a sterile 0.22 micron hydrophilic filter as they are being introduced into infusion reservoir

            The calculated dose of cladribine (7 days x 0.09 mg/kg) should first be added to the infusion reservoir through a filter, then the bacteriostatic NS should be added to the reservoir to obtain a total volume of 100 mL

            Standard IV 24 hr infusion dilution: 24 hr dose/500 mL NS

            Standard IV 7 day infusion dilution: 7 day dose/QS to 100 mL with bacteriostatic NS

            Do not dilute in D5W

            IV Administration

            Single daily infusion: administer diluted in an infusion bag containing 500 mL of NS and repeated for a total of 7 consecutive days

            7 day infusion: administer via ambulatory infusion pump into central line; use 0.22 micron filter to infuse

            Storage

            Store intact vials under refrigeration

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            Images

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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

            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.
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