chlorambucil (Rx)

Brand and Other Names:Leukeran
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Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

tablet

  • 2mg
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Chronic Lymphatic (Lymphocytic) Leukemia

0.1 mg/kg/day for 3-6 weeks or  

0.4 mg/kg (increased by 0.1 mg/kg/dose until response/toxicity observed) biweekly or

0.4 mg/kg (increased by 0.1 mg/kg/dose until response observed) monthly or

0.03-0.1 mg/kg/day continuously

Reduce initial dose if administered within 4 weeks after a full course of radiation/myelosuppressive therapy or patients with bone marrow disease

Not to exceed 0.1 mg/kg/day if bone marrow infiltrated with lymphocytes

Hodgkin's Lymphoma

0.2 mg/kg/day for 3-6 weeks or  

0.4 mg/kg (increased by 0.1 mg/kg/dose until response/toxicity observed) biweekly or

0.4 mg/kg (increased by 0.1 mg/kg/dose until response or toxicity observed) monthly or

0.03-0.1 mg/kg/day continuously

Reduce initial dose if administered within 4 weeks after a full course of radiation/myelosuppressive therapy or patients with bone marrow disease

Not to exceed 0.1 mg/kg/day if bone marrow infiltrated with lymphocytes

Renal Impairment

<1% (including metabolites) excreted in urine; no dose adjustment required

Hepatic Impairment

Primarily metabolized in liver; dose reduction may be required

Monitor

CBC

Discontinue if WBC <3000/mm³ or platelets <150,000/mm³

Other Indications & Uses

Malignant lymphomas (lymphosarcoma, giant follicular lymphoma)

Off-label: Uveitis & meningoencephalitis associeted with Behcet's disease; other NHL; idiopathic membranous nephropathy; RA

Dosage Forms & Strengths

tablet

  • 2mg
more...

Chronic Lymphatic (Lymphocytic) Leukemia (Off-label)

Safety and efficacy not established, but has been used unlabeled

0.1-0.2 mg/kg PO qDay

Chronic Lymphatic (Lymphocytic) Leukemia

0.1 mg/kg/day for 3-6 weeks or  

0.4 mg/kg (increased by 0.1 mg/kg/dose until response/toxicity observed) biweekly or

0.4 mg/kg (increased by 0.1 mg/kg/dose until response observed) monthly or

0.03-0.1 mg/kg/day continuously

Reduce initial dose if administered within 4 weeks after a full course of radiation/myelosuppressive therapy or patients with bone marrow disease

Not to exceed 0.1 mg/kg/day if bone marrow infiltrated with lymphocytes

Hodgkin's Lymphoma

0.2 mg/kg/day for 3-6 weeks or 

0.4 mg/kg (increased by 0.1 mg/kg/dose until response/toxicity observed) biweekly or

0.4 mg/kg (increased by 0.1 mg/kg/dose until response or toxicity observed) monthly or

0.03-0.1 mg/kg/day continuously

Reduce initial dose if administered within 4 weeks after a full course of radiation/myelosuppressive therapy or patients with bone marrow disease

Not to exceed 0.1 mg/kg/day if bone marrow infiltrated with lymphocytes

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Interactions

Interaction Checker

and chlorambucil

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Neutropenia (25-33%)

            Anemia

            Leukopenia

            Thrombocytopenia

            Frequency Not Defined

            Seizures

            Hallucinations

            Peripheral neuropathy

            Nausea

            Vomiting

            Pulmonary fibrosis

            GI effects

            Leukemia

            Myelosuppression

            Hyperuricemia

            Infertility

            Hepatotoxicity & jaundice

            Type I hypersensitivity

            Rash

            Stevens-Johnson syndrome (rare)

            Toxic epidermal necrosis (rare)

            Urticaria

            Erythema multiforme (rare)

            Secondary malignancies

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            Warnings

            Black Box Warnings

            Severe bone marrow suppression can occur with chlorambucil

            Chlorambucil is a carcinogen. Chronic therapy may produce myelocytic leukemia and secondary malignancies

            Chlorambucil may cause infertility. It is teratogenic and mutagenic

            Contraindications

            Hypersensitivity or resistance; demonstrated resistance to chlorambucil previously

            Cautions

            History of seizures; head trauma; those receiving other potentially epileptogenic drugs

            Potentially mutagenic, carcinogenic & teratogenic; avoid pregnancy

            Can cause infertility

            Severely myelosuppressive

            May need lower dosages in liver failure

            Beware of cross-hypersensitivity w/ other alkylating agents

            Reduce dose in preexisting myelosuppressive situations or if WBC/Plt counts fall below normal

            If used within 4 week of radiation/cytotoxic chemotherapy

            Avoid pregnancy

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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

            Alkylating agent of nitrogen mustard family, crosslinks DNA and interferes with DNA replication and RNA transcription; cell cycle nonspecific

            Absorption

            Bioavailability: 70-80%

            Peak Plasma Time: 1 hr

            Distribution

            Protein Bound: 99%

            Vd: 0.3 L/kg

            Metabolism

            Liver

            Metabolites: phenylacetic acid mustard

            Elimination

            Half-Life: 1.5 hr (chlorambucil); 2.5 hr (phenylacetic acid mustard)

            Clearance: 492 ±160 ng/mL (chlorambucil); 306±73 ng/mL (phenylacetic acid mustard)

            Excretion: Urine (20-60% metabolites)

            Dialyzable: No

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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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