nelarabine (Rx)

Brand and Other Names:Arranon
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable solution

  • 5mg/mL

Acute Lymphoblastic Leukemia & Lymphoma

Indicated for T-cell acute lymphoblastic leukemia & T-cell lymphoblastic lymphoma in patients after unsatisfactory treatment with at least 2 chemotherapeutic regimens

1500 mg/sq.meter IV over 2 hours on Days 1, 3, and 5; repeat q21Days  

Monitor: Neurologic status

Chronic Lymphocytic Leukemia (Orphan)

Orphan indication sponsor

  • GlaxoSmithKline LLC; Corporation Service Company, 2711 Centerville Road, Suite 400; Wilmington, DE 19808

Dosage Forms & Strengths

injectable solution

  • 5mg/mL

Acute Lymphoblastic Leukemia & Lymphoma

Indicated for T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma

650 mg/sq.meter IV over 1 hour x5 consecutive days, repeat cycle q21Days  

Monitor: Neurologic status

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Interactions

Interaction Checker

and nelarabine

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Anemia (>50%)

            Neutropenia (>50%)

            Thrombocytopenia (>50%)

            Fatigue (in adults)

            Somnolence (in adults)

            Dizziness (in adults)

            Headache

            Peripheral neurologic disorder

            Hypoesthesia

            Paresthesia

            Asthenia (in adults)

            Pain (in adults)

            Pyrexia (in adults)

            Edema (in adults)

            Petechiae (in adults)

            Cough (in adults)

            Dyspnea (in adults)

            Pleural effusion (in adults)

            Diarrhea (in adults)

            Nausea (in adults)

            Vomiting

            Constipation (in adults)

            Leukopenia (in peds)

            Hepatobiliary d/o (in peds)

            Myalgia (in adults)

            1-10% (selected)

            Seizures (in peds)

            Ataxia (in adults)

            Insomnia (in adults)

            Anorexia (in adults)

            Decreased Ca/Mg (in peds)

            Postmarketing Reports

            Fatal opportunistic infections

            Tumor lysis syndrome

            Demyelination and ascending peripheral neuropathies (similar to Guillain-Barré syndrome)

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            Warnings

            Black Box Warnings

            Neurologic events

            • Severe neurologic events such as altered mental states including severe somnolence, CNS effects including convulsions, and peripheral neuropathy ranging from numbness and paresthesias to motor weakness and paralysis have been reported
            • Events associated with demyelination and ascending peripheral neuropathies similar in appearance to Guillain-Barré syndrome have also been reported
            • These events are not always reversible following cessation of therapy
            • Closely monitor for neurologic events and discontinue therapy for neurologic events of National Cancer Institute (NCI) Common Toxicity Criteria grade 2 or greater

            Contraindications

            None

            Cautions

            Leukopenia, thrombocytopenia, anemia, and neutropenia, including febrile neutropenia, associated with therapy; complete blood counts including platelets should be monitored regularly

            Fetal harm may occur when administered to a pregnant woman; advise pregnant women of potential risk to fetus

            Patients receiving therapy should receive IV hydration according to standard medical practice for management of hyperuricemia in patients at risk for tumor lysis syndrome; consider allopurinol in patients at risk of hyperuricemia

            Somnolence may occur during and for several days after treatment; advise patients to refrain from driving or engaging in hazardous occupations or activities until somnolence has resolved

            Do not administer live vaccines to immunocompromised patients

            Neurologic adverse reactions

            • Nervous system adverse reactions of any grade were reported, and Grade ≥3 (severe, life-threatening, or fatal) adverse reactions were reported for patients following initiation of therapy
            • Common signs and symptoms of drug-related neurotoxicity include somnolence, headache, paresthesia and dysesthesia, dizziness, neuropathy (sensory and motor), cerebellar disturbances and tremor
            • Severe neurologic toxicity can manifest as coma, status epilepticus, craniospinal demyelination, or ascending neuropathy similar in presentation to Guillain-Barré syndrome
            • Patients treated previously or concurrently with intrathecal chemotherapy or previously with craniospinal irradiation may be at increased risk for neurologic adverse events
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            Pregnancy & Lactation

            Pregnancy

            Fetal harm may occur when administered to a pregnant woman; data on use on pregnant women are insufficient to determine drug-associated risk for major birth defects, miscarriage or adverse maternal or fetal outcomeThere are risks associated with untreated leukemia or lymphoma

            Animal data

            • Animal reproduction studies with pregnant rabbits during period of organogenesis resulted in teratogenicity at maternal doses below recommended human adult dose of 1500 mg/m2/day; advise women of potential risk to fetus

            Pregnancy testing

            • Verify pregnancy status of females of reproductive potential prior to starting treatment with drug

            Contraception

            • Females: Potential for genotoxicity; advise females of reproductive potential to use effective contraception during treatment
            • Males: Advise males including those who have had vasectomies, to use condoms during treatment with drug and for 3 months after the last dose

            Lactation

            There are no data on presence of drug in human or animal milk, effect on breastfed child, or on milk production; because of potential for serious adverse reactions in breastfed child from drug, such as severe neurological reactions, advise women not to breastfeed during treatment with drug

            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

            Peak Plasma (adult dose): nelarabine 2-8 mcg/mL; ara-G 26-37 mcg/mL

            Half-Life, Elimination (adult dose): nelarabine 30 min; ara-G 3 hr

            Metabolism: converted to ara-G & methylguanine which are then hydrolyzed or demethylated to guanine & eventually to uric acid & allantoin

            Excretion: partially in urine

            Mechanism of Action

            Converted first to the nucleoside analog, ara-G, & subsequently to the nucleotide analog, ara-GTP, which incorporates into DNA & leads to inhibition of DNA replication & cell death

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            Administration

            IV Administration

            Do not dilute

            Transfer the appropriate dose into polyvinylchloride (PVC) infusion bags or glass containers

            Appropriate dose is transferred to infusion bags or glass containers & infused over 2 hr (adults) or 1 hr (peds)

            Before administration, visually inspect for particulate matter and discoloration

            Storage

            Unopened vials: Store at 25ºC (77ºC); excursion permitted to 15-30ºC (59-89ºF)

            Undiluted solution: Stable in polyvinylchloride (PVC) infusion bags and glass containers for up to 8 hr at up to 30ºC

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            Formulary

            FormularyPatient Discounts

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

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            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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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.