Dosing & Uses
Dosage Forms & Strengths
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
Monitor: Neurologic status
Chronic Lymphocytic Leukemia (Orphan)
Orphan indication sponsor
- GlaxoSmithKline LLC; Corporation Service Company, 2711 Centerville Road, Suite 400; Wilmington, DE 19808
Serious - Use Alternative
Significant - Monitor Closely
Fatigue (in adults)
Somnolence (in adults)
Dizziness (in adults)
Peripheral neurologic disorder
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)
Constipation (in adults)
Leukopenia (in peds)
Hepatobiliary d/o (in peds)
Myalgia (in adults)
Seizures (in peds)
Ataxia (in adults)
Insomnia (in adults)
Anorexia (in adults)
Decreased Ca/Mg (in peds)
Fatal opportunistic infections
Tumor lysis syndrome
Demyelination and ascending peripheral neuropathies (similar to Guillain-Barré syndrome)
Black Box Warnings
The drug should be administered under the supervision of an experienced cancer chemotherapy physician
Administer intravenously only
- 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
- Monitor patients closely for neurologic events and discontinue therapy for neurologic events of National Cancer Institute (NCI) Common Toxicity Criteria grade 2 or greater
Risk of severe neurological problems, sometimes irreversible even on drug discontinuation
Discontinue if CTC grade 2 or higher neurotoxicity
Give IV hydration & consider allopurinol to pts at risk for tumor lysis synd & concomitant hyperuricemia
Do not administer live vaccines to immunocompromised patients
Pregnancy & Lactation
Pregnancy Category: D
Lactation: do not nurse
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.
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
Do not dilute
Appropriate dose is transferred to infusion bags or glass containers & infused over 2 hr (adults) or 1 hr (peds)
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.
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- 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.
|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.|
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.