Dosing & Uses
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
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (13)
- adenovirus types 4 and 7 live, oral
nelarabine decreases effects of adenovirus types 4 and 7 live, oral by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressives may diminish therapeutic effects of vaccines and increase risk of adverse effects (increased risk of infection). Live-attenuated vaccines should be avoided for at least 3mo after cessation of immunosuppressive therapy.
- axicabtagene ciloleucel
nelarabine, axicabtagene ciloleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- brexucabtagene autoleucel
nelarabine, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- ciltacabtagene autoleucel
nelarabine, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- deferiprone
deferiprone, nelarabine. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Avoid use of deferiprone with other drugs known to be associated with neutropenia or agranulocytosis; if an alternative is not possible, monitor absolute neutrophil count more frequently.
- idecabtagene vicleucel
nelarabine, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- influenza virus vaccine quadrivalent, adjuvanted
nelarabine decreases effects of influenza virus vaccine quadrivalent, adjuvanted by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive drugs may reduce the immune response to influenza vaccine.
- influenza virus vaccine trivalent, adjuvanted
nelarabine decreases effects of influenza virus vaccine trivalent, adjuvanted by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive drugs may reduce the immune response to influenza vaccine.
- lisocabtagene maraleucel
nelarabine, lisocabtagene maraleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- palifermin
palifermin increases toxicity of nelarabine by Other (see comment). Avoid or Use Alternate Drug. Comment: Palifermin should not be administered within 24 hrbefore, during infusion of, or within 24 hr after administration of antineoplastic agents. Coadministration of palifermin within 24 hr of chemotherapy resulted in increased severity and duration of oral mucositis.
- ropeginterferon alfa 2b
ropeginterferon alfa 2b, nelarabine. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.
- tisagenlecleucel
nelarabine, tisagenlecleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- tofacitinib
nelarabine, tofacitinib. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
Monitor Closely (18)
- acalabrutinib
acalabrutinib, nelarabine. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration may increase risk of myelosuppressive effects.
- belatacept
belatacept and nelarabine both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.
- cholera vaccine
nelarabine decreases effects of cholera vaccine by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs and corticosteroids (used in greater than physiologic doses), may reduce the immune response to cholera vaccine.
- dengue vaccine
nelarabine decreases effects of dengue vaccine by immunosuppressive effects; risk of infection. Use Caution/Monitor. Immunosuppressive therapies (eg, irradiation, antimetabolites, alkylating agents, cytotoxic drugs, corticosteroids [greater than physiologic doses]) may reduce immune response to dengue vaccine.
- denosumab
nelarabine, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.
- dichlorphenamide
dichlorphenamide and nelarabine both decrease serum potassium. Use Caution/Monitor.
- fingolimod
nelarabine increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .
- hydroxyurea
nelarabine, hydroxyurea. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of myelosuppression.
- influenza A (H5N1) vaccine
nelarabine decreases effects of influenza A (H5N1) vaccine by Mechanism: pharmacodynamic antagonism. Use Caution/Monitor. Immunosuppressive therapies may reduce immune response to H5N1 vaccine.
- influenza virus vaccine (H5N1), adjuvanted
nelarabine decreases effects of influenza virus vaccine (H5N1), adjuvanted by Mechanism: pharmacodynamic antagonism. Use Caution/Monitor. Immunosuppressive therapies may reduce immune response to H5N1 vaccine.
- meningococcal group B vaccine
nelarabine decreases effects of meningococcal group B vaccine by pharmacodynamic antagonism. Use Caution/Monitor. Individuals with altered immunocompetence may have reduced immune responses to the vaccine.
- ofatumumab SC
ofatumumab SC, nelarabine. Either increases effects of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Consider the risk of additive immune system effects when coadministering immunosuppressive therapies with coadministration. When switching from therapies with immune effects, take into account the duration and mechanism of action of these therapies when initiating ofatumumab SC.
- olaparib
nelarabine and olaparib both increase pharmacodynamic synergism. Use Caution/Monitor. Coadministration with other other myelosuppressive anticancer agents, including DNA damaging agents, may potentiate and prolongate the myelosuppressive toxicity.
- siponimod
siponimod and nelarabine both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.
- sipuleucel-T
nelarabine decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.
- trastuzumab
trastuzumab, nelarabine. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .
- trastuzumab deruxtecan
trastuzumab deruxtecan, nelarabine. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .
- ublituximab
ublituximab and nelarabine both increase immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Owing to potential additive immunosuppressive effects, consider duration of effect and mechanism of action of these therapies if coadministered
Minor (4)
- maitake
maitake increases effects of nelarabine by pharmacodynamic synergism. Minor/Significance Unknown. Maitake mushroom has anti-tumor effects (animal/in vitro research).
- taurine
nelarabine decreases levels of taurine by unspecified interaction mechanism. Minor/Significance Unknown.
- vitamin A
vitamin A, nelarabine. Mechanism: pharmacodynamic synergism. Minor/Significance Unknown. Antioxidants such as vitamin A enhance the efficacy, and reduce toxicity, of antineoplastic drugs.
- vitamin E
vitamin E, nelarabine. Mechanism: pharmacodynamic synergism. Minor/Significance Unknown. Antioxidants such as vitamin E enhance the efficacy, and reduce toxicity, of antineoplastic drugs.
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)
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
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.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
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
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| nelarabine intravenous - | 250 mg/50 mL vial |  | |
| nelarabine intravenous - | 250 mg/50 mL vial |  | |
| nelarabine intravenous - | 250 mg/50 mL vial |  | |
| nelarabine intravenous - | 250 mg/50 mL vial |  | |
| Arranon intravenous - | 250 mg/50 mL vial |  | |
| Arranon intravenous - | 250 mg/50 mL vial |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
nelarabine intravenous
NELARABINE - INJECTION
(nel-AR-a-been)
COMMON BRAND NAME(S): Arranon
WARNING: Rarely, serious nervous system problems have occurred with the use of this medication. The risk may be increased if you have previously received chemotherapy injection into a certain part of the spine (intrathecal) or radiation treatment to the head/spine area. Tell your doctor right away if you notice any symptoms of nervous system problems including: extreme sleepiness, confusion, numbness/tingling in hands/feet, loss of coordination, muscle weakness, or unsteadiness while walking. Get medical help right away if any of the following symptoms occur: inability to move (paralysis), seizure. These symptoms may not go away completely even when treatment with nelarabine is stopped. Consult your doctor for details.
USES: This medication is used to treat certain cancers (leukemia, lymphoma). Nelarabine is a chemotherapy drug that works by slowing or stopping the growth of cancer cells.
HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start using nelarabine and each time you get a refill. If you have any questions, ask your doctor or pharmacist.This medication is given by slow injection into a vein, usually by a health care professional. Each treatment period is called a cycle. In adults, it is usually given on days 1, 3, and 5 of each treatment cycle or as directed by your doctor. In children, it is usually given daily for 5 days in a row during each treatment cycle or as directed by the doctor.The dosage is based on your medical condition, age, body size, and response to treatment. Your doctor will check your blood counts to make sure you can receive your next cycle. Keep all medical and laboratory appointments.
SIDE EFFECTS: See also Warning section.Headache, nausea, vomiting, loss of appetite, constipation, diarrhea, cough, shortness of breath, dizziness, drowsiness, and tiredness may occur. In some cases, your doctor may prescribe medication to prevent or relieve nausea and vomiting. Eating several small meals, not eating before treatment, or limiting activity may help lessen some of these effects. If any of these effects last or get worse, tell your doctor or pharmacist promptly.People using this medication may have serious side effects. However, you have been prescribed this drug because your doctor has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.Tell your doctor right away if you have any serious side effects, including: easy bruising/bleeding, swelling ankles/feet.This medication can lower the body's ability to fight an infection. Tell your doctor promptly if you develop any signs of an infection such as sore throat that doesn't go away, fever, or chills.Nelarabine sometimes causes side effects due to the rapid destruction of cancer cells (tumor lysis syndrome). To lower your risk, your doctor may add a medication and tell you to drink plenty of fluids. Tell your doctor right away if you have symptoms such as: low back/side pain (flank pain), signs of kidney problems (such as painful urination, pink/bloody urine, change in the amount of urine), muscle spasms/weakness.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before using nelarabine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood/bleeding disorders (such as anemia, low blood cell counts), kidney problems, liver disease, numbness/tingling in hands/feet (peripheral neuropathy), seizure.Nelarabine can make you more likely to get infections or may make current infections worse. Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, flu). Talk to your doctor if you have been exposed to an infection or for more details.Tell your health care professional that you are using nelarabine before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).To lower your risk of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).Older adults may be more sensitive to the side effects of this drug, especially nervous system problems (such as numbness/tingling in hands/feet).Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using nelarabine. Nelarabine may harm an unborn baby. Your doctor should order a pregnancy test before you start this medication. Women using this medication should ask about reliable forms of birth control during treatment. Men using this medication should use effective barrier protection (such as latex or polyurethane condoms) during treatment and for 3 months after the last dose. If you or your partner become pregnant, talk to your doctor right away about the risks and benefits of this medication.It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: other anti-cancer drugs (especially pentostatin).Tell your doctor or pharmacist if you are taking other products that cause drowsiness such as opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana (cannabis), drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine).Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.
OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: Lab and/or medical tests (such as complete blood count) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.
MISSED DOSE: It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule. Do not double the dose to catch up.
STORAGE: Not applicable. This medication is given in a clinic and will not be stored at home.
MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).
Information last revised May 2023. Copyright(c) 2023 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
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