Nelarabine

Nelarabine is a prescription medication used for the treatment of T-cell acute lymphoblastic leukemia & T-cell lymphoblastic lymphoma in patients after unsatisfactory treatment with at least 2 chemotherapeutic regimens.

• Nelarabine is available under the following different brand names: Arranon

Common side effects of Nelarabine include:

• headache
• nausea
• vomiting
• loss of appetite
• constipation
• diarrhea
• cough
• shortness of breath
• dizziness
• drowsiness
• tiredness
• joint or muscle pain
• swelling in the hands or feet

Serious side effects of Nelarabine include:

• hives
• difficulty breathing
• swelling of the face, lips, tongue, or throat
• extreme drowsiness
• loss of balance or coordination
• problems walking
• numbness or tingling feeling in the hands or feet
• problems with buttoning clothes or picking up small items with the fingers
• seizure
• weakness
• loss of movement in any part of the body
• unexplained muscle pain
• tenderness
• fever
• chills
• tiredness
• mouth sores
• skin sores
• easy bruising
• unusual bleeding
• pale skin
• cold hands and feet
• lightheadedness
• shortness of breath
• tiredness
• muscle cramps
• nausea
• vomiting
• diarrhea
• fast or slow heart rate
• tingling in the hands or feet or around the mouth

Rare side effects of Nelarabine include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult  and pediatric dosage

Injectable solution

• 5 mg/mL

Acute Lymphoblastic Leukemia & Lymphoma

Adult dosage

• 1500 mg/sq.meter IV over 2 hours on Days 1, 3, and 5; repeat every 21 days

Pediatric dosage

• 650 mg/sq.meter IV over 1 hour x5 consecutive days, repeat cycle every 21 days

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Nelarabine has severe interactions with no other drugs
• Nelarabine has serious interactions with the following drugs:
  • adenovirus types 4 and 7 live, oral
  • axicabtagene ciloleucel
  • brexucabtagene autoleucel
  • ciltacabtagene autoleucel
  • deferiprone
  • idecabtagene vicleucel
  • influenza virus vaccine quadrivalent, adjuvanted
  • influenza virus vaccine trivalent, adjuvanted
  • lisocabtagene maraleucel
  • palifermin
  • ropeginterferon alfa 2b
  • tisagenlecleucel
  • tofacitinib
• Nelarabine has moderate interactions with the following drugs:
  • acalabrutinib
  • belatacept
  • cholera vaccine
  • dengue vaccine
  • denosumab
  • dichlorphenamide
  • fingolimod
  • hydroxyurea
  • influenza A (H5N1) vaccine
  • influenza virus vaccine (H5N1), adjuvanted
  • meningococcal group B vaccine
  • ofatumumab SC
  • olaparib
  • siponimod
  • sipuleucel-T
  • trastuzumab
  • trastuzumab deruxtecan
  • ublituximab
• Nelarabine has minor interactions with the following drugs:
  • maitake
  • taurine
  • vitamin A
  • vitamin E

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Nelarabine?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Nelarabine?”

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 the potential risk to fetus
• Patients receiving therapy should receive IV hydration according to standard medical practice for the 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 and above (severe, life-threatening, or fatal) adverse reactions were reported for patients following the 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 and Lactation

• Fetal harm may occur when administered to a pregnant woman; data on use on pregnant women are insufficient to determine a drug-associated risk for major birth defects, miscarriage or adverse maternal or fetal outcome. There are risks associated with untreated leukemia or lymphoma
• 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 the drug and for 3 months after the last dose
• Lactation
  • There are no data on the presence of the drug in human or animal milk, its effect on breastfed child, or on milk production; because of the potential for serious adverse reactions in breastfed child from the drug, such as severe neurological reactions, advise women not to breastfeed during treatment with drug