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Arranon Side Effects

Generic Name: nelarabine

Note: This document contains side effect information about nelarabine. Some of the dosage forms listed on this page may not apply to the brand name Arranon.

For the Consumer

Applies to nelarabine: intravenous solution

Warning

Intravenous route (Solution)

Severe neurologic adverse reactions including altered mental states, severe somnolence, convulsions, and peripheral neuropathy ranging from numbness and paresthesias to motor weakness and paralysis, have been reported with the use of nelarabine. There have also been reports of adverse reactions associated with demyelination, and ascending peripheral neuropathies similar in appearance to Guillain-Barré syndrome. Cessation of therapy has not always resulted in a full recovery from these adverse reactions. Close monitoring is strongly recommended, and nelarabine should be discontinued for neurologic adverse reactions of NCI Common Toxicity Criteria for adverse events Grade 2 or greater.

Along with its needed effects, nelarabine (the active ingredient contained in Arranon) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking nelarabine:

More Common

  • Abdominal pain or cramps
  • anxiety
  • black, tarry stools
  • bleeding gums
  • blood in the urine or stools
  • bloody nose
  • blurred vision
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • change in walking and balance
  • chest pain
  • chills
  • clumsiness or unsteadiness
  • cold sweats
  • coma
  • convulsions
  • cool, pale skin
  • cough or hoarseness
  • decreased or uncontrolled urination
  • difficulty with breathing
  • discouragement
  • dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
  • drowsiness
  • dry mouth
  • fast or irregular heartbeat
  • feeling sad or empty
  • feeling unusually cold
  • fever
  • flushed, dry skin
  • fruit-like breath odor
  • headache
  • incoordination
  • increased hunger
  • increased thirst
  • increased urination
  • irritability
  • loss of appetite
  • loss of interest or pleasure
  • lower back, side, or stomach pain
  • mood or mental changes
  • muscle cramps in hands, arms, feet, legs, or face
  • muscle pain
  • muscle spasms (tetany) or twitching seizures
  • muscle weakness
  • nausea or vomiting
  • nervousness
  • nightmares
  • numbness, tingling, pain, or weakness in hands, feet, fingertips, or mouth
  • pain or tenderness around the eyes and cheekbones
  • painful or difficult urination
  • paralysis or severe weakness of legs
  • rapid breathing
  • seizures
  • shakiness and unsteady walk
  • shivering
  • shortness of breath
  • sleepiness or unusual drowsiness
  • sleeplessness
  • slurred speech
  • small red or purple spots on skin
  • sneezing
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • stuffy or runny nose
  • sunken eyes
  • sweating
  • swelling of hands, ankles, feet, or lower legs
  • swollen glands
  • tightness in chest
  • trouble concentrating
  • trouble sleeping
  • troubled breathing with exertion
  • unable to sleep
  • uncontrolled bowel movements
  • unexplained weight loss
  • unsteadiness, trembling, or other problems with muscle control or coordination
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • wheezing
  • wrinkled skin
  • yellow eyes or skin

Less Common

  • Change in taste
  • loss of memory
  • loss of taste
  • problems with memory

Some side effects of nelarabine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More Common

  • Back pain
  • diarrhea
  • difficulty having a bowel movement (stool)
  • difficulty with moving
  • full or bloated feeling
  • joint pain
  • lack or loss of strength
  • muscle aching or stiffness
  • pain in the arms or legs
  • pressure in the stomach
  • swelling of the abdomen or stomach area
  • swelling or inflammation of the mouth
  • swollen joints

For Healthcare Professionals

Applies to nelarabine: intravenous solution

Hematologic

Very common (10% or more): Anemia (99%), leucopenia (94%), thrombocytopenia (88%), febrile neutropenia (12%)[Ref]

Nervous system

Very common (10% or more): Somnolence (23%), peripheral neurological disorders (sensory and motor) (21%), dizziness (21%), hypoesthesia (17%), paresthesia (15%), headache (15%)

Common (1% to 10%): Seizures (e.g., convulsions, grand mal convulsions, status epilepticus), ataxia, balance disorder, tremor, dysgeusia

Postmarketing reports: Demyelination and ascending peripheral neuropathies similar in appearance to Guillain-Barre syndrome[Ref]

Other

Very common (10% or more): Fatigue (50%), pyrexia (23%), asthenia (17%), Peripheral edema (15%), pain (11%)

Common (1% to 10%): Abnormal gait[Ref]

Gastrointestinal

Very common (10% or more): Nausea (22%), diarrhea (22%), vomiting (22%), constipation (21%)

Common (1% to 10%): Stomatitis, abdominal pain, abdominal distention[Ref]

Respiratory

Very common (10% or more): Cough (26%), dyspnea (20%), pleural effusion (10%)

Common (1% to 10%): Wheezing, epistaxis, exertional dyspnea[Ref]

Hepatic

Very common (10% or more): Transaminases increased (10%)

Common (1% to 10%): Hyperbilirubinemia, aspartate aminotransferase increased[Ref]

Metabolic

Very common (10% or more): Hypokalemia (11%)

Common (1% to 10%): Tumor lysis syndrome, anorexia, hypoglycemia, hypocalcemia, hypomagnesemia[Ref]

Musculoskeletal

Common (1% to 10%): Muscle weakness, arthralgia, back pain, pain in extremity

Rare (less than 0.1%): Rhabdomyolysis[Ref]

Psychiatric

Common (1% to 10%): Confusion, amnesia, insomnia, depression[Ref]

Cardiovascular

Common (1% to 10%): Hypotension, tachycardia[Ref]

Dermatologic

Very common (10% or more): Petechiae (12%)[Ref]

Ocular

Common (1% to 10%): Blurred vision[Ref]

Immunologic

Very common (10% or more): Infection (e.g., sepsis, bacteremia, pneumonia, fungal infection) (39%)[Ref]

Renal

Common (1% to 10%): Blood creatinine increased[Ref]

References

1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

2. "Product Information. Arranon (nelarabine)." GlaxoSmithKline, Research Triangle Park, NC.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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