Arranon Side Effects

Generic Name: nelarabine

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

Not all side effects for Arranon may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to nelarabine: intravenous solution

In addition to its needed effects, some unwanted effects may be caused by nelarabine (the active ingredient contained in Arranon). In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when 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 of the side effects that can occur with nelarabine may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

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

Hematologic side effects including anemia (99%), thrombocytopenia (86%), neutropenia (81%), and febrile neutropenia (12%) have been reported. A case of biopsy confirmed multifocal leukoencephalopathy has also been reported.[Ref]

Nervous system

Nervous system side effects (64%) have been reported including somnolence (23%), dizziness (21%), peripheral neurologic disorders (21%), hypoesthesia (17%), headache (15%), paresthesia (15%), ataxia (9%), depressed level of consciousness (6%), tremor (5%), amnesia (3%), dysgeusia (3%), balance disorder (2%), and sensory loss (2%). Neurologic disorders have included peripheral sensory neuropathy (13%), peripheral motor neuropathy (7%), peripheral neuropathy (5%), neuropathy (4%), demyelination, and ascending peripheral neuropathies similar in appearance to Guillain-Barre syndrome.[Ref]

Other

There were four reported additional fatalities unrelated to treatment with nelarabine (the active ingredient contained in Arranon) [Ref]

Other side effects have included reports of sometimes fatal opportunistic infections in patients receiving nelarabine. A fatal case of cerebral hemorrhage/coma/leukoencephalopathy which was thought to be related to treatment with nelarabine has also been reported.[Ref]

Gastrointestinal

Gastrointestinal side effects including nausea (41%), diarrhea (22%), vomiting (22%), constipation (21%), abdominal pain (9%), anorexia (9%), stomatitis (8%), and abdominal distention (6%) have been reported.[Ref]

General

General side effects including fatigue (50%), pyrexia (23%), asthenia (17%), peripheral edema (15%), edema (11%), pain (11%), infection (9%), rigors (8%), dehydration (7%), abnormal gait (6%), chest pain (5%), and noncardiac chest pain (5%) have been reported.[Ref]

Respiratory

Respiratory side effects including cough (25%), dyspnea (20%), pleural effusion (10%), epistaxis (8%), pneumonia (8%), exertional dyspnea (7%), sinusitis (7%), and wheezing (5%) have been reported.[Ref]

Hepatic

Hepatic side effects including increased AST (6%) have been reported.[Ref]

Metabolic

Metabolic side effects including hyperglycemia (6%) and tumor lysis syndrome have been reported.[Ref]

Musculoskeletal

Musculoskeletal side effects including myalgia (13%), arthralgia (9%), back pain (8%), muscular weakness (8%), and pain in extremity (7%) have been reported. Postmarketing reports of rhabdomyolysis and increased blood creatine phosphokinase have been received.[Ref]

Psychiatric

Psychiatric side effects including confusional state (8%), insomnia (7%), and depression (6%) have been reported.[Ref]

Cardiovascular

Cardiovascular side effects including sinus tachycardia (8%) and hypotension (8%) have been reported.[Ref]

Dermatologic

Dermatologic side effects including petechiae (12%) have been reported.[Ref]

Ocular

Ocular side effects including blurred vision (4%) has been reported.[Ref]

References

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

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