Applies to nelarabine: intravenous solution.
Warning
Intravenous route (Solution)
Severe neurologic adverse reactions, including altered mental states, severe somnolence, CNS effects including 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. Monitor frequently for signs and symptoms of neurologic toxicity. Discontinue nelarabine for neurologic adverse reactions of NCI Common Toxicity Criteria (CTCAE) for adverse events Grade 2 or greater.
Serious side effects of Nelarabine
Along with its needed effects, nelarabine 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 or nurse immediately if any of the following side effects occur while taking nelarabine:
More common
- Abdominal or stomach 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 suddenly from a lying or sitting position
- 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 the hands, arms, feet, legs, or face
- muscle pain
- muscle spasms (tetany) or twitching
- muscle weakness
- nausea or vomiting
- nervousness
- nightmares
- numbness, tingling, pain, or weakness in the hands, feet, fingertips, or mouth
- pain or tenderness around the eyes and cheekbones
- painful or difficult urination
- pale skin
- paralysis or severe weakness of the legs
- pinpoint red spots on the skin
- rapid breathing
- seizures
- shakiness and unsteady walk
- shivering
- sleepiness or unusual drowsiness
- slurred speech
- small red or purple spots on the 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 the hands, ankles, feet, or lower legs
- swollen glands
- tightness in the chest
- trouble concentrating
- trouble sleeping
- troubled breathing with exertion
- uncontrolled bowel movements
- unexplained weight loss
- unsteadiness, trembling, or other problems with muscle control or coordination
- unusual bleeding or bruising
- unusual tiredness or weakness
- wrinkled skin
- yellow eyes or skin
Less common
- Change in taste
- loss of memory
- loss of taste
- problems with memory
Other side effects of Nelarabine
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]
