Applies to netupitant / palonosetron: oral capsule.
Serious side effects
Along with its needed effects, netupitant/palonosetron 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 netupitant / palonosetron:
Incidence not known
- Agitation
- confusion
- dizziness
- fever
- hearing or seeing things that are not there
- muscle twitching
- overactive reflexes
- poor coordination
- shivering
- sweating
- trembling or shaking
Other side effects
Some side effects of netupitant / palonosetron 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
- Headache
- fatigue
- unusual tiredness or weakness
Less common
- constipation
- flushing or redness of the skin
- heartburn
- indigestion
- stomach discomfort, upset, or pain
For Healthcare Professionals
Applies to netupitant / palonosetron: oral capsule.
Gastrointestinal
Common (1% to 10%): Constipation, dyspepsia
Uncommon (0.1% to 1%): Abdominal distention, abdominal pain, diarrhea, flatulence, nausea
Rare (0.01% to 0.1%): Dysphagia, tongue coated
Palonosetron:
Common (1% to 10%): Constipation, dyspepsia[Ref]
Nervous system
Common (1% to 10%): Headache
Uncommon (0.1% to 1%): Dizziness, vertigo
Rare (0.01% to 0.1%): Abnormal taste, hypoesthesia
Palonosetron:
Common (1% to 10%): Headache[Ref]
Dermatologic
Common (1% to 10%): Erythema
Uncommon (0.1% to 1%): Alopecia, urticaria
Palonosetron:
Common (1% to 10%): Erythema[Ref]
Psychiatric
Uncommon (0.1% to 1%): Insomnia
Rare (0.01% to 0.1%): Acute psychosis, altered mood, sleep disorder
Palonosetron:
Common (1% to 10%): Asthenia, fatigue[Ref]
Other
Common (1% to 10%): Asthenia, fatigue
Rare (0.01% to 0.1%): Feeling hot
Palonosetron:
Uncommon (0.1% to 1%): Fatigue[Ref]
Cardiovascular
Uncommon (0.1% to 1%): Atrioventricular (AV) block, AV block first degree, bundle branch block, cardiomyopathy, conduction disorder, electrocardiogram QT prolonged, hypertension
Rare (0.01% to 0.1%): Arrhythmia, AV block second degree, electrocardiogram ST segment depression, electrocardiogram ST-T segment abnormal, hypotension, increased troponin, mitral valve incompetence, myocardial ischemia, ventricular extrasystoles
Palonosetron:
Postmarketing reports: Shock[Ref]
Hepatic
Approximately 0.6% of patients given 0.5 mg of palonosetron developed AST greater than 3 times the upper limit of normal (ULN) and/or ALT greater than 3 x ULN with total bilirubin greater than ULN. Approximately 0.2% of patients given the same dose of palonosetron developed AST greater than 10 x ULN and/or ALT greater than 10 x ULN with total bilirubin greater than ULN, and approximately 0.1% of patients developed AST greater than 3 x ULN and/or ALT greater than 3 x ULN with total bilirubin greater than or equal to 2 x ULN.
Approximately 0.3% of patients given oral formulations of netupitant-palonosetron developed AST greater than 3 x ULN and/or ALT greater than 3 x ULN with total bilirubin greater than ULN, and AST greater than 3 x ULN and/or ALT greater than 3 x ULN with total bilirubin greater than or equal to 2 x ULN occurred in up to 0.1% of patients.[Ref]
Uncommon (0.1% to 1%): Elevated ALT, elevated AST, elevated total bilirubin, increased blood alkaline phosphatase
Rare (0.01% to 0.1%): Increased blood bilirubin
Palonosetron:
Uncommon (0.1% to 1%): Elevated AST, elevated ALT, elevated total bilirubin[Ref]
Hematologic
Uncommon (0.1% to 1%): Leukocytosis, neutropenia
Rare (0.01% to 0.1%): Leukopenia, lymphocytosis[Ref]
Musculoskeletal
Uncommon (0.1% to 1%): Increased blood creatine phosphokinase
Rare (0.01% to 0.1%): Back pain, non-cardiac chest pain
Palonosetron:
Uncommon (0.1% to 1%): Myalgia[Ref]
Ocular
Rare (0.01% to 0.1%): Blurred vision, conjunctivitis
Palonosetron:
Uncommon (0.1% to 1%): Eye swelling[Ref]
Metabolic
Uncommon (0.1% to 1%): Decreased appetite
Rare (0.01% to 0.1%): Hypokalemia[Ref]
Renal
Uncommon (0.1% to 1%): Increased blood creatinine
Rare (0.01% to 0.1%): Cystitis[Ref]
Respiratory
Uncommon (0.1% to 1%): Hiccups
Palonosetron:
Frequency not reported: Dyspnea[Ref]
Hypersensitivity
Palonosetron:
Postmarketing reports: Anaphylactic/anaphylactoid reactions, anaphylaxis[Ref]
