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Akynzeo Side Effects

Generic Name: netupitant / palonosetron

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

For the Consumer

Applies to netupitant/palonosetron: oral capsule

Side effects requiring immediate medical attention

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

Side effects not requiring immediate medical attention

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

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]

References

1. "Product Information. Akynzeo (netupitant-palonosetron)." Eisai Inc, Woodcliff Lake, NJ.

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

3. Cerner Multum, Inc. "Australian Product Information." O 0

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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