Applies to fosnetupitant / palonosetron: intravenous powder for solution, intravenous solution.
Serious side effects
Along with its needed effects, fosnetupitant/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 or nurse immediately if any of the following side effects occur while taking fosnetupitant / palonosetron:
Incidence not known
- Agitation
- confusion
- cough or hoarseness
- dizziness
- fast heartbeat
- fever
- hearing or seeing things that are not there
- hives, itching, skin rash
- irritation
- joint pain, stiffness or swelling
- muscle twitching
- overactive reflexes
- poor coordination
- redness of the skin
- shivering
- sweating
- swelling of the eyelids, face, lips, hands, or feet
- tightness in the chest
- trembling or shaking
- trouble breathing or swallowing
Other side effects
Some side effects of fosnetupitant / 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
- unusual tiredness or weakness
Less common
- Constipation
- heartburn
- indigestion
- stomach discomfort, upset, or pain
For Healthcare Professionals
Applies to fosnetupitant / palonosetron: intravenous powder for injection, intravenous solution.
Gastrointestinal
Frequency not reported: Constipation, dyspepsia
Palonosetron:
Common (1% to 10%): Constipation, dyspepsia[Ref]
Other
Frequency not reported: Asthenia, fatigue
Palonosetron:
Common (1% to 10%): Asthenia, fatigue[Ref]
Nervous system
Frequency not reported: Headache, serotonin syndrome
Palonosetron:
Common (1% to 10%): Headache[Ref]
Dermatologic
Frequency not reported: Erythema
Palonosetron:
Common (1% to 10%): Erythema[Ref]
Hepatic
Palonosetron:
Uncommon (0.1% to 1%): Elevated AST, elevated ALT, elevated total bilirubin[Ref]
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]
Hypersensitivity
Frequency not reported: Hypersensitivity reactions[Ref]
