Demonstrated safety profile in patients receiving chemotherapy

Safety profile of AKYNZEO® capsules in clinical studies1

Adverse reactions occurring during cycle 1 in ≥3% of cancer patients treated with cisplatin-based chemotherapy (and more commonly than with palonosetron)
Adverse reaction AKYNZEO capsules
(n=136)		 Palonosetron 0.5 mg
(n=136)
Dyspepsia 4% 2%
Fatigue 4% 2%
Constipation 3% 1%
Erythema 3% 2%

  • Safety of AKYNZEO has been studied in >1700 healthy subjects and cancer patients1
  • In all studies, dexamethasone was co-administered with AKYNZEO
Adverse reactions occurring during cycle 1 in ≥3% of cancer patients treated with anthracyclines and cyclophosphamide-based chemotherapy (and more commonly than with palonosetron)
Adverse reaction AKYNZEO capsules
(n=725)		 Palonosetron 0.5 mg
(n=725)
Headache 9% 7%
Asthenia 8% 7%
Fatigue 7% 5%

A study of patients receiving AC-based chemotherapy treatment. 725 patients were treated with AKYNZEO capsules during cycle 1; 635 of these patients continued for up to 8 cycles in a multiple-cycle extension.1

A similar safety profile has been demonstrated for AKYNZEO capsules and injection1

AKYNZEO injection contains

  • No polysorbate 80
    (a solubilizing agent that can cause severe nonimmunologic anaphylactoid reactions)1,2
  • No preservatives1
  • No soy or egg lecithin1

In clinical trials

  • No infusion-site reactions related to AKYNZEO3
  • No anaphylaxis attributed to fosnetupitant (NK-1 RA) reported3
  • No significant effect on QT interval1

Hypersensitivity reactions, including anaphylaxis, have been reported in patients receiving palonosetron, one of the components of AKYNZEO, with or without known hypersensitivity to other 5-HT3 RAs.

See IV Data


*AKYNZEO injection has not been studied for the prevention of nausea and vomiting associated with AC chemotherapy.

  • 5-HT3 RA=5-HT3 receptor antagonist; AC=anthracycline plus cyclophosphamide; CINV=chemotherapy-induced nausea and vomiting; IV=intravenous; NK-1 RA=neurokinin-1 receptor antagonist.