Demonstrated safety profile in CINV 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
Oral 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

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

AKYNZEO Injection Contains:

  • No polysorbate 801, 2
    (a solubilizing agent that can cause severe nonimmunologic anaphylactoid reactions)
  • No preservatives1
  • No soy and no egg lecithin1, 3

In Clinical Trials

  • No infusion-site reactions reported4
  • No anaphylaxis attributed to fosnetupitant (NK-1 RA) reported4
  • No significant effect on QTc interval1

Warnings and Precautions

  • 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

Adverse reactions occurring in ≥3% of cancer patients receiving AKYNZEO and AC-based chemotherapy regimens1,†
Adverse reaction, % AKYNZEO capsules
Oral 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

  • 5HT3 RA=5HT3 receptor antagonist; AC=anthracycline-cyclophosphamide; CINV=chemotherapy-induced nausea and vomiting; NK-1 RA=neurokinin-1 receptor antagonist; QTc=corrected QT interval.
  • AKYNZEO for Injection has not been studied for the prevention of nausea and vomiting associated with anthracycline plus cyclophosphamide chemotherapy.