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 (n=136) |
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
Adverse reactions occurring in ≥3% of cancer patients receiving AKYNZEO and AC-based chemotherapy regimens1,† | ||
---|---|---|
Adverse reaction, % | AKYNZEO capsules (n=725) |
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.