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Akynzeo - Health Care Professionals

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AKYNZEO^® demonstrated safety and efficacy over multiple cycles of chemotherapy

Study designed with patients undergoing initial and repeat cycles of chemotherapy who received AKYNZEO capsules¹

Multinational, multicenter, randomized, double-blind, double-dummy, parallel-group study
The primary assessment of this multicycle study was safety, measured primarily by treatment-emergent adverse events; efficacy over multiple cycles was also evaluated
Patients were randomized (3:1 for AKYNZEO Capsules) on Day 1 (AKYNZEO, n=309; aprepitant/palonosetron, n=104) of their first chemotherapy cycle before administration of:

HEC
Cisplatin^†	Streptozocin	Carmustine^†
Mechlorethamine	Cyclophosphamide (≥1500 mg/m²)	Dacarbazine^†

MEC
Oxaliplatin^†	Irinotecan^†	Cytarabine (>1 g/m²)
Carboplatin^†	Daunorubicin^†	Azacitidine
Epirubicin^†	Doxorubicin^†	Alemtuzumab
Idarubicin	Cyclophosphamide^† (<1500 mg/m²)	Bendamustine
Ifosfamide		Clofarabine

^†Cycle 1 chemotherapy.¹

There was no limit to the number of consecutive cycles for each patient¹

AKYNZEO safety and efficacy results in multi-cycle chemotherapy¹

Treatment-emergent adverse events of AKYNZEO were comparable to aprepitant and palonosetron
Efficacy in the AKYNZEO arm was maintained throughout all cycles

AC=anthracycline plus cyclophosphamide; CINV=chemotherapy-induced nausea and vomiting; HEC=highly emetogenic chemotherapy; IV=intravenous; MEC=moderately emetogenic chemotherapy.

Indication

AKYNZEO (netupitant/palonosetron) capsules is indicated in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy.

AKYNZEO (fosnetupitant/palonosetron) injection is indicated in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy.

Limitations of Use

AKYNZEO injection has not been studied for the prevention of nausea and vomiting associated with anthracycline plus cyclophosphamide chemotherapy.

AKYNZEO is a combination of palonosetron, a serotonin-3 (5-HT₃) receptor antagonist, and netupitant or fosnetupitant, substance P/neurokinin-1 (NK-1) receptor antagonists: palonosetron prevents nausea and vomiting during the acute phase and netupitant/fosnetupitant prevents nausea and vomiting during both the acute and delayed phase after cancer chemotherapy.

Important Safety Information

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 receptor antagonists
Serotonin syndrome has been reported with 5-HT₃ receptor antagonists alone but particularly with concomitant use of serotonergic drugs. Serotonin syndrome can be life threatening. Symptoms associated with serotonin syndrome may include the following combination of signs and symptoms: mental status changes, autonomic instability, neuromuscular symptoms, seizures, and gastrointestinal symptoms. Patients should be monitored for the emergence of serotonin syndrome, and if symptoms occur, discontinue AKYNZEO and initiate supportive treatment. Patients should be informed of the increased risk of serotonin syndrome, especially if AKYNZEO is used concomitantly with other serotonergic drugs

Adverse Reactions

Most common adverse reactions (≥3%) for AKYNZEO capsules are headache, asthenia, dyspepsia, fatigue, constipation and erythema. The safety profile of AKYNZEO injection was generally similar to AKYNZEO capsules

Drug Interactions

Use with caution in patients receiving concomitant medications primarily metabolized by CYP3A4. The plasma concentrations of CYP3A4 substrates can increase when co-administered with AKYNZEO. The inhibitory effect on CYP3A4 can last for multiple days
- Dexamethasone doses should be reduced when given with AKYNZEO. A more than two-fold increase in the systemic exposure of dexamethasone was observed 4 days after a single dose of netupitant or a single infusion of fosnetupitant
- Consider the potential effects of increased plasma concentrations of midazolam or other benzodiazepines metabolized via CYP3A4 (alprazolam, triazolam) when administering with AKYNZEO. When administered with netupitant, the systemic exposure to midazolam was significantly increased
Avoid concomitant use of AKYNZEO in patients on chronic use of a strong CYP3A4 inducer such as rifampin as this may decrease the efficacy of AKYNZEO

Use in Specific Populations

Avoid use of AKYNZEO in patients with severe hepatic impairment, severe renal impairment, or end-stage renal disease
Advise women of potential risk to fetus; limited data are available; may cause fetal harm

For more information, please see the full US Prescribing Information for AKYNZEO.

Reference:

1. Gralla RJ, et al. Ann Oncol. 2014;25(7):1333-1339.