Power combined

90% complete response for AKYNZEO^® (n=135) during the overall phase compared to 77% for oral palonosetron (n=136) (p=0.003)^1,2

An oral combination of netupitant and palonosetron for the prevention of chemotherapy-induced nausea and vomiting (CINV)¹

Indication

AKYNZEO is indicated 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 is an oral fixed combination of palonosetron and netupitant: palonosetron prevents nausea and vomiting during the acute phase and netupitant 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 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: headache, asthenia, dyspepsia, fatigue, constipation and erythema

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 two-fold increase in the systemic exposure of dexamethasone was observed 4 days after single dose of netupitant
- —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

For more information about AKYNZEO, please see Full Prescribing Information.

To report SUSPECTED ADVERSE REACTIONS, contact Helsinn at 1-855-541-3498 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

References: 1. AKYNZEO^® (netupitant/palonosetron) capsules. Full Prescribing Information. 2. Hesketh P, Rossi G, Rizzi G, et al. Efficacy and safety of NEPA, an oral combination of netupitant and palonosetron, for prevention of chemotherapy-induced nausea and vomiting following highly emetogenic chemotherapy: a randomized dose-ranging pivotal study. Ann Oncol. 2014;25(7):1340-1346.

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