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Akynzeo - Health Care Professionals

Ready-to-use hanging Vial

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Features of AKYNZEO^® ready-to-use, single dose hanging vial¹

Formulation
	AKYNZEO Injection¹	Cinvanti^® injectable emulsion²	Fosaprepitant for injection³
Contains the following medication(s)	fosnetupitant/palonosetron	aprepitant	fosaprepitant
How product is supplied	ready-to-use solution in hanging vial	injectable emulsion in vial	lyophilized powder in vial
Clinical Pharmacology
Inhibits NK-1 pathway	✓	✓	✓
Inhibits 5-HT₃ pathway	✓	No	No
NK-1 RA half-life	144 hours in cancer patients	9-13 hours in healthy subjects*	9-13 hours in healthy subjects*
5-HT₃ RA half-life	58 hours in cancer patients	N/A	N/A
Administration
Administer 2 medications in a single product	✓	No	No
Accessible via automated dispensing machine	✓	✓	No
Infused directly from the vial	✓	No	No
Does NOT require reconstitution or dilution	✓	No^†	No
Can administer simultaneously with IV dexamethasone	✓	No	No
Ingredients
Contains NO polysorbate 80	✓	✓	No
Storage
Does NOT require refrigeration at any point during distribution, storage, or preparation	✓	No	No

=Specific to AKYNZEO injection (ready-to-use).

^*Data not available in cancer patients.

^†Cinvanti IV infusion requires dilution.²

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Pharmacological data cannot be used to make clinical comparisons of efficacy between treatments.

NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines^®) include netupitant/fosnetupitant and palonosetron fixed combination (AKYNZEO) as a NCCN Category 1 recommended option for parenteral MEC and HEC regimens^4‡

^‡When used in recommended antiemetic combination regimens on day 1.
5-HT₃=5-hydroxytryptamine; HEC=highly emetogenic chemotherapy; IV=intravenous; MEC=moderately emetogenic chemotherapy; NCCN=National Comprehensive Cancer Network; NK-1=neurokinin-1; RA=receptor antagonist.

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

References:

1. AKYNZEO [package insert]. Iselin, NJ: Helsinn Therapeutics US, Inc., February 2023.
2. CINVANTI [prescribing information]. Heron Therapeutics, Inc., San Diego, CA; March 2022.
3. EMEND for Injection [package insert]. Whitehouse Station, NJ: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc; May 2022.
4. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines^®) for Antiemesis V.1.2024. © National Comprehensive Cancer Network, Inc. 2023. All rights reserved. Accessed December 22, 2023. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.