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Akynzeo

Active Substance: netupitant / palonosetron hydrochloride
Common Name: netupitant / palonosetron
ATC Code: A04AA
Marketing Authorisation Holder: Helsinn Birex Pharmaceuticals Ltd
Active Substance: netupitant / palonosetron hydrochloride
Status: Authorised
Authorisation Date: 2015-05-27
Therapeutic Area: Nausea Vomiting Cancer
Pharmacotherapeutic Group: Antiemetics and antinauseants

Therapeutic Indication

Akynzeo is indicated in adults for the:

  • Prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin based cancer chemotherapy.
  • Prevention of acute and delayed nausea and vomiting associated with moderately emetogenic cancer chemotherapy.

What is Akynzeo and what is it used for?

Akynzeo is a medicine used to prevent nausea (feeling sick) and vomiting in adult patients with cancer who are receiving chemotherapy (medicines to treat cancer).

Some chemotherapy is known to induce severe nausea and vomiting, and Akynzeo is used in patients receiving either highly emetogenic (vomit-inducing) chemotherapy based on the cancer medicine cisplatin, or other chemotherapies that are moderately emetogenic.

Akynzeo contains the active substances netupitant and palonosetron.

How is Akynzeo used?

Akynzeo is available as capsules containing 300 mg of netupitant and 0.5 mg of palonosetron. The patient takes one capsule one hour before starting each chemotherapy cycle.

The medicine can only be obtained with a prescription.

How does Akynzeo work?

The two active substances in Akynzeo work by blocking two different mechanisms involved in inducing nausea and vomiting during chemotherapy. Netupitant works by blocking neurokinin-1 (NK1)-receptors, which are found in the nervous system and are responsible for the delayed phase of nausea and vomiting (that occurs after the first 24 hours); palonosetron, on the other hand, blocks 5HT3 receptors in the gut, which are responsible for the immediate phase (that occurs within the first 24 hours).

By having both active substances together, Akynzeo helps provide control for both the immediate and delayed phases of nausea and vomiting than occur following chemotherapy.

One of the active substances, palonosetron, has been authorised on its own in the EU since 2005.

What benefits of Akynzeo have been shown in studies?

In a main study comparing Akynzeo with palonosetron alone, 90% of patients taking Akynzeo (121 out of 135) experienced no vomiting within 5 days of starting highly emetogenic chemotherapy compared with 77% of patients taking palonosetron alone (104 out of 136).

A second main study looked at the benefits of Akynzeo in patients undergoing moderately emetogenic chemotherapy. Around 88% of patients taking Akynzeo experienced no vomiting on day 1 following the first chemotherapy cycle, compared with 85% of patients taking palonosetron. The figures for day 2 to day 5 were 77% for patients in the Akynzeo group and 70% for those in the palonosetron group. This study involved 1,455 patients and the patients took dexamethasone, another medicine used to prevent vomiting, as an additional treatment.

What are the risks associated with Akynzeo?

The most common side effects reported with Akynzeo are headache (seen in 3.6% of patients), constipation (3.0%) and fatigue (1.2%). For the full list of all side effects and restrictions, see the package leaflet.

Why is Akynzeo approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) noted that Akynzeo was effective at preventing both the immediate and delayed phases of nausea and vomiting following chemotherapy, and that the medicine has a favourable safety profile. The Committee therefore concluded that the medicine’s benefits are greater than its risk and recommended that it be approved for use in the EU.

What measures are being taken to ensure the safe and effective use of Akynzeo?

A risk management plan has been developed to ensure that Akynzeo is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Akynzeo, including the appropriate precautions to be followed by healthcare professionals and patients.

Further information can be found in the summary of the risk management plan.

Other information about Akynzeo

The European Commission granted a marketing authorisation valid throughout the European Union for Akynzeo on 27 May 2015.

For more information about treatment with Akynzeo, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Source: European Medicines Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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