What is Akynzeo and what is it used for - Netupitant and Palonosetron?
Akynzeo is a medicine used to prevent nausea and vomiting in adult cancer patients treated with chemotherapy (anticancer therapy).
It is known that some types of chemotherapy induce severe nausea and vomiting; Akynzeo is used in patients treated with highly emetogenic chemotherapy (which induces vomiting) based on cisplatin or other moderately emetogenic chemotherapy.
Akynzeo contains the active substances netupitant and palonosetron.
How is Akynzeo used - Netupitant and Palonosetron?
Akynzeo is available as capsules containing 300 mg of netupitant and 0.5 mg of palonosetron. The patient should take one capsule one hour before the start of each chemotherapy cycle.
The medicine can only be obtained with a prescription.
How does Akynzeo - Netupitant and Palonosetron work?
The two active ingredients contained 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 (which occurs after the first 24 hours); palonosetron, on the other hand, blocks 5-HT3 receptors in the intestine, which are responsible for the immediate phase (which occurs within the first 24 hours). Containing both active ingredients, Akynzeo helps control both the immediate phase and the delayed phase of nausea and vomiting that arise following chemotherapy. One of the active ingredients, palonosetron, has been authorized in the EU since 2005.
What benefit has Akynzeo - Netupitant and Palonosetron shown during the studies?
In a main study comparing Akynzeo with palonosetron alone, 90% of the patients taking Akynzeo (121 of 135) had no vomiting within five days after the start of highly emetogenic chemotherapy compared to 77% of patients who took palonosetron alone (104 of 136). A second main study examined the benefits of Akynzeo in patients undergoing moderately emetogenic chemotherapy. Approximately 88% of the patients who took Akynzeo had no vomiting on the first day after the first chemotherapy cycle, compared to 85% of the patients who received palonosetron. For days 2 to 5 the figures were 77% for patients in the Akynzeo group and 70% for those in the palonosetron group. This study involved 1 455 patients and patients were given concomitantly with dexamethasone, another antiemetic medicine, as an additional treatment.
What is the risk associated with Akynzeo - Netupitant and Palonosetron?
The most common side effects reported for Akynzeo are headache (found in 3.6% of patients), constipation (3.0%) and fatigue (1.2%). For the full list of side effects and limitations, see the package leaflet.
Why has Akynzeo - Netupitant and Palonosetron been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) found that Akynzeo is effective in preventing both the immediate phase and the delayed phase of nausea and vomiting following chemotherapy, and that the medicine has a favorable safety profile. The Committee therefore concluded that the benefits of the medicine outweigh the risks 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 - Netupitant and Palonosetron?
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 is available in the summary of the risk management plan
More information on Akynzeo - Netupitant and Palonosetron
On 27 May 2015, the European Commission issued a marketing authorization for Akynzeo, valid throughout the European Union. For more information about treatment with Akynzeo, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. Last update of this summary: 05-2015.
