Akynzeo (netupitant and palonosetron), Cost, Side Effects, Dosage, Copay And PI | Kunchok Dolma, PharmD | RxEconsult
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Akynzeo (netupitant and palonosetron), Cost, Side Effects, Dosage, And Prescribing Information For Chemotherapy Induced Nausea And Vomiting (CINV) Category: Cancer by - November 7, 2014 | Views: 11582 | Likes: 0 | Comment: 0  

Akynzeo for CINV

Brand Name: Akynzeo 
Generic Name: netupitant and palonosetron
Medication Class: Antiemetic
Manufacturer: Eisai Inc.
Approval date: October 2014

What is Akynzeo and its mechanism of action?

Akynzeo is used for preventing chemotherapy-induced nausea and vomiting (CINV). It is a capsule containing a fixed dose 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 of nausea and vomiting following cancer treatment.

Netupitant blocks the binding of substance P to NK1 (neurokinin 1) receptors. Substance P, a signaling chemical, binds to NK1 receptors in the brain which are commonly associated with delayed phase of nausea and vomiting. Preventing subspace P from binding to its receptor prevents nausea and vomiting in both the delayed and acute phases. 

Palonosetron blocks the activation of serotonin. Cancer drugs stimulate serotonin (5-HT3) receptors, leading to nausea and vomiting in the acute phase. Blocking the activation of serotonin receptors prevents nausea and vomiting in the acute phase.

Both drugs in Akynzeo target two critical signaling pathways associated with chemo-induced nausea and vomiting.

What is Akynzeo used for treating?

Akynzeo is FDA approved for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy.

How effective is Akynzeo?

Akynzeo’s effectiveness was established in two clinical trials of participants receiving cancer chemotherapy.

Efficacy in the Cisplatin-based Chemotherapy

In study one, patients either received one dose oral Akynzeo (300 mg netupitant and 0.5 mg palonosetron) or one dose of 0.5 mg of oral palonosetron. The trial was designed to measure whether Akynzeo prevented vomiting episodes in the acute (0 to 24 hours) and delayed (25 to 120 hours) phases after the start of cancer chemotherapy. When comparing the group that received AKynzeo versus oral palonosetron group, the Akynzeo group had significantly lower numbers of patients experiencing nausea in all three phases. In the acute phase, there was a complete response in 98% of people who received Akynzeo versus 89.7% of people who received palonosetron. In the delayed phase there was a complete response in 90.4% of people who received Akynzeo versus 80.1% of people who received palonosetron. Overall 89.6% of people who received Akynzeo versus 76.5% of people who received palonosetron had a complete response 120 hours after treatment.

Efficacy in the Anthracyclines and Cyclophosphamide-based Chemotherapy

In study two, patients either receive oral Akynzeo (300 mg netupitant and 0.5 mg palonosetron) or 0.5 mg of oral palonosetron. The trials were designed to measure whether Akynzeo prevented vomiting episodes in the delayed phases defined as 25-120 hours after the start of chemotherapy administration.

In the delayed phase there was a complete response in 76.9% of people who received Akynzeo versus 69.5% of people who received palonosetron. Overall 74.3% of people who received Akynzeo versus 66.6% of people who received palonosetron had a complete response 120 hours after treatment.

Interesting Facts about Akynzeo

  • Akynzeo is the first approved fixed combination oral agent that targets two critical signaling pathways associated with chemotherapy-induced nausea and vomiting (CINV).
  • Palonosetron, a component of Akynzeo, is also the active chemical in Aloxi.  Aloxi is used for treating chemotherapy-induced nausea and vomiting. 
  • Netupitant, a new drug, prevents nausea and vomiting during both the acute phase and delayed phase (from 25 to 120 hours) after the start of cancer chemotherapy.

Next: Side Effects, Dosage, Interactions, Cost

 


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