Helsinn Group: AKYNZEO® Injection Now Ready-to-Use in US

Lugano, Switzerland – June 24, 2024 – The Helsinn Group, a global leader in pharmaceuticals with over 45 years of expertise, has announced the availability of AKYNZEO® (fosnetupitant/palonosetron) injection in a ready-to-use vial in the United States. This new formulation preserves the original composition of the previous AKYNZEO Injection (To-be-Diluted) and offers several user-friendly enhancements.

The newly available AKYNZEO injection features multiple benefits aimed at streamlining its administration process. Notably, the injection does not require any reconstitution or dilution, allowing healthcare practitioners to infuse it directly from the vial using an integrated hanging strap. Furthermore, the product does not need refrigeration at any stage, whether during distribution, storage, or preparation. This ease of access is further enhanced by its compatibility with automated dispensing machines, ensuring the medication can be readily available near patient care locations.

AKYNZEO injection is used alongside dexamethasone in adults to prevent both acute and delayed nausea and vomiting caused by initial and recurrent courses of highly emetogenic cancer chemotherapy. However, it should be noted that it has not been studied for effectiveness in preventing nausea and vomiting associated with anthracycline plus cyclophosphamide chemotherapy. Importantly, AKYNZEO injection excludes polysorbate 80 and allergenic excipients such as soy or egg lecithin, and it can be administered concurrently with intravenous dexamethasone sodium phosphate.

Dr. Melanie Rolli, CEO of Helsinn Group, expressed enthusiasm about the product launch, highlighting Helsinn's commitment to innovation in cancer supportive care. She stated, "We are delighted to introduce the AKYNZEO Ready-to-Use vial, which continues our legacy of pioneering advancements in patient and clinician support in cancer care."

For clinicians interested in ordering the new vial, contact with their GPO or distributor is recommended. The National Drug Code (NDC) number for the AKYNZEO injection vial with hanger (Ready-to-Use) is 69639-106-01, and the J Code is J1454 (Injection, fosnetupitant 235 mg and palonosetron 0.25 mg); billing unit (single dose vial [SDV]).

AKYNZEO is the first and only fixed combination of 5-HT3 and NK1 receptor antagonists approved for preventing chemotherapy-induced nausea and vomiting, both acute and delayed. Administered with dexamethasone, a single dose of AKYNZEO has been shown to offer protection for up to five days.

Despite its extensive benefits, there are limitations to AKYNZEO’s use. It has not been studied for nausea and vomiting prevention associated with anthracycline plus cyclophosphamide chemotherapy.

Safety information for AKYNZEO highlights several warnings and precautions. Hypersensitivity reactions, including anaphylaxis, have been reported in patients receiving palonosetron, a component of AKYNZEO, with or without known hypersensitivity to other 5-HT3 receptor antagonists. Additionally, serotonin syndrome has been associated with 5-HT3 receptor antagonists, particularly when used with other serotonergic drugs. Symptoms may include mental status changes, autonomic instability, neuromuscular symptoms, seizures, and gastrointestinal symptoms. Patients should be monitored for these symptoms, and if they occur, AKYNZEO should be discontinued and supportive treatment initiated.

Common adverse reactions (≥3%) for AKYNZEO capsules include headache, asthenia, dyspepsia, fatigue, constipation, and erythema. The safety profile of AKYNZEO injection is generally similar to that of the capsules.

Drug interactions are also noteworthy. AKYNZEO should be used cautiously in patients on medications metabolized by CYP3A4, as it can increase the plasma concentrations of these drugs. Dexamethasone doses should be reduced when given with AKYNZEO due to a significant increase in systemic exposure observed days after infusion. Additionally, AKYNZEO should be avoided in patients on chronic CYP3A4 inducers like rifampin, as this may reduce its efficacy.

Specific population considerations advise against using AKYNZEO in patients with severe hepatic or renal impairment and caution women about potential risks to the fetus.

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