12/06/2018

Helsinn Therapeutics Announces the Assignment of a Product‐Specific Permanent J-code for AKYNZEO® (Fosnetupitant and Palonosetron) for Injection, for Intravenous Use

The Centers for Medicare & Medicaid Services (CMS) released the 2019 Alpha-Numeric HCPCS File, which included the designation of J1454 - Injection, fosnetupitant 235 mg and palonosetron 0.25 mg for AKYNZEO® for injection with the effective date of January 1, 2019.¹

*Note that the product’s NDC code has been “zero‐filled” to ensure creation of an 11‐digit code that meets HIPAA standards.

The zero‐fill location is indicated in bold. HCPCS=Healthcare Common Procedure Coding System; NDC=National Drug Code.

The new intravenous formulation, AKYNZEO® (fosnetupitant and palonosetron) for injection, was approved on April 19, 2018 by the U.S. Food and Drug Administration.³

AKYNZEO® for 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.

Limitation of use:  AKYNZEO® for injection has not been studied for the prevention of nausea and vomiting associated with anthracycline plus cyclophosphamide chemotherapy.⁴

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. ⁴

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 for AKYNZEO capsules and injection: headache, asthenia, dyspepsia, fatigue, constipation and erythema

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.

o   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.

o   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.
• Avoid use in pregnancy, limited data is available, may cause fetal harm.

Please see the full Prescribing Information for AKYNZEO for additional information.

For more information, please visit AKYNZEO.com or contact Jennifer Gruber, Director of Payer Relations and Access, at 908-307-3591 or Jennifer.Gruber@helsinn.com.