Helsinn Akynzeo

Helsinn Cares Reimbursement Support Access Resources for AKYNZEO®

Patient Access Support for Healthcare Professionals

The Helsinn Cares program is designed to provide support and resources for AKYNZEO® reimbursement—and to allow you and your office staff to focus on patient care.

Start the process by enrolling your patients in Helsinn Cares today!

When you enroll your patients in Helsinn Cares, the program can help with confirming benefit coverage and facilitate prior authorizations or appeals, when required. The AKYNZEO® Quick Start Voucher Program provides the first dose of AKYNZEO® free for patients whose insurance company requires prior authorization for coverage of their prescription. And, if your patient meets eligibility criteria, then he or she will be considered for the Patient Assistance Program.

Enroll a Patient in Helsinn Cares. Download the Enrollment Form. Or call 1-84HELSINN-U (1-844-357-4668, select prompt 2).

Resources

AKYNZEO® Prescribing Information

Helsinn Cares Enrollment Form

AKYNZEO® Co-pay card

AKYNZEO® Billing and Coding Guide

Helsinn Cares provides tools—for you and your
patients—to support reimbursement and access to AKYNZEO®.

Helsinn is committed to helping every patient obtain the Helsinn medication
he or she needs. For answers to specific questions on Helsinn Cares,
please call 1-84HELSINN-U (1-844-357-4668, select prompt 2) or fax: 1-844-357-4669.
For medical information, please call: 1-855-541-3495.

Indication

AKYNZEO is indicated for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy. AKYNZEO is an oral fixed 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 after cancer chemotherapy.1

Important Safety Information
Warnings and Precautions

  • Hypersensitivity reactions, including anaphylaxis, have been reported 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: 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
    • Dexamethasone doses should be reduced when given with AKYNZEO. A two-fold increase in the systemic exposure of dexamethasone was observed 4 days after single dose of netupitant
    • 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

For more information about AKYNZEO, please see Full Prescribing Information.

To report SUSPECTED ADVERSE REACTIONS, contact Helsinn at 1-855-541-3498 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Reference:
1. AKYNZEO® (netupitant/palonosetron) capsules. Full Prescribing Information.


AKYNZEO® is a registered trademark of Helsinn Healthcare SA, Switzerland, used under license.

Indication

AKYNZEO is indicated for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy. AKYNZEO is an oral fixed 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 after cancer chemotherapy.1

Important Safety Information
Warnings and Precautions

  • Hypersensitivity reactions, including anaphylaxis, have been reported 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: 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
    • Dexamethasone doses should be reduced when given with AKYNZEO. A two-fold increase in the systemic exposure of dexamethasone was observed 4 days after single dose of netupitant
    • 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

For more information about AKYNZEO, please see Full Prescribing Information.

To report SUSPECTED ADVERSE REACTIONS, contact Helsinn at 1-855-541-3498 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Reference:
1. AKYNZEO® (netupitant/palonosetron) capsules. Full Prescribing Information.


AKYNZEO® is a registered trademark of Helsinn Healthcare SA, Switzerland, used under license.

AKYNZEO® is a registered trademark of Helsinn Healthcare SA, Switzerland, distributed and marketed by Helsinn Therapeutics (U.S.), Inc. under license.
©2017 Helsinn Therapeutics (U.S.), Inc. All rights reserved. HELS-US0041a 02/2017