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AKYNZEO

NETUPITANT AND PALONOSETRON

Manufacturer: Helsinn Therapeutics (U.S.), Inc.

Score: 141.0

Quick Summary

AKYNZEO is a combination drug used for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy. It contains netupitant, a substance P/neurokinin 1 (NK-1) receptor antagonist, and palonosetron, a serotonin-3 (5-HT3) receptor antagonist. The drug is available in capsule and injection forms, with the injection form requiring dilution prior to administration. AKYNZEO has been shown to be effective in preventing nausea and vomiting in patients receiving highly emetogenic chemotherapy, including cisplatin-based chemotherapy. However, it is not recommended for use in patients with severe renal impairment or end-stage renal disease. The most common adverse reactions associated with AKYNZEO include headache, asthenia, dyspepsia, fatigue, constipation, and erythema.

Key Clinical Findings and Indications

  • Prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy
  • Effective in preventing nausea and vomiting in patients receiving highly emetogenic chemotherapy, including cisplatin-based chemotherapy

Important Safety Information

Warning

Hypersensitivity reactions, including anaphylaxis, have been reported in patients receiving AKYNZEO

Contraindications

Adverse Reactions

  • Headache
  • Asthenia
  • Dyspepsia
  • Fatigue
  • Constipation
  • Erythema

Dosing Recommendations

General Guidance

No dose adjustment is necessary for patients with mild or moderate renal impairment

Highly emetogenic chemotherapy

Adult Dose

One AKYNZEO capsule administered 1 hour prior to the start of chemotherapy

Pediatric Dose

Not established

Special Population Considerations

Pregnancy

  • Limited available data with AKYNZEO use in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes

Nursing Mothers

Pediatric Use

  • The safety and effectiveness of AKYNZEO in patients below the age of 18 years have not been established

Geriatric Use

  • Of the 1169 adult cancer patients treated with AKYNZEO capsules in clinical studies, 18% were aged 65 and over, while 2% were aged 75 years and over

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