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Nucynta ER

TAPENTADOL HYDROCHLORIDE

Manufacturer: Collegium Pharmaceutical, Inc.

Score: 144.0

Quick Summary

Nucynta ER is an opioid agonist used for the management of severe and persistent pain in adults, including neuropathic pain associated with diabetic peripheral neuropathy. It is available in extended-release tablets and should be prescribed only by healthcare professionals knowledgeable in the use of opioids. The drug has a boxed warning for serious and life-threatening risks, including addiction, abuse, and misuse, as well as respiratory depression and neonatal opioid withdrawal syndrome. Initial dosing is typically 50 mg twice daily, with titration to achieve adequate analgesia while minimizing adverse reactions. Special considerations are needed for patients with hepatic or renal impairment, pregnant women, nursing mothers, pediatric patients, and geriatric patients.

Key Clinical Findings and Indications

  • Management of severe and persistent pain in adults
  • Neuropathic pain associated with diabetic peripheral neuropathy
  • Available in extended-release tablets

Important Safety Information

Warning

Serious and life-threatening risks from use of Nucynta ER, including addiction, abuse, and misuse, respiratory depression, and neonatal opioid withdrawal syndrome

Contraindications

  • Significant respiratory depression
  • Acute or severe bronchial asthma or hypercarbia
  • Known or suspected gastrointestinal obstruction
  • Hypersensitivity to tapentadol or any other ingredients
  • Concurrent use of monoamine oxidase inhibitors (MAOIs)

Adverse Reactions

  • Nausea
  • Constipation
  • Dizziness
  • Headache
  • Somnolence
  • Respiratory depression
  • Neonatal opioid withdrawal syndrome

Dosing Recommendations

General Guidance

Titrate dose no more than every 3 days, with a maximum daily dose of 500 mg

Severe and persistent pain

Adult Dose

50 mg twice daily, titrated to achieve adequate analgesia

Pediatric Dose

Not established

Special Population Considerations

Pregnancy

  • Use of opioid analgesics for an extended period during pregnancy may cause neonatal opioid withdrawal syndrome
  • Available data with Nucynta ER are insufficient to inform a drug-associated risk for major birth defects and miscarriage

Nursing Mothers

  • Tapentadol is excreted in breast milk, with unknown effects on the infant

Pediatric Use

  • Safety and efficacy not established in pediatric patients less than 18 years of age

Geriatric Use

  • Elderly patients may have increased sensitivity to tapentadol, with a higher risk of respiratory depression
  • Use caution when selecting a dosage for an elderly patient, starting at the low end of the dosing range

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