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SYMPROIC

NALDEMEDINE

Manufacturer: BioDelivery Sciences International Inc

Score: 141.0

Quick Summary

SYMPROIC (naldemedine) is an opioid antagonist used for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain. It works by decreasing the constipating effects of opioids in the gastrointestinal tract without affecting the central nervous system. The recommended dosage is 0.2 mg once daily with or without food. Important safety information includes the risk of gastrointestinal perforation, opioid withdrawal, and hypersensitivity reactions. Special population considerations include use during pregnancy, pediatric use, and geriatric use.

Key Clinical Findings and Indications

  • Treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain
  • Decreases the constipating effects of opioids in the gastrointestinal tract
  • Does not affect the central nervous system

Important Safety Information

Warning

Risk of gastrointestinal perforation and opioid withdrawal

Contraindications

  • Patients with known or suspected gastrointestinal obstruction
  • Patients at increased risk of recurrent obstruction
  • Patients with a history of hypersensitivity reaction to naldemedine

Adverse Reactions

  • Abdominal pain
  • Diarrhea
  • Nausea
  • Gastroenteritis
  • Opioid withdrawal

Dosing Recommendations

General Guidance

No dose adjustments required for patients with mild to moderate renal impairment or hepatic impairment

Opioid-induced constipation

Adult Dose

0.2 mg once daily with or without food

Pediatric Dose

Not established

Special Population Considerations

Pregnancy

  • Use during pregnancy only if the potential benefit justifies the potential risk
  • May precipitate opioid withdrawal in a fetus

Nursing Mothers

  • Not studied in nursing mothers

Pediatric Use

  • Not established in pediatric patients

Geriatric Use

  • No overall differences in safety or effectiveness observed in geriatric patients
  • Greater sensitivity of some older individuals cannot be ruled out

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