MOVANTIK

NALOXEGOL OXALATE

Manufacturer: Valinor Pharma, LLC

Score: 141.0

Quick Summary

MOVANTIK (naloxegol) is an opioid antagonist used for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain. The recommended dosage is 25 mg once daily, which can be reduced to 12.5 mg if not tolerated. Key clinical findings indicate that MOVANTIK is effective in increasing bowel movements and improving symptoms of OIC. Important safety information includes the risk of opioid withdrawal, severe abdominal pain, and gastrointestinal perforation. Contraindications include patients with known or suspected gastrointestinal obstruction, those concomitantly using strong CYP3A4 inhibitors, and patients with a known serious or severe hypersensitivity reaction to MOVANTIK. Special population considerations include use during pregnancy, pediatric use, and geriatric use, with specific recommendations for dosing and monitoring.

Key Clinical Findings and Indications

Treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain
Increases bowel movements and improves symptoms of OIC
Effective in patients with chronic pain related to prior cancer or its treatment who do not require frequent opioid dosage escalation

Important Safety Information

Warning

Risk of opioid withdrawal, severe abdominal pain, and gastrointestinal perforation

Contraindications

Patients with known or suspected gastrointestinal obstruction
Patients concomitantly using strong CYP3A4 inhibitors (e.g., clarithromycin, ketoconazole)
Patients with a known serious or severe hypersensitivity reaction to MOVANTIK

Adverse Reactions

Abdominal pain
Diarrhea
Nausea
Flatulence
Vomiting
Headache
Hyperhidrosis
Opioid withdrawal symptoms

Dosing Recommendations

General Guidance

Reduce dosage to 12.5 mg once daily in patients with renal impairment (CLcr < 60 mL/min) or in patients concomitantly using moderate CYP3A4 inhibitors

Opioid-induced constipation (OIC)

Adult Dose

25 mg once daily, which can be reduced to 12.5 mg if not tolerated

Pediatric Dose

Not established

Special Population Considerations

Pregnancy

Limited available data with MOVANTIK use in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes
May precipitate opioid withdrawal in the pregnant woman and the fetus

Nursing Mothers

Not specified in the provided information

Pediatric Use

The safety and effectiveness of MOVANTIK have not been established in pediatric patients

Geriatric Use

No overall differences in safety or effectiveness were observed between elderly and younger subjects
MOVANTIK exposure was higher in elderly healthy Japanese subjects compared to young subjects
No dosage adjustment is needed in elderly patients