Movantik (naloxelol): Consultation

INDICATIONS AND USAGE

MOVANTIK (naloxegol) is an opioid antagonist indicated for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain

DOSAGE AND ADMINISTRATION

1. Take on an empty stomach at least 1 hour prior to the first meal of the day or 2 hours after the meal

--CONTRAINDICATIONS---

Patients with known or suspected gastrointestinal obstruction and at increased risk of recurrent obstruction
• Concomitant use with strong CYP3A4 inhibitors (e.g., clarithromycin, ketoconazole)
(Increase plasma naloxegol concentrations and may increase the risk of adverse reactions)

Of the CYP superfamily of enzymes, CYP3A4 is the most prevalent CYP enzyme in the liver.
Metabolism and elimination of almost 50% of medications depends on this enzyme.
Moderate inhibitors of CYP3A4 include: fluconazole, miconazole, diltiazem, verapamil, amiodarone, erythromycin, delavirdine, amprenavir, fosamprenavir, conivaptan, echinacea and grapefruit juice ( large quantities).
Strong inhibitors of CYP3A4 include: itraconazole, ketoconazole, clarithromycin, telithromycin, nefazodone, atazanavir, darunavir, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir, tipranavir.

For example, among the macrolide antibiotics, all of them are known inhibitors of CYP3A4 with the exception of azithromycin. For the calcium channel blockers, it is only the non-dihydropyridine calcium channel blockers that are known inhibitors of CYP3A4, but not amlodipine or nifedipine.

Strong CYP3A4 inducers (e.g., rifampin, carbamazepine, St. John’s Wort) • Significantly decrease plasma naloxegol concentrations and may decrease the efficacy of MOVANTIK

WARNINGS AND PRECAUTIONS----

1. Discontinue maintenance laxative therapy before starting MOVANTIK; may resume laxatives if patients have OIC symptoms after taking MOVANTIK for 3 days
2. Discontinue if treatment with the opioid pain medication is also discontinued

--USE IN SPECIFIC POPULATIONS--.

Pregnancy: May precipitate opioid withdrawal in a fetus
Nursing Mothers: Discontinue drug or nursing taking into consideration importance of drug to mother
Hepatic Impairment: avoid in severe impairment

Reference: Package insert

https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204760s000lbl.pdf

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