Naloxegol

Naloxegol is a prescription medication used to treat opioid-induced constipation.

• Naloxegol is available under the following different brand names: Movantik

Common side effects of Naloxegol include:

• stomach/abdominal pain,
• diarrhea,
• nausea,
• gas (flatulence),
• vomiting,
• headache,
• increased or excessive sweating, chills,
• anxiety, or
• yawning

Serious side effects of Naloxegol include:

• severe or worsening stomach pain and diarrhea
• rash;
• hives; 
• swelling of the face, lips, throat, tongue, hands, or feet

Rare side effects of Naloxegol include:

• none 

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Tablet

• 12.5mg
• 25mg

Opioid-Induced Constipation

Adult dosage

• 25 mg orally once a day in the morning; give at least an hour before meals or 2 hours after meals
• Decrease dose to 12.5 mg/day if the patient is unable to tolerate 25 mg/day

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Naloxegol has severe interactions with at least 49 other drugs.
• Naloxegol has serious interactions with at least 37 other drugs.
• Naloxegol has moderate interactions with the following drugs:
  • carbamate
  • duvelisib
  • elagolix
  • encorafenib
  • fedratinib
  • istradefylline
  • lorlatinib
  • rucaparib
  • stiripentol
  • suvorexant
  • tazemetostat
  • tecovirimat
• Naloxegol has minor interactions with no other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Known severe hypersensitivity reaction
• Known or suspected GI obstruction and patients at increased risk of recurrent obstruction; increased risk for GI perforation
• Coadministration with strong CYP3A4 inhibitors; can significantly increase naloxegol systemic exposure, which may precipitate opioid withdrawal symptoms

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Naloxegol?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Naloxegol?”

Cautions

• GI perforation was reported with other PAMORA in patients with conditions associated with reduced structural integrity in the wall of the GI tract (.g, PUD, Ogilvie syndrome, diverticular disease, infiltrative GI malignancies, peritoneal metastases, Crohn’s disease); monitor for development of severe, persistent, or worsening abdominal pain; discontinue naloxegol in patients who develop these symptoms
• Monitor for development of severe abdominal pain and /or diarrhea symptoms after initiating treatment and discontinue if severe symptoms develop; consider restarting therapy at 12.5 mg once daily if appropriate
• Symptoms consistent with opioid withdrawal (e.g., hyperhidrosis, chills, diarrhea, abdominal pain, anxiety, irritability, yawning) reported
• A higher frequency of GI adverse effects related to opioid withdrawal was reported in patients receiving methadone than in other opioid analgesics.
• Patients with disruption to the blood-brain barrier may be at increased risk for opioid withdrawal or reduced analgesia; consider overall risk-benefit in patients with disruptions to the blood-brain barrier; monitor for symptoms of opioid withdrawal.
• Avoid coadministration with other opioid antagonists.

Severe abdominal pain and/or diarrhea

• Severe abdominal pain and/or diarrhea were reported, some of which resulted in hospitalization
• Most cases were with the 25 mg dose
• Symptoms generally occurred within a few days after initiating naloxegol
• Monitor and discontinue therapy if severe symptoms occur
• Consider restarting at 12.5 mg once a day, if appropriate

Pregnancy & Lactation

• Limited available data in pregnant women; insufficient to inform a drug-associated risk of adverse developmental outcomes; therapy may precipitate opioid withdrawal in pregnant women and the fetus.

Lactation

• There are no data on the presence of naloxegol in human milk, effects in nursing infants, or effects on milk production; the drug is present in rat milk; because of the potential for adverse reactions, including opioid withdrawal in breastfed infants, advise women that breastfeeding is not recommended during treatment