Naloxegol

Naloxegol is a prescription medication used to treat opioid-induced constipation in adults with chronic non-cancer pain.

Naloxegol belongs to a group of drugs called mu-receptor opioid antagonists. These work by blocking the effects of opioids in the gastrointestinal tract.

This medication comes in oral tablet form and is taken once daily on an empty stomach. Naloxegol should be taken at least 1 hour before the first meal of the day or 2 hours after the meal.

Do not chew, divide, or break naloxegol tablets. Swallow the tablets whole.

Common side effects of naloxegol include abdominal pain, diarrhea, nausea, flatulence, vomiting, and headache.

Naloxegol is a prescription medication used to treat opioid-induced constipation in adults with chronic non-cancer pain.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medications you are taking
• how you respond to this medication

The recommended dose of naloxegol for the treatment of opioid-induced constipation is 25 mg once daily. The dose may be reduced to 12.5 mg daily if the higher dose is not tolerated.

Serious side effects have been reported with naloxegol including the following:

• Gastrointestinal perforation. Tell your healthcare provider right away if you have some or all of the following symptoms of gastrointestinal perforation, including severe, persistent, or worsening abdominal pain.
• Opioid withdrawal. Tell your healthcare provider right away if you have some or all of the following symptoms of opioid withdrawal, including
  • Excessive sweating
  • Chills
  • Diarrhea
  • Abdominal pain
  • Anxiety
  • Irritability
  • Yawning

Do not take naloxegol if you:

• are allergic to naloxegol or to any of its ingredients
• have a known or suspected gastrointestinal obstruction
• are taking other medications that are strong inhibitors of certain liver enzymes

Serious side effects have been reported with naloxegol. See the “Naloxegol Precautions” section.

Common side effects of naloxegol include the following:

• abdominal pain
• diarrhea
• nausea
• flatulence
• vomiting
• headache

This is not a complete list of naloxegol side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• Ketoconazole (Nizoral)
• Itraconazole (Sporanox)
• Clarithromycin (Biaxin)
• Diltiazem (Cardizem, Dilacor, Taztia XT, Tiazac and other)
• Erythromycin (E-mycin, Ery-Sol, Ery-Tab, Erythrocin, in Pediazole)
• Verapamil (Calan, COvera, Isoptin, Tarka, Verelan)
• Quinidine (Cardioquin, Duraquin, Quinact)
• Cimetidine (Tagamet)
• Rifampin (Rifadin)
• Carbamazepine (Carbatrol, Epitol, Tegretol)
• St. John’s Wort
• Other opioid antagonists such as alvimopan (Entereg) and methylnaltrexone (Relistor)

This is not a complete list of naloxegol drug interactions. Ask your doctor or pharmacist for more information.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Naloxegol falls into category C. There are no well-controlled studies that have been done in pregnant women. Naloxegol may induce opioid withdrawal in fetuses. Naloxegol should be used during pregnancy only if the possible benefit outweighs the possible risk to the unborn baby.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if naloxegol crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using naloxegol.

Naloxegol is a controlled substance.

This medication is effective at relieving constipation in people who have been taking opioid medications for at least 4 weeks.