Naloxegol

Naloxegol helps relieve constipation that is caused by opioid pain medicine used for severe chronic pain. It works by easing constipation without affecting the pain relief provided by the opioid.

Naloxegol is for people who have been using opioid pain medicine for at least 4 weeks, to manage chronic pain that is not related to cancer.

Naloxegol may also be used for other reasons that are not mentioned in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Take naloxegol on an empty stomach, at least 1 hour before or 2 hours after your first meal of the day.

If you cannot swallow a naloxegol tablet whole, you may crush the tablet into powder and mix it with 4 ounces of water. Stir and drink this mixture right away. To get the entire dose, add a little more water to the same glass, swirl gently and drink right away.

Naloxegol can also be given through a nasogastric (NG) feeding tube. Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Call your doctor if your symptoms do not improve after 3 days of treatment.

After you stop using your pain medication, you should also stop taking naloxegol.

Store at room temperature away from moisture and heat.

You should not use naloxegol if you have a blockage in your stomach or intestines.

Tell your doctor if you have symptoms of opioid withdrawal, such as anxiety, feeling irritable, sweating, chills, yawning, stomach pain, and diarrhea.

Stop using naloxegol and call your doctor right away if you have severe stomach pain and/or diarrhea (which can lead to serious medical problems).

Tell your doctor about all your current medicines and any you start or stop using. Many drugs can interact, and some drugs should not be used together.

You should not use naloxegol if you are allergic to it, or if you have:

• a blockage in your stomach or intestines.

Some medicines can cause unwanted or dangerous effects when used with naloxegol. Your doctor may need to change your treatment plan if you also use:

• certain antibiotics;
• antifungal medicine;
• heart medication; or
• antiviral medicine to treat hepatitis C or HIV.

Tell your doctor if you have ever had:

• stomach or intestinal problems (including diverticulitis, or ischemic colitis);
• stomach cancer, colorectal cancer;
• a perforation (a hole or tear) in your esophagus, stomach, or intestines;
• recent surgery on the stomach or intestines; or
• liver or kidney disease.

If you use naloxegol while you are pregnant, your baby could have opioid withdrawal symptoms. Tell your doctor if you are pregnant or plan to become pregnant.

Do not breastfeed while taking naloxegol.

Naloxegol is not approved for use by anyone younger than 18 years old.

Get emergency medical help if you notice signs of an allergic reaction: hives; trouble breathing; swelling of your face, lips, tongue, or throat.

Naloxegol may cause serious side effects. Contact your doctor immediately if you experience:

• symptoms of opioid withdrawal--anxiety, feeling irritable, sweating, chills, yawning, stomach pain, diarrhea.

Stop taking naloxegol and call your doctor right away if you have:

• severe stomach pain that does not go away; or
• severe diarrhea.

Common side effects of naloxegol may include:

• nausea, vomiting, stomach pain;
• diarrhea, gas; or
• headache.

This is not a complete list of side effects, and others may happen. Contact your doctor for medical advice about side effects. You can report side effects to the FDA at 1-800-FDA-1088.

Usual Adult Dose for Constipation - Drug Induced:

Opioid-Induced Constipation - Chronic:Initial dose: 25 mg orally once a day Maintenance dose: 25 mg orally once a day; dose may be reduced to 12.5 mg orally once a day for patients unable to tolerate higher doseComments: Prior to initiation, discontinue all maintenance laxative therapy; laxatives can be used as needed for suboptimal response after 3 days.Use: For the treatment of opioid-induced constipation in adult patients with chronic non-cancer pain.

Take the medicine as soon as you can. If it is almost time for your next dose, skip the missed dose. Do not take two doses at the same time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Do not use any other laxatives that your doctor has not prescribed.

Grapefruit may interact with naloxegol and lead to unwanted side effects. Avoid the use of grapefruit products.

Sometimes it is not safe to use certain medications together. Some drugs can change the levels of other drugs in your blood, which may increase side effects or make the medications less effective.

Tell your doctor about all your other medicines, especially bevacizumab.

This list is not complete. Other drugs may affect naloxegol, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.