Naloxegol reduces constipation caused by opioid pain medicine used to treat severe chronic pain. Naloxegol works by treating constipation without reducing the pain-relieving effects of the opioid.

Naloxegol is used in people who have been taking opioid pain medicine for at least 4 weeks, to treat chronic pain that is not caused by cancer.

Naloxegol may also be used for purposes not listed in this medication guide.

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 at once 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.

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.

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 dose

Comments: 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.

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.

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

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

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Do not eat grapefruit or drink grapefruit juice while taking this medication.

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.

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

Naloxegol may cause serious side effects. Call your doctor at once if you have:

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

Stop taking naloxegol and call your doctor at once if you have:

• severe stomach pain that will 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 occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, 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.

Keep all appointments with your doctor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.