Movantik

Movantik blocks certain effects of opioid medication. An opioid is sometimes called a narcotic.

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

Movantik 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.

Movantik is usually taken once per day. Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

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

If you cannot swallow the 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 4 more ounces of water to the same glass, swirl gently and drink right away.

Movantik 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 Movantik.

Store at room temperature away from moisture and heat.

You should not use Movantik if you have or have ever had 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.

If you take methadone to treat your pain, you may be more likely to have stomach pain and diarrhea while taking Movantik than people who do not take methadone.

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).

Stop taking this medicine and get emergency medical help right away if you have stomach pain that gets worse or does not go away.

Many drugs can interact with naloxegol, and some drugs should not be used together. Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Movantik.

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

• a blockage in your stomach or intestines, or a history of such a blockage.

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;
• imatinib;
• isoniazid;
• nefazodone;
• an antibiotic - clarithromycin, telithromycin;
• antifungal medicine - itraconazole, ketoconazole, posaconazole, voriconazole;
• heart medication - nicardipine, quinidine; or
• antiviral medicine to treat hepatitis C or HIV/AIDS - atazanavir, boceprevir, cobicistat, delavirdine, fosamprenavir, indinavir, nelfinavir, ritonavir, saquinavir, telaprevir.

To make sure this medicine is safe for you, tell your doctor if you have ever had:

• a stomach or intestinal disorder (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 Movantik while you are pregnant, you or 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.

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

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

Call your doctor at once if you have:

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

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

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

Common Movantik side effects 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.

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.

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.

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 while taking Movantik.

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 interact with naloxegol, including prescription ad over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.