Naldemedine

Naldemedine helps relieve constipation that is caused by opioid pain medicine used for severe chronic pain.

Naldemedine is intended for adults who are taking opioid pain medicine for chronic pain that is not due to active cancer.

Naldemedine 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.

You may take naldemedine with or without food.

Call your doctor if your symptoms do not improve, or if they get worse.

Naldemedine may not work as well in people who have been taking opioids for less than 4 weeks.

Store naldemedine in the original container at room temperature, away from moisture and heat.

After you stop using opioid pain medicine, you should also stop taking naldemedine.

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

Stop using naldemedine and call your doctor right away if you have severe stomach pain that does not go away (this can lead to serious medical problems).

Tell your doctor if you have symptoms of opioid withdrawal, such as sweating, feeling hot or cold, tremors, fast heartbeats, agitation, runny nose, watery eyes, vomiting, and diarrhea.

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

• a blockage in your stomach or intestines.

Tell your doctor if you have ever had:

• a stomach or intestinal disorder (including Crohn's disease, diverticulitis, or Ogilvie's syndrome);
• a stomach ulcer; or
• liver disease.

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

This medicine may cause opioid withdrawal symptoms in a nursing baby. Do not breast-feed while taking naldemedine, and for at least 3 days after your last dose.

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

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

Tell your doctor if you have symptoms of opioid withdrawal: sweating, fever, chills, warmth or tingling in your face, tremors, fast heartbeats, feeling anxious or agitated, yawning, runny nose, sneezing, watery eyes, stomach pain, nausea, vomiting, and diarrhea.

Naldemedine may cause serious side effects. Stop using naldemedine and call your doctor right away if you have:

• severe diarrhea; or
• severe stomach pain that does not go away (this can lead to serious medical problems).

Common side effects of naldemedine may include:

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

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:

0.2 mg orally once a dayComments:-Opioid analgesic doses do not require adjustments when starting this drug.-Treatment should be discontinued if opioid pain medication is discontinued.Use: Treatment of opioid-induced constipation (OIC) in patients with chronic, non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation

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

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

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

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

Other drugs may affect naldemedine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you begin or stop using.