Pronunciation:

nal-DEM-e-deen

Brand Names:

• Symproic

Dosage Forms:

• Tablet

Classifications:

Therapeutic—

Gastrointestinal Agent

Pharmacologic—

Opioid Antagonist

Uses of This Medicine:

Naldemedine is used to treat constipation that is caused by opioids (narcotic pain medicines) in adults with long-lasting pain that is not caused by cancer, or in patients with long-lasting pain caused by a previous cancer or its treatment who do not need weekly increases in opioid dosage.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of naldemedine in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of naldemedine in the elderly. However, elderly patients are more sensitive to the effects of this medicine than younger adults.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Levoketoconazole

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abametapir
• Adagrasib
• Alvimopan
• Berotralstat
• Capmatinib
• Clarithromycin
• Fedratinib
• Fexinidazole
• Itraconazole
• Mavacamten
• Methylnaltrexone
• Nalorphine
• Naloxone
• Naltrexone
• Omaveloxolone
• Phenobarbital
• Primidone
• Samidorphan
• Venetoclax

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Crohn's disease or
• Diverticulitis or
• Ogilvie syndrome or
• Peptic ulcer or
• Stomach or bowel cancer—May increase risk for more serious side effects.

• Patients at increased risk of stomach blockage or
• Stomach or bowel blockage, known or suspected—Should not be used in patients with these conditions.

Proper Use of This Medicine:

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Swallow the tablet whole. Do not crush, break, or chew it. You may take it with or without food.

It is important that you take this medicine together with narcotic pain medicines. If you stop taking narcotic pain medicines, you should also stop taking naldemedine.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For constipation caused by opioids:
    • Adults—0.2 milligrams (mg) once a day for at least 4 weeks (with narcotic pain medicines).
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to decide if you should continue to take it.

This medicine may cause a tear (perforation) in your stomach or bowels. Check with your doctor right away if you have a severe stomach pain that does not go away.

This medicine may cause withdrawal symptoms. Tell your doctor right away if you have increased sweating, chills, increased tearing, redness on the face, neck, arms, and upper chest, feeling cold, abdominal or stomach pain, diarrhea, nausea, and vomiting.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Diarrhea

nausea

stomach pain

Less common

Fast heartbeat

fever

hives, itching, or rash

hoarseness

irritation

joint pain, stiffness, or swelling

loss of appetite

redness of the skin

swelling of the eyelids, face, lips, hands, or feet

tightness in the chest

troubled breathing or swallowing

vomiting

weakness

Incidence not known

Bloody, black, or tarry stools

chills

feeling cold

heartburn

increased sweating

indigestion

redness on the face, neck, arms, and upper chest

severe abdominal or stomach pain, cramping, or burning

vomiting of material that looks like coffee grounds, severe and continuous

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known

Fast, pounding, or irregular heartbeat or pulse

increased tearing

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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