Relistor (Oral)

Methylnaltrexone bromide is used to treat constipation 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 from a past cancer or its treatment who do not need weekly increases in opioid dosage.

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

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to use it.

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

If severe or persistent (non-stop) diarrhea occurs while using this medicine, check with your doctor right away.

Do not suddenly stop using this medicine without checking first with your doctor. Doing so may cause withdrawal symptoms, such as anxiety, chills, increased tearing, redness on the face, neck, arms, and upper chest, feeling cold, diarrhea, irritability, stomach pain, increased sweating, and yawning.

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 or vitamin supplements.

In deciding to use a medicine, you and your doctor must weigh the risks of taking the medicine against the benefits it may provide. Here are some important considerations for this medicine:

Allergies

Inform your doctor if you have ever had an unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

There have not been appropriate studies on the effects of methylnaltrexone in children. Safety and effectiveness have not been established for this age group.

Geriatric

So far, studies have not shown any specific problems in older adults that would limit the use of methylnaltrexone. However, older patients are more likely to experience diarrhea, which may require caution in dosing for those taking this medicine.

Breast Feeding

There are not enough studies in women to determine the risk to infants when using this medication while breastfeeding. Consider the potential benefits and risks before taking this medication during breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together even if an interaction might occur. In these cases, your doctor may need to adjust the dose or take other precautions. It is very important that your healthcare professional knows if you are taking any of the medicines listed below while using this medicine. The following interactions have been selected for their importance and may not include all possible interactions.

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some situations. If both medicines are prescribed together, your doctor may change the dose or frequency of one or both medicines.

• Morphine
• Morphine Sulfate Liposome
• Naldemedine
• Naloxegol
• Oxycodone
• Oxymorphone

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used around the time of eating food or certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect how you can use this medicine. Be sure to tell your doctor if you have any other medical issues, especially:

• Crohn's disease or
• Diverticulitis or
• Ogilvie's syndrome (decreased movement of food in the intestines) or
• Peptic ulcer or
• Stomach or bowel cancer—These may increase the risk of more serious side effects.

• Liver disease or
• Severe kidney disease—Use with caution as the effects may be stronger due to slower removal of the medicine from the body.

• Known or suspected stomach or bowel blockage, or increased risk of blockage—This medicine should not be used in patients with these conditions.

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:

Incidence not known

• Chills
• diarrhea
• fear or nervousness
• increased sweating
• severe abdominal or stomach pain
• severe or persistent diarrhea
• yawning

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:

Less common

• Full or bloated feeling
• headache
• muscle spasms
• pressure in the stomach
• runny nose
• swelling of the abdominal or stomach area
• vomiting

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.

In the U.S.

• Relistor

Available Dosage Forms:

• Tablet

Therapeutic Class: Gastrointestinal Agent

Pharmacologic Class: Methylnaltrexone

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 comes with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Take this medicine with water on an empty stomach at least 30 minutes before the first meal of the day.

Stop taking other laxatives before starting treatment with methylnaltrexone. You should also stop using this medicine if you have stopped taking narcotic pain medicines.

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 in patients with chronic non-cancer pain: Adults—450 milligrams (mg) once a day in the morning 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.

Keep out of the reach of children.

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

• Which drugs cause opioid-induced constipation?