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Naloxegol (Oral route)

Pronunciation:

nal-OX-ee-gol

Brand Names:

  • Movantik

Dosage Forms:

  • Tablet

Classifications:

Pharmacologic—

Opioid Antagonist

Uses of This Medicine:

Naloxegol 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.

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 naloxegol 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 naloxegol in the elderly.

Pregnancy—

Pregnancy CategoryExplanation
All TrimestersCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

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.

  • Atazanavir
  • Boceprevir
  • Clarithromycin
  • Cobicistat
  • Conivaptan
  • Delavirdine
  • Idelalisib
  • Indinavir
  • Itraconazole
  • Ketoconazole
  • Lopinavir
  • Nefazodone
  • Nelfinavir
  • Posaconazole
  • Ritonavir
  • Saquinavir
  • Telaprevir
  • Telithromycin
  • Tipranavir
  • Voriconazole

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.

  • Abiraterone
  • Alvimopan
  • Aprepitant
  • Carbamazepine
  • Ceritinib
  • Ciprofloxacin
  • Crizotinib
  • Darunavir
  • Diltiazem
  • Dronedarone
  • Efavirenz
  • Enzalutamide
  • Erythromycin
  • Etravirine
  • Fluconazole
  • Fosaprepitant
  • Fosphenytoin
  • Imatinib
  • Methylnaltrexone
  • Miconazole
  • Mifepristone
  • Mitotane
  • Nalmefene
  • Nalorphine
  • Naloxone
  • Naltrexone
  • Netupitant
  • Nilotinib
  • Oxcarbazepine
  • Phenytoin
  • Primidone
  • Rifabutin
  • Rifampin
  • Rifapentine
  • Samidorphan
  • St John's Wort
  • Ticagrelor
  • Verapamil

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. 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 is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

  • Grapefruit Juice

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's syndrome or
  • Peptic ulcer or
  • Stomach or bowel cancer—May increase risk for more serious side effects.
  • Kidney disease, moderate to severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
  • Stomach or bowel blockage, or history of—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.

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

Swallow the tablet whole. Do not crush, break, or chew it.

Stop taking other laxatives before starting treatment with naloxegol. Also, stop taking naloxegol if you have stopped taking narcotic pain medicines.

Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

If you have trouble swallowing the tablet, you may crush it and mix it with 120 mL of water and drink it right away. Refill the glass with water, stir, and drink right away to make sure to get full dose of this medicine.

If you have trouble swallowing the tablet, it may also be given through a nasogastric tube: Draw up 30 mL of water into a 60 mL syringe and flush the nasogastric tube. Crush the tablet to a powder and mix it with 60 mL of water in a container. Draw up the mixture using 60 mL syringe and give it through the tube. Add 60 mL of water to the container mixture and use the same 60 mL syringe to flush the tube for any remaining medicine.

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—25 milligrams (mg) once a day in the morning. Your doctor may adjust your dose as needed.
      • 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. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.

Do not take this medicine together with clarithromycin, itraconazole, or ketoconazole. Using these medicines together may cause or worsen opioid withdrawal symptoms, such as anxiety, chills, diarrhea, irritability, stomach pain, sweating, and yawning.

Call your doctor right away if you have severe stomach pain or diarrhea while you are using this medicine.

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.

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:

Less common
Abdominal or stomach pain
anxiety
chills
diarrhea
increased sweating
irritability
yawning
Incidence not known
Bloody, black or tarry stools
heartburn
indigestion
nausea
severe abdominal or stomach pain, cramping, or burning
trouble breathing
vomiting of material that looks like coffee grounds, severe and continuing

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:

More common
Bloated
excess air or gas in the stomach or bowels
full feeling
passing gas
Less common
Headache
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.


Last Updated: 7/4/2017
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