Menu
Movantik® (naloxegol)

Movantik® (naloxegol)

Want more information?

Please visit the product website for MOVANTIK

View Full Prescribing Information

Movantik® is a proprietary 25 mg once daily (if not tolerated, reduced to 12.5 mg once daily) oral PAMORA approved by the U.S. Food and Drug Administration for the treatment of opioid-induced constipation (OIC) in adult 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.

Movantik® is the first oral PAMORA approved in the U.S. for the treatment of OIC and is recommended by the American Gastroenterological Association (AGA) guideline1 and the National Comprehensive Cancer Network (NCCN) guideline2.

RedHill acquired Movantik® from AstraZeneca in April 2020 and has been promoting Movantik® since then to pain physicians, gastroenterologists, primary care physicians, nurse practitioners/physician’s assistants and additional specialists.

OIC is a condition caused by prescription opioid pain medicines. Opioids play an important role in chronic pain relief and work by binding to mu-receptors in the central nervous system, but they can also bind to mu-receptors in the bowel, which can result in patients suffering from OIC.

OIC is the most common and debilitating gastrointestinal adverse effect associated with opioid therapy, estimated to affect between 40-80% of the millions of patients taking chronic opioid therapy each year1.

Important Safety Information

MOVANTIK may cause serious side effects, including:

  • Opioid withdrawal: You may have symptoms of opioid withdrawal during treatment with MOVANTIK, including sweating, chills, diarrhea, stomach pain, anxiety, irritability, and yawning. Patients taking methadone to treat their pain may be more likely to experience stomach pain and diarrhea. Tell your doctor if you have any of these symptoms
  • Severe Stomach Pain and/or Diarrhea: This can happen within a few days of starting MOVANTIK and can lead to hospitalization. If either of these side effects occurs, stop taking MOVANTIK and call your doctor immediately
  • Tear in your stomach or intestinal wall (perforation): Stomach pain that is severe can be a sign of a serious medical condition. If you get stomach pain that gets worse or does not go away, stop taking MOVANTIK and get emergency medical help right away


Do not take MOVANTIK if you:

  • Have a bowel blockage (intestinal obstruction) or have a history of bowel blockage
  • Are allergic to MOVANTIK or any of the ingredients in MOVANTIK


MOVANTIK can interact with other medicines and cause side effects, including opioid withdrawal symptoms (see symptoms above). Tell your doctor or pharmacist before you start or stop any medicines during treatment with MOVANTIK

Before you take MOVANTIK, tell your doctor about all of your medical conditions, including if you:

  • Have any stomach, bowel (intestines) problems, including inflammation in parts of the large intestine (diverticulitis), or inflammation and injury of the intestines caused by reduced blood flow (ischemic colitis)
  • Have had recent surgery on the stomach or intestines
  • Have any kidney, or liver problems
  • Are pregnant or plan to become pregnant. Taking MOVANTIK during pregnancy may cause opioid withdrawal symptoms in you or your unborn baby. Tell your healthcare provider right away if you become pregnant during treatment with MOVANTIK
  • Are breastfeeding or plan to breastfeed. It is not known if MOVANTIK passes into your breast milk. Taking MOVANTIK while you are breastfeeding may cause opioid withdrawal in your baby. You and your healthcare provider should decide if you will take MOVANTIK or breastfeed. You should not breastfeed if you take MOVANTIK


Tell your doctor about all of the medicines you take,
 including prescription and over-the-counter medicines, vitamins, and herbal supplements. Other medicines may affect the way MOVANTIK works

If you stop taking your opioid pain medicine, stop taking MOVANTIK and tell your doctor

Avoid eating grapefruit or drinking grapefruit juice during treatment with MOVANTIK

The most common side effects of MOVANTIK include: Stomach (abdomen) pain, diarrhea, nausea, gas, vomiting, headache, and excessive sweating

APPROVED USE FOR MOVANTIK

MOVANTIK is a prescription medicine used to treat constipation that is caused by prescription pain medicines called opioids, in adults with long-lasting (chronic) pain that is not caused by active cancer.


Please also see full prescribing information 


You are encouraged to report Adverse Reactions to RedHill Biopharma Inc. at 1-833-ADRHILL (1-833-237-4455) or FDA at 1-800-FDA-1088 or
 www.fda.gov/medwatch.

 

 

 

 



1 Crockett, Seth D., et al. American Gastroenterological Association Institute guideline on the medical management of opioid-induced constipation, Gastroenterology 156.1 (2019): 218-226.

National Comprehensive Cancer Network (NCCN) Clinical Practice guidelines in Adult Cancer Pain. Version. 2.2013. http://www.nccn.org/professionals/physician_gls/pdf/pain.pdf. Accessed June 2013.

MOVANTIK  is registered trademark of RedHill Biopharma, Inc
©2020 RedHill Biopharma LTD.                     All right reserved.              US-MOV-040       08/2020