What to expect with MOVANTIK

In adults with chronic non-cancer pain

  • MOVANTIK 25 mg was shown to be effective for OIC in 2 clinical studies

    In these studies, MOVANTIK worked quickly, often within 6-12 hours of the first dose

MOVANTIK

taken in

the AM,

as directed

bowel

movement

in the PM

  • MOVANTIK should be taken at least before your first meal of the day, or 2 hours after the meal.

IMPORTANT SAFETY INFORMATION ABOUT MOVANTIK

.

  • 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.

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.