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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), 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.
IMPORTANT SAFETY INFORMATION ABOUT MOVANTIK
MOVANTIK® (naloxegol) is contraindicated in:
Patients with known or suspected gastrointestinal (GI) obstruction and patients at increased risk of recurrent
obstruction, due to the potential for GI perforation
Patients receiving strong CYP3A4 inhibitors (eg, clarithromycin, ketoconazole) because these medications
can significantly increase exposure to naloxegol which may precipitate opioid withdrawal symptoms
Patients with a known serious or severe hypersensitivity reaction to MOVANTIK or any of its excipients
Symptoms consistent with opioid withdrawal, including hyperhidrosis, chills, diarrhea, abdominal pain, anxiety, irritability,
and yawning, occurred in patients treated with MOVANTIK. Patients receiving methadone as therapy for their pain
condition were observed in the clinical trials to have a higher frequency of GI adverse reactions that may have
been related to opioid withdrawal than patients receiving other opioids. Patients with disruptions to the blood-brain
barrier may be at increased risk for opioid withdrawal or reduced analgesia. These patients (eg, multiple sclerosis,
recent brain injury, Alzheimer’s disease, and uncontrolled epilepsy) were not enrolled in the clinical studies.
Take into account the overall risk-benefit profile when using MOVANTIK in such patients. Monitor for symptoms
of opioid withdrawal when using MOVANTIK in such patients
Severe abdominal pain and/or diarrhea have been reported, generally within a few days of initiation of MOVANTIK.
Monitor and discontinue if severe symptoms occur. Consider restarting MOVANTIK at 12.5 mg once daily
Cases of GI perforation have been reported with the use of another peripherally acting opioid antagonist in patients
with conditions that may be associated with localized or diffuse reduction of structural integrity in the wall
of the GI tract. Monitor for severe, persistent, or worsening abdominal pain; discontinue if this symptom develops
Avoid concomitant use of moderate CYP3A4 inhibitors (eg, diltiazem, erythromycin, verapamil) because they may increase
the risk of adverse reactions. Use of strong CYP3A4 inducers (eg, rifampin, carbamazepine, St. John’s Wort) is
not recommended because they may decrease the efficacy of MOVANTIK. Avoid concomitant use of MOVANTIK with another
opioid antagonist due to the increased risk of opioid withdrawal
The use of MOVANTIK during pregnancy may precipitate opioid withdrawal in the pregnant woman and the fetus. Because
of the potential for adverse reactions, including opioid withdrawal in breastfed infants, advise women that breastfeeding
is not recommended during treatment with MOVANTIK
The most common adverse reactions with MOVANTIK as compared to placebo in clinical trials were: abdominal pain (21% vs 7%), diarrhea (9% vs 5%), nausea (8% vs 5%), flatulence (6% vs 3%), vomiting (5% vs 4%), headache (4% vs 3%), and hyperhidrosis (3% vs <1%)
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OIC Doctor Discussion Guide
Could you be suffering from opioid-induced constipation (OIC)?
OIC is a different type of constipation. Please answer the following questions to help guide your discussion with your health care provider today!
This guide is for your personal use. AstraZeneca will not collect any personal information from you.
I am taking this/these opioid pain medications for chronic pain:
___ Codeine
___ Hydrocodone
___ Morphine
___ Oxycodone
___ Fentanyl
___ Tramadol
Other: ____________________________
My constipation started or worsened after I began taking an opioid pain medication.
___ Yes
___ No
___ I don’t know
I am experiencing the following symptoms:
___ Fewer than 3 spontaneous bowel movements per week
___ Unable to have a complete bowel movement
___ Hard or lumpy stool
___ Straining when trying to go to the bathroom
___ Feeling like I need to "go" but not being able to
I have used the following to manage my constipation:
___ Lifestyle changes like diet and/or exercise
___ Over-the-counter laxatives (see below)
___ Prescription laxatives
___ I have not yet tried to manage the problem
Other: _________________________________
I am using or have previously used the following over-the-counter laxatives to manage my constipation (please indicate length of time used):
