INDICATION
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MOVANTIK® (naloxegol) is indicated 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 (eg, weekly) opioid dosage escalation.

Safety

Well-established safety profile

MOVANTIK has been studied in 1497 patients1

Adverse reactions in KODIAC-04 and KODIAC-05 that occurred in ≥3% of patients receiving MOVANTIK 12.5 mg or 25 mg, and at an incidence greater than placebo1:

 
MOVANTIK 25 mg
(n=446)
MOVANTIK 12.5 mg
(n=441)
Placebo
(n=444)
Abdominal pain*
21%
12%
7%
Diarrhea
9%
6%
5%
Nausea
8%
7%
5%
Flatulence
6%
3%
3%
Vomiting
5%
3%
4%
Headache
4%
4%
3%
Hyperhidrosis
3%
<1%
<1%

Safety data for KODIAC-07 and KODIAC-08 were similar to those observed in KODIAC-04 and KODIAC-05.1

*Includes: abdominal pain, abdominal pain upper, abdominal pain lower, and gastrointestinal pain.1
12-week extension study of KODIAC-04 (n=302).1
52-week, phase 3, open-label study of MOVANTIK vs usual care (n=844).1
Reference: 1. MOVANTIK® (naloxegol). Prescribing information. RedHill Biopharma Inc; 2020.
IMPORTANT SAFETY INFORMATION ABOUT MOVANTIK
  • MOVANTIK® (naloxegol) is contraindicated in:
    • Patients with known or suspected gastrointestinal (GI) obstruction and patients at 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 peripherally acting opioid antagonists, including MOVANTIK. Postmarketing cases of GI perforation, including fatal cases, were reported when MOVANTIK was used in patients at risk of GI perforation (eg, infiltrative gastrointestinal tract malignancy, recent gastrointestinal tract surgery, diverticular disease including diverticulitis, ischemic colitis, or concomitantly treated with bevacizumab). 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%)
INDICATION

MOVANTIK® (naloxegol) is indicated 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 (eg, weekly) opioid dosage escalation.

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.

RedHill Biopharma Inc. supports the responsible use of medications, including those containing opioids, as treatment options for patients with chronic non-cancer pain.

This site is intended for US health care professionals only.

RedHill Biopharma Inc. (U.S. Office)
8045 Arco Corporate Drive, Suite 200
Raleigh, NC 27617
Tel: +1-984-444-7010
Fax: +1-919-406-0400
info@redhillus.com

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Think you have opioid-induced constipation?

Think you have opioid-induced constipation?

Begin the quiz

Are you currently taking any opioid pain medication(s) for chronic non-cancer pain?

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Yes
No
Not sure
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MOVANTIK is meant for people taking opioids in order to treat opioid-induced constipation in adults with chronic non-cancer pain.

If you’re experiencing constipation, talk to your doctor about your options for treatment.2,3

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How many bowel movements do you have per week?

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≤1
2-3
4 or more
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MOVANTIK is for the treatment of opioid-induced constipation in adults with chronic non-cancer pain. Having less than 3 bowel movements per week while taking opioids can be a symptom of opioid-induced constipation.

If you’re experiencing constipation, talk to your doctor
about your options for treatment.2,3

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When completing a bowel movement, have you experienced any of the following?

Select all that apply

Straining
Hard or lumpy
stools
Sense of incomplete evacuation
Submit

You may have opioid-induced constipation.1-3

Talk to you doctor about your symptoms and learn how
MOVANTIK may be able to help.

References: 1. Brock C, Olesen SS, Olesen AE, Frøkjaer JB, Andresen T, Drewes AM. Opioid-induced bowel dysfunction: pathophysiology and management. Drugs. 2012;72:1847-1865. 2. MOVANTIK® (naloxegol). Prescribing information. RedHill Biopharma Inc; 2020. 3. Chey WD, Webster L, Sostek M, Lappalainen J, Barker PN, Tack J. Naloxegol for opioid-induced constipation in patients with noncancer pain. N Engl J Med. 2014;370:2387-2396.