Movantik

Last updated on RxList: 4/23/2020
Movantik Side Effects Center

What Is Movantik?

Movantik (naloxegol) is an opioid antagonist used to treat opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain.

What Are Side Effects of Movantik?

Common side effects of Movantik include:

Dosage for Movantik

The recommended adult dosage of Movantik is 25 mg once daily in the morning.

What Drugs, Substances, or Supplements Interact with Movantik?

Movantik may interact with azole antifungals, antibiotics, diltiazem, verapamil, quinidine, cimetidine, rifampin, carbamazepine, St. John's Wort, other opioid antagonists, or grapefruit or grapefruit juice. Tell your doctor all medications and supplements you use. During pregnancy, Movantik should be used only if prescribed. Babies born to mothers who have used Movantik during pregnancy may suffer withdrawal symptoms.

Movantik During Pregnancy and Breastfeeding

It is unknown if this drug passes into breast milk. Because of the potential for undesirable effects on a nursing infant, breastfeeding while using Movantik is not recommended. Withdrawal symptoms may occur if you suddenly stop taking this medication.

Additional Information

Our Movantik (naloxegol) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Movantik Consumer Information

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Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • symptoms of opioid withdrawal--anxiety, feeling irritable, sweating, chills, yawning, stomach pain, diarrhea.

Stop taking naloxegol and call your doctor at once if you have:

  • severe stomach pain that will not go away; or
  • severe diarrhea.

Common side effects may include:

  • nausea, vomiting, stomach pain;
  • diarrhea, gas; or
  • headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Movantik (Naloxegol Tablets)

QUESTION

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Movantik Professional Information

SIDE EFFECTS

Serious and important adverse reactions described elsewhere in labeling include:

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The data described below reflect exposure to MOVANTIK in 1497 patients in clinical trials, including 537 patients exposed for greater than six months, and 320 patients exposed for 12 months.

The safety data described in Table 1 are derived from two double-blind, placebo-controlled trials (Studies 1 and 2) in patients with OIC and non-cancer related pain [see Clinical Studies]. Study 3 (n=302) was a safety extension study that allowed patients from Study 1 to continue the same blinded treatment for an additional 12 weeks. Safety data for patients in Study 3 are similar to those listed in Table 1. Study 4 (n=844) was a Phase 3, 52-week, multi-center, open-label, randomized, parallel group, safety and tolerability study of naloxegol versus usual care treatment for OIC (as determined by the investigator and excluding peripheral opioid antagonists) in patients with non-cancer related pain. The population enrolled in Study 4 was similar to that of the other studies. Eligible patients were randomized in a 2:1 ratio to receive either naloxegol 25 mg once daily or usual care treatment for OIC. The most commonly used laxatives in the usual care group were rectal stimulants (e.g., bisacodyl), oral stimulants (e.g., senna), and oral osmotics (e.g., macrogol, magnesium). Safety data for patients in Study 4 are similar to those listed in Table 1.

Table 1 lists adverse reactions in pooled Studies 1 and 2 occurring in ≥ 3% of patients receiving MOVANTIK 12.5 mg or 25 mg and at an incidence greater than placebo.

Table 1. Adverse Reactions* in Patients with OIC and Non-Cancer Pain (Studies 1 and 2)

Adverse Reaction 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%
*Adverse reactions occurring in ≥3% of patients receiving MOVANTIK 12.5 mg or 25 mg and at an incidence greater than placebo.

Opioid Withdrawal

Possible opioid withdrawal, defined as at least three adverse reactions potentially related to opioid withdrawal that occurred on the same day and were not all related to the gastrointestinal system, occurred in less than 1% (1/444) of placebo subjects, 1% (5/441) receiving MOVANTIK 12.5 mg, and 3% (14/446) receiving MOVANTIK 25 mg in Studies 1 and 2 regardless of maintenance opioid treatment. Symptoms included but were not limited to hyperhidrosis, chills, diarrhea, abdominal pain, anxiety, irritability, and yawning. Patients receiving methadone as therapy for their pain condition were observed in Studies 1 and 2 to have a higher frequency of gastrointestinal adverse reactions than patients receiving other opioids [39% (7/18) vs. 26% (110/423) in the 12.5 mg group; 75% (24/32) vs. 34% (142/414) in the 25 mg group].

Read the entire FDA prescribing information for Movantik (Naloxegol Tablets)

© Movantik Patient Information is supplied by Cerner Multum, Inc. and Movantik Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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