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This document outlines critical safety information and warnings associated with the use of Movantik (naloxegol). Please review this information carefully and discuss any concerns with your healthcare provider.

• Opioid Withdrawal: Although uncommon, some individuals using Movantik (naloxegol) may experience withdrawal symptoms, such as sweating, chills, diarrhea, stomach pain, anxiety, and irritability. These symptoms are more likely in those using methadone for pain management. Additionally, Movantik might reduce the effectiveness of opioid pain medications in rare cases. If you experience withdrawal symptoms or find your pain medication less effective, contact your healthcare provider.

• Severe Stomach Pain or Diarrhea: Movantik (naloxegol) can lead to severe stomach pain or diarrhea, potentially requiring hospitalization. These side effects typically occur within a few days of starting the medication and are more prevalent in those taking a daily dose of 25 mg. Inform your prescriber if you experience severe stomach pain or diarrhea; you may need a dose adjustment to 12.5 mg daily or a different medication.

• Gastrointestinal Injury: Rarely, Movantik (naloxegol) users have reported gastrointestinal issues, including inflammation or tears in the gut wall, which can be serious and necessitate hospitalization. Before starting Movantik, inform your prescriber if you have a history of bowel or gut problems. Contact your healthcare team immediately if you experience severe, persistent, or worsening stomach pain, chills, or fever. Risks include gastrointestinal cancer, recent gastrointestinal surgery, and conditions like Crohn's disease, diverticulitis, or colitis. Taking Avastin (bevacizumab) also increases risk.

• Allergic Reactions: Allergic reactions to Movantik (naloxegol) can occur, presenting as rashes and hives, or more severe symptoms like facial swelling and anaphylaxis. Seek medical attention immediately if you notice these symptoms, including rash, hives, dizziness, choking sensation, difficulty breathing, swelling around the eyes, lips, or tongue after taking the medication.

Contraindications: Movantik (naloxegol) should not be used in the following conditions due to serious health risks:

• Presence of medical conditions causing blockage of the stomach passageway.
• Concurrent use of certain medications that interact with Movantik (naloxegol), such as clarithromycin, itraconazole, and ketoconazole.

Always consult your healthcare provider if you have any of these conditions or if you're taking any interacting medications before starting Movantik (naloxegol).

When taking this medication, some individuals may experience mild side effects such as stomach pain, diarrhea, nausea, or passing gas. These symptoms are common and usually not a cause for concern. However, if they persist or become troublesome, it is advisable to consult a healthcare provider for guidance.

In some instances, users may encounter additional side effects like vomiting, headache, or sweating. While these are typically manageable, be sure to seek advice from a healthcare professional if they worsen.

On a more serious note, the medication can occasionally lead to severe side effects that require immediate medical attention. These include intense stomach pain or persistent diarrhea, which could indicate a rare but serious tear in the stomach or intestinal wall. Symptoms of opioid withdrawal, such as anxiety, irritability, or severe abdominal cramps, also demand prompt medical evaluation.

A very serious allergic reaction, although rare, can occur. Symptoms such as hives, rash, swelling of the face, lips, or tongue, and difficulty breathing necessitate urgent medical intervention. Always remain vigilant for these signs and seek immediate help should they arise.