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This section provides essential safety information regarding the use of Vivitrol. It is crucial to carefully consider these warnings and speak with your healthcare provider if you have any concerns.

• Increased Sensitivity to Opioids: After discontinuing opioid medications, such as during or after Vivitrol treatment, your sensitivity to opioids may heighten. This can result in life-threatening effects if opioids are reintroduced, even at previously tolerated doses. Your healthcare provider may prescribe naloxone to counteract opioid overdoses in emergencies.

• Opioid Withdrawal Risks: Initiating Vivitrol therapy after using opioid medications can trigger severe withdrawal symptoms, including nausea, vomiting, sweating, and agitation.

• Liver Concerns: Some individuals have reported liver issues when starting Vivitrol, likely due to other health conditions. However, sudden opioid withdrawal may exacerbate existing liver problems.

• Depression and Suicidal Thoughts: Vivitrol treatment is associated with reports of depression and suicidal ideations. Promptly inform your healthcare team if you observe mood changes or have thoughts of self-harm.

• Injection Site Reactions: Vivitrol must be administered by a healthcare professional. Common injection site reactions include pain, swelling, and bruising. Rarely, severe reactions may occur, potentially leading to tissue damage. Notify your prescriber if you experience severe symptoms such as blisters or intense pain.

• Severe Allergic Reactions: Some users have experienced severe allergic reactions, including hives, facial swelling, and anaphylaxis. Rarely, allergic pneumonia has been reported, causing wheezing or shortness of breath. Seek immediate medical attention if you experience symptoms like hives, a rash, swelling, or breathing difficulties.

Contraindications: Do not use Vivitrol if any of the following conditions apply, as it may pose serious health risks. Consult your healthcare provider if:

• You are currently using opioids for pain management.
• You are physiologically dependent on opioids.
• You are undergoing opioid withdrawal.
• You have not passed the naloxone challenge test.
• You have a positive urine test for opioids.

Always ensure you follow the guidance of your healthcare provider when considering Vivitrol treatment.

When taking this medication, you may experience some common side effects that are generally mild, such as nausea, headache, dizziness, drowsiness, anxiety, tiredness, and loss of appetite. It's also common to have symptoms at the injection site, including pain, redness, swelling, itching, bruising, or tenderness. These usually resolve on their own, but if they persist or worsen, it's advisable to consult your healthcare provider. Additionally, symptoms like trouble sleeping, vomiting, diarrhea, and joint pain might occur, though they are typically manageable.

For individuals using opiates regularly, mild withdrawal signs such as abdominal cramps, restlessness, bone or joint pain, muscle aches, and a runny nose can appear. More sudden and severe withdrawal symptoms, including vomiting, diarrhea, and mental changes, should be reported to your healthcare provider immediately.

Some users may experience an increase in liver enzymes, which could indicate liver issues, especially at higher doses. Symptoms of liver damage, such as dark urine, persistent nausea, loss of appetite, abdominal pain, or yellowing skin and eyes, require urgent medical attention. Rarely, serious side effects such as a fast or irregular heartbeat, depression, breathing difficulties, or severe allergic reactions, including rash or trouble breathing, may occur. These require immediate medical help.

In rare instances, serious injection site reactions can lead to permanent injury if untreated. If you encounter any severe side effects like chest pain, severe dizziness, or signs of a serious allergic reaction, seek medical assistance promptly. Always inform your healthcare provider about any side effects you experience.

It is important to inform your doctor and pharmacist about all the medications and supplements you are currently taking, including prescribed, over-the-counter, herbal, and dietary supplements, as Vivitrol can interact with various substances. Here are some critical interactions to be aware of:

1. Medications to Avoid: Vivitrol should not be used with certain opioid medications, as these interactions can be harmful. These include, but are not limited to, alfentanil, Buprenorphine, Fentanyl, hydrocodone, morphine, Oxycodone, and Tramadol. Your doctor might choose to avoid prescribing Vivitrol or modify your current medications to prevent these interactions.

2. Medications Usually Not Recommended: Some drugs, like naldemedine and naloxegol, are generally not recommended with Vivitrol unless absolutely necessary. In such cases, your doctor may adjust the dosages or timing of these medications.

3. Increased Side Effect Risk: Using Vivitrol with certain other medications, such as yohimbine, may heighten the risk of side effects. If these drugs are prescribed together, dosage adjustments might be necessary for safe use.

4. Laboratory Interference: Vivitrol may affect lab test results, such as drug screenings, leading to false outcomes. It's crucial to inform lab personnel and healthcare providers that you are using this medication.

By communicating openly with your healthcare providers about your medication regimen, you can help ensure safe and effective treatment.