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The following safety information outlines key risks and precautions associated with the use of naltrexone (ReVia). It is crucial to understand these warnings and discuss any concerns with your healthcare provider.

• Increased Sensitivity to Opioids: After completing naltrexone (ReVia) treatment for opioid use disorder, your body may become more sensitive to opioids. This heightened sensitivity could lead to severe and potentially life-threatening effects if opioids are consumed again, even at previously tolerated doses.

• Opioid Withdrawal: Initiating naltrexone (ReVia) while currently using opioids can trigger significant withdrawal symptoms such as nausea, vomiting, sweating, and agitation. These symptoms may appear as soon as five minutes after taking naltrexone (ReVia) and can persist for two days or longer.

• Liver Concerns: Although rare, naltrexone (ReVia) might lead to liver damage. It's essential to discuss your medical history with your healthcare provider, especially if you have liver issues. Your doctor may decide to monitor your liver health more closely. Be vigilant for symptoms like fatigue, dark urine, stomach upset, abdominal pain, or jaundice, and seek medical advice immediately if they occur.

• Mental Health Risks: There have been reports of depression and suicidal thoughts in individuals taking naltrexone (ReVia). It is uncertain if these mood changes are directly related to the medication. Notify your healthcare provider promptly if you experience mood changes or have thoughts of self-harm. Immediate medical attention is advised for severe depression or suicidal thoughts.

Contraindications: Naltrexone (ReVia) should not be used in the following situations without consulting your healthcare provider, as it may result in serious health complications:

• Concurrent use of opioids for pain management or maintenance therapy (such as methadone or buprenorphine).
• Experiencing active opioid withdrawal.
• A failed naloxone challenge test.

Please ensure you are fully informed and have discussed any potential risks with your healthcare provider before starting naltrexone (ReVia).

Common side effects:

• Nausea
• Vomiting
• Headaches
• Dizziness
• Anxiety
• Tiredness
• Trouble sleeping

Less common but important to monitor:

• Mild opiate withdrawal symptoms
• Abdominal cramps
• Restlessness
• Joint or muscle pain
• Runny nose
• Dry mouth
• Decreased appetite
• Excessive thirst
• Skin rash
• Depression
• Irritability
• Diarrhea
• Constipation
• Sexual problems

Serious side effects:

• Severe liver disease symptoms
• Very serious allergic reaction
• Rash
• Swelling
• Severe dizziness
• Trouble breathing

Interactions with high risk of serious adverse effects and should be avoided:

• Alfentanil
• Alphaprodine
• Anileridine
• Benzhydrocodone
• Buprenorphine
• Butorphanol
• Codeine
• Diacetylmorphine
• Difenoxin
• Dihydrocodeine
• Diphenoxylate
• Ethylmorphine
• Fentanyl
• Hydrocodone
• Hydromorphone
• Ketobemidone
• Levorphanol
• Meperidine
• Methadone
• Morphine
• MorphineSulfate Liposome
• Nalbuphine
• Nicomorphine
• Opium
• OpiumAlkaloids
• Oxycodone
• Oxymorphone
• Papaveretum
• Paregoric
• Piritramide
• Propoxyphene
• Remifentanil
• Sufentanil
• Tapentadol
• Tilidine
• Tramadol

Interactions with moderate risk that may require dose adjustment, closer monitoring, or timing changes:

• Bremelanotide
• Naldemedine
• Naloxegol

Interactions with low risk that usually do not require a change in therapy:

• Lofexidine
• Yohimbine