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When considering the use of Lybalvi (olanzapine/samidorphan), it's crucial to be aware of the important safety information and potential risks associated with this medication. Below is a summary of key safety warnings and precautions:

• Increased Risk in Elderly with Dementia: Older adults with dementia-related psychosis should not use Lybalvi, as it can increase the risk of severe and potentially fatal complications such as heart problems, strokes, and infections. Discuss alternative treatments with a healthcare provider if you are or care for someone in this category.

• Opioid Withdrawal and Overdose Risks: Lybalvi contains samidorphan, which can induce withdrawal symptoms in individuals dependent on opioids. Symptoms include restlessness, anxiety, and seizures. Avoid using Lybalvi if you are currently taking opioids or experiencing withdrawal. Also, be cautious of potential life-threatening opioid overdose if attempting to counteract samidorphan effects with opioids.

• Severe Skin Reactions: Although rare, serious skin reactions like DRESS may occur. Discontinue use and seek medical help if you notice symptoms such as rashes, blisters, or facial swelling.

• Neuroleptic Malignant Syndrome: This is a rare but serious condition associated with antipsychotic medications. Symptoms include fever, muscle stiffness, and confusion. Immediate medical intervention is necessary if these occur.

• Metabolic Changes: Lybalvi may lead to weight gain and elevated blood sugar and cholesterol levels. Regular monitoring and a healthy lifestyle are recommended.

• Movement Disorders: Long-term use can cause irreversible movement disorders, known as tardive dyskinesia. Report any uncontrollable movements to your healthcare provider promptly.

• Blood Pressure Changes: This medication can cause dizziness and falls due to lowered blood pressure. Stand slowly from sitting or lying positions to mitigate these effects.

• Infection Risk: Lybalvi can decrease white blood cell counts, increasing infection risk. Regular blood tests may be needed, especially if you have a history of low blood cell counts.

• Seizure Risk: Patients with a history of seizures should use caution, as Lybalvi can potentially induce seizures.

• High Prolactin Levels: Prolonged use may increase prolactin levels, potentially affecting fertility and causing menstrual irregularities or other hormonal issues.

• Cognitive Impairment and Drowsiness: Lybalvi can cause significant drowsiness and impair concentration. Be cautious when performing activities that require alertness, and avoid alcohol and other sedatives.

• Anticholinergic Effects: Possible side effects include difficulty urinating and constipation. Avoid using with other anticholinergic medications without consulting a healthcare provider.

• Swallowing Difficulties: If experiencing difficulty swallowing, take care to chew food thoroughly to prevent choking or aspiration.

Contraindications: Do not use Lybalvi if you are currently taking opioids or undergoing opioid withdrawal. Always discuss your full medical history and current medications with your healthcare provider before starting Lybalvi. If you suspect an overdose or an adverse reaction, seek emergency medical assistance immediately.

When taking this medication, some common side effects may include drowsiness, dizziness, lightheadedness, stomach upset, dry mouth, constipation, increased appetite, and weight gain. These effects are generally mild and may subside as your body adjusts. However, if they persist or worsen, it's advisable to consult a healthcare provider.

More serious side effects, although rare, require immediate medical attention. These include difficulty swallowing, shaking, slow heartbeat, fainting, mood changes, numbness or tingling in limbs, yellowing of the skin or eyes, severe stomach pain, trouble urinating, and interrupted breathing during sleep. The medication may also cause blood sugar levels to rise, potentially leading to diabetes; symptoms of which include increased thirst and urination. Monitoring blood sugar levels is crucial, especially for those already diagnosed with diabetes.

Weight gain and increased cholesterol levels may occur, potentially raising the risk of heart disease. Additionally, some individuals may experience tardive dyskinesia, characterized by unusual or uncontrolled movements, which could become permanent. An increase in prolactin levels is another possible side effect, potentially causing issues such as unwanted breast milk or changes in menstrual cycles in females, and decreased sexual ability or enlarged breasts in males.

In rare cases, this medication can lead to neuroleptic malignant syndrome (NMS), a severe condition with symptoms like fever, muscle stiffness, severe tiredness, confusion, sweating, and irregular heartbeat. Seizures and serious allergic reactions, including rash, itching, and difficulty breathing, are also possible and require urgent medical care. If you notice any other effects not listed, consult your healthcare provider promptly.

Some medications can interact with this drug. For instance, using metoclopramide together with this medication may cause interactions. Additionally, taking opioid pain relievers like morphine or methadone while on this treatment can lead to opioid withdrawal. You should avoid using opioids during and shortly before or after completing treatment with olanzapine/samidorphan, as this can also increase the risk of an opioid overdose. Consult your doctor about the appropriate timing for starting or stopping olanzapine/samidorphan, and how long to wait before using opioids again.

Furthermore, inform your healthcare provider if you're using other substances that cause drowsiness. These can include alcohol, cannabis, sleep or anxiety medications (such as alprazolam, lorazepam, zolpidem), muscle relaxants (like carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine). Be sure to read the labels on all your medications, including those for allergies or colds, as they might contain ingredients that cause drowsiness. Your pharmacist can help you safely use these products.

Lastly, this medication may interfere with certain laboratory tests, like drug tests, potentially leading to inaccurate results. It’s important to inform lab personnel and all your doctors that you're using this medication.