Olanzapine/samidorphan

What is Olanzapine/samidorphan?

• Olanzapine/samidorphan (LYBALVI) is a combination of olanzapine, an atypical antipsychotic, and samidorphan, an opioid antagonist.

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What are the uses of this medicine?

This medicine is ) used in adults: • to treat schizophrenia • alone for short-term (acute) or maintenance treatment of manic or mixed episodes that happen with bipolar I disorder • in combination with valproate or lithium to treat manic or mixed episodes that happen with bipolar I disorder

How does this medicine work?

• The mechanism of action of olanzapine is unclear; however, its efficacy in the treatment of schizophrenia or bipolar I disorder could be mediated through a combination of dopamine and serotonin type 2 (5HT2) antagonism.
• The mechanism of action of samidorphan could be mediated through opioid receptor antagonism.

Who Should Not Use this medicine ?

This medicine cannot be used in patients:

• who are using opioids
• who are undergoing acute opioid withdrawal

What drug interactions can this medicine cause?

Avoid coadministration with:

• Strong CYP3A4 Inducers
• Strong CYP1A2 Inhibitors
• CYP1A2 Inducer
• CNS Acting Drugs
• Anticholinergic Drug
• Antihypertensive Agent
• Levodopa and Dopamine Agonists

Is this medicine FDA approved?

• It was approved for use in the United States in 2021.

How should this medicine be used?

• In patients who use opioids, delay initiation of LYBALVI for a minimum of 7 days after last use of short-acting opioids and 14 days after last use of long-acting opioids.

Recommended Dosage in Schizophrenia

• Initiate LYBALVI at 5 mg/10 mg (contains 5 mg of olanzapine and 10 mg of samidorphan) or 10 mg/10 mg (contains 10 mg of olanzapine and 10 mg of samidorphan) orally once daily.
• The recommended dosage is 10 mg/10 mg, 15 mg/10 mg (contains 15 mg of olanzapine and 10 mg of samidorphan), or 20 mg/10 mg (contains 20 mg of olanzapine and 10 mg of samidorphan) once daily.
• Dosage may be adjusted at weekly intervals of 5 mg (based on the olanzapine component of LYBALVI) depending upon clinical response and tolerability, up to the maximum recommended dosage of 20 mg/10 mg once daily.

Recommended Dosage in Bipolar I Disorder

• Monotherapy: Initiate LYBALVI at 10 mg/10 mg or 15 mg/10 mg once daily. The recommended dosage is 10 mg/10 mg, 15 mg/10 mg, or 20 mg/10 mg once daily.

• Maintenance Monotherapy: Administer LYBALVI at 5 mg/10 mg, 10 mg/10 mg, 15 mg/10 mg,or 20 mg/10 mg once daily.

• Adjunctive to lithium or valproate: Initiate LYBALVI at 10 mg/10 mg once daily. The recommended dosage is 10 mg/10 mg, 15 mg/10 mg or 20 mg/10 mg, once daily.

Administration

• Take LYBALVI exactlyas your healthcare provider tells you to take it. Do not changethe dose or stop taking LYBALVIwithout first talking to your healthcare provider.
• Take LYBALVI 1 time each day with or without food.
• Swallow LYBALVI tablets whole. Do not split or combine different strength LYBALVI tablets.
• If you take too much LYBALVI, call your Poison Control Center at 1-800-222-1222 or go to the nearest hospital emergency room right away.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form: As Tablets (olanzapine/samidorphan): 5 mg/10 mg, 10 mg/10 mg, 15 mg/10 mg and 20 mg/10 mg.

This medicine is available in fallowing brand namesː

• LYBALVI

What side effects can this medication cause?

The most common side effects of LYBALVI when used to treat people with schizophrenia include:

• weight gain
• sleepiness
• dry mouth
• headache

The most common side effects of LYBALVI when used alone to treat people with mixed or manic episodes that happen with bipolar I disorder include:

• weakness
• dry mouth
• constipation
• increased appetite
• sleepiness
• dizziness
• shaking

The most common side effects of LYBALVI when used in combination with lithium or valproate to treat people with mixed or manic episodes that happen with bipolar I disorder include:

• dry mouth
• weight gain
• increased appetite
• dizziness
• back pain
• constipation
• problems speaking
• mouth watering
• memory problems
• numbness and tingling in your arm and legs

What special precautions should I follow?

Do not drive a car, operate machinery, or do other dangerous activities until you know how LYBALVI affects you. LYBALVI may make you feel drowsy. • Avoid drinking alcohol during treatment with LYBALVI. • Avoid getting over-heated or dehydrated. o Do not exercise too much. o In hot weather, stay inside in a cool place if possible. o Stay out of the sun. Do not wear too much clothing or heavy clothing. o Drink plenty of water

• This medicine may cause Increased incidence of cerebrovascular adverse reactions (e.g., stroke, transient ischemic attack, including fatalities).
• LYBALVI can precipitate opioid withdrawal in patients who are dependent on opioids. Prior to initiating LYBALVI, there should be at least a 7-day opioid-free interval from the last use of short-acting opioids, and at least a 14-day opioid-free interval from the last use of long-acting opioids to avoid precipitation of opioid withdrawal.
• Use with caution with other anticholinergic drugs and in patients with urinary retention, prostatic hypertrophy, constipation, paralytic ileus or related conditions.
• This medicne may elevate prolactin levels.
• Use cautiously in patients with a history of seizures or with conditions that lower the seizure threshold.
• Perform complete blood counts in patients with a history of a clinically significant low white blood cell (WBC) count. Consider discontinuation if clinically significant decline in WBC in the absence of other causative factors.
• Monitor heart rate and blood pressure and warn patients with known cardiovascular or cerebrovascular disease, and risk of dehydration or syncope.
• Monitor for hyperglycemia/diabetes mellitus, dyslipidemia, and weight gain.
• Discontinue if Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) is suspected.

What to do in case of emergency/overdose?

• Overdose with olanzapine, a component of LYBALVI, symptoms included agitation/aggressiveness, dysarthria, tachycardia, various extrapyramidal symptoms, and reduced level of consciousness ranging from sedation to coma.
• Less commonly reported symptoms include: aspiration, cardiopulmonary arrest, cardiac arrhythmias (such as supraventricular tachycardia and 1 patient experiencing sinus pause with spontaneous resumption of normal rhythm), delirium, possible neuroleptic malignant syndrome, respiratory depression/arrest, convulsion, hypertension, and hypotension.

Management of Overdose

• No specific antidotes for LYBALVI are known.
• In managing overdose, provide supportive care, including close medical supervision and monitoring, and consider the possibility of multiple drug involvement. If an overdose occurs, consult a certified Poison Control Center (1-800-222-1222) for additional overdosage management recommendations.

Can this medicine be used in pregnancy?

• May cause extrapyramidal and/or withdrawal symptoms in neonates with third trimester exposure.
• There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, including LYBALVI, during pregnancy. Healthcare providers are encouraged to register patients by contacting the National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-2388 or visit

Can this medicine be used in children?

• The safety and effectiveness of LYBALVI have not been established in pediatric patients.

What should I know about storage and disposal of this medication?

• Store LYBALVI at room temperature between 68°F to 77°F (20°C to 25°C) in the original bottle.
• Keep theLYBALVI bottle tightly closed, in a dry place, and with the desiccant pack in the bottle to protect from
• moisture.
• Keep LYBVALI and all medicines out of the reach of children.

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• Dailymed label info on Olanzapine/samidorphan
• FDA Olanzapine/samidorphan