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Generic name: olanzapine and samidorphan Dosage form: tablets Drug class: Psychotherapeutic combinations

Medically reviewed by Judith Stewart, BPharm. Last updated on Sep 2, 2021.

Lybalvi is a prescription medicine which contains two medicines (olanzapine and samidorphan) used in adults:

It is not known if this medicine is safe or effective in children.

Lybalvi may cause serious side effects, including:

If your healthcare provider prescribes Lybalvi in combination with valproate or lithium, also read the Medication Guide that comes with those medicines.

You should not take this medicine if you are taking opioids or are experiencing acute opioid withdrawal. See Lybalvi side effects.

Before you start treatment, tell your healthcare provider about all of your medical conditions, including if you:

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Lybalvi and other medicines may affect each other causing possible serious side effects. Lybalvi may affect the way other medicines work, and other medicines may affect how Lybalvi works. Especially tell your healthcare provider if you:

Your healthcare provider can tell you if it is safe to take Lybalvi with your other medicines. Do not start or stop any medicines while taking Lybalvi without first talking to your healthcare provider. Know the medicines you take. Keep a list of your medicines to show your healthcare provider and pharmacist when you get a new medicine.

Lybalvi may cause serious side effects, including:

It is important that you tell your family and the people closest to you of this increased sensitivity to opioids and the risk of overdose. You or someone close to you should get emergency medical help right away if you:

Tell your healthcare provider if you are taking Lybalvi before a medical procedure or surgery.

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

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

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

These are not all the possible side effects. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA1088.

Other drugs may interact with olanzapine and samidorphan, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

Keepall medicines out of the reach of children and pets.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use this medicine for a condition for which it is not prescribed. Do not give it to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information that is written for healthcare providers.

Active ingredients: olanzapine and samidorphan Inactive ingredients: colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate and microcrystalline cellulose. The film coating ingredients include hypromellose, titanium dioxide, triacetin and iron oxide yellow (5 mg/10 mg); iron oxide yellow and iron oxide red (10 mg/10 mg); FD&C Blue No. 2/indigo carmine aluminum lake (15 mg/10 mg); iron oxide red (20 mg/10 mg)

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