OLANZAPINE AND SAMIDORPHAN L-MALATE

Atypical Antipsychotic

Oral

Mechanism of Action

12.1 Mechanism of Action 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 (5HT 2 ) antagonism. The mechanism of action of samidorphan could be mediated through opioid receptor antagonism.

Indications

an atypical antipsychotic

and samidorphan

an opioid antagonist

Contraindications

• 4 CONTRAINDICATIONS LYBALVI is contraindicated in patients: who are using opioids [ see Warnings and Precautions ( 5.3
• 5.4 )
• Drug Interactions ( 7.3 )] . who are undergoing acute opioid withdrawal [see Warnings and Precautions ( 5.3
• 5.4 )
• Drug Interactions ( 7.3 )] . If LYBALVI is administered with lithium or valproate

FDA Warnings

5 WARNINGS AND PRECAUTIONS Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related Psychosis : Increased incidence of cerebrovascular adverse reactions (e
, stroke, transient ischemic attack, including fatalities)
3 ) Vulnerability to Life-Threatening Opioid Overdose : Risk of Opioid Overdose from Attempts to Overcome LYBALVI Opioid Blockade: Attempts to overcome LYBALVI opioid blockade with high or repeated doses of opioids may lead to fatal opioid intoxication, particularly if LYBALVI therapy is interrupted or discontinued
4 ) Risk of Resuming Opioids in Patients with Prior Opioid Use : Patients with a history of chronic opioid use prior to LYBALVI treatment may have decreased opioid tolerance if LYBALVI therapy is interrupted or discontinued

Known Side Effects

8 documented side effects by frequency

Drug Not Working

>10%

Weight Gain

>10%

Drowsiness

1-10%

Nausea

1-10%

Fatigue

1-10%

Anxiety

1-10%

Vomiting

1-10%

Condition Worsened

0.1-1%

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Compare With

9 available comparisons

Formulations

Dosage Forms

Tablet

Route

Oral