Usual Adult Dose for Schizophrenia

Initial dose: 40 mg orally once a day
Maintenance dose: 40 to 160 mg orally per day
Maximum dose: 160 mg/day

Comments:

• Initial dose titration is not needed.
• This drug should be taken with food (at least 350 calories); drug exposure is expected to be significantly lower if not taken with food.

Use: For the treatment of schizophrenia

Usual Adult Dose for Bipolar Disorder

Initial dose: 20 mg orally once a day
Maintenance dose: 20 mg to 120 mg orally once a day
Maximum dose: 120 mg/day

Comments:

• Initial dose titration is not needed; this drug should be taken with food (at least 350 calories) drug exposure is expected to be significantly lower if not taken with food.
• Initial and maintenance doses are the same for monotherapy and for adjunctive therapy; in monotherapy studies, efficacy in the lower dose range of 20 to 60 mg per day was, on average, comparable to higher doses of 80 mg to 120 mg.
• The efficacy in the treatment of mania associated with bipolar disorder has not been established.

Uses:

• Monotherapy treatment of patients with major depressive episodes associated with bipolar I disorder (bipolar depression)
• Adjunctive treatment with lithium or valproate in patients with major depressive episodes associated with bipolar I disorder (bipolar depression)

Usual Pediatric Dose for Bipolar Disorder

10 to 17 years:
Initial dose: 20 mg orally once a day
Maintenance dose: 20 mg to 80 mg orally once a day
Maximum dose: 80 mg/day

Comments:

• Initial dose titration is not needed; this drug should be taken with food (at least 350 calories) drug exposure is expected to be significantly lower if not taken with food.
• The dose may be increased after 1 week based on clinical response.
• In monotherapy studies, efficacy in the lower dose range of 20 to 40 mg per day were, on average, comparable to doses up to 80 mg.
• The efficacy in the treatment of mania associated with bipolar disorder has not been established.

Use: Monotherapy treatment of patients with major depressive episodes associated with bipolar I disorder (bipolar depression)

Usual Pediatric Dose for Schizophrenia

13 to 17 years:
Initial dose: 40 mg orally once a day
Maintenance dose: 40 to 80 mg orally per day
Maximum dose: 80 mg/day

Comments:

• Initial dose titration is not needed.
• This drug should be taken with food (at least 350 calories); drug exposure is expected to be significantly lower if not taken with food.

Use: For the treatment of schizophrenia

Renal Dose Adjustments

Mild Renal Dysfunction (CrCl 50 mL/min or greater): No adjustment recommended.

Moderate to Severe Renal Dysfunction (CrCl less than 50 mL/min):

• Initial dose 20 mg orally once a day
• Maximum dose: 80 mg/day

Liver Dose Adjustments

Mild Liver Dysfunction (Child-Pugh less than 7): No adjustment recommended.

Moderate Liver Dysfunction (Child-Pugh Score 7 to 9):

• Initial dose 20 mg orally once a day
• Maximum dose: 80 mg/day

Severe Liver Dysfunction (Child-Pugh Score 10 to 15):

• Initial dose 20 mg orally once a day
• Maximum dose: 40 mg/day

Dose Adjustments

Patients who are antipsychotic naive and patients with a history of cardiovascular or cerebrovascular disease: Consider a lower starting dose and a slower titration due to risk of orthostatic hypotension and syncope.

Concomitant Use with CYP450 3A4 Inhibitors:

• Use with strong inhibitors is contraindicated.
• If a moderate CYP450 3A4 inhibitor is to be added to therapy with this drug, the dose of this drug should be reduced by one-half.
• If this drug is to be added to existing moderate CYP450 3A4 inhibitor therapy:
• Initial dose: 20 mg orally once a day
• Maximum dose: 80 mg/day

Concomitant Use with CYP450 3A4 Inducers:

• Use with strong inducers is contraindicated.
• If a moderate CYP450 3A4 inducer is to be given concomitantly with this drug, the dose may need to be increased after chronic treatment of 7 or more days.

Precautions

US BOXED WARNINGS:
INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS:

• Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.
• This drug is not approved for use in patients with dementia-related psychosis.

SUICIDAL THOUGHTS AND BEHAVIORS:

• Antidepressants increased the risk of suicidal thoughts and behavior in pediatric and young adults in short-term studies.
• Closely monitor for clinical worsening and emergence of suicidal thoughts and behaviors.

CONTRAINDICATIONS:

• Hypersensitivity to the active component or any of the ingredients
• The concomitant administration of strong CYP450 3A4 inducers (e.g., avasimibe, carbamazepine, phenytoin, rifampin, St. John's wort, etc.)
• The concomitant administration of strong CYP450 3A4 inhibitors (e.g., clarithromycin, ketoconazole, mibefradil, ritonavir, voriconazole, etc.)

Safety and efficacy have not been established in patients younger than 10 years (bipolar disorder) and 13 years (schizophrenia).

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Tablets should be swallowed whole, and should be taken with food containing at least 350 calories.
• Grapefruit and grapefruit juice should be avoided.

Storage requirements: Protect from light.

General:

• Controlled clinical trials assessing long-term (e.g., longer than 6 weeks) use are not available; the physician who prescribes this drug should periodically re-evaluate the long-term risks and benefits for the individual patient.
• Improvements may take days to weeks; patients should be closely monitored during this time.

Monitoring:

• Cardiovascular: Orthostatic vital signs in at-risk patients
• Hematologic: CBC frequently during the first few months in patients with preexisting low WBC and/or a prior history of drug-induced leukopenia or neutropenia.
• Metabolic: Monitor for increases in blood sugar, weight, and lipids

Patient advice:

• Patients, families, and caregivers should be educated on the risks of suicidal thoughts and behaviors, as well as the risk of mania and hypomania; patients should be instructed on what to watch for and when to seek medical advice.
• This drug may impair judgment, thinking, or motor skills; have patients avoid driving or operating machinery until adverse effects are determined.
• Advise patients to speak to their physician or health care professional if they are pregnant, intend to become pregnant, or are breastfeeding.
• Advise patients that this drug may cause metabolic changes such as increases in blood sugar, body weight and lipids.
• Patients should avoid overheating and dehydration.
• Patients should speak with their healthcare provider if they are taking or plan to take any new prescription or over the counter medications because there is a potential for drug interactions; patients should be advised to avoid alcohol as it may make some side effects worse.

Frequently asked questions

• Can you stop taking Latuda immediately?
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