CAPLYTA Capsule (2019)

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Intra-Cellular Therapies, Inc

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BOXED WARNING SECTION

WARNING: 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 ...

1. Indications and Usage

CAPLYTA is indicated for the treatment of schizophrenia in adults [see Clinical Studies (14)].

2. Dosage and Administration

2.1 Recommended Dosage The recommended dosage of CAPLYTA is 42 mg administered orally once daily with food. Dose titration is not required. 2.2 Dosage Recommendations for Concomitant Use with CYP3A4 Inducers ...

3. Dosage Forms and Strengths

CAPLYTA capsules are available as a 42 mg strength (equivalent to 60 mg lumateperone tosylate). The capsule has a blue cap and opaque white body imprinted with "ITI-007 42 mg."

4. Contraindications

CAPLYTA is contraindicated in patients with history of hypersensitivity reaction to lumateperone. Reactions have included pruritus, rash (e.g. allergic dermatitis, papular rash, and generalized rash), ...

5. Warnings and Precautions

5.1 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. Analyses ...

6. Adverse Reactions

The following adverse reactions are discussed in detail in other sections of the labeling: Increased Mortality in Elderly Patients with Dementia-Related Psychosis [see Boxed Warning, Warnings and Precautions ...

6.1. Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another ...

7. Drug Interactions

7.1 Drugs Having Clinically Important Interactions with CAPLYTA Table 2. Clinically Important Drug Interactions with CAPLYTA: Moderate or Strong CYP3A4 Inhibitors Clinical Impact Concomitant use ...

8.1. Pregnancy

Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, including CAPLYTA, during pregnancy. Healthcare providers ...

8.2. Lactation

Risk Summary There are no available data on the presence of lumateperone or its metabolites in human milk or animal milk, the effects on the breastfed infant, or the effects on milk production. Toxicity ...

8.3. Females and Males of Reproductive Potential

Infertility Based on findings from animal studies, lumateperone may impair male and female fertility [see Nonclinical Toxicology (13.1)].

8.4. Pediatric Use

Safety and effectiveness of CAPLYTA have not been established in pediatric patients.

8.5. Geriatric Use

Controlled clinical studies of CAPLYTA did not include any patients aged 65 or older to determine whether or not they respond differently from younger patients. Antipsychotic drugs increase the risk of ...

8.6. Hepatic Impairment

Use of CAPLYTA is not recommended for patients with moderate (Child-Pugh class B) to severe hepatic impairment (Child-Pugh class C). Patients with moderate and severe hepatic impairment experienced higher ...

10. Overdosage

No specific antidotes for CAPLYTA are known. In managing overdose, provide supportive care, including close medical supervision and monitoring and consider the possibility of multiple drug involvement. ...

11. Description

CAPLYTA capsules contains lumateperone, an atypical antipsychotic, present as lumateperone tosylate salt with the chemical name 4-((6bR,10aS)-3-methyl-2,3,6b,9,10,10a-hexahydro-1 ...

12.1. Mechanism of Action

The mechanism of action of lumateperone in the treatment of schizophrenia is unknown. However, the efficacy of lumateperone could be mediated through a combination of antagonist activity at central serotonin ...

12.2. Pharmacodynamics

Lumateperone has high binding affinity for serotonin 5-HT2A receptors (Ki = 0.54 nM) and moderate binding affinity for dopamine D2 (Ki = 32 nM) receptors. Lumateperone ...

12.3. Pharmacokinetics

Following once daily oral administration of CAPLYTA, lumateperone steady state is reached in about 5 days. Increase in steady-state exposure is approximately dose-proportional in the range of 21 mg to ...

13.1. Carcinogensis, Mutagenesis, Impairment of Fertility

Carcinogenesis Lifetime carcinogenicity studies were conducted in rats and mice, and results showed no carcinogenic potential in either species. In Sprague-Dawley rats, males were administered lumateperone ...

13.2. Animal Toxicology and/or Pharmacology

Oral administration of lumateperone caused systemic intracytoplasmic accumulation of pigmented material in dogs, rats, and mice at clinically relevant exposures (AUC). Intracytoplasmic pigmentation appeared ...

14. Clinical Studies

CAPLYTA was evaluated for the treatment of schizophrenia in two placebo-controlled trials. Study 1 (NCT01499563) was a four-week, randomized, double-blind, placebo-controlled, multi-center study in adult ...

16.1. How Supplied

CAPLYTA (lumateperone) capsules are supplied in boxes of 30. Each box contains 3 blister packs of 10 capsules. Capsule Strength Capsule Color Imprint Codes NDC Code 42 mg Blue cap and opaque white ...

16.2. Storage and Handling

Store at controlled room temperature 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

17. Patient Counseling Information

Physicians should discuss all relevant safety information with patients, including, but not limited to, the following: Neuroleptic Malignant Syndrome: Counsel patients about a potentially fatal ...