Lumateperone tosylate

What is Lumateperone tosylate?

• Lumateperone tosylate (CAPLYTA) is an atypical antipsychotic used for the treatment of schizophrenia.

What are the uses of this medicine?

• This medicine is indicated for the treatment of schizophrenia in adults.

How does this medicine work?

• 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 5-HT2A receptors and postsynaptic antagonist activity at central dopamine D2 receptors.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• history of hypersensitivity reaction to lumateperone. Reactions have included pruritus, rash (e.g. allergic dermatitis, papular rash, and generalized rash), and urticaria.

What drug interactions can this medicine cause?

• Avoid concomitant use of CAPLYTA with moderate(eg: Amprenavir, ciprofloxacin, cyclosporine, diltiazem, erythromycin, fluconazole, fluvoxamine, verapamil ) or strong CYP3A4 inhibitors (eg:Clarithromycin, grapefruit juice, itraconazole, voriconazole, nefazodone, ritonavir, nelfinavir).
• Avoid concomitant use of CAPLYTA with CYP3A4 inducers (eg: Carbamazepine, phenytoin, rifampin, St. John’s wort, bosentan, efavirenz, etravirine, modafinil, nafcillin, aprepitant, armodafinil, pioglitazone, prednisone)
• Avoid concomitant use of CAPLYTA with UGT inhibitors (eg: Valproic acid, probenecid)

Is this medicine FDA approved?

• It was approved for use in the United States in 2019.

How should this medicine be used?

Recommended Dosage The recommended dosage of CAPLYTA is 42 mg administered orally once daily with food. Dose titration is not required.

Dosage Recommendations for Patients with Hepatic Impairment Avoid use of CAPLYTA in patients with moderate or severe hepatic impairment (Child-Pugh B or C).

Administration

• Administer CAPLYTA with food.

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

This medicine is available in fallowing doasage form:

• As Capsules: 42 mg

This medicine is available in fallowing brand namesː

• CAPLYTA

What side effects can this medication cause?

The most common side effects of this medicine include:

• Somnolence/ Sedation
• Nausea
• Dry Mouth
• Dizziness
• Creatine Phosphokinase Increased
• Fatigue
• Vomiting
• Hepatic Transaminases Increased2
• Decreased Appetite

What special precautions should I follow?

• Increased incidence of cerebrovascular adverse reactions (e.g., stroke and transient ischemic attack).
• Counsel patients about a potentially fatal adverse reaction, Neuroleptic Malignant Syndrome (NMS), that has been reported with administration of antipsychotic drugs. Manage with immediate discontinuation and close monitoring.
• Tardive dyskinesia may occur. Discontinue treatment if clinically appropriate.
• Monitor for hyperglycemia/diabetes mellitus, dyslipidemia, and weight gain.
• Perform complete blood counts (CBC) in patients with pre-existing low white blood cell count (WBC) or history of leukopenia or neutropenia. Consider discontinuing CAPLYTA if clinically significant decline in WBC occurs in 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.
• Seizures may occur. Use cautiously in patients with a history of seizure or with conditions that lower seizure threshold.
• CAPLYTA, like other antipsychotics, may cause somnolence and has the potential to impair judgment, thinking, and motor skills. Patients should be cautioned about operating hazardous machinery, including motor vehicles, until they are reasonably certain that therapy with CAPLYTA does not affect them adversely.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Available data from case reports on CAPLYTA use in pregnant women are insufficient to establish any drug associated risks for birth defects, miscarriage, or adverse maternal or fetal outcomes.

Can this medicine be used in children?

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

What are the active and inactive ingredients in this medicine?

Active Ingredient:

• LUMATEPERONE

Inactive Ingredients:

• MANNITOL
• CROSCARMELLOSE SODIUM
• TALC
• MAGNESIUM STEARATE
• GELATIN

Who manufactures and distributes this medicine?

• Packager: Intra-Cellular Therapies, Inc

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

• 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).

• Dailymed label info on Lumateperone tosylate
• FDA Lumateperone tosylate

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