LURASIDONE HYDROCHLORIDE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

LURASIDONE HYDROCHLORIDE (UNII: O0P4I5851I) (LURASIDONE - UNII:22IC88528T)

Available from:

Alembic Pharmaceuticals Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

 Lurasidone hydrochloride tablets are indicated for: - Monotherapy treatment of adult and pediatric patients (10 to 17 years) with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies (14.2)] . - Adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies (14.2)]. - Known hypersensitivity to lurasidone HCl or any components in the formulation. Angioedema has been observed with lurasidone [see Adverse Reactions (6.1)]. - Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin, ritonavir, voriconazole, mibefradil, etc.) [see Drug Interactions (7.1)] . - Strong CYP3A4 inducers (e.g., rifampin, avasimibe, St. John’s wort, phenytoin, carbamazepine, etc.) [see Drug Interactions (7.1)]. Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to lurasidone hydrochloride during pregnancy. For

Product summary:

Lurasidone hydrochloride tablets 20 mg are white to off white, round shaped, biconvex, film-coated tablets debossed with ‘515’ on one side and ‘L’ on other side. Lurasidone hydrochloride tablets 40 mg are white to off white, round shaped, biconvex, film-coated tablets debossed with ‘516’ on one side and ‘L’ on other side. Lurasidone hydrochloride tablets 60 mg are white to off white, capsule shaped, biconvex, film-coated tablets debossed with ‘L 551’ on one side and plain on other side. Lurasidone hydrochloride tablets 80 mg are pale green, oval shaped, biconvex, film-coated tablets debossed with ‘L 517’ on one side and plain on other side. Lurasidone hydrochloride tablets 120 mg are white to off white, oval shaped, biconvex, film-coated tablets debossed with ‘L 518’ on one side and plain on other side. Tablets are supplied in the following strengths and package configurations (Table 39). Table 39: Package Configuration for Lurasidone Hydrochloride Tablets Storage Store lurasidone hydrochloride tablets at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

LURASIDONE HYDROCHLORIDE - LURASIDONE HYDROCHLORIDE TABLET, FILM
COATED
Alembic Pharmaceuticals Inc.
----------
MEDICATION GUIDE
Lurasidone Hydrochloride
(loo-RAS-i-done Hye-droe-Klor-ide)
Tablets
What is the most important information I should know about lurasidone
hydrochloride tablets? Lurasidone
hydrochloride tablets may cause serious side effects, including:
• Increased risk of death in elderly people with dementia-related
psychosis. Medicines like lurasidone
hydrochloride tablets can raise the risk of death in elderly people
who have lost touch with reality
(psychosis) due to confusion and memory loss (dementia). Lurasidone
hydrochloride tablets are not
approved for the treatment of people with dementia-related psychosis.
• Increased risk of suicidal thoughts or actions in children and
young adults. Antidepressant medicines may
increase suicidal thoughts or actions in some children and young
adults within the first few months of
treatment and when the dose is changed.
• Depression and other serious mental illnesses are the most
important causes of suicidal thoughts and
actions. Some people may have a particularly high risk of having
suicidal thoughts or actions. These
include people who have (or have a family history of) depression,
bipolar illness (also called manic-
depressive illness), or a history of suicidal thoughts or actions.
How can I watch for and try to prevent suicidal thoughts and actions
in myself or a family member?
o Pay close attention to any changes, especially sudden changes in
mood, behaviors, thoughts, or feelings.
This is very important when an antidepressant medicine is started or
when the dose is changed.
o Call the healthcare provider right away to report new or sudden
changes in mood, behavior, thoughts, or
feelings.
o Keep all follow-up visits with the healthcare provider as scheduled.
Call the healthcare provider between
visits as needed, especially if you have concerns about symptoms.
Call a healthcare provider right away if you or your family member has
any of the followi

Summary of Product characteristics

LURASIDONE HYDROCHLORIDE - LURASIDONE HYDROCHLORIDE TABLET, FILM
COATED
ALEMBIC PHARMACEUTICALS INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LURASIDONE
HYDROCHLORIDE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
LURASIDONE HYDROCHLORIDE TABLETS.
LURASIDONE HYDROCHLORIDE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2010
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED
PSYCHOSIS; AND SUICIDAL THOUGHTS AND BEHAVIORS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS TREATED WITH
ANTIPSYCHOTIC DRUGS
ARE AT AN INCREASED RISK OF DEATH. LURASIDONE HYDROCHLORIDE TABLETS
ARE NOT
APPROVED FOR THE TREATMENT OF PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS
(5.1).
ANTIDEPRESSANTS INCREASED THE RISK OF SUICIDAL THOUGHTS AND BEHAVIOR
IN PEDIATRIC
AND YOUNG ADULT PATIENTS. CLOSELY MONITOR FOR CLINICAL WORSENING AND
EMERGENCE OF
SUICIDAL THOUGHTS AND BEHAVIORS (5.2).
RECENT MAJOR CHANGES
Warnings and Precautions, Metabolic Changes, Hyperprolactinemia (5.6,
5.7)
12/2019
INDICATIONS AND USAGE
Lurasidone hydrochloride is an atypical antipsychotic indicated for
the treatment of: (1)
Depressive episode associated with Bipolar I Disorder (bipolar
depression) in adults and pediatric
patients (10 to 17 years) as monotherapy (1,14.2)
Depressive episode associated with Bipolar I Disorder (bipolar
depression) in adults as adjunctive
therapy with lithium or valproate (1, 14.2)
DOSAGE AND ADMINISTRATION
Lurasidone hydrochloride tablets should be taken with food (at least
350 calories). Administration with food
substantially increases the absorption of lurasidone hydrochloride
(2.3, 12.3). (2)
INDICATION
STARTING DOSE
RECOMMENDED DOSE
Bipolar Depression – adults (2.2)
20 mg per day
20 mg to 120 mg per day
Bipolar Depression – pediatric patients
(10 to 17 years) (2.2)
20 mg per day
20 mg to 80 mg per day
Moderate and Severe Renal Impairment: Recommended starting dose