VRAYLAR- cariprazine capsule, gelatin coated VRAYLAR- cariprazine kit

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

CARIPRAZINE (UNII: F6RJL8B278) (CARIPRAZINE - UNII:F6RJL8B278)

Dostupno od:

Allergan, Inc.

INN (International ime):

CARIPRAZINE

Sastav:

CARIPRAZINE 1.5 mg

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

VRAYLAR® is indicated for: - Treatment of schizophrenia in adults [see Clinical Studies ( 14.1 )] - Acute treatment of manic or mixed episodes associated with bipolar I disorder in adults [see Clinical Studies ( 14.2 )] - Treatment of depressive episodes associated with bipolar I disorder (bipolar depression) in adults [see Clinical Studies ( 14.3 )] - Adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies ( 14.4 )] VRAYLAR is contraindicated in patients with history of a hypersensitivity reaction to cariprazine. Reactions have ranged from rash, pruritus, urticaria, and reactions suggestive of angioedema (e.g., swollen tongue, lip swelling, face edema, pharyngeal edema, and swelling face). Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to VRAYLAR during pregnancy. For more information, contact the National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/. Risk Summary Neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery (see Clinical Considerations).  There are no available data on VRAYLAR use in pregnant women to inform any drug-associated risks for birth defects or miscarriage. The major active metabolite of cariprazine, DDCAR, has been detected in adult patients up to 12 weeks after discontinuation of VRAYLAR [see Clinical Pharmacology ( 12.3 )].   Based on animal data, VRAYLAR may cause fetal harm. Administration of cariprazine to rats during the period of organogenesis caused malformations, lower pup survival, and developmental delays at drug exposures less than the human exposure at the maximum recommended human dose (MRHD) of 6 mg/day. However, cariprazine was not teratogenic in rabbits at doses up to 4.6 times the MRHD of 6 mg/day [see Data] .  The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Advise pregnant women of the potential risk to a fetus. Clinical Considerations Fetal/Neonatal Adverse Reactions Extrapyramidal and/or withdrawal symptoms, including agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding disorder have been reported in neonates whose mothers were exposed to antipsychotic drugs during the third trimester of pregnancy. These symptoms have varied in severity. Some neonates recovered within hours or days without specific treatment; others required prolonged hospitalization. Monitor neonates for extrapyramidal and/or withdrawal symptoms and manage symptoms appropriately. Data Animal Data Administration of cariprazine to pregnant rats during the period of organogenesis at oral doses of 0.5, 2.5, and 7.5 mg/kg/day, which are 0.2 to 3.5 times the maximum recommended human dose (MRHD) of 6 mg/day based on AUC of total cariprazine (i.e. sum of cariprazine, DCAR, and DDCAR), caused fetal developmental toxicity at all doses, which included reduced body weight, decreased male anogenital distance, and skeletal malformations of bent limb bones, scapula, and humerus. These effects occurred in the absence or presence of maternal toxicity. Maternal toxicity, observed as a reduction in body weight and food consumption, occurred at doses 1.2 and 3.5-times the MRHD of 6 mg/day based on AUC of total cariprazine. At these doses, cariprazine caused fetal external malformations (localized fetal thoracic edema), visceral variations (undeveloped/underdeveloped renal papillae and/or distended urethrae), and skeletal developmental variations (bent ribs, unossified sternebrae). Cariprazine had no effect on fetal survival.  Administration of cariprazine to pregnant rats during pregnancy and lactation at oral doses of 0.1, 0.3, and 1 mg/kg/day, which are 0.03 to 0.4 times the MRHD of 6 mg/day based on AUC of total cariprazine, caused a decrease in postnatal survival, birth weight, and post-weaning body weight of first generation pups at the dose that is 0.4 times the MRHD of 6 mg/day based on AUC of total cariprazine in absence of maternal toxicity. First generation pups also had pale, cold bodies and developmental delays (renal papillae not developed or underdeveloped and decreased auditory startle response in males). Reproductive performance of the first generation pups was unaffected; however, the second generation pups had clinical signs and lower body weight similar to those of the first generation pups. Administration of cariprazine to pregnant rabbits during the period of organogenesis at oral doses of 0.1, 1, and 5 mg/kg/day, which are 0.02 to 4.6 times the MRHD of 6 mg/day based on AUC of total cariprazine, was not teratogenic. Maternal body weight and food consumption were decreased at 4.6 times the MRHD of 6 mg/day based on AUC of total cariprazine; however, no adverse effects were observed on pregnancy parameters or reproductive organs. Risk Summary Lactation studies have not been conducted to assess the presence of cariprazine in human milk, the effects on the breastfed infant, or the effects on milk production. Cariprazine is present in rat milk. The development and health benefits of breastfeeding should be considered along with the mother’s clinical need for VRAYLAR and any potential adverse effects on the breastfed infant from VRAYLAR or from the underlying maternal condition. Safety and effectiveness in pediatric patients have not been established. Pediatric studies of VRAYLAR have not been conducted. Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric patients [see Boxed Warning , Warnings and Precautions ( 5.2 )] . Clinical trials of VRAYLAR did not include sufficient numbers of patients aged 65 and older to determine whether or not they respond differently from younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Antipsychotic drugs increase the risk of death in elderly patients with dementia-related psychosis. VRAYLAR is not approved for the treatment of patients with dementia-related psychosis [see Boxed Warning and Warning s and Precautions ( 5.1 , 5.3 ) ] . No dosage adjustment for VRAYLAR is required in patients with mild to moderate hepatic impairment (Child-Pugh score between 5 and 9) [see C linical Pharmacology   ( 12.3 ) ]. Usage of VRAYLAR is not recommended in patients with severe hepatic impairment (Child-Pugh score between 10 and 15). VRAYLAR has not been evaluated in this patient population. No dosage adjustment for VRAYLAR is required in patients with mild to moderate (CrCL ≥ 30 mL/minute) renal impairment [see Clinical Pharmacology   ( 12.3 ) ]. Usage of VRAYLAR is not recommended in patients with severe renal impairment (CrCL < 30 mL/minute). VRAYLAR has not been evaluated in this patient population. No dosage adjustment for VRAYLAR is needed for patients who smoke. VRAYLAR is not a substrate for CYP1A2; smoking is not expected to have an effect on the pharmacokinetics of VRAYLAR. No dosage adjustment is required based on patient’s age, sex, or race. These factors do not affect the pharmacokinetics of VRAYLAR  [ see Clinical Pharmacology   ( 12.3 ) ] . VRAYLAR is not a controlled substance. VRAYLAR has not been systematically studied in animals or humans for its abuse potential or its ability to induce tolerance.   VRAYLAR has not been systematically studied in animals or humans for its potential for physical dependence.

Proizvod sažetak:

VRAYLAR (cariprazine) capsules are supplied as follows: Store at 20ºC to 25°C (68ºF to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature] . Protect 3 mg and 4.5 mg capsules from light to prevent potential color fading.

Status autorizacije:

New Drug Application

Uputa o lijeku

VRAYLAR- CARIPRAZINE
Allergan, Inc.
----------
MEDICATION GUIDE
VRAYLAR® (VRAY-lar)
(cariprazine)
capsules
What is the most important information I should know about VRAYLAR?
VRAYLAR may cause serious side effects, including:
•
Increased risk of death in elderly people with dementia related
psychosis. Medicines like
VRAYLAR can raise the risk of death in elderly who have lost touch
with reality (psychosis) due
to confusion and memory loss (dementia). VRAYLAR is not approved for
the treatment of
patients with dementia-related psychosis.
•
Increased risk of suicidal thoughts and actions. VRAYLAR and
antidepressant medicines may
increase suicidal thoughts or actions in some children and young
adults especially within the first
few months of treatment or when the dose is changed.
○ Depression and other mental illnesses are the most important
causes of suicidal thoughts and
actions.
How can I watch for and try to prevent suicidal thoughts and actions
in myself or a family member?
○ Pay close attention to any changes, especially sudden changes in
mood, behaviors, thoughts, or
feelings. This is very important when VRAYLAR or the antidepressant
medicine is started or when the
dose is changed.
○ Call the healthcare provider right away to report new or sudden
changes in mood, behavior, thoughts,
or feelings, or if you develop suicidal thoughts or actions.
○ 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 following symptoms,
especially if they are new, worse, or worry you:
•
thoughts about suicide or dying
•
attempts to commit suicide
•
new or worse depression
•
new or worse anxiety
•
feeling very agitated or restless
•
panic attacks
•
trouble sleeping (insomnia)
•
new or worse irritability
•
acting aggressive, being angry, or violent
•
acting on dangerous impulses
•
an extreme increase

Svojstava lijeka

VRAYLAR- CARIPRAZINE CAPSULE, GELATIN COATED
VRAYLAR- CARIPRAZINE
ALLERGAN, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VRAYLAR SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR VRAYLAR.
VRAYLAR (CARIPRAZINE) CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 2015
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. VRAYLAR IS NOT APPROVED FOR THE
TREATMENT OF
PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS. (5.1)
ANTIDEPRESSANTS INCREASED THE RISK OF SUICIDAL THOUGHTS AND BEHAVIORS
IN PEDIATRIC
AND YOUNG ADULT PATIENTS. CLOSELY MONITOR ALL ANTIDEPRESSANT-TREATED
PATIENTS FOR
CLINICAL WORSENING AND EMERGENCE OF SUICIDAL THOUGHTS AND BEHAVIORS.
SAFETY AND
EFFECTIVENESS OF VRAYLAR HAVE NOT BEEN ESTABLISHED IN PEDIATRIC
PATIENTS (5.2, 8.4)
INDICATIONS AND USAGE
VRAYLAR is an atypical antipsychotic indicated for:
Treatment of schizophrenia in adults (1)
Acute treatment of manic or mixed episodes associated with bipolar I
disorder in adults (1)
Treatment of depressive episodes associated with bipolar I disorder
(bipolar depression) in adults (1)
Adjunctive therapy to antidepressants for the treatment of major
depressive disorder (MDD) in adults
(1)
DOSAGE AND ADMINISTRATION
Administer VRAYLAR once daily with or without food (2)
Starting Dose Recommended Dose
Schizophrenia (2.2)
1.5 mg daily
1.5 mg to 6 mg daily
Bipolar Mania (2.3)
1.5 mg daily
3 mg to 6 mg daily
Bipolar Depression (2.4)
1.5 mg daily
1.5 mg or 3 mg daily
Adjunctive therapy to antidepressants for MDD (2.5)1.5 mg daily
1.5 mg or 3 mg daily
Schizophrenia and Bipolar Mania: Maximum recommended daily dosage is 6
mg. Dosages above 6 mg
daily do not confer significant benefit, but increase the risk of
dose-related adverse reactions (2.2, 2.3)
Bip