Israel - English - Ministry of Health

dexcel ltd, israel - cariprazine as hydrochloride - hard capsule - cariprazine as hydrochloride 1.5 mg - cariprazine - - for the treatment of schizophrenia in adult patients- acute treatment of manic or mixed episodes associated with bipolar i disorder in adult- treatment of depressive episodes associated with bipolar i disorder (bipolar depression) in adults

Israel - English - Ministry of Health

dexcel ltd, israel - cariprazine as hydrochloride - hard capsule - cariprazine as hydrochloride 3 mg - cariprazine - - for the treatment of schizophrenia in adult patients- acute treatment of manic or mixed episodes associated with bipolar i disorder in adult- treatment of depressive episodes associated with bipolar i disorder (bipolar depression) in adults

Israel - English - Ministry of Health

dexcel ltd, israel - cariprazine as hydrochloride - hard capsule - cariprazine as hydrochloride 4.5 mg - cariprazine - - for the treatment of schizophrenia in adult patients- acute treatment of manic or mixed episodes associated with bipolar i disorder in adult- treatment of depressive episodes associated with bipolar i disorder (bipolar depression) in adults

Israel - English - Ministry of Health

dexcel ltd, israel - cariprazine as hydrochloride - hard capsule - cariprazine as hydrochloride 6 mg - cariprazine - - for the treatment of schizophrenia in adult patients- acute treatment of manic or mixed episodes associated with bipolar i disorder in adult- treatment of depressive episodes associated with bipolar i disorder (bipolar depression) in adults

Australia - English - Department of Health (Therapeutic Goods Administration)

gedeon richter australia pty ltd - cariprazine hydrochloride, quantity: 6.54 mg (equivalent: cariprazine, qty 6 mg) - capsule, hard - excipient ingredients: pregelatinised maize starch; magnesium stearate; titanium dioxide; brilliant blue fcf; allura red ac; gelatin; propylene glycol; butan-1-ol; purified water; isopropyl alcohol; shellac; strong ammonia solution; ethanol absolute; iron oxide black; potassium hydroxide - reagila? is indicated for the treatment of schizophrenia in adult patients.

Australia - English - Department of Health (Therapeutic Goods Administration)

gedeon richter australia pty ltd - cariprazine hydrochloride, quantity: 4.905 mg (equivalent: cariprazine, qty 4.5 mg) - capsule, hard - excipient ingredients: pregelatinised maize starch; magnesium stearate; titanium dioxide; brilliant blue fcf; iron oxide yellow; allura red ac; gelatin; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; simethicone; ethanol; shellac; sulfuric acid - reagila? is indicated for the treatment of schizophrenia in adult patients.

Australia - English - Department of Health (Therapeutic Goods Administration)

gedeon richter australia pty ltd - cariprazine hydrochloride, quantity: 3.27 mg (equivalent: cariprazine, qty 3 mg) - capsule, hard - excipient ingredients: pregelatinised maize starch; magnesium stearate; titanium dioxide; brilliant blue fcf; iron oxide yellow; allura red ac; gelatin; propylene glycol; butan-1-ol; purified water; isopropyl alcohol; shellac; strong ammonia solution; ethanol absolute; iron oxide black; potassium hydroxide - reagila? is indicated for the treatment of schizophrenia in adult patients.

Australia - English - Department of Health (Therapeutic Goods Administration)

gedeon richter australia pty ltd - cariprazine hydrochloride, quantity: 1.635 mg (equivalent: cariprazine, qty 1.5 mg) - capsule, hard - excipient ingredients: magnesium stearate; pregelatinised maize starch; titanium dioxide; gelatin; propylene glycol; butan-1-ol; purified water; isopropyl alcohol; shellac; strong ammonia solution; ethanol absolute; iron oxide black; potassium hydroxide - reagila? is indicated for the treatment of schizophrenia in adult patients.

United States - English - NLM (National Library of Medicine)

allergan, inc. - cariprazine (unii: f6rjl8b278) (cariprazine - unii:f6rjl8b278) - cariprazine 1.5 mg - 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.

Singapore - English - HSA (Health Sciences Authority)

mitsubishi tanabe pharma singapore pte. ltd. - cariprazine hydrochloride 1.635mg eqv cariprazine - capsule, gelatin coated - cariprazine hydrochloride 1.635mg eqv cariprazine 1.5mg