abilify maintena fda pi

ABILIFY MAINTENA activity is presumably primarily due to the parent drug, aripiprazole, and to a lesser extent, to its major metabolite, dehydro-aripiprazole, which has been shown to have affinities for D2 receptors similar to the parent drug and represents about 29% of the parent drug exposure in plasma.

ABILIFY MAINTENA is contraindicated with a known hypersensitivity reaction to aripiprazole (see Important Safety Information below).For more information about ABILIFY MAINTENA, please visit: The Phase 3 clinical trial supporting regulatory approval demonstrated the efficacy and safety of ABILIFY MAINTENA in the maintenance monotherapy treatment of BP-I. endstream endobj 2033 0 obj <>/Metadata 121 0 R/Pages 2030 0 R/StructTreeRoot 149 0 R/Type/Catalog>> endobj 2034 0 obj <>/MediaBox[0 0 595.32 842.04]/Parent 2030 0 R/Resources<>/Font<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI]/XObject<>>>/Rotate 0/StructParents 0/Tabs/S/Type/Page>> endobj 2035 0 obj <>stream National Alliance on Mental Illness website. Our pipeline consists of several late-stage development programmes and our products are available in more than 100 countries. ABILIFY MAINTENA provides healthcare professionals (HCPs) a new treatment option for their patients who have established tolerability with oral aripiprazole,” said Joseph Calabrese, MD, Director of the Mood Disorders Program at University Hospitals Cleveland Medical Center, and Professor of Psychiatry at Case Western Reserve University School of Medicine. ��ۢ�MѿO��i/�:�ɴOFn��Iǝg�����ݙ��s�W�u�7>�`�0�Q�1f��Xcl������9cX1��X��u��Zg�ٱ�Vbm��͎����")�Nx��J�48�1���Yr�G4�ꃍ�p/+1 6'sN4 �26��sQ'cz�e�s�R�:�����`���)��v�}���a�W���"�����x��_��Tv�6;��q Abilify Mycite, a drug-device combination product comprised of aripiprazole tablets embedded with an Ingestible Event Marker (IEM) sensor intended to track drug ingestion, is indicated for the: Treatment of adults with schizophrenia [see Clinical Studies (14.1) ] ���X�����/��'5�؁흵o?R�\'뒜 �`(�%��h~�SaD0��׌�{N��(܈$J8E��QЄ�ؠdک[•_s��Qقf��;#�K�v n�%X3����I�H&qc��Y�૵��z~E��z����q�ӷ��Y��9��? Serious Mental Illness (SMI) Among U.S. multiple dose administration of Abilify Maintena, dehydro-aripiprazole, the active metabolite represents about 29.1-32.5% of aripiprazole AUC in plasma.

Every day, we strive for improved treatment and a better life for people living with psychiatric and neurological disorders — we call this Progress in Mind.Our approximately 5,000 employees in 55 countries are engaged in the entire value chain throughout research, development, production, marketing and sales. The clinical trial was a 52-week, double-blind, placebo-controlled, randomized withdrawal trial in adults with BP-I aged 18 to 65 years, who were stabilized with ABILIFY MAINTENA prior to randomization.ABILIFY MAINTENA (aripiprazole) for extended-release injectable suspension is an atypical antipsychotic for intramuscular use. 2032 0 obj <> endobj “Receiving ABILIFY MAINTENA each month as prescribed and administered by a HCP, provides patients an opportunity to be free from taking their daily antipsychotic for bipolar I disorder; it is important to note that concomitant oral antipsychotic must be administered for 14 days after the first injection.”Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at increased risk of death. Adults. We have research centres in China and Denmark and production facilities in China, Denmark, France and Italy. Otsuka Pharmaceutical Company is a global healthcare company with the corporate philosophy: “Otsuka-people creating new products for better health worldwide.” Otsuka researches, develops, manufactures and markets innovative products, with a focus on pharmaceutical products for the treatment of diseases and nutraceutical products for the maintenance of everyday health.In pharmaceuticals, Otsuka is a leader in the challenging area of mental health and also has research programs on several under-addressed diseases including tuberculosis, a significant global public health issue. ABILIFY MAINTENA is not approved for the treatment of patients with dementia-related psychosis. You can ask your pharmacist or Excretion After administration of multiple doses of 400 mg or 300 mg of Abilify Maintena, the observed mean aripiprazole terminal elimination half-life is 46.5 and 29.9 days, respectively. Pharmacokinetic Study ABILIFY MAINTENA ® (aripiprazole) keeps blood concentrations of aripiprazole within therapeutic levels throughout the month in adult patients with schizophrenia. Learn more about Otsuka Pharmaceutical Company on its global website at H. Lundbeck A/S (LUN.CO, LUN DC, HLUYY) is a global pharmaceutical company specialized in psychiatric and neurological disorders. The Otsuka group of companies employed 45,000 people worldwide and had consolidated sales of approximately USD 11 billion (€ 9.9 billion) in 2016.All Otsuka stories start by taking the road less travelled. 2068 0 obj <>stream If you would like more information, talk with your healthcare provider. It was created by Otsuka in Japan and has been co-developed and co-commercialized by the alliance between Otsuka and Lundbeck. ;�Ҹ���4��]^�$f���[����(��E�y����X��ܫ�gt�ʖ �C'Uٞ�W�Ȁ�8�1�+R7y��s:��lu5w�ޤb�N�lU܍��*'�~ȳEQ.���*{�n�Jgm��y���R������E���Y_*�3gM�z��o˻ Report adverse events involving aripiprazole (Abilify, Abilify Maintena, Aristada, and generics) to the FDA MedWatch program, using the information in the “Contact FDA…

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