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A NOAEL could not be determined and, at the lowest tested dose of 3 mg/kg/day, there is no safety margin relative to the systemic exposures (AUCClinical studies of oral aripiprazole did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects. In this trial, 21.4% of these patients demonstrated ≥7% increase in body weight and 15.4% demonstrated a ≥7% decrease in body weight.Post-marketing case reports suggest that patients can experience intense urges, particularly for gambling, and the inability to control these urges while taking aripiprazole. The development and health benefits of breastfeeding should be considered along with the mother's clinical need for Abilify Maintena and any potential adverse effects on the breastfed infant from Abilify Maintena or from the underlying maternal condition.Abilify Maintena has not been studied in children 18 years of age or younger. The medicine is given once a month by slow injection into the buttock or deltoid (shoulder) muscle by a doctor or nurse. Connect by calling


(PDF/1008.54 KB) (PDF/91.43 KB) However, juvenile animal studies have been conducted in rats and dogs.Aripiprazole in juvenile rats caused mortality, CNS clinical signs, impaired memory and learning, and delayed sexual maturation when administered at oral doses of 10, 20, 40 mg/kg/day from weaning (21 days old) through maturity (80 days old). (PDF/96.1 KB) The United Kingdom (UK) withdrew from the European Union (EU) on 31 January 2020 and is no longer an EU Member State. Agranulocytosis has also been reported Possible risk factors for leukopenia/neutropenia include pre-existing low white blood cell count (WBC)/absolute neutrophil count (ANC) and a history of drug-induced leukopenia/neutropenia. Consider the benefits and risks of Abilify Maintena and possible risks to the fetus when prescribing Abilify Maintena to a pregnant woman. Whether antipsychotic drug products differ in their potential to cause tardive dyskinesia is unknown.The risk of developing tardive dyskinesia and the likelihood that it will become irreversible are believed to increase as the duration of treatment and the total cumulative dose of antipsychotic drugs administered to the patient increase.
For patients with diseases, conditions, or medications that could exacerbate these effects, complete fall risk assessments when initiating treatment and recurrently during therapy. 2047 0 obj <>/Filter/FlateDecode/ID[<3E67178C7A085C49B61147DC5EF95498><00ABDF5C077BBA41BC0147EC5F6DC4CA>]/Index[2032 37]/Info 2031 0 R/Length 86/Prev 652705/Root 2033 0 R/Size 2069/Type/XRef/W[1 3 1]>>stream Administer once monthly.Lay out and confirm that components listed below are provided in the kit:The reconstituted extended-release injectable suspension is a uniform, homogeneous suspension that is opaque and milky-white in color.Abilify Maintena is contraindicated in patients with a known hypersensitivity to aripiprazole. (PDF/962.07 KB)

h�bbd```b``��� `�4�d����,A`�B0��d�f�e����j`v �dTm��7Oa`bd`��M�+����[� #A (PDF/46.78 KB) Discontinue Abilify Maintena in patients with severe neutropenia (absolute neutrophil count <1000/mmAs with other antipsychotic drugs, use Abilify Maintena cautiously in patients with a history of seizures or with conditions that lower the seizure threshold.

(PDF/91.43 KB) (PDF/90.47 KB) h�Ė�n�:�_E��E��% (PDF/1014.92 KB) (PDF/48.31 KB) (PDF/901.53 KB) This analysis did not reveal evidence of differences in safety differential adverse reaction incidence on the basis of age, gender, or race alone; however, there were few subjects ≥65 years of age.In the data from the short-term, double-blind, placebo-controlled trial with Abilify Maintena in patients with schizophrenia, the percent of patients reporting any injection site-related adverse reaction (all reported as injection site pain) was 5.4% for patients treated with gluteal administered Abilify Maintena and 0.6% for placebo. Table 4 shows the proportion of Abilify Maintena-treated patients with normal and borderline fasting glucose at baseline and their changes in fasting glucose measurements.During a 52-week, open-label bipolar I disorder study in those patients who initiated Abilify Maintena treatment, 1.1% with normal baseline fasting glucose experienced a shift to high while receiving Abilify Maintena and 9.8% with borderline fasting glucose experienced a shift to high. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.Extrapyramidal and/or withdrawal symptoms, including agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding disorder have been reported in neonates who were exposed to antipsychotic drugs (including oral aripiprazole) during the third trimester of pregnancy.