High doses of sugammadex (up to 96 mg/kg) were well tolerated in 12 of the 13 subjects. One male subject experienced several adverse events associated with a probable hypersensitivity reaction to sugammadex. Pharmacokinetics were dose linear over the range 32-96 mg/kg, with elimination predominantly via the renal route.
High doses of sugammadex (up to 96 mg/kg) were well tolerated in 12 of the 13 subjects. One male subject experienced several adverse events associated with a probable hypersensitivity reaction to sugammadex. Pharmacokinetics were dose linear over the range 32-96 mg/kg, with elimination predominantly via the renal route.
IntroductionTwo risk minimization (RM) tools—a healthcare professional frequently asked questions (HCP-FAQs) brochure and a patient/caregiver information brochure (PCIB)—were developed for HCPs and for adolescents (aged ≥ 13 years) receiving aripiprazole for bipolar I mania and their caregivers.ObjectivesThis study evaluated the effectiveness of these RM tools in improving the awareness and education of HCPs and patients/caregivers.MethodThe RM tools were distributed to HCPs (identified in agreement with the marketing authorization holder [MAH] and local regulatory authorities), who in turn distributed the PCIBs to patients/caregivers. A web-based survey was then conducted targeting HCPs and patients/caregivers.ResultsThe response rate was low: 118 of 23,282 invited HCPs and 16 patients/caregivers completed the survey. Overall, 42% (49/118) of HCP respondents were aware of aripiprazole RM tools; of these, 59% (29/49) of HCPs read them at least once and 66% (19/29) of these used the RM tools while discussing the benefit–risk profile of aripiprazole with patients/caregivers. In total, 30 of the 118 HCPs (25%) were aware of the PCIB, and 26 distributed it to their patients/caregivers, whereas seven HCPs advised them to read the brochure. Overall, 15 of the 16 patients/caregivers were aware of the PCIB, and 13 read/referred to it. Of these, 12 found the PCIB useful, and five monitored their weight while receiving aripiprazole and reported potential risks immediately to their HCP.ConclusionThe response rate to the survey was low, and the tools displayed limited utility and effectiveness in improving awareness and education in a small number of responders. Therefore, the aripiprazole risk management plan was amended, and the tools were discontinued.Electronic supplementary materialThe online version of this article (10.1007/s40264-018-0662-2) contains supplementary material, which is available to authorized users.
BACKGROUND Wearable sensors in digital health help facilitate real-time, point-of-care monitoring. However, wearable sensors may pose a risk for skin irritation through the use of adhesive patches. Little is known about how patient- and product-related factors impact the risk of skin irritation. Aripiprazole tablets with sensor (AS, Abilify MyCite®) is a digital medicine system indicated for the treatment of patients with schizophrenia, bipolar I disorder, and major depressive disorder. AS includes aripiprazole tablets with an embedded ingestible event marker, a wearable sensor attached to the skin through an adhesive patch, a smartphone app, and a web-based portal. To continuously improve the final product, successive iterations of sensor patches were developed, including RP4, which was replaced by DW5, followed by RW2. OBJECTIVE This analysis pooled safety data of clinical studies in adult participants using the RP4, DW5, and RW2 patches of AS and evaluated adverse events related to patch wear. METHODS We analyzed safety data from 6 long-term and 6 short-term studies in adults aged 18–65 years from May 2010 to August 2020. All studies evaluated safety, with short-term studies also specifically examining human factors associated with use of the components of AS. Healthy volunteers or patients with schizophrenia, bipolar I disorder, or major depressive disorder were enrolled; those who received ≥ 1 exposure to the patch component of AS were included in the safety analysis. Adverse events related to patch wear were evaluated: abrasions, blisters, dermatitis, discoloration, erythema, irritation, pain, pruritus, rash, and skin reactions were grouped as skin irritation events (SIEs). RESULTS The analysis included 763 participants (mean age 42.6 years, 47.1% White, 55% male). Participants were healthy volunteers (35.3%) or patients with schizophrenia (52.7%), bipolar I disorder (7.5%), or major depressive disorder (4.6%). Overall, 13.6% (n/N = 104/763) of the participants reported at least 1 SIE; any SIEs experienced were localized to the patch site. Incidence of SIEs decreased as the patch versions developed; ≥ 1 SIE was experienced by 18.1% (28/155), 14.2% (55/387), and 9.2% (28/306) of participants who used RP4, DW5, and RW2 patches, respectively. Incidence of SIE-related treatment discontinuation was low, reported in 1.9% (3/155), 3.1% (12/387), and 1.3% (4/306) of participants who used RP4, DW5, and RW2 patches, respectively. Incidence of SIEs was higher in long-term studies than in short-term studies (15.8% vs 8.8%), with 22.4%, 17.6%, and 5.6% of participants in long-term studies reporting ≥ 1 SIE for RP4, DW5, and RW2 patches, respectively. CONCLUSIONS The pooled safety analysis indicated that incidence of SIEs decreased as the patch versions evolved from RP4 through RW2. These results further suggest that information derived from reported adverse events may have informed product design and development, which improved both tolerability and wearability of successive products. CLINICALTRIAL 316-13-204, 316-13-205, 316-13-206A (NCT02091882), 316-13-206B (NCT02091882), 316-13-215 (NCT02722967), 316-14-220 (NCT02219009), 031-201-00186 (NCT03568500), 031-201-00266, 031-201-00301 (NCT03892889), 031-201-00383, 031-201-00420, 031-201-00469.
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