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BAQSIMI(glucagon)nasal powder(八)
outcome.
b Difference calculated as (percentage with success in BAQSIMI) – (percentage with success in IMG).
c
2-sided 95% confidence interval (CI) of paired differences using a Wald-Min correction; non-inferiority margin = -10%.
d Percentage based on number of patients.
14.2 Pediatric Patients
Study 3 (NCT01997411) was a randomized, multicenter, clinical study that assessed BAQSIMI compared to intramuscularglucagon (IMG) in pediatric patients aged 4 years and older with type 1 diabetes. Insulin was used toreduce blood glucose levels, and glucagon was administered after glucose reached <80 mg/dL. Efficacy wasassessed based on percentage of patients with a glucose increase of ≥20 mg/dL from glucose nadir within 30minutes following BAQSIMI administration.
Forty-eight patients were enrolled and received at least one dose of study drug. The mean age in the YoungChildren cohort (4 to <8 years) was 6.5 years. In the Children cohort (8 to <12 years), mean age was 11.1 yearsand in the Adolescents cohort (12 to <17 years) mean age was 14.6 years. In all age cohorts, the population waspredominantly male and white.
Across all age groups, all (100%) patients in both treatment arms achieved an increase in glucose ≥20 mg/dL fromglucose nadir within 20 minutes of glucagon administration. The mean time to reach a glucose increase of≥20 mg/dL for BAQSIMI and IMG for all age groups is shown in Table 7.
Table 7: Mean Time to Reach Glucose Increase of ≥20 mg/dL from Nadir in Pediatric Patients with Type 1
Diabetes in Study 3
Increase from Nadir
Mean Time Post-Glucagon Administration (minutes)
Young Children
(4 to <8 years old)
Children
(8 to <12 years old)
Adolescents
(12 to <17 years old)
IMG
a
N=6
BAQSIMI
3 mg
N=12
IMG
a
N=6
BAQSIMI
3 mg
N=12
IMG
a
N=12
BAQSIMI
3 mg
N=12
≥20 mg/dL 10.8 10.8 12.5 11.3 12.5 14.2
a
0.5 mg or 1 mg of IMG (based upon body weight)
16 HOW SUPPLIED/STORAGE AND HANDLING
BAQSIMI is supplied as an intranasal device containing one 3 mg dose of glucagon as a preservative free, whitepowder.
BAQSIMI One Pack™ carton contains 1 intranasal device (NDC 0002-6145-11)
BAQSIMI Two Pack™ carton contains 2 intranasal devices (NDC 0002-6145-27)
Store at temperatures up to 86°F (30°C) in the shrink wrapped tube provided.
Keep BAQSIMI in the shrink wrapped tube until ready to use. If the tube has been opened, BAQSIMI mayhave been exposed to moisture and may not work as expected.
Discard BAQSIMI and tube after use.
17 PATIENT COUNSELING INFORMATION
Advise the patient and family members or caregivers to read the FDA-approved patient labeling (PatientInformation and Instructions for Use).
Recognition of Severe Hypoglycemia:
Inform patient and family members or caregivers on how to recognize the signs and symptoms of severehypoglycemia and the risks of prolonged hypoglycemia.
Administration:Review the Patient Information and Instructions for Use with the patient and family members or caregivers.
Serious Hypersensitivity:
Inform patients that allergic reactions can occur with BAQSIMI. Advise patients to seek immediate medicalattention if they experience any symptoms of serious hypersensitivity reactions [see Warnings and Precautions(5.3)].
Literature issued: July 2019
Marketed by: Lilly USA, LLC, Indianapolis, IN 46285, USA
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