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Baqsimi ® (glukagon näspulver)
Denna information är endast avsedd för sjukvårdspersonal verksam i Sverige och som svar på din fråga. Informationen nedan är på engelska
A 4-period, crossover study evaluated the PK, PD, and safety of a single dose or repeated dose NG 3 mg in 23 adult participants with T1DM and in 9 adult participants with T2DM.1,2 The mean age of the participants was 39 ± 12 years.2 The participants’ blood glucose concentrations at baseline ranged from 40 to 181 mg/dL.1,2
There have been no studies conducted with repeated doses of NG in pediatric or elderly participants.
The 4 treatments were administered at least 1 week apart and 4 hours after a low carbohydrate breakfast and consisted of NG as
a single 3-mg dose
two 3-mg doses 15 minutes apart in the same nostril
two 3-mg doses 15 minutes apart in opposite nostrils, and
Blood glucagon concentrations were similar within 10 minutes after dosing in all NG treatment groups and continued to increase for 20 to 30 minutes in treatment groups with repeated NG dosing. The higher blood glucagon concentration with repeated NG dosing did not result in clinically meaningful increases in glucose response compared with single dosing of NG (Table 1).2
Table 1. Change From Baseline in PK Parameters of Glucagon and PD Parameters of Glucose After Repeat Dose of NG1,2
Parametera |
Treatment
1b |
Treatment
2c |
Treatment
3d |
Treatment
4e |
Change from baseline in PK parameters of glucagon |
||||
AUC0-1.5hr, hr.pg/mL |
2359 |
3878f |
4440f |
3381f |
AUC0-3 hr, hr.pg/mL |
2471 |
4097f |
4639f |
3611f |
Cmax,pg/mL |
4958 |
7141 |
8083 |
6654 |
Tmax,hr, median |
0.17 |
0.33 |
0.50 |
0.33 |
Change from baseline in PD parameters of glucose |
||||
AUEC0-1.5hr, mg/dL∙hr |
93 |
97 |
111 |
106 |
AUEC0-3 hr, mg/dL∙hr |
157 |
168 |
190 |
194 |
Cmax,mg/dL |
90 |
98 |
108g |
105 |
Tmax,hr, median |
0.75 |
1.00 |
1.00 |
1.00 |
Abbreviations: AUC0-1.5 hr/0-3 hr = area under the curve from time zero to 1.5 or 3 hours; AUEC0-1.5 hr/0-3 hr = area under the effect curve from time zero to 1.5 or 3 hours; Cmax = maximum concentration; hr = hour; NG = nasal glucagon (glucagon nasal powder); PD = pharmacodynamics; PK = pharmacokinetics; Tmax = time to maximum concentration.
a Data presented as mean unless indicated otherwise.
b A single 3-mg dose.
c Two 3-mg doses 15 minutes apart in the same nostril.
d Two 3-mg doses 15 minutes apart in opposite nostrils.
e Two 3-mg doses concurrently in both nostrils.
f Significantly different from single dosing (Treatment 1), p≤.043.
g Significantly different from single dosing (Treatment 1), p=.049.
Single or repeated dosing of NG was well tolerated in the treatment groups. The most common adverse reactions were
lacrimation
headache, and
nasal discomfort.2
The adverse reactions were reported as mild (88.3%), moderate (11.3%), or severe (0.4%) with
33% being resolved in less than 5 minutes
43% being resolved within 15 minutes, and
51% being resolved within 30 minutes after dosing.2
One serious adverse reaction of cellulitis was reported, but was deemed not related to NG treatment by the investigators.2
1. Dulude H, Sicard É, Rufiange M, et al. Pharmacokinetics (PK), pharmacodynamics (PD), and safety following single or repeated 3 mg doses of nasal glucagon (NG) in adults with type 1 or type 2 diabetes (T1D or T2D) [abstract]. Pediatr Diabetes. 2016;17(suppl 24):85. http://dx.doi.org/10.1111/pedi.12451
2. Dulude H, Sicard É, Rufiange M, et al. Pharmacokinetics, pharmacodynamics, and safety following single or repeated 3-mg doses of nasal glucagon in adults with type 1 or type 2 diabetes. Oral presentation at: 42nd Annual Meeting of the International Society for Pediatric and Adolescent Diabetes; October 26-29, 2016; Valencia, Spain.
Glossary
NG = nasal glucagon
PD = pharmacodynamic
PK = pharmacokinetic
T1DM = type 1 diabetes mellitus
T2DM = type 2 diabetes mellitus
Datum fӧr senaste ӧversyn 2019 M09 05