on (ACE) ligand-binding immunogenicity assay. No neutralizing antibodies weredetected.
7 DRUG INTERACTIONS
7.1 Beta-blockers
Patients taking beta-blockers may have a transient increase in pulse and blood pressure when given BAQSIMI.
7.2 Indomethacin
In patients taking indomethacin, BAQSIMI may lose its ability to raise blood glucose or may even produce
hypoglycemia.
7.3 Warfarin
BAQSIMI may increase the anticoagulant effect of warfarin.
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
Available data from case reports and a small number of observational studies with glucagon use in pregnantwomen over decades of use have not identified a drug-associated risk of major birth defects, miscarriage oradverse maternal or fetal outcomes. Multiple small studies have demonstrated a lack of transfer of pancreatic
glucagon across the human placental barrier during early gestation. In a rat reproduction study, no embryofetaltoxicity was observed with glucagon administered by injection during the period of organogenesis at dosesrepresenting up to 40 times the human dose, based on body surface area (mg/m2) (see Data).
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. Inthe U.S. general population, the estimated background risk of major birth defects and miscarriage in clinicallyrecognized pregnancies is 2-4% and 15-20%, respectivelyDataAnimal Data
In pregnant rats given animal sourced glucagon twice-daily by injection at doses up to 2 mg/kg (up to 40 times thehuman dose based on body surface area extrapolation, mg/m2) during the period of organogenesis, there was noevidence of increased malformations or embryofetal lethality.
8.2 Lactation
Risk Summary
There is no information available on the presence of glucagon in human or animal milk, the effects of the drug onthe breastfed infant, or the effects of the drug on milk production. However, glucagon is a peptide and would beexpected to be broken down to its constituent amino acids in the infant's digestive tract and is therefore, unlikely tocause harm to an exposed infant.
8.4 Pediatric Use
The safety and effectiveness of BAQSIMI for the treatment of severe hypoglycemia in patients with diabetes havebeen established in pediatric patients ages 4 years and above. Use of BAQSIMI for this indication is supported byevidence from a study in 48 pediatric patients from 4 to <17 years of age with type 1 diabetes mellitus. [see
Clinical Studies (14.2)].
The safety and effectiveness of BAQSIMI have not been established in pediatric patients younger than 4 years ofage.
8.5 Geriatric Use
Clinical studies of BAQSIMI did not include sufficient numbers of subjects aged 65 and over to determine whetherthey respond differently from younger subjects. Limited clinical trial experience has not identified differences inresponses between the elderly and younger patients.
10 OVERDOSAGE
If overdosage occurs, the patient may experience nausea, vomiting, inhibition of GI tract motility, increase in bloodpressure and pulse rate. In case of suspected overdosing, serum potassium levels may decrease and should bemonitored and corrected if needed. If the patient develops a dramatic increase in blood pressure, phentolaminemesylate has been shown to be effective in lowering blood pressure for the short time that control would beneeded.
11 DESCRIPTION
BAQSIMI contains glucagon, an antihy |
