se effects on the breastfed childfrom FIASP® or insulin aspart or from the underlying maternalcondition.
8.4 Pediatric Use
The safety and effectiveness of FIASP® in pediatric patients havenot been established.
8.5 Geriatric Use
In the three controlled clinical studies, 192 of 1219 (16%) FIASP®treated patients with type 1 or type 2 diabetes were ≥ 65 years of ageand 24 of 1219 (2%) were ≥ 75 years of age. No overall differences insafety or effectiveness were observed between these elderly patientsand younger adult patients.
Nevertheless, caution should be exercised when FIASP® is administeredto geriatric patients. In elderly patients with diabetes, theinitial dosing, dose increments, and maintenance dosage should beconservative to avoid hypoglycemia [see Warnings and Precautions(5.3), Adverse Reactions (6.1) and Clinical Studies (14)].
Pharmacokinetic/pharmacodynamic study to assess the effect ofage on the onset of FIASP® action has been performed [see ClinicalPharmacology (12.3)].
8.6 Renal Impairment
Patients with renal impairment may be at increased risk of hypoglycemiaand may require more frequent FIASP® dose adjustmentand more frequent blood glucose monitoring [see Warnings andPrecautions (5.3) and Clinical Pharmacology (12.3)].
8.7 Hepatic Impairment
Patients with hepatic impairment may be at increased risk of hypoglycemiaand may require more frequent FIASP® dose adjustmentand more frequent blood glucose monitoring [see Warnings andPrecautions (5.3) and Clinical Pharmacology (12.3)].
10 OVERDOSAGE
Excess insulin administration may cause hypoglycemia andhypokalemia [see Warnings and Precautions (5.3, 5.5)].
Mildepisodes of hypoglycemia usually can be treated with oralglucose. Adjustments in drug dosage, meal patterns, or exercise,may be needed. More severe episodes with coma, seizure orneurologic impairment may be treated with intramuscular/subcutaneous glucagon or concentrated intravenous glucose.
Sustained carbohydrate intake and observation may be necessarybecause hypoglycemia may recur after apparent clinical recovery.Hypokalemia must be corrected appropriately.
11 DESCRIPTION
FIASP® (insulin aspart injection) is a rapid-acting insulin analogfor subcutaneous or intravenous administration used to lower bloodglucose. Insulin aspart is homologous with regular human insulinwith the exception of a single substitution of the amino acid prolineby aspartic acid in position B28, and is produced by recombinantDNA technology utilizing Saccharomyces cerevisiae.
Insulin asparthas the empirical formula C256H381N65O79S6 and a molecularweight of 5825.8 daltons.
Figure 1. Structural Formula of Insulin Aspart
FIASP® (insulin aspart injection) is an aqueous, sterile, clear andcolorless solution. Each mL contains 100 units of insulin aspart andthe inactive ingredients: arginine (as L-arginine hydrochloride), USP(3.48 mg); disodium phosphate dihydrate, USP (0.53 mg); glycerol,USP (3.3 mg); metacresol, USP (1.72 mg); niacinamide, USP (20.8mg); phenol, USP (1.50 mg); zinc (as zinc acetate), USP (19.6 mcg)and water for injection, USP. FIASP® has a pH of 7.1. Hydrochloricacid and/or sodium hydroxide may be added to adjust pH.
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
The primary activity of FIASP® is the regulation of glucosemetabolism. Insulins, including insulin aspart, the active ingredientin FIASP&re |
