lycemia for other products may be misleading and also,may not be representative of hypoglycemia rates that occur inclinical practice.
Incidence rates for severe hypoglycemia in adults with type 1 andtype 2 diabetes mellitus treated with FIASP® in clinical trials areshown in Table 3 [see Clinical Studies (14)].
Table 3. Proportion (%) of Patients with Type 1 Diabetesand Type 2 Diabetes Experiencing at Least One Episodeof Severe Hypoglycemia in Adult Clinical TrialsStudy A (Type 1) Study B (Type 2)
Mealtime FIASP®
+ Insulin detemir
(N=386)
Postmeal FIASP®
+ Insulin detemir
(N=377)
FIASP® +
Insulin glargine
(N=341)
Severe
hypoglycemia* 6.7 8.0 3.2
*Severe hypoglycemia: an episode requiring assistance of anotherperson to actively administer carbohydrate, glucagon, or otherresuscitative actionsAllergic Reactions
Severe, life-threatening, generalized allergy, including anaphylaxis,generalized skin reactions, angioedema, bronchospasm, hypotension,and shock may occur with any insulin, including FIASP®, andmay be life threatening [see Warnings and Precautions (5.6)].
In theclinical program, generalized hypersensitivity reactions (manifestedby generalized skin rash and facial edema) was reported in 0.4% ofpatients treated with FIASP®. Allergic skin manifestations reportedwith FIASP® in 1.7% of patients from the clinical program includeeczema, rash, rash pruritic, urticaria and dermatitis.
LipodystrophyAdministration of insulin, including FIASP®, has resulted in lipohypertrophy(enlargement or thickening of tissue) and lipoatrophy(depression in the skin). In the clinical program, lipodystrophy wasreported in 0.4% of patients treated with FIASP® [see Dosage andAdministration (2.2)].
Injection Site Reactions
As with other insulin therapy, patients may experience rash, redness,inflammation, bruising or itching at the site of FIASP® injection.
These reactions usually resolve in a few days to a few weeks, butin some occasions, may require discontinuation of FIASP®. Inthe clinical program, injection site reactions occurred in 1.6%of patients treated with FIASP®. In Study A, patients with type 1diabetes treated with FIASP® reported 2.2% injection site reactions.
Weight Gain
Weight gain can occur with insulin therapy, including FIASP®,and has been attributed to the anabolic effects of insulin and thedecrease in glucosuria. In Study A, patients with type 1 diabetestreated with FIASP® gained an average of 0.7 kg and in Study B,patients with type 2 diabetes treated with FIASP® gained an average
of 2.7 kg.
Peripheral Edema
Insulin, including FIASP®, may cause sodium retention and edema,particularly if previous poor metabolic control is improved byintensified insulin therapy. In the clinical program, peripheral edemaoccurred in 0.8% of patients treated with FIASP®.
6.2 Immunogenicity
As with all therapeutic proteins, there is a potential for immunogenicity.
The detection of antibody formation is highly dependent onthe sensitivity and specificity of the assay and may be influencedby several factors such as: assay methodology, sample handling,
timing of sample collection, concomitant medication, andunderlying disease. For these reasons, comparison of the incidenceof antibodies to FIASP® in the studies described below with theincidence of antibodies in other studies or to other products ma |
