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Fiasp

Last reviewed on RxList: 10/30/2019
Fiasp Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 10/30/2019

What Is Fiasp?

Fiasp (insulin aspart injection) is a rapid-acting human insulin analog indicated to improve glycemic control in adults with diabetes mellitus.

What Are Side Effects of Fiasp?

Common side effects of Fiasp include:

Dosage for Fiasp

The dosage of Fiasp is individualized and adjusted based on the route of administration, the individual's metabolic needs, blood glucose monitoring results, and glycemic control goal.

What Drugs, Substances, or Supplements Interact with Fiasp?

Fiasp may interact with:

Tell your doctor all medications and supplements you use.

Fiasp During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Fiasp; it is unknown how it would affect a fetus. It is unknown if Fiasp passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Fiasp (insulin aspart injection) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

SLIDESHOW

Diabetes: What Raises and Lowers Your Blood Sugar Level? See Slideshow
Fiasp Professional Information

SIDE EFFECTS

The following adverse reactions are also discussed elsewhere:

Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug, and may not reflect the rates actually observed in clinical practice.

The data in Table 1 reflect the exposure of 763 patients with type 1 diabetes to FIASP in one clinical trial with a mean exposure duration of 25 weeks [see Clinical Studies]. The mean age was 44.4 years and the mean duration of diabetes was 19.9 years. 59% were male, 93% were Caucasian, 2% were Black or African American and 7% were Hispanic. The mean BMI was 26.7 kg/m2 and the mean HbA1c at baseline was 7.6%.

The data in Table 2 reflect the exposure of 341 patients with type 2 diabetes to FIASP in one clinical trial with a mean exposure duration of 24 weeks [see Clinical Studies]. The mean age was 59.6 years and the mean duration of diabetes was 13.2 years. 47% were male, 80% were Caucasian, 6% were Black or African American and 8% were Hispanic. The mean BMI was 31.5 kg/m2 and the mean HbA1c at baseline was 8.0%.

Common adverse reactions, excluding hypoglycemia, were defined as events occurring in ≥5% and occurring at the same rate or greater for FIASP-treated subjects than comparator-treated subjects.

Table 1. Adverse Reactions (%*) in Patients with Type 1 Diabetes

  Mealtime FIASP +
Insulin detemir
(N=386)
Postmeal FIASP +
Insulin detemir
(N=377)
Nasopharyngitis 20.2 23.9
Upper respiratory tract
infection
9.1 7.4
Nausea 4.9 5.0
Diarrhea 5.4 3.2
Back pain 5.2 4.0
*Incidence ≥ 5% and occurring at the same rate or greater with FIASP than comparator

Table 2. Adverse Reactions (%*) in Patients with Type 2 Diabetes

  FIASP + Insulin glargine
(N=341)
Urinary tract infection 5.9
*Incidence ≥ 5% and occurring at the same rate or greater with FIASP than comparator

Hypoglycemia

Hypoglycemia is the most commonly observed adverse reaction in patients using insulin, including FIASP [see WARNINGS AND PRECAUTIONS]. The rates of reported hypoglycemia depend on the definition of hypoglycemia used, diabetes type, insulin dose, intensity of glucose control, background therapies, and other intrinsic and extrinsic patient factors. For these reasons, comparing rates of hypoglycemia in clinical trials for FIASP with the incidence of hypoglycemia for other products may be misleading and also, may not be representative of hypoglycemia rates that occur in clinical practice.

Incidence rates for severe hypoglycemia in adults with type 1 and type 2 diabetes mellitus treated with FIASP in clinical trials are shown in Table 3 [see Clinical Studies].

Table 3. Proportion (%) of Patients with Type 1 Diabetes and Type 2 Diabetes Experiencing at Least One Episode of Severe Hypoglycemia in Adult Clinical Trials

  Study 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 another person to actively administer carbohydrate, glucagon, or other resuscitative actions

Allergic Reactions

Severe, life-threatening, generalized allergy, including anaphylaxis, generalized skin reactions, angioedema, bronchospasm, hypotension, and shock may occur with any insulin, including FIASP, and may be life threatening [see WARNINGS AND PRECAUTIONS]. In the clinical program, generalized hypersensitivity reactions (manifested by generalized skin rash and facial edema) was reported in 0.4% of patients treated with FIASP. Allergic skin manifestations reported with FIASP in 1.7% of patients from the clinical program include eczema, rash, rash pruritic, urticaria and dermatitis.

Lipodystrophy

Administration of insulin, including FIASP, has resulted in lipohypertrophy (enlargement or thickening of tissue) and lipoatrophy (depression in the skin). In the clinical program, lipodystrophy was reported in 0.4% of patients treated with FIASP [see DOSAGE AND ADMINISTRATION].

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, but in some occasions, may require discontinuation of FIASP. In the clinical program, injection site reactions occurred in 1.6% of patients treated with FIASP. In Study A, patients with type 1 diabetes 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 the decrease in glucosuria. In Study A, patients with type 1 diabetes treated 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 by intensified insulin therapy. In the clinical program, peripheral edema occurred in 0.8% of patients treated with FIASP.

Immunogenicity

As with all therapeutic proteins, there is a potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay and may be influenced by several factors such as: assay methodology, sample handling, timing of sample collection, concomitant medication, and underlying disease. For these reasons, comparison of the incidence of antibodies to FIASP in the studies described below with the incidence of antibodies in other studies or to other products may be misleading.

In a 26-week study in adult subjects with type 1 diabetes (Study A [see Clinical Studies]), among the 763 subjects who received FIASP, 97.2% were positive for cross-reacting anti-insulin antibodies (AIA) at least once during the study, including 90.3% that were positive at baseline. A total of 24.8% of patients who received FIASP were positive for anti-drug (insulin aspart) antibodies (ADA) at least once during the study, including 17.3% that were positive at baseline.

Read the entire FDA prescribing information for Fiasp (Insulin Aspart Injection for Subcutaneous or Intravenous Use)

QUESTION

Diabetes is defined best as... See Answer
Related Resources for Fiasp

© Fiasp Patient Information is supplied by Cerner Multum, Inc. and Fiasp Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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