Indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.

Do not mix FIASP with any other insulin.

Accidental mix-ups between insulin products have been reported. To avoid medication errors between FIASP and other insulins, instruct patients to always check the insulin label before each injection.

Repeated insulin injections into areas of lipodystrophy or localized cutaneous amyloidosis have been reported to result in hyperglycemia; and a sudden change in the injection site (to an unaffected area) has been reported to result in hypoglycemia.

Severe hypoglycemia can cause seizures, may lead to unconsciousness, may be life-threatening, or cause death. Hypoglycemia can impair concentration ability and reaction time; this may place an individual and others at risk in situations where these abilities are important (e.g. driving or operating other machinery). FIASP, or any insulin, should not be used during episodes of hypoglycemia.

All insulin products, including FIASP, can cause a shift in potassium from the extracellular to intracellular space, possibly leading to hypokalemia. Untreated hypokalemia may cause respiratory paralysis, ventricular arrhythmia and death.

Severe, life-threatening, generalized allergy, including anaphylaxis, can occur with insulin products, including FIASP.

Patients with renal and hepatic impairment may be at increased risk of hypoglycemia and may require more frequent FIASP dose adjustment and more frequent blood glucose monitoring.

Thiazolidinediones (TZDs), which are peroxisome proliferator-activated receptor (PPAR)- gamma agonists, can cause dose-related fluid retention, particularly when used in combination with insulin. Fluid retention may lead to or exacerbate heart failure. Patients treated with insulin, including FIASP, and a PPAR-gamma agonist should be observed for signs and symptoms of heart failure.

FIASP is contraindicated

• During episodes of hypoglycemia
• In patients with known hypersensitivity to insulin aspart or one of the excipients in FIASP

Weight gain can occur with insulin therapy, including FIASP, and has been attributed to the anabolic effects of insulin and the decrease in glucosuria.

Insulin, including FIASP, may cause sodium retention and edema, particularly if previous poor metabolic control is improved by intensified insulin therapy.

As with all therapeutic proteins, there is a potential for immunogenicity.

Pump or infusion set malfunctions can lead to a rapid onset of hyperglycemia and ketoacidosis. Prompt identification and correction of the cause of hyperglycemia or ketosis is necessary. Interim therapy with subcutaneous injection of FIASP may be required. Patients using continuous subcutaneous insulin infusion pump therapy must be trained to administer insulin by injection and have alternate insulin therapy available in case of pump failure.

Dose reductions and increased frequency of glucose monitoring may be required when FIASP is co-administered with these drugs: antidiabetic agents, ACE inhibitors, angiotensin II receptor blocking agents, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, pramlintide, salicylates, somatostatin analogs (e.g., octreotide), and sulfonamide antibiotics.

Dose increases and increased frequency of glucose monitoring may be required when FIASP is co-administered with these drugs: atypical antipsychotics (e.g., olanzapine and clozapine), corticosteroids, danazol, diuretics, estrogens, glucagon, isoniazid, niacin, oral contraceptives, phenothiazines, progestogens (e.g., in oral contraceptives), protease inhibitors, somatropin, sympathomimetic agents (e.g., albuterol, epinephrine, terbutaline), and thyroid hormones.

Dose adjustment and increased frequency of glucose monitoring may be required when FIASP is co-administered with these drugs: alcohol, beta-blockers, clonidine, and lithium salts, pentamidine may cause hypoglycemia, which may sometimes be followed by hyperglycemia. 

Increased frequency of glucose monitoring may be required when FIASP is co-administered with these drugs: beta-blockers, clonidine, guanethidine, and reserpine.

There are no available data with FIASP in pregnant women to inform a drug-associated risk for major birth defects and miscarriage.

There are no data on the presence of FIASP in human milk, the effects on the breastfed infant, or the effect on milk production. One small published study reported that exogenous insulin, including insulin aspart, was present in human milk.

GoToSource

• Use in patients under the age of 2. GoToSource

• Diabetic ketoacidosis. GoToSource

Hypoglycemia (low blood sugar), local injection site reactions, lipodystrophy (localized loss of body fat), rash, pruritus (severe itching) and hypokalemia (low blood potassium level). GoToSource

Insulin antibodies. GoToSource

Weight gain. GoToSource

No major injury lawsuits reported.