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

NOVOLOG has not been studied in children with type 2 diabetes.

NOVOLOG is contraindicated during episodes of hypoglycemia.

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

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

Weight gain has occurred with some insulin therapies including NOVOLOG.

All insulin products, including NOVOLOG, can cause a shift in potassium from the extracellular to intracellular space, possibly leading to hypokalemia.

Hypoglycemia is the most common adverse effect of all insulin therapies, including NOVOLOG. Severe hypoglycemia can cause seizures, may lead to unconsciousness may be life threatening or cause death.

The risk of hypoglycemia after an injection is related to the duration of action of the insulin and, in general, is highest when the glucose lowering effect of the insulin is maximal. Other factors which may increase the risk of hypoglycemia include changes in meal pattern (e.g., macronutrient content or timing of meals), changes in level of physical activity, or changes to co-administered medication. Patients with renal or hepatic impairment may be at higher risk of hypoglycemia.

Administration of insulin, including NOVOLOG, subcutaneously and via subcutaneous insulin infusion by external pump, has resulted in lipoatrophy (depression in the skin) or lipohypertrophy (enlargement or thickening of tissue) in some patients.

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. Make any changes to a patient’s insulin regimen under close medical supervision with increased frequency of blood glucose monitoring. Advise patients who have repeatedly injected into areas of lipodystrophy or localized cutaneous amyloidosis to change the injection site to unaffected areas and closely monitor for hypoglycemia. For patients with type 2 diabetes, dosage adjustments of concomitant anti-diabetic products may be needed.

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

Patients treated with insulin, including NOVOLOG, and a PPAR-gamma agonist should be observed for signs and symptoms of heart failure.

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 NOVOLOG, and a PPAR-gamma agonist should be observed for signs and symptoms of heart failure. If heart failure develops, it should be managed according to current standards of care, and discontinuation or dose reduction of the PPAR-gamma agonist must be considered.

Use with antidiabetic agents, ACE inhibitors, angiotensin II receptor blocking agents, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, pramlintide, propoxyphene, salicylates, somatostatin analog (e.g., octreotide), and sulfonamide antibiotics, may increase the risk of hypoglycemia.

Use with 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, may decrease the blood glucose lowering effect of NOVOLOG.

Use with alcohol, beta-blockers, clonidine, and lithium salts, may increase or decrease the blood glucose lowering effect of NOVOLOG.

Use with Pentamidine may cause hypoglycemia, which may sometimes be followed by hyperglycemia. Pentamidine may cause hypoglycemia, which may sometimes be followed by hyperglycemia.

Available information from published randomized controlled trials with insulin aspart use during the second trimester of pregnancy have not reported an association with insulin aspart and major birth defects or adverse maternal or fetal outcomes.

There are no data on the presence of NOVOLOG 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

• Gestational diabetes. GoToSource

• Use in patients with type 1 diabetes under the age of 6. GoToSource 

• Use in patients with type 2 diabetes under the age of 18. GoToSource

Hypersensitivity reactions. GoToSource

Edema (swelling) and acute neuropathy (nerve damage). GoToSource

Increased cross-reactive insulin antibodies. GoToSource

Weight gain. GoToSource

Hypoglycemia (low blood sugar). GoToSource

No major injury lawsuits reported.