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Clinical Trial Experience

Because clinical trials are conducted under widely varying designs, the adverse reaction rates reported in one clinical trial may not be easily compared to those rates reported in another clinical trial, and may not reflect the rates actually observed in clinical practice.

• Hypoglycemia
  Hypoglycemia is the most commonly observed adverse reaction in patients using insulin, including NovoLog [see WARNINGS AND PRECAUTIONS].
• Insulin initiation and glucose control intensification
  Intensification or rapid improvement in glucose control has been associated with a transitory, reversible ophthalmologic refraction disorder, worsening of diabetic retinopathy, and acute painful peripheral neuropathy. However, long-term glycemic control decreases the risk of diabetic retinopathy and neuropathy.
• Lipodystrophy
  Long-term use of insulin, including NovoLog (insulin aspart [rdna origin] inj) , can cause lipodystrophy at the site of repeated insulin injections or infusion. Lipodystrophy includes lipohypertrophy (thickening of adipose tissue) and lipoatrophy (thinning of adipose tissue), and may affect insulin absorption. Rotate insulin injection or infusion sites within the same region to reduce the risk of lipodystrophy.
• Weight gain
  Weight gain can occur with some insulin therapies, including NovoLog (insulin aspart [rdna origin] inj) , and has been attributed to the anabolic effects of insulin and the decrease in glucosuria.
• Peripheral Edema
  Insulin may cause sodium retention and edema, particularly if previously poor metabolic control is improved by intensified insulin therapy.
• Frequencies of adverse drug reactions
  The frequencies of adverse drug reactions during NovoLog (insulin aspart [rdna origin] inj) clinical trials in patients with type 1 diabetes mellitus and type 2 diabetes mellitus are listed in the tables below.

Table 1: Treatment-Emergent Adverse Events in Patients with Type 1 Diabetes Mellitus (Adverse events with frequency ≥ 5% and occurring more frequently with NovoLog (insulin aspart [rdna origin] inj) compared to human regular insulin are listed)

Table 2: Treatment-Emergent Adverse Events in Patients with Type 2 Diabetes Mellitus (except for hypoglycemia, adverse events with frequency ≥ 5% and occurring more frequently with NovoLog (insulin aspart [rdna origin] inj) compared to human regular insulin are listed)

Postmarketing Data

The following additional adverse reactions have been identified during postapproval use of NovoLog (insulin aspart [rdna origin] inj) . Because these adverse reactions are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency. Medication errors in which other insulins have been accidentally substituted for NovoLog have been identified during postapproval use [see Patient Counseling Information].

A number of substances affect glucose metabolism and may require insulin dose adjustment and particularly close monitoring.

• The following are examples of substances that may increase the blood-glucoselowering effect and susceptibility to hypoglycemia: oral antidiabetic products, pramlintide, ACE inhibitors, disopyramide, fibrates, fluoxetine, monoamine oxidase (MAO) inhibitors, propoxyphene, salicylates, somatostatin analog (e.g., octreotide), sulfonamide antibiotics.
• The following are examples of substances that may reduce the blood-glucoselowering effect: corticosteroids, niacin, danazol, diuretics, sympathomimetic agents (e.g., epinephrine, salbutamol, terbutaline), isoniazid, phenothiazine derivatives, somatropin, thyroid hormones, estrogens, progestogens (e.g., in oral contraceptives), atypical antipsychotics.
• Beta-blockers, clonidine, lithium salts, and alcohol may either potentiate or weaken the blood-glucose-lowering effect of insulin.
• Pentamidine may cause hypoglycemia, which may sometimes be followed by hyperglycemia.
• The signs of hypoglycemia may be reduced or absent in patients taking sympatholytic products such as beta-blockers, clonidine, guanethidine, and reserpine.

Last reviewed on RxList: 7/28/2009
This monograph has been modified to include the generic and brand name in many instances.