HUMALOG 75-25 SIDE EFFECTS

SIDE EFFECTS

The following adverse reactions are discussed elsewhere in the labeling:

• Hypoglycemia
• Medication Errors
• Hypersensitivity Reactions
• Hypokalemia

Adverse Reactions From Clinical Studies Or Postmarketing Reports

The following adverse reactions have been identified during post-marketing use of HUMALOG Mix75/25. Because some of these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Adverse Reactions Associated With 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. Over the long-term, improved glycemic control decreases the risk of diabetic retinopathy and neuropathy.

Hypersensitivity Reactions

Severe, life-threatening, generalized allergy, including anaphylaxis.

Hypoglycemia

Hypoglycemia is the most commonly observed adverse reaction in HUMALOG Mix75/25.

Hypokalemia

HUMALOG Mix75/25 can cause a shift in potassium from the extracellular to intracellular space, possibly leading to hypokalemia.

Injection Site Reactions

HUMALOG Mix75/25 can cause local injection site reactions including redness, swelling, or itching at the site of injection. These reactions usually resolve in a few days to a few weeks, but in some occasions, may require discontinuation. Localized reactions and generalized myalgias have been reported with the use of meta-cresol, which is an excipient in HUMALOG Mix75/25.

Lipodystrophy

Administration of insulin subcutaneously, including HUMALOG Mix75/25, has resulted in lipoatrophy (depression in the skin) or lipohypertrophy (enlargement or thickening of tissue)  in some patients.

Medication Errors

Medication errors in which other insulins have been accidentally substituted for HUMALOG Mix75/25 have been identified during postapproval use.

Peripheral Edema

Insulin, including HUMALOG Mix75/25, may cause sodium retention and edema, particularly if previously poor metabolic control is improved by intensified insulin therapy.

Weight Gain

Weight gain can occur with insulin therapy, including HUMALOG Mix75/25, and has been attributed to the anabolic effects of insulin and the decrease in glycosuria.

Immunogenicity

As with all therapeutic peptides, insulin administration may cause anti-insulin antibodies to form. The incidence of antibody formation with HUMALOG Mix75/25 is unknown.

SRC: NLM .