Humalog Mix50/50 KwikPen
Generic: INSULIN LISPRO
Basic Information
Manufacturer
Eli Lilly and Company
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
SUBCUTANEOUS
FDA Set ID
b34cd3ff-d0af-4852-b4ef-2a8b4a93aeae
Indications & Usage
1 INDICATIONS AND USAGE HUMALOG Mix50/50 is indicated to improve glycemic control in adults with diabetes mellitus.
HUMALOG ® Mix50/50™ is a mixture of insulin lispro protamine, an intermediate-acting human insulin analog, and insulin lispro, a rapid-acting human insulin analog, indicated to improve glycemic control in adults with diabetes mellitus.
( 1 ) Limitations of Use: The proportions of rapid-acting and intermediate-acting insulins are fixed and do not allow for basal versus prandial dose adjustments.
( 1 ) Limitations of Use The proportions of rapid-acting and intermediate-acting insulins in HUMALOG Mix50/50 are fixed and do not allow for basal versus prandial dose adjustments.
HUMALOG ® Mix50/50™ is a mixture of insulin lispro protamine, an intermediate-acting human insulin analog, and insulin lispro, a rapid-acting human insulin analog, indicated to improve glycemic control in adults with diabetes mellitus.
( 1 ) Limitations of Use: The proportions of rapid-acting and intermediate-acting insulins are fixed and do not allow for basal versus prandial dose adjustments.
( 1 ) Limitations of Use The proportions of rapid-acting and intermediate-acting insulins in HUMALOG Mix50/50 are fixed and do not allow for basal versus prandial dose adjustments.
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are discussed elsewhere in the labeling: Hypoglycemia [see Warnings and Precautions ( 5.3 )] Hypoglycemia Due to Medication Errors [see Warnings and Precautions ( 5.4 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.5 )] Hypokalemia [see Warnings and Precautions ( 5.6 )] Adverse reactions observed with HUMALOG Mix50/50 include hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, weight gain, edema, pruritus, and rash.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Adverse Reactions from Clinical Studies or Postmarketing Reports The following adverse reactions have been identified during post-marketing use of HUMALOG Mix50/50.
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 Mix50/50.
Hypokalemia HUMALOG Mix50/50 can cause a shift in potassium from the extracellular to intracellular space, possibly leading to hypokalemia.
Injection site reactions HUMALOG Mix50/50 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 Mix50/50.
Lipodystrophy Administration of insulin subcutaneously, including HUMALOG Mix50/50, has resulted in lipoatrophy (depression in the skin) or lipohypertrophy (enlargement or thickening of tissue) [see Dosage and Administration ( 2.1 )] in some patients.
Localized cutaneous amyloidosis Localized cutaneous amyloidosis at the injection site has occurred.
Hyperglycemia has been reported with repeated insulin injections into areas of localized cutaneous amyloidosis; hypoglycemia has been reported with a sudden change to an unaffected injection site.
Medication Errors Medication errors in which other insulins have been accidentally substituted for HUMALOG Mix50/50 have been identified during postapproval use.
Peripheral Edema Insulins, including HUMALOG Mix50/50, 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 insulins, including HUMALOG Mix50/50, and has been attributed to the anabolic effects of insulin and the decrease in glycosuria.
Immunogenicity As with all therapeutic proteins, insulin administration may cause anti-insulin antibodies to form.
The incidence of antibody formation with HUMALOG Mix50/50 is unknown.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Adverse Reactions from Clinical Studies or Postmarketing Reports The following adverse reactions have been identified during post-marketing use of HUMALOG Mix50/50.
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 Mix50/50.
Hypokalemia HUMALOG Mix50/50 can cause a shift in potassium from the extracellular to intracellular space, possibly leading to hypokalemia.
Injection site reactions HUMALOG Mix50/50 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 Mix50/50.
Lipodystrophy Administration of insulin subcutaneously, including HUMALOG Mix50/50, has resulted in lipoatrophy (depression in the skin) or lipohypertrophy (enlargement or thickening of tissue) [see Dosage and Administration ( 2.1 )] in some patients.
Localized cutaneous amyloidosis Localized cutaneous amyloidosis at the injection site has occurred.
Hyperglycemia has been reported with repeated insulin injections into areas of localized cutaneous amyloidosis; hypoglycemia has been reported with a sudden change to an unaffected injection site.
Medication Errors Medication errors in which other insulins have been accidentally substituted for HUMALOG Mix50/50 have been identified during postapproval use.
Peripheral Edema Insulins, including HUMALOG Mix50/50, 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 insulins, including HUMALOG Mix50/50, and has been attributed to the anabolic effects of insulin and the decrease in glycosuria.
Immunogenicity As with all therapeutic proteins, insulin administration may cause anti-insulin antibodies to form.
The incidence of antibody formation with HUMALOG Mix50/50 is unknown.