Insulin

Humulin R Kwikpen

Approved 28 Oct 1982SubcutaneousSolution

Indications

HUMULIN R is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. HUMULIN ® R is a short-acting human insulin indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. ( 1 )

Contraindications

HUMULIN R is contraindicated: during episodes of hypoglycemia [see Warnings and Precautions ( 5.3 )] in patients with hypersensitivity to HUMULIN R or any of its excipients [see Warnings and Precautions ( 5.5 )] Do not use during episodes of hypoglycemia. ( 4 ) Do not use in patients with hypersensitivity to HUMULIN R or any of its excipients. ( 4 )

Warnings and precautions

Never share needles or syringes with another person. ( 5.1 ) Hyperglycemia or Hypoglycemia with Changes in Insulin Regimen: Make changes to a patient's insulin regimen (e.g., insulin strength, manufacturer, type, injection site or method of administration) under close medical supervision with increased frequency of blood glucose monitoring. ( 5.2 ) Hypoglycemia: May be life-threatening. Increase frequency of blood glucose monitoring with changes to: insulin dosage, co-administered glucose lowering medications, meal pattern, physical activity; in patients with renal or hepatic impairment or with hypoglycemia unawareness.

( 5.3 ) Hypoglycemia Due to Medication Errors: Accidental mix-ups between insulin products can occur. Instruct patients to check insulin labels before injection. ( 5.4 ) Hypersensitivity Reactions : Severe, life-threatening, generalized allergy, including anaphylaxis, can occur. Discontinue HUMULIN R, monitor, and treat if indicated. ( 5.5 ) Hypokalemia: May be life-threatening. Monitor potassium levels in patients at risk for hypokalemia and treat if indicated.

( 5.6 ) Fluid Retention and Heart Failure with Concomitant Use of Thiazolidinediones (TZDs) : Observe for signs and symptoms of heart failure; consider dosage reduction or discontinuation if heart failure occurs. ( 5.7 )

5.1 Never Share Needles or Syringes between Patients Patients using HUMULIN R vials must never share needles or syringes with another person. Sharing poses a risk for transmission of blood-borne pathogens.

Adverse reactions

The following adverse reactions are also discussed elsewhere in the labeling: Hypoglycemia [see Warnings and Precautions ( 5.3 )] Hypoglycemia Due to Medication Errors [see Warnings and Precautions ( 5.4 )] Hypersensitivity [see Warnings and Precautions ( 5.5 )] Hypokalemia [see Warnings and Precautions ( 5.6 )] Adverse reactions observed with HUMULIN R 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 additional adverse reactions have been identified during clinical studies or from postmarketing reports with use of HUMULIN R. 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 to 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 allergic reactions may include anaphylaxis, generalized skin reactions, rash, angioedema, bronchospasm, hypotension, and shock.

Hypoglycemia Hypoglycemia is the most commonly observed adverse reaction in HUMULIN R. Hypokalemia HUMULIN R can cause a shift in potassium from the extracellular to intracellular space, possibly leading to hypokalemia. Injection Site Reactions Injection site reactions may include injection site hematoma, pain, hemorrhage, erythema, nodules, swelling, discoloration, pruritus, warmth, and injection site mass. Lipodystrophy Administration of insulin subcutaneously, including HUMULIN R, has resulted in lipoatrophy (depression in the skin) or lipohypertrophy (enlargement or thickening of tissue) in some patients [see Dosage and Administration ( 2.2 )] .

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 HUMULIN R have been identified during postapproval use.

Peripheral Edema Insulins, including HUMULIN R, 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 HUMULIN R, and has been attributed to the anabolic effects of insulin. Immunogenicity As with all therapeutic proteins, insulin administration may cause anti-insulin antibodies to form.

The incidence of antibody formation with HUMULIN R is unknown.

Humulin R Kwikpen

Indications

Contraindications

Warnings and precautions

Two medicines in one question?

5.3Hypoglycemia

5.4Hypoglycemia Due to Medication Errors

5.5Hypersensitivity Reactions

5.6Hypokalemia

5.7Fluid Retention and Heart Failure with Concomitant Use of PPAR-gamma Agonists Thiazolidinediones

Interactions

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

Adverse reactions

Composition

Official product information

At a glance

Guidelines