Patients can start and stay on Humalog U-200 KwikPen as their insulin needs increase^*

Humalog and Insulin Lispro Injection are rapid-acting insulin analogs indicated to improve glycemic control in adults and children with diabetes mellitus. Humalog Mix75/25 and Humalog Mix50/50, and Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25 are mixtures of intermediate-acting and rapid-acting insulin analogs indicated to improve glycemic control in patients with diabetes mellitus.

Limitations of Use: The proportions of rapid-acting and intermediate-acting insulins in Humalog Mix75/25 and Humalog Mix50/50, and Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25 are fixed and do not allow for basal versus prandial dose adjustments.

Humalog, Insulin Lispro Injection, Humalog Mix75/25, Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25, and Humalog Mix50/50 are contraindicated during episodes of hypoglycemia and in patients who are hypersensitive to these insulins or any of their excipients.

Never share a Humalog, Insulin Lispro Injection, Humalog Mix75/25, Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25, or Humalog Mix50/50 prefilled pen, cartridge, reusable pen compatible with Lilly 3 mL cartridges, or syringe between patients, even if the needle is changed. Patients using vials must never share needles or syringes with another person. Sharing poses a risk for transmission of blood-borne pathogens.

Hyperglycemia or Hypoglycemia with Changes in Insulin Regimen: Changes in insulin strength, manufacturer, type, injection site, or method of administration may affect glycemic control and predispose to hypoglycemia or hyperglycemia. Any changes in insulin regimen should be made cautiously under close medical supervision and the frequency of blood glucose monitoring should be increased. Due to reports of hyperglycemia and hypoglycemia, 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 blood glucose. For patients with type 2 diabetes, dosage adjustments of concomitant antidiabetic products may be needed.

Hypoglycemia: Severe hypoglycemia may be life threatening and can cause seizures or death. Hypoglycemia is the most common adverse reaction of Humalog, Insulin Lispro Injection, Humalog Mix75/25, Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25, and Humalog Mix50/50. Monitor blood glucose and increase monitoring frequency with changes to insulin dosage, use with glucose-lowering medications, meal pattern, physical activity; in patients with renal or hepatic impairment; and in patients with hypoglycemia unawareness.

Hypoglycemia Due to Medication Errors: Instruct patients to always check the insulin label before each injection to avoid medication errors. Humalog U-200 should not be transferred from the Humalog KwikPen to a syringe as overdose and severe hypoglycemia can occur.

Hypersensitivity Reactions: Severe, life-threatening, generalized allergy, including anaphylaxis, can occur with Humalog, Insulin Lispro Injection, Humalog Mix75/25, Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25, and Humalog Mix50/50. If hypersensitivity reactions occur, discontinue the use of insulin and treat per standard of care until signs and symptoms resolve.

Hypokalemia: Hypokalemia may be life threatening. Insulins, including Humalog, Insulin Lispro Injection, Humalog Mix75/25, Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25, and Humalog Mix50/50, cause a shift in potassium from the extracellular to intracellular space possibly leading to hypokalemia, which, if untreated, may result in respiratory paralysis, ventricular arrhythmia, and death. Monitor potassium levels in patients at risk for hypokalemia (e.g., patients using potassium-lowering medications or medications sensitive to serum potassium concentrations).

Fluid Retention and Heart Failure with Concomitant Use of PPAR-gamma Agonists: Thiazolidinediones (TZDs), which are PPAR-gamma agonists, can cause dose-related fluid retention, particularly when used in combination with insulin, including Humalog, Insulin Lispro Injection, Humalog Mix75/25, Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25, and Humalog Mix50/50. This may lead to or exacerbate heart failure. Observe patients for signs and symptoms of heart failure and consider discontinuation or dose reduction of the PPAR-gamma agonist.

Hyperglycemia and Ketoacidosis Due to Insulin Pump Device Malfunction: Malfunction of the insulin pump device, infusion set, or insulin degradation can rapidly lead to hyperglycemia and ketoacidosis. Patients using subcutaneous insulin infusion pumps must be trained to administer insulin by injection and have alternate insulin therapy available in case of pump failure.

Adverse reactions associated with Humalog, Insulin Lispro Injection, Humalog Mix75/25, Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25, and Humalog Mix50/50 include hypoglycemia, hypokalemia, allergic reactions, injection-site reactions, lipodystrophy, pruritus, rash, weight gain, and peripheral edema.

Some medications may alter glucose metabolism, insulin requirements, and the risk for hypoglycemia or hyperglycemia. Signs of hypoglycemia may be reduced or absent in patients taking anti-adrenergic drugs. Particularly close monitoring may be required.

Please see links to Full Prescribing Information, Patient Information and Instructions for Use at the bottom of the page for more information.

HI BOI SP U100 75/25 HCP ISI 10JAN2020