Device Options
Humalog® KwikPen®
- Humalog KwikPen is a small, lightweight, prefilled insulin pen for patients with type 2 or type 1 diabetes who want a portable device. Humalog KwikPen must be stored outside the refrigerator after the first use and taken just about anywhere. Patients can carry it in their purse, backpack, or pocket because it's the size of a marker.*
- Unopened Humalog should be stored in a refrigerator at 36°F to 46°F (2°C to 8°C) and can be used until the expiration date on the carton or label.
- In-use Humalog KwikPen should be stored at room temperature, below 86°F (30°C) and must be used within 28 days or be discarded, even if it still contains Humalog.
*Store at room temperature below 86 degrees F.
Select Important Safety Information
Never share a Humalog or Insulin Lispro Injection prefilled pen, cartridge, reusable pen compatible with Lilly 3 mL cartridges, or syringe between patients as it poses a risk for transmission of bloodborne pathogens.
Instruct patients to always check the insulin label before each injection to avoid medication errors. Do NOT transfer Humalog U-200 from the Humalog KwikPen to a syringe as overdose and severe hypoglycemia can occur.
Humalog® Junior KwikPen®
- Humalog Junior KwikPen is an insulin pen that offers the combined benefits of a rapid acting insulin in a prefilled disposable pen and half-unit dosing.
- In-use Humalog KwikPen should be stored at room temperature, below 86ºF (30ºC) and must be used within 28 days or be discarded, even if it still contains Humalog.
Use of Humalog U-100 in an Insulin Pump
For some people, an insulin pump can help improve diabetes management and make it more flexible. A pump may be a good option for someone who:
- Regularly tests their blood sugar
- Is active and has an inconsistent meal and physical activity schedule
- Has demonstrated the ability to manage his/her diabetes but doesn’t want to draw attention to it
Select Important Safety Information
Insulin pump or infusion set malfunction or degradation of the insulin in the pump reservoir can rapidly result in hyperglycemia and ketoacidosis. Patients should be instructed to carry alternate insulin therapy in case of pump failure.
Catheter occlusions and infusion-site reactions have been reported in patients receiving Humalog U-100 or Insulin Lispro Injection as a continuous subcutaneous infusion.
Humalog U-100 or Insulin Lispro Injection in an external insulin pump is approved for use in adults and children with diabetes mellitus. Humalog U-100 and Insulin Lispro Injection have not been studied in children with type 2 diabetes or in children with type 1 diabetes less than 3 years of age.
When used in a pump, do not mix Humalog U-100 with any other insulin or liquid. Do not use Humalog Mix75/25, Humalog Mix50/50, or Humalog U-200 in a pump.
Indication for Humalog Brand of Insulins and Lilly's Non-Branded Insulin Lispro Products
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.
Important Safety Information for Humalog Brand of Insulins and Lilly’s Non-Branded Insulin Lispro Products
Contraindications
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.
Warnings and Precautions
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
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.
Drug Interactions
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