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Important Safety Information for Lyumjev

Contraindications
Lyumjev is contraindicated during episodes of hypoglycemia and in patients with hypersensitivity to insulin lispro-aabc or one of the excipients in Lyumjev.

Warnings and Precautions
Never Share a Lyumjev Prefilled Pen, Cartridge, or Syringe Between Patients, even if the needle is changed. Patients using Lyumjev 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, may lead to unconsciousness, and can cause seizures or death. Hypoglycemia is the most common adverse reaction of Lyumjev. 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. Lyumjev U-200 should not be transferred from the Lyumjev KwikPen® to a syringe as overdose and severe hypoglycemia can occur.

Hypokalemia: Hypokalemia may be life threatening. Insulins, including Lyumjev, 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).

Hypersensitivity Reactions: Severe, life-threatening, generalized allergy, including anaphylaxis, can occur with Lyumjev. If hypersensitivity reactions occur, discontinue the use of insulin and treat per standard of care until signs and symptoms resolve.

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 Lyumjev. 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.

Adverse Reactions
Adverse reactions associated with Lyumjev include hypoglycemia, hypokalemia, allergic reactions, injection-site reactions, lipodystrophy, localized cutaneous amyloidosis, 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 click to access Lyumjev Full Prescribing Information including Lyumjev Patient Prescribing Information.

Please click to access Lyumjev U-100 KwikPen Instructions for Use, Lyumjev U-100 vial Instructions for Use, and Lyumjev U-200 KwikPen Instructions for Use.

UR HCP ISI 15JUN2020