Apidra SoloStar SC Injection

Apidra SoloStar is a rapid-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.

Regulation of glucose metabolism is the primary activity of insulins and insulin analogs, including insulin glulisine. Insulins lower blood glucose by stimulating peripheral glucose uptake by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulins inhibit lipolysis and proteolysis and enhance protein synthesis.

Individualize and adjust the dosage of insulin glulisine based on the route of administration, individual's metabolic needs, blood glucose monitoring results, and glycemic control goal.

Dosage adjustments may be needed when switching from another insulin, with changes in physical activity, changes in concomitant medications, changes in meal patterns, changes in renal or hepatic function or during acute illness.

Subcutaneous Injection:

• Inject within 15 minutes before a meal or within 20 minutes after starting a meal into the abdomen, thigh, or upper arm.
• Rotate injection sites within the same region to reduce the risk of lipodystrophy and localized cutaneous amyloidosis.
• Should generally be used in regimens with intermediate or long-acting insulin.

Continuous Subcutaneous Infusion (Insulin Pump):

• Administer by continuous subcutaneous infusion using an insulin pump in a region recommended in the instructions from the pump manufacturer.
• Rotate infusion sites within the same region to reduce the risk of lipodystrophy and localized cutaneous amyloidosis.
• Do not dilute or mix insulins in external insulin pumps.

Intravenous Administration: Administer only under medical supervision after diluting to concentrations from 0.05 to 1 unit/mL insulin glulisine in 0.9% sodium chloride injection, USP using polyvinyl chloride infusion bags.

Drugs that Increase Hypoglycemia Risk or Increase or Decrease Blood Glucose Lowering Effect: Adjustment of dosage may be needed; closely monitor blood glucose.

Drugs that Blunt Hypoglycemia Signs and Symptoms (e.g., beta-blockers, clonidine, guanethidine, and reserpine): Increased frequency of glucose monitoring may be required.

• Do not use during episodes of hypoglycemia.
• Do not use in patients with hypersensitivity to insulin glulisine or any of its excipients.

Adverse reactions commonly associated with APIDRA include hypoglycemia, allergic reactions, injection site= reactions, lipodystrophy, pruritus, rash, and weight gain.

Pregnancy Category C. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks

Nursing mothers: It is unknown whether insulin glulisine is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Insulin Glulisine is administered to a nursing woman. Use of Insulin Glulisine is compatible with breastfeeding, but women with diabetes who are lactating may require adjustments of their insulin doses.

Never share an Apidra SoloStar injection pen between patients, even if the needle is changed.

Hyperglycemia or Hypoglycemia with Changes in Apidra SoloStar 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.

Hypoglycemia: May be life-threatening. Increase frequency of glucose monitoring with changes to: insulin dosage, coadministered glucose lowering medications, meal pattern, physical activity; and in patients with renal impairment or hepatic impairment or hypoglycemia unawareness.

Hypoglycemia Due to Medication Errors: Accidental mix-ups between insulin products can occur. Instruct patients to check insulin labels before injection.

Hypokalemia: May be life-threatening. Monitor potassium levels in patients at risk for hypokalemia and treat if indicated.

Hypersensitivity and Allergic Reactions: Severe, life-threatening, generalized allergy, including anaphylaxis, can occur. Discontinue Apidra SoloStar, monitor and treat if indicated.

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

Hyperglycemia and Ketoacidosis Due to Apidra SoloStar Pump Device Malfunction: Monitor glucose and administer Apidra SoloStar by subcutaneous injection if pump malfunction occurs.

Pediatric use: The safety and effectiveness of subcutaneous injections of Apidra SoloStar have been established in pediatric patients (age 4 to 17 years) with type 1 diabetes. Apidra SoloStar has not been studied in pediatric patients with type 1 diabetes younger than 4 years of age and in pediatric patients with type 2 diabetes. As in adults, the dosage of Apidra SoloStar must be individualized in pediatric patients based on metabolic needs and frequent monitoring of blood glucose

Geriatric use: In clinical trials (n=2408), Apidra SoloStar was administered to 147 patients ≥65 years of age and 27 patients ≥75 years of age. The majority of this small subset of elderly patients had type 2 diabetes. The change in HbA1c values and hypoglycemia frequencies did not differ by age. Nevertheless, caution should be exercised when Apidra SoloStar is administered to geriatric patients.

Renal impairment: Dose reduction may be needed.

Hepatic impairment: Dose reduction may be needed.

Excess insulin may cause hypoglycemia and, particularly when given intravenously, hypokalemia. Mild episodes of hypoglycemia usually can be treated with oral glucose. Adjustments in drug dosage, meal patterns, or exercise may be needed. More severe episodes of hypoglycemia with coma, seizure, or neurologic impairment may be treated with intramuscular/subcutaneous glucagon or concentrated intravenous glucose. Sustained carbohydrate intake and observation may be necessary because hypoglycemia may recur after apparent clinical recovery. Hypokalemia must be corrected appropriately.

Rapid Acting Insulin

Unopened Apidra SoloStar vials and cartridge systems should be stored in a refrigerator 2°C-8°C. Protect from light. Apidra SoloStar should not be stored in the freezer and it should not be allowed to freeze. Discard if it has been frozen. Unopened vials/cartridge systems not stored in a refrigerator must be used within 28 days.

Opened vials, whether or not refrigerated, must be used within 28 days. If refrigeration is not possible, the open vial in use can be kept unrefrigerated for up to 28 days away from direct heat and light, as long as the temperature is not greater than 25°C.