Apidra SoloStar100IU/ml

Apidra SoloStar 100IU/ml is a rapid-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.

Rapid Acting Insulin

Regulation of glucose metabolism is the primary activity of insulins and insulin analogs, including Apidra SoloStar 100IU/ml. 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. The glucose lowering activities of Apidra SoloStar 100IU/ml and of regular human insulin are equipotent when administered by the intravenous route. After subcutaneous administration, the effect of Apidra SoloStar 100IU/ml is more rapid in onset and of shorter duration compared to regular human insulin.

Individualize and adjust the dosage of Apidra SoloStar 100IU/ml 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 Apidra SoloStar 100IU/ml in 0.9% sodium chloride injection, USP using polyvinyl chloride infusion bags. 

Subcutaneous administration: Apidra SoloStar 100IU/ml should be given within 15 minutes before a meal or within 20 minutes after starting a meal. Apidra SoloStar 100IU/ml given by subcutaneous injection should generally be used in regimens with an intermediate or long acting insulin. Apidra SoloStar 100IU/ml should be administered by subcutaneous injection in the abdominal wall, thigh, or upper arm. Injection sites should be rotated within the same region (abdomen, thigh or upper arm) from one injection to the next to reduce the risk of lipodystrophyContinuous subcutaneous infusion (insulin pump): Apidra SoloStar 100IU/ml may be administered by continuous subcutaneous infusion in the abdominal wall. Do not use diluted or mixed insulins in external insulin pumps. Infusion sites should be rotated within the same region to reduce the risk of lipodystrophy. The initial programming of the external insulin infusion pump should be based on the total daily insulin dose of the previous regimen. Intravenous administration: Apidra SoloStar 100IU/ml can be administered intravenously under medical supervision for glycemic control with close monitoring of blood glucose and serum potassium to avoid hypoglycemia and hypokalemia. For intravenous use, Apidra SoloStar 100IU/ml should be used at concentrations of 0.05 Units/mL to 1 Unit/mL Apidra SoloStar 100IU/ml in infusion systems using polyvinyl chloride (PVC) bags. Apidra SoloStar 100IU/ml has been shown to be stable only in normal saline solution (0.9% sodium chloride). Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not administer insulin mixtures intravenously.

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 Apidra SoloStar 100IU/ml 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 risksNursing mothers: It is unknown whether Apidra SoloStar 100IU/ml is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Apidra SoloStar 100IU/ml is administered to a nursing woman. Use of Apidra SoloStar 100IU/ml is compatible with breast feeding, but women with diabetes who are lactating may require adjustments of their insulin doses.

Never share an Apidra SoloStar 100IU/ml injection pen between patients, even if the needle is changed.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.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 100IU/ml, 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 Insulin Pump Device Malfunction: Monitor glucose and administer Apidra SoloStar 100IU/ml by subcutaneous injection if pump malfunction occurs. 

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.

Unopened Apidra SoloStar 100IU/ml vials and cartridge systems should be stored in a refrigerator 2°C-8°C. Protect from light. Apidra SoloStar 100IU/ml 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.

Pediatric use: The safety and effectiveness of subcutaneous injections of Apidra SoloStar 100IU/ml have been established in pediatric patients (age 4 to 17 years) with type 1 diabetes. Apidra SoloStar 100IU/ml 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 100IU/ml must be individualized in pediatric patients based on metabolic needs and frequent monitoring of blood glucoseGeriatric use: In clinical trials (n=2408), Apidra SoloStar 100IU/ml 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 100IU/ml is administered to geriatric patients.Renal impairment: Dose reduction may be neededHepatic impairment: Dose reduction may be needed

Rapid Acting Insulin

Regulation of glucose metabolism is the primary activity of insulins and insulin analogs, including Apidra SoloStar 100IU/ml. 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.

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 risksNursing mothers: It is unknown whether Apidra SoloStar 100IU/ml is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Apidra SoloStar 100IU/ml is administered to a nursing woman. Use of Apidra SoloStar 100IU/ml is compatible with breastfeeding, but women with diabetes who are lactating may require adjustments of their insulin doses.

Pediatric use: The safety and effectiveness of subcutaneous injections of Apidra SoloStar 100IU/ml have been established in pediatric patients (age 4 to 17 years) with type 1 diabetes. Apidra SoloStar 100IU/ml 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 100IU/ml must be individualized in pediatric patients based on metabolic needs and frequent monitoring of blood glucoseGeriatric use: In clinical trials (n=2408), Apidra SoloStar 100IU/ml 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 100IU/ml is administered to geriatric patients.Renal impairment: Dose reduction may be needed.Hepatic impairment: Dose reduction may be needed.