Apidra SoloStar SC Injection

Insulin Glulisine is indicated to improve glycemic control in adults and children 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. The glucose lowering activities of Insulin Glulisine and of regular human insulin are equipotent when administered by the intravenous route. After subcutaneous administration, the effect of Insulin Glulisine is more rapid in onset and of shorter duration compared to regular human insulin.

Insulin Glulisine is a recombinant insulin analog that is equipotent to human insulin (i.e. one unit of Insulin Glulisine has the same glucose lowering effect as one unit of regular human insulin) when given intravenously. When given subcutaneously, Insulin Glulisine has a more rapid onset of action and a shorter duration of action than regular human insulin.

The dosage of Insulin Glulisine must be individualized. Blood glucose monitoring is essential in all patients receiving insulin therapy. The total daily insulin requirement may vary and is usually between 0.5 to 1 Unit/kg/day. Insulin requirements may be altered during stress, major illness, or with changes in exercise, meal patterns, or coadministered drugs.

Subcutaneous administration: Insulin Glulisine should be given within 15 minutes before a meal or within 20 minutes after starting a meal. Insulin Glulisine given by subcutaneous injection should generally be used in regimens with an intermediate or long acting insulin. Insulin Glulisine 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 lipodystrophy

Continuous subcutaneous infusion (insulin pump): Insulin Glulisine 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: Insulin Glulisine 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, Insulin Glulisine should be used at concentrations of 0.05 Units/mL to 1 Unit/mL insulin glulisine in infusion systems using polyvinyl chloride (PVC) bags. Insulin Glulisine 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.

Possible absence of hypoglycaemic warning symptoms with beta-blockers. Decreased hypoglycaemic effect with corticosteroids, danazol, diazoxide, diuretics, glucagon, isoniazid, phenothiazine derivatives, somatropin, sympathomimetic agents, thyroid hormones, oestrogens, progestins (e.g. in oral contraceptives), protease inhibitors and atypical antipsychotics (e.g. olanzapine and clozapine). Increased hypoglycaemic effect with oral antidiabetic agents, ACE inhibitors, disopyramide, fibrates, fluoxetine, MAOIs, pentoxifylline, propoxyphene, salicylates and sulfonamide antibiotics. Decreased insulin resistance with octreotide and lanreotide. Increased risk of wt gain and peripheral oedema with pioglitazone, rosiglitazone. Decreased effect of sermorelin.

Insulin Glulisine is contraindicated during episodes of hypoglycemia, in patients who are hypersensitive to Insulin Glulisine or to any of its excipients.

When used in patients with known hypersensitivity to Insulin Glulisine or its excipients, patients may develop localized or generalized hypersensitivity reactions

Some times severe, life-threatening allergic reactions can happen with insulin. If you think you are having a severe allergic reaction, get medical help right away. Signs of insulin allergy include:

• rash all over your body
• shortness of breath
• wheezing (trouble breathing)
• fast pulse
• sweating
• low blood pressure

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 breast feeding, but women with diabetes who are lactating may require adjustments of their insulin doses.

Renal or hepatic impairment. Regular monitoring of blood glucose and HbA1c. Rotate Inj sites to reduce lipodystrophy . Pregnancy, lactation.

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

Pediatric use: The safety and effectiveness of subcutaneous injections of Insulin Glulisine have been established in pediatric patients (age 4 to 17 years) with type 1 diabetes. Insulin Glulisine 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 Insulin Glulisine must be individualized in pediatric patients based on metabolic needs and frequent monitoring of blood glucose

Geriatric use: In clinical trials (n=2408), Insulin Glulisine 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 Insulin Glulisine is administered to geriatric patients.

Renal impairment: Dose reduction may be needed

Hepatic impairment: Dose reduction may be needed

Unopened Insulin Glulisine vials and cartridge systems should be stored in a refrigerator 2°C-8°C. Protect from light. Insulin Glulisine 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.