Glarine Cartridge^®

Glarine^® is a preparation of Insulin Glargine. Insulin Glargine is a recombinant human insulin analog that is a long acting, parenteral blood glucose lowering agent. The primary activity of insulin, including Insulin Glargine, is regulation of glucose metabolism. Insulin and its analogs lower blood glucose by stimulating peripheral glucose uptake, especially by skeletal muscle and fat and by inhibiting hepatic glucose production. Insulin inhibits lipolysis and proteolysis and enhances protein synthesis.

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Glarine^® is indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus.

Instructions for patient
Before injecting this Insulin:

1. According to the instruction of Biopen flexi insulin device, insert the Glarine^® cartridge into the pen correctly, equip the needle and let the cartridge reach room temperature before using it.
2. Remove the needle cap and discharge air bubbles in the cartridge.
3. Adjust the dosage button to get correct dose and inject to the specific site.
4. In order to avoid cross contamination, do not let the needle touch anything during the process of preparation.

To be used only with Biopen flexi insulin device. For detail description, please see the Patient Instruction Leaflet provided with Biopen flexi insulin device. Administer Glarine^® subcutaneously once daily at any time of day but at the same time every day.

Dosage
Initiation of Glarine® therapy
Type 1 diabetes
In patients with type 1 diabetes, Glarine^® must be used concomitantly with short acting insulin. The recommended starting dose of Glarine^® in patients with type 1 diabetes should be approximately one-third of the total daily insulin requirements. Short acting, pre-meal insulin should be used to satisfy the remainder of the daily insulin requirements. The dosage recommendation when changing to Glarine^® in pediatric patients (age 6 to 15 years) with type 1 diabetes is the same as for adults.
Type 2 diabetes
The recommended starting dose of Glarine^® in patients with type 2 diabetes who are not currently treated with insulin is 0.2 IU/kg or up to 10 IU once daily. One may need to adjust the amount and timing of short or rapid acting insulins and dosages of any oral antidiabetic drugs.

Changing to Glarine® from other insulin therapies

• If changing from a treatment regimen with an intermediate or long acting insulin to a regimen with Glarine®, a change in the dose of the basal insulin may be required and the amount and timing of the shorter acting insulins and doses of any oral antidiabetic drugs may need to be adjusted.
• If changing patients from once daily NPH insulin to once daily Glarine®, the recommended initial Glarine® dose is the same as the dose of NPH that is being discontinued.
• If changing patients from twice daily NPH insulin to once daily Glarine®, the recommended initial Glarine® dosage is 80% of the total NPH dose that is being discontinued. This dosage reduction will lower the likelihood of hypoglycemia.

Pregnancy: For insulin glargine no clinical data on exposed pregnancies from controlled clinical studies are available. The use of insulin glargine may be considered during pregnancy, if clinically needed.

Lactation: There are either no or only limited data on the presence of insulin glargine in human milk, the effects on breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for insulin glargine and any potential adverse effects on the breastfed child from insulin glargine or from the underlying maternal condition.

Use in children and adolescents
The safety and effectiveness of insulin glargine have been established in pediatric patients (age 6 to 15 years) with type 1 diabetes. The safety and effectiveness of insulin glargine in pediatric patients younger than 6 years of age with type 1 diabetes and pediatric patients with type 2 diabetes have not been established.

A Biopen should never be shared between patients, even if the needle is changed. If hyperglycemia or hypoglycemia occurs with changes in insulin regimen, changes need to be made 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. In patients at higher risk for hypoglycemia and patients who have reduced symptomatic awareness of hypoglycemia, increased frequency of blood glucose monitoring is recommended. Accidental mix-ups between insulin products can occur. Patients should be instructed to check insulin labels before injection. Severe, life-threatening, generalized allergy, including anaphylaxis, can occur. On that case, Insulin glargine should be discontinued. The patient should be monitored and treated if indicated. Hypokalemia may be life-threatening. Potassium level in patients at risk of hypokalemia should be monitored and treated if indicated. Fluid retention and heart failure may occur with concomitant use of thiazolidinediones (TZD). Patients should be observed for signs and symptoms of heart failure and dosage reduction or discontinuation be considered of TZD if heart failure occurs.

Most common side effects are hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, pruritus, rash, edema and weight gain.

Insulin glargine is contraindicated in patients with known hypersensitivity to insulin glargine or any other components of this product. It is also contraindicated during episodes of hypoglycemia.

Drug interaction with medication: A number of drugs can affect glucose metabolism and therefore may require dose adjustment.
Drugs that may Increase the risk of hypoglycemia: Antidiabetic agents, ACE inhibitors, angiotensin II receptor blocking agents, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, pramlintide, salicylates, somatostatin analogs (e.g., octreotide) and sulfonamide antibiotics. Dose reductions and increased frequency of glucose monitoring may be required when insulin glargine is co-administered with these drugs.

Drugs that may decrease the blood glucose lowering effect of insulin glargine: Atypical antipsychotics (e.g., olanzapine and clozapine), corticosteroids, danazol, diuretics, estrogens, glucagon, isoniazid, niacin, oral contraceptives, phenothiazines, progestogens, protease inhibitors, somatropin, sympathomimetic agents (e.g., albuterol, epinephrine, terbutaline) and thyroid hormones. Dose increases and increased frequency of glucose monitoring may be required when insulin glargine is co-administered with these drugs.

Drugs that may increase or decrease the blood glucose lowering effect of insulin glargine: Alcohol, beta-blockers, clonidine and lithium salts. Pentamidine may cause hypoglycemia, which may sometimes be followed by hyperglycemia. Dose adjustment and increased frequency of glucose monitoring may be required when insulin glargine is co-administered with these drugs.

Drugs that may blunt signs and symptoms of hypoglycemia: Beta-blockers, clonidine, guanethidine and reserpine. Increased frequency of glucose monitoring may be required when insulin glargine is co-administered with these drugs.

Drug Interaction with food and others: Not applicable.

Excess insulin administration may cause hypoglycemia and hypokalemia. Mild episodes of hypoglycemia can usually be treated with oral carbohydrates. 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. After apparent clinical recovery from hypoglycemia, continued observation and additional carbohydrate intake may be necessary to avoid recurrence of hypoglycemia. Hypokalemia must be corrected appropriately.

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Keep out of the reach and sight of children. Store at 2°C - 8°C in a refrigerator. Do not freeze. Do not mix with other insulin. Protect from light. After first use, the insulin should be kept under below 30°C for 28 days and consume within this time.

Glarine^® cartridge: 1 ml solution contains Insulin Glargine (rDNA) USP 100 IU.

Packing
Glarine^® cartridge: Each box contains 3 cartridges of 3 ml.