Apidra Penfill100IU/ml

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

• Type 1 diabetes mellitus: Established, FDA-approved use as mealtime (bolus) insulin, given in combination with a longer-acting or intermediate-acting (basal) insulin as part of a basal-bolus regimen.
• Type 2 diabetes mellitus: Established, FDA-approved use as mealtime insulin, either alone or in combination with oral antidiabetic medicines or basal insulin, when diet, exercise, and other agents do not achieve adequate glycemic control.
• Continuous subcutaneous insulin infusion (insulin pump): Approved for use in external insulin pumps in adults as an alternative to multiple daily injections.

Apidra Penfill is not a substitute for basal insulin and must be used as part of a complete diabetes management plan individualized by a physician based on blood glucose monitoring.

Each mL of Insulin Glulisine injection contains 100 units (3.49 mg) of insulin glulisine, a recombinant human insulin analog produced by DNA technology in a non-pathogenic strain of Escherichia coli.

Apidra Penfill is a rapid-acting, recombinant human insulin analog created by substituting asparagine at position B3 with lysine and lysine at position B29 with glutamic acid in the human insulin molecule. This modification reduces self-association of insulin molecules, allowing faster absorption from subcutaneous tissue compared with regular human insulin.

It is supplied as a clear, colorless, sterile aqueous solution for subcutaneous injection or use in an external insulin pump, and may be administered intravenously under close medical supervision in a healthcare setting.

Apidra Penfill belongs to the therapeutic class of rapid-acting insulin analogs, a subclass of antidiabetic agents used for mealtime (prandial/bolus) glycemic control.

Insulin Glulisine lowers blood glucose by binding to the insulin receptor on peripheral tissues, stimulating glucose uptake by skeletal muscle and adipose tissue, and inhibiting hepatic glucose output. It also inhibits lipolysis and proteolysis while enhancing protein synthesis.

Onset and Duration

Due to two amino acid substitutions in the insulin molecule, Insulin Glulisine has reduced self-association, giving it a faster onset and shorter duration of action than regular human insulin.

Apidra Penfill should be administered by subcutaneous injection into the abdominal wall, thigh, or upper arm, or by continuous subcutaneous infusion via an insulin pump. Injection sites should be rotated to reduce the risk of lipodystrophy.

• Inject within 15 minutes before or shortly (within 20 minutes) after starting a meal because of its rapid onset of action.
• Do not administer intravenously except under direct medical supervision with appropriate glucose monitoring.
• If mixing with NPH insulin for subcutaneous injection is specifically directed by the prescriber, draw Apidra Penfill into the syringe first and inject the mixture immediately after mixing.
• Do not mix Apidra Penfill with other insulins when used in an insulin pump or when given intravenously.
• Visually inspect the solution before use; it should be clear and colorless. Do not use if particulate matter or discoloration is seen.

Several medicines can alter the blood-glucose-lowering effect of Apidra Penfill, increasing the risk of hypoglycemia or hyperglycemia.

Medicines That May Increase Hypoglycemia Risk

Oral antidiabetic agents, ACE inhibitors, angiotensin II receptor blockers, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, propoxyphene, salicylates, somatostatin analogs (e.g., octreotide), and sulfonamide antibiotics may enhance the glucose-lowering effect of Apidra Penfill.

Medicines That May Decrease Effectiveness

Corticosteroids, danazol, diuretics, sympathomimetic agents, isoniazid, niacin, oral contraceptives, phenothiazines, atypical antipsychotics, protease inhibitors, somatropin, and thyroid hormones may reduce the blood-glucose-lowering effect of Apidra Penfill.

Masking of Hypoglycemia Symptoms

Beta-blockers, clonidine, and reserpine may blunt the warning signs of hypoglycemia during treatment with Apidra Penfill.

Alcohol may potentiate or prolong the hypoglycemic effect of Apidra Penfill. Always inform your physician of all medicines and supplements being used.

The most common and most serious adverse effect of Apidra Penfill is hypoglycemia, which can be severe and, in rare cases, life-threatening.

Common Side Effects

• Hypoglycemia (low blood sugar): sweating, shakiness, palpitations, hunger, confusion, headache
• Injection-site reactions: redness, swelling, itching, or pain
• Lipodystrophy (thickening or pitting of fat tissue) with repeated injection at the same site
• Weight gain
• Peripheral edema, particularly when starting insulin therapy or intensifying control

Less Common but Serious

• Hypersensitivity/allergic reactions, including rare systemic reactions such as generalized rash, angioedema, bronchospasm, hypotension, or shock
• Hypokalemia (low blood potassium)

See Precautions and Warnings and Overdose Effects for more on managing hypoglycemia related to Apidra Penfill.

Apidra Penfill should be used during pregnancy only if clearly needed, with the potential benefit justifying the potential risk to the fetus; a physician should be consulted before use. Good glycemic control before and during pregnancy is important for both mother and baby, and insulin requirements often change during pregnancy and the postpartum period, requiring closer monitoring and dose adjustment.

It is not known whether Apidra Penfill is excreted in human milk in clinically significant amounts; however, insulin is generally considered compatible with breastfeeding when medically indicated. Breastfeeding mothers using Apidra Penfill may need adjustments in insulin dose and diet, and should do so under medical supervision.

Hypoglycemia is the most common and most serious risk with Apidra Penfill and can occur with dose errors, delayed or missed meals, unplanned exercise, alcohol use, or changes in insulin sensitivity. Patients should be trained to recognize and manage hypoglycemia.

Key Precautions

• Never share an Apidra Penfill pen or syringe between patients, even if the needle is changed.
• Because of its rapid onset, inject Apidra Penfill close to a meal (within 15 minutes before or shortly after starting to eat); do not inject and then delay eating.
• Do not mix Apidra Penfill with other insulins in an insulin pump reservoir or for intravenous administration.
• If mixing with NPH insulin in the same syringe for injection is specifically directed by the prescriber, draw up Apidra Penfill first and inject the mixture immediately.
• Any change of insulin brand, type, or strength should be made only under medical supervision.
• Concurrent illness, changes in diet, renal or hepatic impairment, and certain medicines can alter insulin requirements - see Interaction and Use in Special Populations.
• Thiazolidinediones used together with insulin, including Apidra Penfill, may increase the risk of fluid retention and heart failure, particularly in patients with pre-existing cardiac disease.

Overdose of Apidra Penfill can cause severe hypoglycemia, which may present as confusion, seizures, loss of consciousness, or, in rare cases, be life-threatening.

• Mild hypoglycemia can often be treated promptly with oral glucose or a sugar-containing food or drink.
• Severe hypoglycemia with unconsciousness or inability to swallow requires immediate medical attention - contact emergency services or a poison control center right away; glucagon injection or intravenous glucose administered by a trained caregiver or healthcare professional may be needed.
• Severe or prolonged hypoglycemic episodes may also require monitoring of blood potassium levels.

Do not attempt to manage a severe overdose of Apidra Penfill at home without professional guidance.

Unopened Apidra Penfill vials, cartridges, or pens should be stored in a refrigerator (2°C to 8°C); do not freeze, and discard if it has been frozen.

Once in use, Apidra Penfill may be kept at room temperature (below 25-30°C, as specified on the product label) away from direct heat and light, and should be discarded after the period stated on the package (commonly 28 days), even if some solution remains. Keep out of reach of children.

Pediatric Use

Apidra Penfill safety and efficacy for subcutaneous injection have been established in pediatric patients aged 4 years and older with diabetes mellitus. Use in an insulin pump has not been established in pediatric patients. See Pediatric Uses for details.

Elderly

Limited data are available in patients over 65 years of age. Insulin requirements may be lower in elderly patients due to reduced renal function; dosing of Apidra Penfill should be conservative, with careful monitoring for hypoglycemia.

Renal Impairment

Insulin clearance may be reduced in renal impairment, potentially decreasing insulin requirements for Apidra Penfill; closer blood glucose monitoring and dose adjustment are recommended.

Hepatic Impairment

Insulin requirements may be reduced in hepatic impairment because of decreased capacity for gluconeogenesis and insulin metabolism; monitor blood glucose closely and adjust the Apidra Penfill dose as needed.

Apidra Penfill is typically used long-term/lifelong as part of ongoing diabetes management, since diabetes mellitus is a chronic condition. Duration and regimen are determined by the treating physician based on glycemic control, and treatment should not be stopped without medical advice.

Insulin Glulisine is classified as a rapid-acting insulin analog, within the broader drug class of insulins and antidiabetic agents.

Insulin Glulisine works by binding to insulin receptors on target cells, activating downstream signaling that promotes glucose uptake into skeletal muscle and fat cells and suppresses hepatic glucose production. Two amino acid modifications compared with human insulin (replacement of asparagine with lysine at position B3, and lysine with glutamic acid at position B29) reduce molecular self-association, allowing faster absorption from subcutaneous tissue and a more rapid onset of glucose-lowering action than regular human insulin.

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The safety and efficacy of Apidra Penfill given by subcutaneous injection have been established in pediatric patients 4 years of age and older with diabetes mellitus, with a similar safety and effectiveness profile to that seen in adults.

• Safety and efficacy of Apidra Penfill in children younger than 4 years have not been established.
• Use of Apidra Penfill in an external insulin pump has not been established in pediatric patients of any age.
• Dosing must be individualized by a pediatric specialist based on body weight, meal patterns, and blood glucose monitoring; children may be more susceptible to hypoglycemia and require close supervision by caregivers.