Insulin Glulisine (rDNA origin) Injection

Insulin glulisine is a rapid-acting insulin analog approved to improve blood sugar control in people with diabetes mellitus.

• Apidra (subcutaneous injection): improves glycemic control in adults and pediatric patients (age 4 and older) with type 1 diabetes mellitus
• Apidra (subcutaneous injection): improves glycemic control in adults with type 2 diabetes mellitus
• Apidra (intravenous): used for glycemic control in clinical settings under direct medical supervision
• Apidra SoloStar (prefilled pen, subcutaneous injection): improves glycemic control in adults and pediatric patients with diabetes mellitus

Insulin glulisine works by mimicking the body's natural insulin. It signals muscle and fat cells to take up glucose from the bloodstream and tells the liver to produce less glucose. It also slows the breakdown of fat and protein and supports protein building. The net effect is a meaningful drop in blood sugar levels after meals.

Compared to regular human insulin, insulin glulisine is absorbed faster and clears the body more quickly, making it better suited for mealtime dosing — it can be given just before or shortly after eating rather than 30 minutes ahead.

Your dose of Apidra will be individualized by your prescriber based on your blood sugar readings, eating habits, activity level, and overall diabetes management goals. No single standard dose applies to everyone.

• Subcutaneous injection: given within 15 minutes before a meal or within 20 minutes after starting a meal
• Insulin pump (continuous subcutaneous infusion): delivered continuously; reservoir must be changed at least every 48 hours
• Intravenous: given only in a medical setting under supervision; requires dilution
• Apidra should generally be used alongside an intermediate- or long-acting insulin for full 24-hour coverage

Dose adjustments may be needed if your kidney or liver function changes, if you start or stop other medications, or if your activity level or meal patterns shift. Always follow your prescriber's instructions.

The most common side effect of Apidra, like all insulins, is low blood sugar (hypoglycemia).

Seek emergency care immediately for severe low blood sugar with loss of consciousness, or for signs of a serious allergic reaction such as difficulty breathing, swelling of the face or throat, or rapid heartbeat.

Low blood sugar (hypoglycemia) is the most serious risk. Severe episodes can cause seizures, unconsciousness, and death. The risk rises with missed meals, extra exercise, too-high a dose, kidney or liver disease, or taking other glucose-lowering medications. Older adults, children, and those with reduced awareness of low blood sugar need extra monitoring.

• Hypokalemia (low potassium): All insulins can shift potassium into cells, potentially causing dangerous drops in blood potassium — which can lead to abnormal heart rhythms or respiratory failure. Patients on potassium-affecting medications need close monitoring.
• Serious allergic reactions: Anaphylaxis can occur. Stop Apidra and seek emergency care if you have signs of a severe allergic reaction.
• Heart failure risk with TZD diabetes pills: Taking insulin together with thiazolidinediones (like pioglitazone) can cause fluid retention and worsen or trigger heart failure.
• Insulin pump failure: A blocked or malfunctioning pump can cause rapid-onset high blood sugar and diabetic ketoacidosis. Always have a backup injection plan.
• Never share an Apidra SoloStar pen or needles — sharing spreads blood-borne infections.

Several medications can change how insulin glulisine works in your body — making your blood sugar go too low or too high.

• Drugs that can increase low blood sugar risk: other diabetes medications, ACE inhibitors, angiotensin II receptor blockers, disopyramide, fibrates, fluoxetine, MAO inhibitors, pentoxifylline, pramlintide, salicylates, octreotide, sulfonamide antibiotics
• Drugs that can reduce insulin's effectiveness (raising blood sugar): corticosteroids, atypical antipsychotics, diuretics, estrogens, danazol, glucagon, isoniazid, niacin, phenothiazines, oral contraceptives (progestogens), protease inhibitors, somatropin, sympathomimetics (albuterol, epinephrine), thyroid hormones
• Drugs with unpredictable effects (can raise or lower blood sugar): alcohol, beta-blockers, clonidine, lithium, pentamidine
• Drugs that hide low blood sugar warning signs: beta-blockers, clonidine, guanethidine, reserpine — you may not feel the usual shaking or racing heartbeat that signals a low
• Thiazolidinedione diabetes pills (TZDs): can cause fluid retention and heart failure when combined with any insulin

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

• Do not use Apidra if you are currently experiencing low blood sugar (hypoglycemia)
• Do not use if you have ever had a serious allergic reaction to insulin glulisine or any ingredient in Apidra
• Tell your prescriber if you have kidney disease — you may need more frequent dose adjustments and blood sugar monitoring
• Tell your prescriber if you have liver disease — you may also be at higher risk for low blood sugar
• Older adults (65+): dosing should start conservatively and be increased gradually to lower the risk of hypoglycemia
• Children: Apidra is approved for pediatric patients 4 years and older with type 1 diabetes; children have a higher rate of severe hypoglycemia than adults in clinical trials
• Pregnancy: poorly controlled diabetes during pregnancy carries serious risks for mother and baby; discuss your insulin management plan with your doctor if you are pregnant or planning to become pregnant
• Breastfeeding: insulin glulisine may pass into breast milk; discuss the benefits and potential risks with your doctor
• Visual impairment: use Apidra SoloStar with caution if you rely on audible clicks to dial your dose

Too much insulin glulisine causes low blood sugar (hypoglycemia). Mild lows can usually be treated by eating or drinking fast-acting sugar. Severe episodes with seizures, unconsciousness, or neurological symptoms may need emergency glucagon or intravenous glucose given by a healthcare professional.

When given intravenously in excess, insulin can also cause dangerously low potassium (hypokalemia), which must be corrected. After apparent recovery, blood sugar can drop again, so continued monitoring and carbohydrate intake may be needed.

Apidra has a faster onset of action and shorter duration of activity than regular human insulin when injected under the skin. In studies of people with type 1 diabetes, Apidra given 2 minutes before a meal controlled post-meal blood sugar rises just as well as regular human insulin given 30 minutes before the meal. It can also be given up to 15 minutes after starting a meal with comparable results. When given intravenously, Apidra and regular human insulin produce equivalent glucose disposal at the same dose.

After a subcutaneous injection, insulin glulisine is absorbed faster than regular human insulin — reaching peak blood levels roughly twice as quickly in people with type 1 diabetes (about 60 minutes vs. 120 minutes for regular insulin). The body also clears it more rapidly, with an apparent half-life of about 42 minutes after subcutaneous injection compared to 86 minutes for regular insulin. Absorption is similar whether you inject into the abdomen, upper arm, or thigh, and about 70% of the injected dose reaches the bloodstream. Kidney or liver impairment can reduce clearance and raise the risk of low blood sugar.

Dispense in the original sealed carton with the enclosed Instructions for Use. Do not freeze. are summarized in the following table: Not in-use (unopened) Refrigerated (36°F-46°F ).