Insulin glulisine

What is Insulin glulisine?

• Insulin glulisine (Apidra; Apidra solostar) is a rapid-acting human insulin analog used to improve glycemic control in adults and pediatric patients with diabetes mellitus.

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What are the uses of this medicine?

• Insulin glulisine (Apidra; Apidra solostar) is a fast (rapid) acting man-made insulin used to control high blood sugar in adults and children with diabetes mellitus.

Limitations of use:

• It is not known if APIDRA is safe or effective in children less than 4 years of age with type 1 diabetes.
• It is not known if APIDRA is safe or effective in children with type 2 diabetes.

How does this medicine work?

• 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.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• are having an episode of low blood sugar (hypoglycemia).
• have an allergy to insulin glulisine or any of the ingredients in APIDRA.

What drug interactions can this medicine cause?

• Dose adjustment and increased frequency of glucose monitoring may be required when APIDRA is coadministered with Antidiabetic agents, ACE inhibitors, angiotensin II receptor blocking agents, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, pramlintide, salicylates, somatostatin analog (e.g., octreotide), and sulfonamide antibiotics.
• Dose adjustment and increased frequency of glucose monitoring may be required when APIDRA is coadministered with Atypical antipsychotics, corticosteroids, danazol, diuretics, estrogens, glucagon, isoniazid, niacin, phenothiazine derivatives, progestogens (e.g., in oral contraceptives), protease inhibitors, somatropin, sympathomimetic agents (e.g., albuterol, epinephrine, terbutaline), and thyroid hormones.
• Dose adjustment and increased frequency of glucose monitoring may be required when APIDRA is coadministered with Alcohol, beta-blockers, clonidine, and lithium salts.
• Increased frequency of glucose monitoring may be required when APIDRA is coadministered with Beta-blockers, clonidine, guanethidine, and reserpine.

Is this medicine FDA approved?

• Initial U.S. Approval: 2004

How should this medicine be used?

Recommended dosage:

• Individualize and adjust the dosage of APIDRA based on the patient'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 an 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 in 0.9% sodium chloride injection, USP using polyvinyl chloride infusion bags.

Administration:

• Use APIDRA exactly as your healthcare provider tells you to. Your healthcare provider should tell you how much APIDRA to use and when to use it.
• Know the amount of APIDRA you use. Do not change the amount of APIDRA you use unless your healthcare provider tells you to.
• Know the best time for you to take your insulin. This may change if you take a different type of insulin or if the way you give your insulin changes, for example, using an insulin pump instead of giving injections under the skin (subcutaneous injections).
• Check your insulin label each time you give your injection to make sure you have the correct insulin. This is especially important if you also take long-acting insulin.
• Do not reuse needles. Always use a new needle for each injection. Reuse of needles increase your risk of having blocked needles, which may cause you to get the wrong dose of APIDRA. Using a new needle for each injection lowers your risk of getting an infection.
• APIDRA is a rapid-acting insulin. Take APIDRA within 15 minutes before a meal or within 20 minutes after starting a meal.
• APIDRA is injected under the skin (subcutaneously) of your upper arms, thighs, buttocks, or stomach area (abdomen), or by continuous infusion under the skin (subcutaneously) through an insulin pump into an area of your body recommended in the instructions that come with your insulin pump.
• Change (rotate) injection sites within the area you chose with each dose to reduce your risk of getting lipodystrophy (pits in skin or thickened skin) and localized cutaneous amyloidosis (skin with lumps) at the injection sites:
• Do not use the exact same spot for each injection.
• Do not inject where the skin has pits, is thickened, or has lumps.
• Do not inject where the skin is tender, bruised, scaly, or hard, or into scars or damaged skin.
• Check your blood sugar levels. Ask your healthcare provider what your blood sugar should be and when you should check your blood sugar levels.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As APIDRA injection 100 units/mL (U-100) is available as:
• 10 mL multiple-dose vial
• 3 mL single-patient-use SoloStar® prefilled pen

This medicine is available in fallowing brand namesː

• APIDRA; APIDRA SOLOSTAR

What side effects can this medication cause?

The most common side effects of this medicine include:

• low blood sugar (hypoglycemia)
• weight gain
• itching
• rash
• swelling
• allergic reactions including reactions at your injection site
• skin thickening or pits at the injection site (lipodystrophy)

APIDRA may cause serious side effects that can lead to death, including:

• hypoglycemia
• severe allergic reaction
• hypokalemia
• heart failure

What special precautions should I follow?

While using APIDRA do not:

• drive or operate heavy machinery until you know how APIDRA affects you.
• drink alcohol or use over-the-counter medicines that contain alcohol.
• Never share an APIDRA SoloStar pen between patients, even if the needle is changed.
• Changes in an insulin regimen (e.g., insulin, insulin strength, manufacturer, type, injection site or method of administration) may affect glycemic control and predispose to hypoglycemia or hyperglycemia. 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 is the most common adverse reaction of all insulin therapies, including APIDRA. 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.
• Accidental mix-ups between insulin products can occur. Instruct patients to check insulin labels before injection.
• All insulin products, including APIDRA, cause a shift in potassium from the extracellular to intracellular space, possibly leading to hypokalemia. May be life-threatening. Monitor potassium levels in patients at risk for hypokalemia and treat if indicated.
• Severe, life-threatening, generalized allergy, including anaphylaxis, can occur. Discontinue APIDRA, monitor and treat if indicated.
• Thiazolidinediones (TZDs), which are peroxisome proliferator-activated receptor (PPAR) gamma agonists, can cause dose-related fluid retention, particularly when used in combination with insulin. Fluid retention may lead to or exacerbate heart failure. Observe for signs and symptoms of heart failure; consider dosage reduction or discontinuation of TZD if heart failure occurs. '
• Malfunction of the insulin pump or insulin infusion set or insulin degradation can rapidly lead to hyperglycemia and ketoacidosis. Monitor glucose and administer APIDRA by subcutaneous injection if pump malfunction occurs.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• hypoglycemia
• hypokalemia

Management of overdosage:

• 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.

Can this medicine be used in pregnancy?

• Available data have not established an association with insulin glulisine use during pregnancy and major birth defects, miscarriage or adverse maternal or fetal outcomes.
• It is not known if APIDRA may harm your unborn baby or breastfeeding baby.

Can this medicine be used in children?

• It is not known if APIDRA is safe or effective in children less than 4 years of age with type 1 diabetes.
• It is not known if APIDRA is safe or effective in children with type 2 diabetes.

What are the active and inactive ingredients in this medicine?

• Active ingredient: insulin glulisine
• Inactive ingredients: metacresol, tromethamine, sodium chloride, polysorbate 20, and water for injection. Hydrochloric acid and sodium hydroxide may be added to adjust the pH.

Who manufactures and distributes this medicine?

• sanofi-aventis U.S. LLC
• Bridgewater, NJ
• A SANOFI COMPANY

What should I know about storage and disposal of this medication?

• Keep in the refrigerator or below 77°F (25°C).
• Keep vials away from direct heat and light.
• Dispose of any opened vial after 28 days after the first use, even if there is insulin left in the vial.

• Dailymed label info on Insulin glulisine
• FDA Insulin glulisine

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