APIDRA 100U/ML SOLOSTAR PF PEN  (5x3 ML)

Generic Name: insulin glulisine
Brand Name: Apidra
Drug Class: Insulin

Apidra is available in three formats:

• 10 mL vial. Each mL contains 100 units of insulin glulisine.

• Penfill Cartridge 5x3 mL. Each mL contains 100 units of insulin glulisine.

• SoloSTAR disposable pre-filled pen. Each mL contains 100 units of insulin glulisine.

Insulin is a naturally occurring hormone made by the pancreas that helps your body use or store glucose (sugar) it gets from food. For people with diabetes, either the pancreas does not make enough insulin to meet the body's requirements, or the body cannot properly use the insulin that is made. As a result, glucose cannot be used or stored properly and accumulates in the bloodstream. Insulin injected under the skin helps to lower blood glucose levels.

Insulin glulisine is used to treat adults with type 1 or type 2 diabetes mellitus when insulin is required. It is also used to treat children 6 years or older with type 1 diabetes mellitus.

There are many different types of insulin and they are absorbed at different rates and work for varying periods of time. Insulin glulisine is a rapid-acting insulin. It takes 5 minutes to begin working after the injection, has its maximum effects between 30 and 90 minutes, and stops working after 2 to 4 hours.

Your required dose of insulin depends on how much natural insulin your pancreas is producing and how well your body is able to use the insulin. Your doctor or diabetes educator will determine the appropriate dose for you according to various lifestyle factors and the blood glucose values obtained while monitoring your blood glucose.

Your dose of insulin should be injected subcutaneously (under the skin) to the stomach, upper arm, or thigh regions, exactly as instructed by your doctor or diabetes educator. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. This will help prevent skin problems from the injections. The dose of insulin is measured in international units (IU). Each mL of insulin contains 100 IU.

When insulin glulisine is injected under the skin, it should be given within 15 minutes before or within 20 minutes after starting a meal. Longer-acting insulins are often used along with insulin glulisine to cover the periods of time between doses of insulin glulisine. There are many variations of insulin dosing. To reduce irritation at the place of injection, allow insulin glulisine to reach room temperature before injecting.

Insulin glulisine should be clear and colourless. Do not use the insulin if you notice anything unusual in the appearance of the solution, such as cloudiness, discoloration, or clumping.

Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are using the medication without consulting your doctor.

It is important that this medication be used exactly as prescribed by your doctor. The timing of insulin with respect to your meals is crucial to keeping blood glucose under control.

Keep unopened insulin glulisine in the refrigerator until needed and use it before the expiry date on the label. Never allow insulin to freeze. Open vials can be refrigerated for up to 28 days. Open vials may also be stored at room temperature for up to 28 days as long as the temperature is not greater than 25°C. Opened prefilled pens should not be refrigerated but should be kept at room temperature for no more than 28 days, as long as the temperature is not greater than 25°C. Insulin sets (reservoirs, tubing, and catheters) used with insulin pumps, and the insulin within them, should be discarded after no more than 2 days of use or after exposure to temperatures that are greater than 37°C.

Do not use Apidra if you:

• are allergic to insulin glulisine or any ingredients of the medication.

The following medications could potentially interact with Apidra:

• ACE inhibitors (e.g., ramipril, enalapril, lisinopril)

• acetylsalicylic acid

• alcohol

• atypical antipsychotics (e.g., clozapine, olanzapine, quetiapine, risperidone)

• beta-blockers (e.g., propranolol, labetalol, atenolol)

• clarithromycin

• inhaled corticosteroids (e.g., budesonide, ciclesonide, fluticasone)

• oral corticosteroids (e.g., dexamethasone, hydrocortisone, prednisone)

• danazol

• diabetes medications (e.g., canagliflozin, chlorpropamide, gliclazide, glyburide, insulin, liraglutide, metformin, rosiglitazone, sitagliptin)

• disopyramide

• diuretics (e.g., furosemide, hydrochlorothiazide)

• epinephrine

• estrogens (e.g., conjugated estrogen, estradiol, ethinyl estradiol)

• glucagon

• hepatitis C antivirals (e.g., glecaprevir and pibrentasvir, ledipasvir, sofosbuvir, voxilaprevir)

• HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)

• isoniazid

• lanreotide

• mifepristone

• monoamine oxidase inhibitors (MAOIs; e.g., phenelzine, selegiline, tranylcypromine)

• niacin

• octreotide

• oral contraceptives

• pasireotide

• pegvisomant

• progestins (e.g., dienogest, levonorgestrel, medroxyprogesterone, norethindrone)

• quinine

• quinolone antibiotics (e.g., ciprofloxacin, norfloxacin, ofloxacin)

• St. John's wort

• selective serotonin reuptake inhibitors (SSRIs; e.g., citalopram, fluoxetine, paroxetine, sertraline)

• somatostatin

• somatropin

• sulfamethoxazole

• sunitinib

• tacrolimus

• testosterone

• thyroid replacement hormones (e.g., levothyroxine)

Possible side effects include:

• redness, itching, swelling, or bleeding at the place of injection

• thickening of the skin at the injection site

• signs of low blood glucose:

  • anxiety

  • blurred vision

  • confusion

  • difficulty concentrating

  • difficulty speaking

  • dizziness

  • drowsiness

  • fast heartbeat

  • headache

  • hunger

  • nausea

  • nervousness

  • numbness or tingling of the lips, fingers, or tongue

  • sweating

  • tiredness

  • trembling

  • weakness

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