Fiasp Penfill

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) exactly as instructed by your doctor or diabetes educator. The dose of insulin is measured in international units (IU). Each 1 mL of insulin contains 100 IU. Insulin aspart is injected under the skin up to 2 minutes before the start of a meal. When necessary, insulin aspart may be injected up to 20 minutes after starting a meal. Longer-acting insulins are often used along with insulin aspart to cover the periods of time between doses of insulin aspart. There are many variations of insulin dosing

Insulin aspart 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 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 taking the medication without consulting your doctor.

It is very important that you use Fiasp Penfill (Insulin-aspart-rapid) exactly as prescribed by your doctor. The timing of insulin with respect to your meals is crucial to keeping blood glucose under control and preventing unwanted side effects. If you miss a dose, check your blood glucose to determine whether a dose is needed. If necessary, insulin aspart may be used up to 20 minutes after starting a meal. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Keep unopened bottles of insulin in the refrigerator until needed. They may be used until the expiry date on the label. Never allow insulin to freeze. Insulin that is currently in use may be kept at room temperature for no more than 28 days and then discarded. Insulin must not be exposed to extremely hot temperatures and it needs to be protected from light. Keep insulin out of reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Fiasp 10 mL vial
Each 1 mL of the water-clear colourless solution contains 100 Units of insulin aspart (equivalent to 3.5 mg). Nonmedicinal ingredients: glycerol, phenol, metacresol, zinc, disodium phosphate dihydrate, arginine hydrochloride, niacinamide (vitamin B3), and water for injection. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH.

Fiasp Penfill
Each 1 mL of the water-clear colourless solution contains 100 Units of insulin aspart (equivalent to 3.5 mg). Nonmedicinal ingredients: glycerol, phenol, metacresol, zinc, disodium phosphate dihydrate, arginine hydrochloride, niacinamide (vitamin B3), and water for injection. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH.

Fiasp Flextouch Pre-filled Insulin Pen
Each 1 mL of the water-clear colourless solution contains 100 Units of insulin aspart (equivalent to 3.5 mg). Nonmedicinal ingredients: glycerol, phenol, metacresol, zinc, disodium phosphate dihydrate, arginine hydrochloride, niacinamide (vitamin B3), and water for injection. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH.

Do not take Fiasp Penfill (Insulin-aspart-rapid) if you:

• are allergic to insulin aspart or any ingredients of the medication
• are experiencing an episode of Hypoglycemia (low blood sugar)

There may be an interaction between insulin aspart and any of the following:

• acetylsalicylic acid (Asa)
• American ginseng
• androgens (e.g., testosterone)
• atypical antipsychotics (e.g., Clozapine, Olanzapine, Quetiapine, Risperidone)
• beta-adrenergic blockers (e.g., Atenolol, Propranolol, Sotalol)
• Ceritinib
• chloroquine
• clarithromycin
• corticosteroids (e.g., Dexamethasone, Hydrocortisone, Prednisone)
• Danazol
• Disopyramide
• Epinephrine
• estrogens (e.g., conjugated estrogen, Estradiol, ethinyl estradiol)
• garlic
• ginger
• glucagon
• Goserelin
• Hepatitis C antivirals (e.g., daclatasvir, ledipasvir, paritaprevir, sofosbuvir)
• HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
• hydroxychloroquine
• Lanreotide
• Leuprolide
• loop diuretics (e.g., bumetanide, Furosemide)
• mifepristone
• monoamine oxidase inhibitors (M.O.S. e.g., Moclobemide, Phenelzine, Rasagiline, Selegiline, Tranylcypromine)
• Niacin
• Nilotinib
• Octreotide
• other diabetes medications (e.g., Acarbose, Canagliflozin, Dapagliflozin, Glyburide, Linagliptin, Liraglutide, metformin, Pioglitazone, Rosiglitazone, Sitagliptin)
• Pasireotide
• progestins (e.g., Dienogest, Levonorgestrel, medroxyprogesterone, Norethindrone)
• quinine
• quinolone antibiotics (e.g., ciprofloxacin, Norfloxacin, Ofloxacin)
• selective serotonin reuptake inhibitors (SSRIs; e.g., Citalopram, Fluoxetine, Paroxetine, Sertraline)
• Sirolimus
• somatostatin
• sulfonamide antibiotics ("sulfas"; e.g., sulfisoxazole, sulfamethoxazole)
• Sunitinib
• Tacrolimus
• Tramadol
• thiazide diuretics (water pills; e.g., Hydrochlorothiazide, Indapamide, Metolazone)
• Vorinostat

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Fiasp Penfill (Insulin-aspart-rapid). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Fiasp Penfill (Insulin-aspart-rapid).

Allergic reactions: If you notice signs of a serious allergic reaction (e.g., swelling of the face or throat, difficulty breathing, wheezing, or itchy skin rash), stop taking the medication and seek immediate medical attention.

Appearance of insulin: The contents of the vial of insulin aspart should be clear and colourless. Do not use Fiasp Penfill (Insulin-aspart-rapid) if you notice anything unusual about its appearance, such as cloudiness, discoloration, or clumping.

Changes at injection site: Fatty tissue under the skin at the injection site may shrink or thicken if you inject yourself too often at the same site. To help avoid this effect, change the site with each injection. Talk to your doctor or diabetes educator if you notice your skin pitting or thickening at the injection site.

Changes in insulin requirements: Many things can affect blood glucose levels and insulin requirements. These include:

• certain medical conditions (e.g., infections, Thyroid conditions, liver or Kidney Disease)
• certain medications that increase or decrease blood glucose levels
• diet
• exercise
• illness
• injury
• stress
• surgery
• travelling over time zones

It is important your doctor know your current health situation and any changes that may affect the amount of insulin you need. Blood glucose should be monitored regularly as recommended by your doctor or diabetes educator.

Diabetic identification: It is important to either wear a bracelet (or necklace) or carry a card indicating you have diabetes and are taking insulin.

Family and friends: Educate your family and friends about the signs and symptoms of hypoglycemia (low blood glucose). Keep a Glucagon kit available and instruct them on its proper use in case you experience severe low blood glucose and you lose consciousness.

Low blood glucose (hypoglycemia): Hypoglycemia may occur if too much insulin is used, if meals are missed, or if you exercise more than usual. Symptoms of mild-to-moderate hypoglycemia may occur suddenly and can include cold sweat, nervousness or shakiness, fast heartbeat, headache, hunger, confusion, lightheadedness, weakness, and numbness or tingling of the tongue, lips, or fingers. Mild-to-moderate hypoglycemia may be treated by eating foods or drinks that contain sugar. People taking insulin should always carry a quick source of sugar, such as hard candies, glucose tablets, juice, or regular soft drinks (not diet soft drinks). Signs of severe hypoglycemia can include disorientation, loss of consciousness, and seizures. People who are unable to take sugar by mouth or who are unconscious may require an injection of glucagon or treatment with intravenous (into the vein) glucose.

Kidney function: Insulin requirements may be decreased in kidney disease. If you have reduced kidney function or kidney disease, discuss with your doctor how Fiasp Penfill (Insulin-aspart-rapid) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Fiasp Penfill (Insulin-aspart-rapid), and whether any special monitoring is needed.

Liver function: Insulin requirements may be decreased in liver disease. If you have liver problems, discuss with your doctor how Fiasp Penfill (Insulin-aspart-rapid) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Fiasp Penfill (Insulin-aspart-rapid), and whether any special monitoring is needed.

Pregnancy: The safety and effectiveness of insulin aspart have not been determined for use during pregnancy. Fiasp Penfill (Insulin-aspart-rapid) should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Fiasp Penfill (Insulin-aspart-rapid), contact your doctor immediately. It is essential to maintain good blood glucose control throughout pregnancy. Insulin requirements usually decrease during the first trimester and increase during the second and third trimesters.

Breast-feeding: It is not known if insulin aspart passes into breast milk. If you are a breast-feeding mother and are taking Fiasp Penfill (Insulin-aspart-rapid), it may affect your baby. Insulin requirements often fluctuate while breast-feeding. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Fiasp Penfill (Insulin-aspart-rapid) have not been established for children under the age of 2 years with Type 1 Diabetes and children under the age of 18 years with type 2 diabetes.