Tresiba Flextouch

The recommended 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 your blood glucose levels.

Your dose of insulin should be injected subcutaneously (under the skin) exactly as instructed by your doctor or diabetes educator. Do not inject insulin degludec into a vein and do not use insulin degludec in insulin infusion pumps. Insulin degludec is injected under the skin once daily. In addition to insulin degludec, a fast-acting insulin is usually used to control the impact of food intake on blood glucose levels during the day. There are many variations of insulin dosing.

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.

Insulin degludec 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. It is not necessary to shake or rotate the vial before use. It should not be mixed with any other insulins.

It is important to take Tresiba Flextouch (Insulin-degludec-ultra-long-acting) 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, inject it as soon as possible as long as there is at least 8 hours until your next dose. If there is less than 8 hours until your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. 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.

Do not stop using Tresiba Flextouch (Insulin-degludec-ultra-long-acting) without consulting your doctor. When insulin degludec or any other insulin is stopped, blood glucose levels can become dangerously high.

Store unopened Penfill® cartridges and FlexTouch® pre-filled insulin pens in the refrigerator until needed. They may be used until the expiry date on the label. If necessary, they may be stored at room temperature for 8 weeks. Never allow insulin to freeze.

Insulin that is currently in use may be kept at room temperature (below 30°C) for no more than 8 weeks and then discarded. Do not expose insulin to extremely hot temperatures or to sunlight. Keep insulin out of the 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.

Aside from the risk of hypoglycemia (low blood sugar levels), this product has few adverse effects. If you think this medication may be causing adverse effects, talk to your health care professional. He or she can help you to determine whether or not the medication is the source of the problem.

100 units/mL
Each mL of sterile, aqueous, clear, colourless solution, contains 100 units of insulin degludec. Nonmedicinal ingredients: glycerol, phenol, metacresol, zinc acetate, and water for injection. Hydrochloric acid or sodium hydroxide may be added to adjust pH.

200 units/mL
Each mL of sterile, aqueous, clear, colourless solution contains 200 units of insulin degludec. Nonmedicinal ingredients: glycerol, phenol, metacresol, zinc acetate, and water for injection. Hydrochloric acid or sodium hydroxide may be added to adjust pH.

The Penfill® 3 mL cartridge is made of glass (type 1), containing a halobutyl rubber closure shaped as a plunger and closed with a halobutyl/polyisoprene rubber closure.

The FlexTouch® Pre-filled pen (multidose disposable pen) comprises a pen-injector with a cartridge (3 mL). The cartridge is made of glass (type 1), containing a halobutyl rubber closure shaped as a plunger and closed with a halobutyl/polyisoprene rubber closure.

Do not use Tresiba Flextouch (Insulin-degludec-ultra-long-acting) if you:

• are allergic to insulin degludec or any ingredients of the medication
• are experiencing low blood sugar

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

• ACE inhibitors (e.g., Enalapril, Lisinopril, Ramipril)
• alcohol
• androgens (e.g., testosterone)
• antipsychotics (e.g., Aripiprazole, Clozapine, Haloperidol, Olanzapine, Quetiapine, Risperidone)
• beta-blockers (e.g., Atenolol, Metoprolol, Pindolol, Propranolol, Sotalol)
• birth control pills
• Buserelin
• diuretics (water pills; e.g., Furosemide, Hydrochlorothiazide, triamterene)
• inhaled corticosteroids (e.g., budesonide, ciclesonide, fluticasone)
• Danazol
• decongestants (e.g., Pseudoephedrine)
• Disopyramide
• Epinephrine
• estrogens (e.g., conjugated estrogen, Estradiol, ethinyl estradiol)
• glucagon
• Goserelin
• HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
• Lanreotide
• Leuprolide
• Liraglutide
• mifepristone
• monoamine oxidase inhibitors (M.O.S. e.g., Moclobemide, Phenelzine, Rasagiline, Selegiline, Tranylcypromine)
• Niacin
• Octreotide
• oral corticosteroids (e.g., Dexamethasone, Hydrocortisone, Prednisone, Prednisolone)
• oral medications for diabetes (e.g., Gliclazide, Glyburide, Pioglitazone, Rosiglitazone)
• Pasireotide
• Pegvisomant
• progestins (e.g., Dienogest, Levonorgestrel, medroxyprogesterone, Norethindrone)
• quinine
• quinolone antibiotics (e.g., ciprofloxacin, Norfloxacin, Ofloxacin)
• salicylates (e.g., Asa)
• selective serotonin reuptake inhibitors (SSRIs; e.g., Citalopram, Fluoxetine, Paroxetine, Sertraline)
• Somatropin
• sulfa antibiotics (e.g., sulfamethoxazole)
• Sunitinib
• Tacrolimus
• testosterone
• thyroid replacement therapy (if starting or changing dose)

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 Tresiba Flextouch (Insulin-degludec-ultra-long-acting). 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 Tresiba Flextouch (Insulin-degludec-ultra-long-acting).

Allergic reactions: If you notice signs of a serious allergic reaction (swelling of face or throat, sudden sweating, vomiting, difficulty breathing, rapid heartbeat, itchy skin rash, and dizziness), stop using the medication and seek immediate medical attention.

Appearance of insulin: The contents of the pre-filled pen or insulin cartridge degludec should be clear and colourless. Do not use Tresiba Flextouch (Insulin-degludec-ultra-long-acting) if you notice anything unusual about its appearance, such as cloudiness, discoloration, or clumping.

Blood glucose monitoring: It is important for anyone using insulin to monitor their blood glucose levels regularly, as recommended by their doctor or diabetes educator. It is especially important to test blood glucose more often when your insulin dose or schedule changes, or when you are ill or under stress. If blood tests consistently show high or low blood glucose levels, contact your doctor or diabetes educator.

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, or kidney or liver disease)
• certain medications that increase or decrease blood glucose levels
• diet
• exercise
• illness
• injury
• stress
• surgery
• travelling over time zones

It is important to tell your doctor about 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.

Diabetes 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 or you lose consciousness.

High blood glucose (hyperglycemia): Hyperglycemia may occur if your insulin dose is too low or you miss a dose of insulin. Symptoms of hyperglycemia generally build up over hours or days. Contact your doctor or diabetes educator if you experience symptoms of hyperglycemia, such as increased need to urinate, nausea, vomiting, drowsiness, Dry Mouth, flushed dry skin, loss of appetite, and a fruity odour to your breath.

If hyperglycemia is permitted to continue, a condition known as diabetic ketoacidosis may occur. In this condition, your body starts to use body fat as fuel, eventually leading to a large concentration of acid in the blood stream. This can result in unconsciousness, coma, or death. To prevent this from occurring, you may need to have your insulin dose adjusted.

Kidney function: Kidney Disease or reduced kidney function may change the amount of insulin needed by the body. If you have kidney problems, discuss with your doctor how Tresiba Flextouch (Insulin-degludec-ultra-long-acting) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Tresiba Flextouch (Insulin-degludec-ultra-long-acting), and whether any special monitoring is needed. Your doctor may want to test your kidney function regularly with blood tests while you are taking Tresiba Flextouch (Insulin-degludec-ultra-long-acting).

Liver function: Liver disease or reduced liver function may change the amount of insulin needed by the body. If you have liver problems, discuss with your doctor how Tresiba Flextouch (Insulin-degludec-ultra-long-acting) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Tresiba Flextouch (Insulin-degludec-ultra-long-acting), and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking Tresiba Flextouch (Insulin-degludec-ultra-long-acting).

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 (tongue, lips, or fingers). Mild-to-moderate hypoglycemia may be treated by eating foods or drinks that contain sugar. You should always carry a quick source of sugar, such as hard candies, glucose tablets, juice, or regular soft drinks (not diet soft drinks). If you experience symptoms of hypoglycemia, eat one of these sources of sugar and then rest. If you feel symptoms of hypoglycemia coming on, don't take insulin.

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.

Pregnancy: 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. Therefore, contact your doctor if you are pregnant or are thinking about pregnancy.

Breast-feeding: It is not known if insulin degludec passes into breast milk. If you are a breast-feeding mother and are using Tresiba Flextouch (Insulin-degludec-ultra-long-acting), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding. Breast-feeding mothers may require adjustments in their insulin dose or diet.

Children: The safety and effectiveness of using Tresiba Flextouch (Insulin-degludec-ultra-long-acting) have not been established for children who are less than 2 years of age.

This product must be injected under the skin (subcutaneously): Clean the tip of the cartridge with an alcohol swab and attach a needle. Select the required dose. Clean the skin at the injection site with an alcohol swab. Pinch the skin and inject the insulin into the fold. If you use a short needle, pinching the skin may not be necessary, ask your pharmacist. Wait a few days before injecting the same site again. Keep the injector and the cartridge you are using at room temperature and discard the cartridge after 56 days. Unopened cartridges should be stored in the refrigerator. Use this medication regularly and continuously to maintain its beneficial effects. Insulin users should be aware of the symptoms of low blood sugar, which include confusion, headache, hunger, mood changes, palpitations, rapid breathing, cold sweats and shakiness. These symptoms require immediate treatment, to bring your blood sugar back up to a safe level. This can be done with a quick source of sugar, such as: 4 or 5 glucose tablets 59 to 79 mL of liquid glucose 15 to 20 mL (3 or 4 teaspoons) of honey, maple syrup or corn syrup 6 to 8 LifeSavers type candies 150 to 200 mL (2/3 to 3/4 cup) of fruit juice or regular soft drink (not a diet soft drink) 4 or 5 packets of white sugar (3 or 4 teaspoons) dissolved in water Inform your health care professional if these symptoms have occurred, as it may mean that your diet and/or medication needs to be adjusted.<br/><br/>Insulin users must check their blood sugar levels regularly using an appropriate device. Dispose of used syringes and needles safely. Your pharmacist can tell you the best way to do this. If you forget a dose and there is more than 8 hours left before the next dose, take immediately the missed dose. Do not double the next dose to catch up. In order not to cause hypoglycemia, avoid excessive alcohol consumption. Do not drink alcohol on an empty stomach.