Tresiba Flextouch

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes Tresiba Flextouch (Insulin-degludec-ultra-long-acting). If you are concerned about side effects, discuss the risks and benefits of Tresiba Flextouch (Insulin-degludec-ultra-long-acting) with your doctor.

The following side effects have been reported by at least 1% of people taking Tresiba Flextouch (Insulin-degludec-ultra-long-acting). Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• redness, itching, or swelling at the site of the injection

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• fluid retention causing swollen joints
• signs of an allergic reaction (e.g., rash, itching, or Hives)
• signs of low blood glucose (Hypoglycemia; e.g., anxiety; blurred vision; changes in 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)
• signs of low potassium in the body (e.g., weakness, fatigue, muscle cramps, Constipation)

Stop taking the medication and seek immediate medical attention if any of the following occur:

• seizures
• symptoms of a serious allergic reaction (e.g., swelling of face or throat, sudden sweating, vomiting, difficulty breathing, rapid heartbeat, itchy skin rash, and dizziness)
• unconsciousness

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking Tresiba Flextouch (Insulin-degludec-ultra-long-acting).

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.