Tresiba FlexTouch

The active ingredient in Tresiba FlexTouch is insulin degludec. Insulin degludec is a long-acting basal insulin product that helps manage hyperglycemia (high blood sugar levels). This type of insulin therapy works to lower high blood glucose levels by stimulating our muscles and our fat to take up glucose from the blood and by blocking our liver from making more. It also blocks fat and protein breakdown, leaving more fat and muscle for glucose to be absorbed from the bloodstream. If high blood sugar levels are left untreated, patients can develop several complications related to their heart, eyes, nerves, and kidneys. In Type 1 Diabetes, persistently high blood sugar levels can increase the risk of diabetic ketoacidosis, a life-threatening condition that Tresiba Kwikpen cannot treat.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Tresiba FlexTouch. However, the following is a synopsis of the general guidelines for the use of Tresiba FlexTouch:

• Tresiba FlexTouch should be used exactly as prescribed. The insulin dose you use will depend on a number of factors, including your age, blood glucose control, type of diabetes, prior insulin use, and more.
• Before using, check the insulin to ensure it is clear and colorless. Cloudy insulin pens or those that are past their expiration date should not be used and should be taken to your pharmacy to be disposed of.
• Tresiba FlexTouch is a subcutaneous injection, meaning that it is injected into the fat layer right under your skin. Injection sites can include the stomach area, thigh, buttocks, or deltoid of the upper arm. It is typically used once daily, and you should be injecting at the same time every day. Ensure you rotate your injection site each day to minimize the risk of injection site reactions. Change the needle each time to prevent infection, and do not reuse or share needles with others. Dispose of used needles in a sharps container provided by your local pharmacy.
• Do not mix the insulin with any other insulin or solutions.
• Do not use in an insulin pump.
• Do not drive or operate heavy machinery until you know how this medication affects you. Sometimes, your dose may be too high and cause hypoglycemia or low blood sugar events that can affect your daily functioning.
• Do not drink alcohol or use over-the-counter medications that contain alcohol while on Tresiba FlexTouch. Alcohol can lower your blood glucose, and when combined with insulin, could cause hypoglycemia. Watch for symptoms of low blood sugar.
• If you miss a dose, contact your prescriber or pharmacist. They will know or recommend what is best for you.

Some mild or common side effects of Tresiba FlexTouch include:

• Hypoglycemia or low blood sugar. If left unaddressed, this could be life-threatening. Symptoms to watch for include dizziness, lightheadedness, sweating, confusion, headache, changes in vision, slurred speech, shakiness, fast heartbeat, anxiety, increased irritability, mood swings, or increased appetite.
• Injection site reactions, such as redness, swelling, or pain at the site of injection.
• Skin thickening or buildup of fat at the injection site (lipodystrophy).
• Weight gain.
• Swelling.
• Infections.

Some individuals may experience serious side effects while using Tresiba FlexTouch. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Severe hypoglycemia (low blood sugar).
• Signs of hypokalemia (low potassium levels in the blood) such as muscle weakness, cramping, spasms, and heart palpitations.
• New onset of shortness of breath, trouble breathing, swelling of the lower limbs and feet, and sudden weight gain. These may be symptoms of heart failure, which can develop if this medication is used with TZDs.
• Signs of a severe allergic reaction such as difficulty breathing, hives, rash, or swelling of the face or body.

These are not all of the possible side effects of Tresiba FlexTouch. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Tresiba FlexTouch, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including:

• Liver problems
• Kidney problems
• Use thiazolidinediones or TZDs
• Heart failure or any other heart problems
• Are pregnant or planning to become pregnant
• Are breastfeeding or planning to breastfeed

Do not use Tresiba FlexTouch if you have:

• Hypoglycemia or low blood sugar
• An allergy to insulin degludec or any of the other ingredients in Tresiba FlexTouch

Tresiba FlexTouch is a long-acting insulin. It typically starts to work in about 1 to 2 hours, and levels will remain steady for up to 24 hours.

When Tresiba FlexTouch is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Other diabetes medications including GLP-1 agonists, DPP4 inhibitors, and SGLT-2 inhibitors
• ACE inhibitors
• ARBs
• Disopyramide
• Fibrates
• Fluoxetine
• MAOIs
• Pentoxifylline
• Pramlintide
• Salicylates
• Somatostatin analogs such as octreotide
• Sulfonamides
• Atypical antipsychotics such as olanzapine and clozapine
• Corticosteroids
• Danazol
• Diuretics
• Estrogens
• Glucagon
• Isoniazid
• Niacin
• Oral contraceptives
• Phenothiazines
• Progestogens
• Protease inhibitors
• Somatropin
• Sympathomimetic agents such as albuterol, epinephrine, and terbutaline
• Thyroid hormones
• Beta-blockers
• Clonidine
• Lithium
• Pentamidine
• Guanethidine
• Reserpine

Tresiba FlexTouch is available as a 3 mL prefilled pen that contains either 100 units or 200 units of insulin degludec per mL.

New pens that have not been used yet should be kept in the fridge. Do not freeze. If the pen is frozen, it should be discarded. Once opened, store the pen at room temperature and protect it from heat or light for up to 56 days. Keep the pen out of reach of children.

Tresiba FlexTouch is manufactured by the pharmaceutical company Novo Nordisk A/S.

Currently, there is no generic available for the brand-name Tresiba FlexTouch.

Consult your doctor or pharmacist before starting, stopping, or changing medications while using Tresiba FlexTouch.

Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. They will know or recommend what is best for you.

Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend what is best for you.