Tresiba FlexTouch (Insulin Degludec (U-200))

• It is used to lower blood sugar in patients with high blood sugar (diabetes).

• Tell all of your health care providers that you take Tresiba FlexTouch. This includes your doctors, nurses, pharmacists, and dentists.
• Allergic reactions have happened with this medicine. Rarely, some reactions can be very bad or life-threatening. Talk with the doctor.
• Low blood sugar may happen with Tresiba FlexTouch. Very low blood sugar can lead to seizures, passing out, long lasting brain damage, and sometimes death. Talk with the doctor.
• Low blood potassium may happen with this medicine. If not treated, this can lead to a heartbeat that is not normal, very bad breathing problems, and sometimes death. Talk with the doctor.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how Tresiba FlexTouch affects you.
• Some diabetes drugs like pioglitazone or rosiglitazone may cause heart failure or make it worse in people who already have it. Using insulin with these drugs may increase this risk. If you also take one of these drugs, talk with the doctor.
• Be sure you have the right insulin product. Insulin products come in many containers like vials, cartridges, and pens. Be sure that you know how to measure and get your dose ready. If you have any questions, call your doctor or pharmacist.
• It may be harder to control your blood sugar during times of stress like when you have a fever, an infection, an injury, or surgery. A change in level of physical activity or exercise and a change in diet may also affect your blood sugar. Talk with your doctor.
• Wear disease medical alert ID (identification).
• Do not drive if your blood sugar has been low. There is a greater chance of you having a crash.
• Check your blood sugar as you have been told by your doctor.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Talk with your doctor before you drink alcohol.
• Do not share pen or cartridge devices with another person even if the needle has been changed. Sharing these devices may pass infections from one person to another. This includes infections you may not know you have.
• This brand of insulin is 2 times stronger than other brands. Use extra care when you measure a dose. Accidental overdose may lead to very bad side effects or life-threatening low blood sugar. Talk with the doctor.
• If you are 65 or older, use this medicine with care. You could have more side effects.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Tresiba FlexTouch while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

For all patients taking Tresiba FlexTouch:

• It is given as a shot into the fatty part of the skin on the top of the thigh, belly area, or upper arm.
• If you will be giving yourself the shot, your doctor or nurse will teach you how to give the shot.
• Follow how to use as you have been told by the doctor or read the package insert.
• Wash your hands before use.
• Move site where you give the shot each time.
• Do not use if the solution is cloudy, leaking, or has particles.
• Do not use if solution changes color.
• Throw away needles in a needle/sharp disposal box. Do not reuse needles or other items. When the box is full, follow all local rules for getting rid of it. Talk with a doctor or pharmacist if you have any questions.
• Do not use out dated insulin.
• Do not mix with other liquids.
• Do not move this medicine from the pen to a syringe or mix with other types of insulin.
• Follow the diet and workout plan that your doctor told you about.

Children:

• Give Tresiba FlexTouch (insulin degludec (U-200)) at the same time of day.

What do I do if I miss a dose?

Adults:

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Be sure there are at least 8 hours between the doses.
• Do not take 2 doses at the same time or extra doses.

Children:

• Call your child's doctor to find out what to do.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Nose and throat irritation.
• Headache.
• Loose stools (diarrhea).
• Weight gain.
• Irritation where the shot is given.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Tresiba FlexTouch, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Tresiba FlexTouch. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Tresiba FlexTouch.

Review Date: October 4, 2017