Tresiba

Tresiba is a prescription medication used to treat adults and children with type 1 and type 2 diabetes. This analog (synthetic) insulin is similar to the insulin the body naturally produces and acts on cells in a similar way. Tresiba is an "ultra-long acting" insulin that helps keep blood glucose at consistent levels for long periods of time, allowing the time between doses to be extended.

Tresiba comes as a solution to be injected subcutaneously (just under the skin) once daily. It can be injected any time of day.

Common side effects include low blood sugar, allergic reactions, injection site reactions, itching and rash. Tresiba should not be used in those who have increased ketones in their blood or urine (diabetic ketoacidosis).

Tresiba is a prescription medication used to treat patients 1 year and older with type 1 and type 2 diabetes. 

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Tresiba is not recommended for children who require less than 5 units. 

• Novo Nordisk, Inc.

Serious side effects have been reported with Tresiba. See the “Tresiba Precautions” section.

Common side effects of Tresiba include the following:

• low blood sugar
• injection site reactions. The signs may include: pain, redness, hives, swelling and itching. The reactions usually disappear after a few days. See your doctor if they do not disappear after a few weeks. Stop using Tresiba and see a doctor right away if the reactions become serious. 
• skin changes where you use the injection (lipodystrophy). It is not known if Tresiba may cause lipodystrophy but such skin changes have been seen with other types of insulin. Fatty tissue under the skin may shrink (lipoatrophy) or get thicker (lipohypertrophy). Changing where you inject each time may reduce the risk of developing these skin changes. If you notice these skin changes, tell your doctor. If you keep injecting in the same place, these reactions can become more severe and affect the amount of medicine your body gets from the pen.
• itching
• rash
• edema (swelling of hands and feet)
• weight gain

This is not a complete list of Tresiba side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• other medicines for diabetes (oral and injectable)
• sulfonamides
• beta-blockers, clonidine, and reserpine. These may make it harder to recognize the warning signs of too low blood sugar.
• monoamine oxidase (MAO) inhibitors
• angiotensin converting enzyme (ACE) inhibitors

Some medications can increase your blood sugar levels and can affect your insulin treatment such as the following:

• Atypical antipsychotics
• diuretics
• danazol
• oral contraceptives
• thyroid hormones
• sympathomimetics such as epinephrine (adrenaline), salbutamol or terbutaline

This is not a complete list of drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Tresiba including the following:

• Low blood sugar (hypoglycemia). If you get too low blood sugar, eat glucose tablets or another high sugar snack, like sweets, biscuits or fruit juice (always carry glucose tablets or a high sugar snack, just in case). Signs of low blood sugar include:
  • headache
  • slurred speech
  • fast heartbeat
  • cold sweat
  • cool pale skin
  • feeling sick
  • feeling very hungry
  • tremor
  • feeling nervous or worried
  • feeling unusually tired, weak and sleepy
  • feeling confused
  • difficulty in concentrating
  • short-lasting changes in your sight
• High blood sugar (hyperglycemia). This can occur if you eat more or exercise less than usual, drink alcohol, get an infection or a fever, have not used enough insulin, keep using less insulin than you need, forget to use your insulin or stop using insulin without talking to your doctor. Signs of very high blood sugar include:
  • flushed, dry skin
  • feeling sleepy or tired
  • dry mouth
  • fruity (acetone) breath
  • urinating more often
  • feeling thirsty
  • losing your appetite
  • feeling or being sick (nausea or vomiting)

These may be signs of a very serious condition called ketoacidosis. This is a build-up of acid in the blood because the body is breaking down fat instead of sugar. If not treated, this could lead to diabetic coma and eventually death. If you have very high blood sugar, get medical help immediately. 

• Hypersensitivity reactions: Severe, life-threatening, generalized allergy, including anaphylaxis, can occur. Seek immediate attention if you develop an allergic reaction. 
• Low potassium in your blood (hypokalemia). 
• Heart failure. Taking certain diabetes pills called thiazolidinediones or “TZDs” with Tresiba may cause heart failure in some people. This can happen even if you have never had heart failure or heart problems before. If you already have heart failure, it may get worse while you take TZDs with Tresiba. Your healthcare provider should monitor you closely while you are taking TZDs with Tresiba. Tell your healthcare provider if you have any new or worse symptoms of heart failure including shortness of breath, tiredness, swelling of your ankles or feet and sudden weight gain. Treatment with TZDs and Tresiba may need to be adjusted or stopped by your healthcare provider if you have new or worse heart failure.

If you are switching from other insulin products, the insulin dose may need to be changed. Talk to your doctor.

Always check the insulin label before each injection to avoid accidentally confusing Tresiba with other insulin products. 

Never share a Tresiba FlexTouch pen between patients, even if the needle is changed.

Your insulin dose may need to change because of:

• change in level of physical activity or exercise
• increased stress
• change in diet
• weight gain or loss
• illness 

Drive or operate heavy machinery, until you know how Tresiba affects you.

Avoid alcohol while using Tresiba. If you drink alcohol, your need for insulin may change. Your blood sugar level may either rise or fall. You should therefore monitor your blood sugar level more often than usual.

Do not take Tresiba:

• if you are allergic to Tresiba or any of its ingredients
• during episodes of low blood sugar

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Tresiba, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Tresiba, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Tresiba or to any of its ingredients
• have liver problems
• have kidney problems
• take medications used to lower potassium
• drink alcohol
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant. 

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Tresiba falls into category C. There are no well-controlled studies that have been done in pregnant women. Tresiba should be used during pregnancy only if the possible benefit outweighs the possible risk to the unborn baby.

Your insulin dose may need to be changed during pregnancy and after delivery. Careful control of your diabetes is needed in pregnancy. Avoiding too low blood sugar (hypoglycemia) is particularly important for the health of your baby.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is unknown whether Tresiba is excreted in human milk. Because many drugs, including human insulin, are excreted in human milk, caution should be exercised when this medication is administered to a nursing mother. Women with diabetes who are lactating may require adjustments in insulin dose, meal plan, or both.

Use Tresiba exactly as prescribed.

Tresiba is injected used once a day, at any time of the day. 

This medication is given as an injection under the skin in the stomach area, upper arm or thigh. Never inject Tresiba into a vein or muscle.

The place within the chosen area should be altered with each injection to reduce the risk of lipodystrophy (changes in the distribution of body fat) under the skin that can affect the amount of Tresiba absorbed.

Always follow your doctor’s recommendation for dose.

Do not do any conversion of your dose. The dose counter always shows the selected dose in units. Both the 100 units/mL and 200 units/mL Tresiba FlexTouch pens are made to deliver your insulin dose in units.

If you miss or are delayed in taking your dose of Tresiba:

• Take your dose as soon as you remember then continue with your regular dosing schedule.
• Make sure there are at least 8 hours between your doses.

Check your blood sugar levels. Ask your healthcare provider what your blood sugars should be and when you should check your blood sugar levels.

Do not reuse or share your needles with other people. You may give other people a serious infection or get a serious infection from them. Never use a syringe to remove Tresiba from the FlexTouch pen

If you want to change your usual diet, check with your doctor or pharmacist first as a change in diet may alter your need for insulin.

Based on your blood sugar level your doctor may change your dose. When using other medicines, ask your doctor if your treatment needs to be adjusted.

Do not stop using your insulin without speaking to your doctor. If you stop using your insulin this could lead to a very high blood sugar level and ketoacidosis (a condition with too much acid in the blood).

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your age

Type 1 Diabetes Mellitus: The recommended starting dose of Tresiba, for patients who have never used insulin, is approximately one-third to one-half of the total daily insulin dose. Your doctor will explain how to divide the number of units throughout the day. 

Type 2 Diabetes Mellitus: The recommended starting dose of Tresiba,  for patients who have never used insulin, is 10 units once daily. 

Starting Dose in Patients Already on Insulin Therapy for Type 1 and Type 2 Diabetes Mellitus: Tresiba will be initiated at the same unit dose as the total daily long or intermediate-acting insulin unit dose.

If you use too much Tresiba, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the pen label and carton, after ‘EXP’. 

Unused Tresiba: Store between 36°F to 46°F (2°C and 8°C). Do not store in the freezer or directly adjacent to the refrigerator cooling element. Do not freeze. Do not use Tresiba if it has been frozen.

Unopened FlexTouch disposable prefilled pen: Not in-use (unopened) Tresiba disposable prefilled pen should be stored in a refrigerator (36°F - 46°F [2°C - 8°C]). Discard after expiration date.

Open (In-Use) FlexTouch disposable prefilled pen: The in-use Tresiba FlexTouch pen should NOT be refrigerated but should be kept at room temperature (below 86°F [30°C]) away from direct heat and light. The opened (in-use) Tresiba FlexTouch pen may be used for up to 56 days (8 weeks) after being opened, if it is kept at room temperature.