Tresiba Flextouch 100 Pens

What are the Indications for Tresiba FlexTouch 100?

Tresiba is a long-acting insulin that is approved to lower blood sugar levels in adults and children aged one year and older with type 1 and 2 diabetes.

How is Tresiba FlexTouch 100 used?

Storage

Unopened Tresiba FlexTouch 100 pens and vials should be stored in their original packaging upright in a refrigerator at 36-46°F (2-8°C) or at room temperature up to 86°F (30°C). Do not freeze it and do not use it if it has been frozen.

Keep Tresiba away from light and out of reach of children.

Instructions

Read the instructions in the patient information leaflet on how to prepare, use, and measure the correct dose of Tresiba FlexTouch 100 and/or as advised by your healthcare provider. Your healthcare provider will determine the appropriate dose and schedule based on your individual needs, blood glucose monitoring results, and medical history.

Do not change your dosage and take more than what is prescribed or stop using Tresiba without consulting with your doctor. Tresiba FlexTouch 100 must be used once a day at any time of the day for adults and pediatric patients must use it at the same time each day.

Adults who miss a dose must take it as soon as they remember and continue with their normal dosing schedule. There should be at least 8 hours between doses. Do not catch up by taking two doses at once. If children miss a dose, contact their doctor for information and instructions.

If you took more than prescribed, contact your doctor immediately or seek emergency medical care.

Inject Tresiba under the skin of your upper legs, upper arms, or stomach area. Use a different site each time you inject and do not inject it directly into a vein or muscle.

Do not share your Tresiba FlexTouch 100 with anyone, even if the needle has been changed, because you can transmit serious infections to each other.

Dosage

Tresiba FlexTouch 100 is available as a 3 milliliter (ml) single-use pen with 100 units of insulin degludec per ml of solution or as a 10 milliliter (ml) multi-dose vial with 100 units of insulin degludec per ml of solution.

Your dosage will be determined by your type of diabetes, metabolic requirements, results from your blood glucose monitoring, and glycemic control goals. Three to four days should pass between dose increases.

Your dosage may have to be reviewed if your physical activity, diet, renal or hepatic function change, or during an acute illness.

SIDE EFFECTS

It’s important to understand that although Tresiba FlexTouch 100 is FDA-approved, it comes with side effects that may or may not affect you.

Before using Tresiba FlexTouch 100, you should discuss possible side effects with your doctor or pharmacist.

Common Side Effects

Not all side effects require medical attention. As your body adjusts to Tresiba, side effects may go away. Tell your doctor if you experience the following symptoms, and they become severe or do not go away on their own:

• Low blood sugar
• Allergic reactions
• Skin reaction at the injection site
• Skin thickening/pits at the injection site (lipodystrophy)
• Itching
• Rash
• Swelling of the hands/feet
• Weight gain
• Runny/stuffy nose
• Upper respiratory tract infection
• Headache
• Sinusitis
• Upset stomach or stomach pain
• Diarrhea

Serious Side Effects

Severe adverse reactions while using Tresiba FlexTouch 100 may occur. Seek emergency medical care or call 911 if you experience any of the following symptoms:

• Low blood sugar: dizziness or light-headedness, blurred vision, anxiety, irritability or mood changes, sweating, slurred speech, hunger, confusion, rapid heartbeat. This may occur if you don’t consume enough calories or do unusually strenuous exercise.
• Severe allergic reaction: a rash over your whole body, sweating, extreme drowsiness, swelling of your face, tongue, or throat, difficulty breathing, feeling faint, dizziness, rapid heartbeat, shortness of breath, or becoming confused.
• Low potassium levels:muscle cramps, weakness, irregular heartbeat, fluttering in the chest, increased thirst/urination, numbness/tingling, muscle cramps/weakness, or feeling limb.
• Heart failure:shortness of breath, swelling of ankles and feet, and sudden weight gain.

The information above does not list all possible side effects. Contact your doctor or pharmacist if you experience any side effects not listed. You or your doctor may report side effects to the FDA by calling 1-800-FDA-1088.

WARNINGS & PRECAUTIONS

Before using Tresiba FlexTouch 100, tell your doctor or pharmacist:

• If you take any other prescription or over-the-counter medications, vitamins, or herbal supplements, or use other insulin.
• If you use thiazolidinediones (TZDs) as it can cause heart failure and fluid retention if used together with Tresiba
• If you suffer from hyper or hypoglycemia
• If you are pregnant or plan to become pregnant
• If you are breastfeeding or plan to breastfeed

Tresiba FlexTouch 100 should not be used by children under the age of one year.

Let your doctor know when you get ill as your insulin needs may change when your body is stressed.

If you are traveling across time zones, check with your doctor how to adjust your insulin schedule. Always make sure you travel with extra insulin and supplies.

If you change your diet, gain/lose weight, or change your level of exercise/physical activity, let your doctor know as your insulin dose may need to be adjusted.

Hypokalemia

Tresiba FlexTouch 100 can cause or worsen hypokalemia (low potassium levels in the blood) and can increase the risk of adverse side effects. While you use Tresiba, your doctor will check your potassium levels to see if you are at risk for or have hypokalemia.

Kidney or liver disease

You are more at risk of suffering from low blood sugar while using Tresiba FlexTouch 100 if you have kidney or liver problems. Speak to your healthcare provider about how to prevent low blood sugar.

Pregnant or planning to become pregnant

It is not known if Tresiba FlexTouch 100 will harm an unborn baby. If you become pregnant, your insulin needs may change so speak to your doctor about the most effective way to control your diabetes while pregnant.

Breastfeeding or planning to breastfeed

Tresiba may pass into breastmilk so speak to your doctor before breastfeeding to make sure it is safe for your nursing baby.

INTERACTIONS & CONTRAINDICATIONS

Do not use Tresiba if:

• You experience episodes of hyperglycemia.
• You are hypersensitive to insulin degludec or any other ingredients in Tresiba.

Beta-blockers

Beta-blocker medications may prevent some of the symptoms of low blood sugar, like a fast/pounding heartbeat. Make sure you regularly monitor your blood glucose levels while taking these medicines.

Thiazolidinediones (TZDs)

If you take diabetes medicine called TZDs together with Tresiba FlexTouch 100 it may lead to heart failure in some people, even if you haven’t had heart problems before. If you have heart failure, it may get worse if you take TZDs. Your doctor should monitor you closely and adjust/stop your treatment with TZDs and Tresiba. Contact your doctor immediately or visit the emergency room if you experience shortness of breath, tiredness, swelling of the ankles/feet, or sudden weight gain.

Alcohol

Avoid drinking alcohol when using Tresiba FlexTouch 100, as it can cause your blood sugar levels to drop too low and make it difficult to control.