Tresiba Flextouch 200 Pens

What are the Indications for Tresiba FlexTouch 200?

Tresiba is a long-acting insulin that is approved to control blood sugar levels in adults and children who are at least one year old with type 1 and 2 diabetes.

How is Tresiba FlexTouch 200 used?

Storage

Tresiba FlexTouch 200 pens should be stored unopened and upright in their original packaging in a refrigerator at 36-46°F (2-8°C) or at room temperature up to 86°F (30°C). Do not freeze the pens 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 200 and follow your doctor’s instructions. Based on the results of your blood glucose monitoring, and your medical history, your healthcare practitioner will decide on the best dose and schedule for you.

Do not change your dosage, take more than the recommended dose, or stop using it without speaking to your doctor first. Adults must use Tresiba FlexTouch 200 once daily at any time of the day while pediatric patients must use it at the same time each day.

Adults must take any missed dose as soon as they remember and continue with their normal dosing schedule. At least 8 hours should pass between doses. Do not take two doses at once to catch up. If a child misses a dose, contact their doctor for instructions.

If you took more than the recommended dose, contact your doctor immediately or get emergency help.

Inject Tresiba under the skin of your upper legs, upper arms, or stomach area. Do not inject it straight into a vein or muscle and use a different place each time.

Do not share your Tresiba FlexTouch 200 pen with anybody, even if the needle has been changed, as you risk spreading serious infections to each other.

Dosage

Tresiba FlexTouch 200 is available as a 3 milliliter (ml) disposable pen with 200 units of insulin degludec per ml of solution.

Your dosage will depend on your type of diabetes, your metabolic needs, the results from your blood glucose monitoring, and glycemic control objectives. Three to four days should pass between dose increases.

You may need to adjust your dosage if there is a change in your physical activity, diet, renal or hepatic function, or during an acute illness.

SIDE EFFECTS

It’s important to understand that although Tresiba FlexTouch 200 is FDA-approved, it comes with side effects that may or may not affect you.

Before using Tresiba FlexTouch 200, 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 200 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 200, tell your doctor or pharmacist:

• If you take any other prescription or over-the-counter medications, vitamins, or herbal supplements, or use other insulins.
• If you are allergic to Tresiba, or any other medications or foods.
• 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

Children under the age of one should not use Tresiba FlexTouch 200.

Contact your doctor if you become ill as your body’s insulin requirements may change.

Check with your doctor how to adjust your insulin schedule if you are traveling across different time zones. Always bring extra insulin and supplies with you when you travel.

If you change your diet, gain/lose weight, or increase or decrease your level of exercise/physical activity, let your doctor know as they may need to adjust your insulin dosage.

Hypokalemia

Hypokalemia (low potassium levels in the blood) can be brought on or get worse when you take Tresiba FlexTouch 200 and increase the risk of serious side effects. Your doctor will monitor your potassium levels while you take Tresiba if you are at risk of, or already have hypokalemia.

Kidney or liver disease

If you have kidney or liver problems, you are more likely to experience low blood sugar while taking Tresiba FlexTouch 200. Consult your doctor for information on how to avoid low blood sugar.

Pregnant or planning to become pregnant

It is not known if Tresiba FlexTouch 200 is safe to use during pregnancy. 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 to nurse your baby.

INTERACTIONS & CONTRAINDICATIONS

Do not use Tresiba If you experience episodes of hyperglycemia, or if you are hypersensitive to insulin degludec or any other ingredients in it.

Beta-blockers

Some of the signs and symptoms of low blood sugar, such as a rapid or pounding heartbeat, may be disguised with beta-blocker medication. Monitor your blood glucose levels frequently while taking these medications.

Thiazolidinediones (TZDs)

Using certain diabetes medicines called TZDs together with Tresiba FlexTouch 200 may cause heart failure in some people, even if you have never had any heart issues before. If you already have heart failure, it could get worse. Your treatment with TZDs and Tresiba may have to be adjusted or stopped. If you become fatigued, have swollen ankles or feet, experience shortness of breath, or suddenly gain weight, call your doctor right away or go to the emergency room.

Alcohol

Drinking alcohol can affect your blood sugar levels and cause them to drop too low. It is better to avoid drinking alcohol while using Tresiba.