Tresiba

Name: Tresiba

Tresiba Overview

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).

Uses of Tresiba

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. 

Manufacturer

  • Novo Nordisk, Inc.

Uses for Tresiba

Insulin degludec has the following uses:

Insulin degludec is indicated to improve glycemic control in adults with type 1 or type 2 diabetes mellitus.1

Insulin degludec has the following limitations of use:

Not recommended for treating diabetic ketoacidosis.1

Additional Information

AHFS First Release. For additional information until a more detailed monograph is developed and published, the manufacturer's labeling should be consulted. It is essential that the manufacturer's labeling be consulted for more detailed information on usual uses, dosage and administration, cautions, precautions, contraindications, potential drug interactions, laboratory test interferences, and acute toxicity.

Contraindications

Tresiba is contraindicated:

• During episodes of hypoglycemia [see Warnings and Precautions (5.3)]. • In patients with hypersensitivity to Tresiba or one of its excipients [see Warnings and Precautions (5.5)].

Principal display panel u-100

NDC 0169-2660-15

List: 266015

Tresiba®

FlexTouch®

(insulin degludec injection)

For Single Patient Use Only

100 units/mL (U-100)

5×3 mL Prefilled Pens

For subcutaneous use only

Rx Only

Recommended for use with NovoFine®,
NovoFine® Plus or NovoTwist® disposable needles.

Keep in a cold place until first use.

Store at 36°F to 46°F (2°C to 8°C).

Do not freeze.

After first use, store between 36°F to 86°F (2°C to 30°C).

Protect from light.

Principal display panel u-200

NDC 0169-2550-13

List: 255013

Tresiba®

FlexTouch®

(insulin degludec injection)

For Single Patient Use Only

200 units/mL (U-200)

3×3 mL Prefilled Pens

For subcutaneous use only

Rx Only

Recommended for use with
NovoFine®, NovoFine® Plus or NovoTwist®
disposable needles.

Keep in a cold place
until first use.

Store at 36°F to 46°F (2°C to 8°C).

Do not freeze.

After first use, store between 36°F to 86°F (2°C to 30°C).

Protect from light.

Tresiba 
insulin degludec injection injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0169-2660
Route of Administration SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
INSULIN DEGLUDEC (INSULIN DEGLUDEC) INSULIN DEGLUDEC 100 U  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 19.6 mg  in 1 mL
PHENOL 1.50 mg  in 1 mL
METACRESOL 1.72 mg  in 1 mL
ZINC 32.7 ug  in 1 mL
WATER  
HYDROCHLORIC ACID  
SODIUM HYDROXIDE  
Packaging
# Item Code Package Description
1 NDC:0169-2660-15 5 SYRINGE, PLASTIC in 1 CARTON
1 3 mL in 1 SYRINGE, PLASTIC
2 NDC:0169-2660-97 1 SYRINGE, PLASTIC in 1 CARTON
2 3 mL in 1 SYRINGE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA203314 09/25/2015
Tresiba 
insulin degludec injection injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0169-2550
Route of Administration SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
INSULIN DEGLUDEC (INSULIN DEGLUDEC) INSULIN DEGLUDEC 200 U  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN 19.6 mg  in 1 mL
PHENOL 1.50 mg  in 1 mL
METACRESOL 1.72 mg  in 1 mL
ZINC 71.9 ug  in 1 mL
WATER  
HYDROCHLORIC ACID  
SODIUM HYDROXIDE  
Packaging
# Item Code Package Description
1 NDC:0169-2550-13 3 SYRINGE, PLASTIC in 1 CARTON
1 3 mL in 1 SYRINGE, PLASTIC
2 NDC:0169-2550-97 1 SYRINGE, PLASTIC in 1 CARTON
2 3 mL in 1 SYRINGE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA203314 09/25/2015
Labeler - Novo Nordisk (622920320)
Establishment
Name Address ID/FEI Operations
Novo Nordisk A/S 305914798 MANUFACTURE(0169-2660, 0169-2550)
Establishment
Name Address ID/FEI Operations
Novo Nordisk A/S 305156788 API MANUFACTURE(0169-2660, 0169-2550)
Establishment
Name Address ID/FEI Operations
Novo Nordisk Pharmaceuticals Industries, Inc. 622920320 MANUFACTURE(0169-2660, 0169-2550)
Revised: 12/2016   Novo Nordisk

What should I avoid while using Tresiba?

Insulin can cause low blood sugar. Avoid driving or operating machinery until you know how this medicine will affect you.

Avoid medication errors by always checking the medicine label before injecting your insulin.

Avoid drinking alcohol. It can cause low blood sugar and may interfere with your diabetes treatment.

Tresiba side effects

Get emergency medical help if you have signs of an allergic reaction to Tresiba: hives, itching, skin rash; wheezing, tiredness, trouble breathing; feeling like you might pass out; nausea, diarrhea; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • fluid retention - weight gain, swelling in your hands or feet, feeling short of breath; or

  • low potassium - leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling.

Common Tresiba side effects may include:

  • low blood sugar;

  • itching, mild skin rash; or

  • thickening or hollowing of the skin where you injected the medicine.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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