background image

1

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use TRESIBA

®

 

safely and effectively. See full prescribing information for TRESIBA

®

.

TRESIBA

®

 (insulin degludec injection), for subcutaneous use 

Initial U.S. Approval: 2015

———  RECENT MAJOR CHANGES  ———

Dosage and Administration (2.1) 

 

 

11/2018

Warnings and Precautions (5.1) 

 

 

11/2018

———  INDICATIONS AND USAGE  ———

TRESIBA

®

 is a long-acting human insulin analog indicated to improve glycemic control in 

patients 1 year of age and older with diabetes mellitus (1).
Limitations of Use:
• Not recommended for treating diabetic ketoacidosis.

———  DOSAGE AND ADMINISTRATION  ———

• See Full Prescribing Information for important administration instructions (2.1).
• Rotate injection sites to reduce the risk of lipodystrophy (2.1).
• For pediatric patients requiring less than 5 units of TRESIBA

®

 each day, use a TRESIBA

®

 

U-100 vial (2.1).

• In adults, inject subcutaneously once daily at any time of day (2.2).
• In pediatric patients inject subcutaneously once daily at the same time every day (2.2).
• Individualize dose based on type of diabetes, metabolic needs, blood glucose monitoring 

results and glycemic control goal (2.2).

• The recommended days between dose increases are 3 to 4 days (2.2).
• See Full Prescribing Information for recommended starting dose in insulin naïve patients and 

patients already on insulin therapy (2.3, 2.4).

 ———  DOSAGE FORMS AND STRENGTHS  ———

TRESIBA

®

 injection is available in the following package sizes:

• 100 units/mL (U-100): 3 mL single-patient-use FlexTouch

®

 (3).

• 200 units/mL (U-200): 3 mL single-patient-use FlexTouch

®

 (3).

• 100 units/mL (U-100): 10 mL multiple-dose vial (3).

———  CONTRAINDICATIONS  ———

• During episodes of hypoglycemia (4).
• Hypersensitivity to TRESIBA

®

 or one of its excipients (4).

———  WARNINGS AND PRECAUTIONS  ———

 Never share

 a TRESIBA

®

 FlexTouch

®

 pen between patients, even if the needle is changed (5.1).

• 

Hyper- or hypoglycemia with changes in insulin regimen:

 Carry out under close medical 

supervision and increase frequency of blood glucose monitoring (5.2).

• 

Hypoglycemia:

 May be life-threatening. Increase monitoring with changes to: insulin dosage, 

co-administered glucose lowering medications, meal pattern, physical activity; and in 

patients with renal impairment or hepatic impairment or hypoglycemia unawareness (5.3, 

5.4, 6.1).

• 

Hypoglycemia due to medication errors: 

Accidental mix-ups between insulin products can 

occur. Instruct patients to check insulin labels before injection. DO NOT transfer TRESIBA

®

 

into a syringe for administration as overdosage and severe hypoglycemia can result (5.4).

• 

Hypersensitivity reactions:

 Severe, life-threatening, generalized allergy, including 

anaphylaxis, can occur. Discontinue TRESIBA

®

, monitor and treat if indicated (5.5).

• 

Hypokalemia:

 May be life-threatening. Monitor potassium levels in patients at risk for 

hypokalemia and treat if indicated (5.6).

 Fluid retention and heart failure with concomitant use of Thiazolidinediones (TZDs):

 Observe 

for signs and symptoms of heart failure; consider dosage reduction or discontinuation if heart 

failure occurs (5.7).

———  ADVERSE REACTIONS  ———

Adverse reactions commonly associated with TRESIBA

®

 are:

• hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, pruritus, rash, 

edema and weight gain (6.1).

To report SUSPECTED ADVERSE REACTIONS, contact Novo Nordisk at  

1-800-727-6500 or FDA at 1−800−FDA−1088 or www.fda.gov/medwatch.

———  DRUG INTERACTIONS  ———

• 

Drugs that may increase the risk of hypoglycemia:

 antidiabetic agents, ACE inhibitors, 

angiotensin II receptor blocking agents, disopyramide, fibrates, fluoxetine, monoamine 

oxidase inhibitors, pentoxifylline, pramlintide, propoxyphene, salicylates, somatostatin 

analog (e.g., octreotide), and sulfonamide antibiotics (7).

• 

Drugs that may decrease the blood glucose lowering effect:

 atypical antipsychotics, 

corticosteroids, danazol, diuretics, estrogens, glucagon, isoniazid, niacin, oral 

contraceptives, phenothiazines, progestogens (e.g., in oral contraceptives), protease 

inhibitors, somatropin, sympathomimetic agents (e.g., albuterol, epinephrine, terbutaline), 

and thyroid hormones (7).

• 

Drugs that may increase or decrease the blood glucose lowering effect:

 Alcohol, beta-

blockers, clonidine, lithium salts, and pentamidine (7).

• 

Drugs that may blunt the signs and symptoms of hypoglycemia:

 beta-blockers, clonidine, 

guanethidine, and reserpine (7).

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient 

labeling.

Revised: 11/2018

FULL PRESCRIBING INFORMATION: CONTENTS*

INDICATIONS AND USAGE

DOSAGE AND ADMINISTRATION

 

2.1   Important Administration Instructions

 

2.2   General Dosing Instructions

 

2.3   Starting Dose in Insulin Naïve Patients

 

2.4   Starting Dose in Patients Already on Insulin Therapy

DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

WARNINGS AND PRECAUTIONS

 

5.1   Never Share a TRESIBA

®

 FlexTouch

®

 Pen, Needle, or Syringe Between Patients

 

5.2   Hyperglycemia or Hypoglycemia with Changes in Insulin Regimen

 

5.3   Hypoglycemia

 

5.4   Hypoglycemia Due to Medication Errors

 

5.5   Hypersensitivity and Allergic Reactions

 

5.6   Hypokalemia

 

5.7   Fluid Retention and Congestive Heart Failure with Concomitant Use of a PPAR 

Gamma Agonist

ADVERSE REACTIONS

 

6.1   Clinical Trial Experience

 

6.2   Immunogenicity

DRUG INTERACTIONS

USE IN SPECIFIC POPULATIONS

 

8.1   Pregnancy

 

8.2   Lactation

 

8.4   Pediatric  Use

 

8.5   Geriatric  Use

 

8.6   Renal  Impairment

 

8.7   Hepatic  Impairment

10 OVERDOSAGE
11 DESCRIPTION
12 

CLINICAL PHARMACOLOGY

 

12.1   Mechanism of Action

 

12.2   Pharmacodynamics

 

12.3   Pharmacokinetics

13 

NONCLINICAL TOXICOLOGY

 

13.1   Carcinogenesis, Mutagenesis, Impairment of Fertility

14 

CLINICAL STUDIES

 

14.1   Type 1 Diabetes – Adult

 

14.2   Type 1 Diabetes – Pediatric Patients 1 Year of Age and Older

 

14.3  Type 2 Diabetes – Adult

 

14.4  Safety Outcomes Trial

16 

HOW SUPPLIED/STORAGE AND HANDLING

 

16.1   How  Supplied

 

16.2   Recommended  Storage

17 

PATIENT COUNSELING INFORMATION

*Sections or subsections omitted from the full prescribing information are not listed.

Содержание FlexTouch

Страница 1: ...heart failure with concomitant use of Thiazolidinediones TZDs Observe for signs and symptoms of heart failure consider dosage reduction or discontinuation if heart failure occurs 5 7 ADVERSE REACTIONS...

Страница 2: ...le prefilled pens should never be shared between patients even if the needle is changed Patients using TRESIBA vials should never share needles or syringes with another person Sharing poses a risk for...

Страница 3: ...etes percentages of adult and pediatric patients with type 1 diabetes randomized to TRESIBA who experienced at least one episode of hypoglycemia in clinical trials see Clinical Studies 14 and adults w...

Страница 4: ...observed with human insulin which were probably secondary to maternal hypoglycemia 8 2 Lactation Risk Summary There are no data on the presence of insulin degludec in human milk the effects on the bre...

Страница 5: ...TRESIBA at steady state was independent of age Geriatrics Pharmacokinetic and pharmacodynamic response of TRESIBA was compared in 13 younger adult 18 35 years and 14 geriatric 65 years subjects with t...

Страница 6: ...once daily according to the approved labeling The any time each day TRESIBA arm was designed to simulate a worst case scenario injection schedule of alternating short and long once daily dosing inter...

Страница 7: ...in HbA1c was analyzed using ANOVA with treatment region sex and anti diabetic treatment at screening as fixed effects and age and baseline HbA1c as covariates In Study E there were 12 3 of subjects in...

Страница 8: ...administered in both treatment arms The mean age of the trial population was 55 7 years and mean duration of diabetes was 7 7 years 58 6 were male 61 3 were White 7 6 Black or African American 21 0 w...

Страница 9: ...vial pack U 200 single patient use FlexTouch Pen 3 mL 200 units mL 600 Units 0169 2550 13 160 Units 2 Unit 3 pens pack TRESIBA U 100 FlexTouch dials in 1 unit increments TRESIBA U 200 FlexTouch dials...

Страница 10: ...hem Never inject TRESIBA into a vein or muscle Never use a syringe to remove TRESIBA from the FlexTouch pen What should I avoid while taking TRESIBA While taking TRESIBA do not Drive or operate heavy...

Страница 11: ...e Figure B Figure B Step 2 Check the liquid in the Pen See Figure C TRESIBA should look clear and colorless Do not use it if it looks cloudy or colored Figure C Step 3 Select a new needle Pull off the...

Страница 12: ...ing the Pen NovoFine NovoTwist Figure R Figure S Step 16 Replace the Pen cap by pushing it straight on See Figure T Figure T After your injection Put your used TRESIBA FlexTouch Pen and needles in a F...

Страница 13: ...se counter Dose selector Dose pointer Dose button Figure A Step 1 Pull Pen cap straight off See Figure B Figure B Step 2 Check the liquid in the Pen See Figure C TRESIBA should look clear and colorles...

Страница 14: ...needle attached Storing without the needle attached helps prevent leaking blocking of the needle and air from entering the Pen NovoFine NovoTwist Figure R Figure S Step 16 Replace the Pen cap by push...

Страница 15: ...let any air bubbles rise to the top See Figure G Figure G Step 7 Slowly push the plunger up until the tip of the plunger reaches the line for your prescribed TRESIBA dose See Figure H Figure H Step 8...

Страница 16: ...are kept in the refrigerator After 56 days throw away TRESIBA vials that have been kept at room temperature below 86 F 30 C Vial in use Store the TRESIBA vial you are currently using in the refrigera...

Отзывы:

Похожие инструкции для FlexTouch