INSULIN DEGLUDEC injection, solution

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

INSULIN DEGLUDEC (UNII: 54Q18076QB) (INSULIN DEGLUDEC - UNII:54Q18076QB)

Commercializzato da:

Novo Nordisk Pharma, Inc.

Via di somministrazione:

SUBCUTANEOUS

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

Insulin Degludec is indicated to improve glycemic control in patients 1 year of age and older with diabetes mellitus. Limitations of Use Insulin Degludec is contraindicated: Risk Summary Available data from one unpublished trial and the published literature with Insulin Degludec use during pregnancy have not identified a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. In a randomized, parallel-group, open-label actively controlled clinical trial that included 91 pregnant women with type 1 diabetes who were administered Insulin Degludec once daily and insulin aspart, beginning in gestational weeks 8 to 13 or prior to conception, no clear evidence of maternal or fetal risk associated with Insulin Degludec use was observed (see Data ). There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see Clinical Considerations). Rats and rabbits were exposed to insulin degludec in animal reproduction studies during organogene

Dettagli prodotto:

Insulin Degludec injection is available as a clear and colorless solution as follows: Table 17: Presentations of Insulin Degludec Insulin Degludec Presentation Total volume Concentration Total units available in presentation NDC number Max dose per injection Dose increment Package Size U-100 single-patient-use FlexTouch Pen 3 mL 100 units/mL 300 Units 73070-403-15 80 Units 1 Unit 5 pens/pack U-100 multiple-dose Vial 10 mL 100 units/mL 1,000 Units 73070-400-11 _ _ 1 vial/pack U-200 single-patient-use FlexTouch Pen 3 mL 200 units/mL 600 Units 73070-503-15 160 Units 2 Unit 3 pens/pack Additional Information about Insulin Degludec FlexTouch: Dispense in the original sealed carton with the enclosed Instructions for Use. Store Insulin Degludec vials in the original carton to protect from light. Store unused Insulin Degludec in a refrigerator (36ºF to 46ºF [2ºC to 8ºC]). Do not store in the freezer or directly adjacent to the refrigerator cooling element. Do not freeze. Do not use Insulin Degludec if it has been frozen. The storage conditions are summarized in Table 18: Table 18: Storage Conditions for Insulin Degludec Not in-use (unopened) In-use (opened) Refrigerated (36°F to 46°F [2°C to 8°C]) Room Temperature (up to 86°F [30°C]) Room Temperature (up to 86°F [30°C]) Refrigerated (36°F to 46°F [2°C to 8°C]) 3 mL single-patient-use Insulin Degludec U-100 FlexTouch Until expiration date 56 days (8 weeks) 56 days (8 weeks) 56 days (8 weeks) 10 mL multiple-dose Insulin Degludec U-100 Vial Until expiration date 56 days (8 weeks) 56 days (8 weeks) 56 days (8 weeks) 3 mL single-patient-use Insulin Degludec U-200 FlexTouch Until expiration date 56 days (8 weeks) 56 days (8 weeks) 56 days (8 weeks)

Stato dell'autorizzazione:

Biologic Licensing Application

Scheda tecnica

INSULIN DEGLUDEC- INSULIN DEGLUDEC INJECTION, SOLUTION
NOVO NORDISK PHARMA, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
INSULIN DEGLUDEC SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR INSULIN
DEGLUDEC.
INSULIN DEGLUDEC INJECTION, FOR SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 2015
THIS PRODUCT IS TRESIBA (INSULIN DEGLUDEC).
INDICATIONS AND USAGE
Insulin Degludec 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:
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Injection: Available as:
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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Not recommended for the treatment of diabetic ketoacidosis.
See Full Prescribing Information for important administration
instructions (2.1).
Inject Insulin Degludec subcutaneously into the thigh, upper arm, or
abdomen (2.1).
Rotate injection sites to reduce risk of lipodystrophy and localized
cutaneous amyloidosis (2.1).
For pediatric patients requiring less than 5 units of Insulin Degludec
each day, use an Insulin Degludec
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).
100 units/mL (U-100): 3 mL single-patient-use FlexTouch prefilled pen
(3).
®
100 units/mL (U-100): 10 mL multiple-dose vial (3).
200 units/mL (U-200): 3 mL single-patient-use FlexTouch prefilled pen
(3).
®
During episodes of hypoglycemia (4).
Hypersensitivity to insulin degludec o