LEVEMIR- insulin detemir injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

INSULIN DETEMIR (UNII: 4FT78T86XV) (INSULIN DETEMIR - UNII:4FT78T86XV)

Available from:

Novo Nordisk

INN (International Name):

INSULIN DETEMIR

Composition:

INSULIN DETEMIR 100 [iU] in 1 mL

Administration route:

SUBCUTANEOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

LEVEMIR is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. Limitations of Use LEVEMIR is not recommended for the treatment of diabetic ketoacidosis. LEVEMIR is contraindicated: Risk Summary Available data from published studies and postmarketing case reports with LEVEMIR use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In a randomized, parallel-group, open-label clinical trial that included 152 pregnant women with type 1 diabetes who were administered LEVEMIR once or twice daily, beginning in gestational weeks 8 to 12 or prior to conception, no clear evidence of maternal or fetal risk associated with LEVEMIR was observed (see Data). There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see Clinical Considerations). Animal reproduction studies were conducted in non-diabetic pregnant rats and rabbits with insulin detemir administrat

Product summary:

LEVEMIR (insulin detemir) injection 100 units/mL (U-100) is a clear and colorless solution available in the following presentations: Presentation NDC 3 mL Single-patient-use FlexPen pen 0169-6432-10 10 mL Multiple-dose vial 0169-3687-12 Additional Information about LEVEMIR FlexPen: Dispense in the original sealed carton with the enclosed Instructions for Use. Store unused (unopened) LEVEMIR in the refrigerator between 36° to 46°F (2° and 8°C). Do not store in the freezer or directly adjacent to the refrigerator cooling element. Do not freeze. Do not use LEVEMIR if it has been frozen. Keep unused LEVEMIR in the carton so that it stays clean and protected from light. Remove the needle from the LEVEMIR FlexPen pen after each injection and store without a needle attached. Use a new needle for each injection. The storage conditions for vials and LEVEMIR FlexPen prefilled pens are summarized in Table 11: LEVEMIR Presentation Not in-use (unopened) In-use (opened) Refrigerated (36°F to 46°F [2°C and 8°C]) Room Temperature (up to 86°F [30°C]) Refrigerated (36°F to 46°F [2°C and 8°C]) Room Temperature (up to 86°F [30°C]) 3 mL single-patient-use LEVEMIR FlexPen Until expiration date 42 days Do not refrigerate 42 days 10 mL multiple-dose vial Until expiration date 42 days 42 days 42 days

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

LEVEMIR- INSULIN DETEMIR INJECTION, SOLUTION
NOVO NORDISK
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LEVEMIR SAFELY AND
EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR LEVEMIR.
LEVEMIR (INSULIN DETEMIR) INJECTION, FOR SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 2005
INDICATIONS AND USAGE
LEVEMIR is a long-acting human insulin analog indicated to improve
glycemic control in adult and pediatric
patients with diabetes mellitus (1).
Limitations of Use:
Not recommended for the treatment of diabetic ketoacidosis.
DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Injection: 100 units/mL (U-100) of insulin detemir available as:
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
Adverse reactions associated with LEVEMIR include hypoglycemia,
allergic reactions, injection site
reactions, lipodystrophy, rash and pruritus (6).
®
®
See Full Prescribing Information for important administration
instructions (2.1).
Inject subcutaneously into the thigh, upper arm, or abdomen (2.1).
Rotate injection sites to reduce risk of lipodystrophy and localized
cutaneous amyloidosis (2.1).
Individualize and titrate the dose of LEVEMIR based on the patient’s
metabolic needs, blood glucose
monitoring results, and glycemic control goal (2.2).
Administer subcutaneously once daily or in divided doses twice daily
(2.2).
See Full Prescribing Information for recommended starting dose in
insulin naïve patients and patients
already on insulin therapy (2.3, 2.4).
3 mL single-patient-use FlexPen prefilled pen (3)
®
10 mL multiple-dose vial (3)
During episodes of hypoglycemia (4)
Hypersensitivity to insulin detemir or any of the excipients in
LEVEMIR (4)
_Never Share_ a LEVEMIR FlexPen, insulin syringe, or needle between
patients, even if the needle is
changed (5.1).
_Hyperglycemia or hypoglycemia with changes in insulin regimen: _Make
changes to a patient’s insulin
regimen (e.g., insulin strength,