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:

REMEDYREPACK INC.

Administration route:

SUBCUTANEOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

LEVEMIR is indicated to improve glycemic control in adults and children with diabetes mellitus. Important Limitations of Use: - LEVEMIR is not recommended for the treatment of diabetic ketoacidosis. Intravenous rapid-acting or short-acting insulin is the preferred treatment for this condition. LEVEMIR is contraindicated in patients with hypersensitivity to LEVEMIR or any of its excipients. Reactions have included anaphylaxis [ see Warnings and Precautions (5.5) and Adverse Reactions (6.1) ]. Pregnancy Category B Risk Summary The background risk of birth defects, pregnancy loss, or other adverse events that exists for all pregnancies is increased in pregnancies complicated by hyperglycemia. Female patients should be advised to tell their physician if they intend to become, or if they become pregnant while taking LEVEMIR. A randomized controlled clinical trial of pregnant women with type I diabetes using LEVEMIR during pregnancy did not show an increase in the risk of fetal abnormal

Product summary:

LEVEMIR is available in the following package sizes: each presentation containing 100 Units of insulin detemir per mL (U-100). FlexTouch can be used with NovoFine ® or NovoTwist ® disposable needles. Each FlexTouch is for use by a single patient. LEVEMIR FlexTouch must never be shared between patients, even if the needle is changed. Unused (unopened) LEVEMIR should be stored in the refrigerator between 2° and 8°C (36° to 46°F). 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. Unused (unopened) LEVEMIR can be kept until the expiration date printed on the label if it is stored in a refrigerator. Keep unused LEVEMIR in the carton so that it stays clean and protected from light. If refrigeration is not possible, unused (unopened) LEVEMIR can be kept unrefrigerated at room temperature, below 30°C (86°F) as long as it is kept as cool as possible and away from direct heat and light. Unrefrigerated LEVEMIR should be discarded 42 days after it is first kept out of the refrigerator, even if the FlexTouch or vial still contains insulin. Vials: After initial use, vials should be stored in a refrigerator, never in a freezer. If refrigeration is not possible, the in-use vial can be kept unrefrigerated at room temperature, below 30°C (86°F) as long as it is kept as cool as possible and away from direct heat and light. Refrigerated LEVEMIR vials should be discarded 42 days after initial use. Unrefrigerated LEVEMIR vials should be discarded 42 days after they are first kept out of the refrigerator. LEVEMIR FlexTouch: After initial use, the LEVEMIR FlexTouch must NOT be stored in a refrigerator and must NOT be stored with the needle in place. Keep the opened (in use) LEVEMIR FlexTouch away from direct heat and light at room temperature, below 30°C (86°F). Unrefrigerated LEVEMIR FlexTouch should be discarded 42 days after they are first kept out of the refrigerator. Always remove the needle after each injection and store the LEVEMIR FlexTouch without a needle attached. This prevents contamination and/or infection, or leakage of insulin, and will ensure accurate dosing. Always use a new needle for each injection to prevent contamination. The storage conditions are summarized in Table 13: Not in-use (unopened) Refrigerated Not in-use (unopened) Room Temperature (below 30°C) In-use (opened) 3 mL LEVEMIR FlexTouch Until expiration date 42 days * 42 days * Room Temperature (below 30°C) (Do not refrigerate) 10 mL vial Until expiration date 42 days * 42 days  * Refrigerated or Room Temperature (below 30°C) Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. LEVEMIR should be inspected visually prior to administration and should only be used if the solution appears clear and colorless. Mixing and diluting: LEVEMIR must NOT be mixed or diluted with any other insulin or solution [See Warnings and Precautions (5.3)] .

Authorization status:

New Drug Application

Summary of Product characteristics

LEVEMIR- INSULIN DETEMIR INJECTION, SOLUTION
REMEDYREPACK INC.
----------
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 [RDNA ORIGIN] INJECTION) SOLUTION FOR SUBCUTANEOUS
INJECTION
INITIAL U.S. APPROVAL: 2005
RECENT MAJOR CHANGES
Warnings and Precautions ( 5.1) 02/2015
INDICATIONS AND USAGE
LEVEMIR is a long-acting human insulin analog indicated to improve
glycemic control in adults and children with diabetes
mellitus. ( 1)
Important Limitations of Use:
Not recommended for treating diabetic ketoacidosis. Use intravenous,
rapid-acting or short-acting insulin instead.
DOSAGE AND ADMINISTRATION
The starting dose should be individualized based on the type of
diabetes and whether the patient is insulin-naïve ( 2.1,
2.2, 2.3)
Administer subcutaneously once daily or in divided doses twice daily.
Once daily administration should be given with
the evening meal or at bedtime ( 2.1)
Rotate injection sites within an injection area (abdomen, thigh, or
deltoid) to reduce the risk of lipodystrophy ( 2.1)
Converting from other insulin therapies may require adjustment of
timing and dose of LEVEMIR. Closely monitor
glucoses especially upon converting to LEVEMIR and during the initial
weeks thereafter ( 2.3)
DOSAGE FORMS AND STRENGTHS
Solution for injection 100 Units/mL (U-100) in
3 mL LEVEMIR FlexTouch
10 mL vial ( 3)
CONTRAINDICATIONS
Do not use in patients with hypersensitivity to LEVEMIR or any of its
excipients ( 4)
WARNINGS AND PRECAUTIONS
Never Share a LEVEMIR FlexTouch between patients, even if the needle
is changed ( 5.1).
Dose adjustment and monitoring: Monitor blood glucose in all patients
treated with insulin. Insulin regimens should be
modified cautiously and only under medical supervision ( 5.2)
Administration: Do not dilute or mix with any other insulin or
solution. Do not administer subcutaneously via an insulin
pump, intramuscularly, or intravenously becau