Levemir (Insulin Detemir Subcutaneous) - Indications and Dosage

INDICATIONS AND USAGE

LEVEMIR is indicated for once- or twice-daily subcutaneous administration for the treatment of adult and pediatric patients with type 1 diabetes mellitus or adult patients with type 2 diabetes mellitus who require basal (long acting) insulin for the control of hyperglycemia.

DOSAGE AND ADMINISTRATION

LEVEMIR can be administered once- or twice-daily. The dose of LEVEMIR should be adjusted according to blood glucose measurements. The dosage of LEVEMIR should be individualized based on the physician’s advice, in accordance with the needs of the patient.

• For patients treated with Levemir once-daily, the dose should be administered with the evening meal or at bedtime.
• For patients who require twice-daily dosing for effective blood glucose control, the evening dose can be administered either with the evening meal, at bedtime, or 12 hours after the morning dose.

LEVEMIR should be administered by subcutaneous injection in the thigh, abdominal wall, or upper arm. Injection sites should be rotated within the same region. As with all insulins, the duration of action will vary according to the dose, injection site, blood flow, temperature, and level of physical activity.

Dose Determination for LEVEMIR

• For patients with type 1 or type 2 diabetes on basal-bolus treatment, changing the basal insulin to LEVEMIR can be done on a unit-to-unit basis. The dose of LEVEMIR should then be adjusted to achieve glycemic targets. In some patients with type 2 diabetes, more LEVEMIR may be required than NPH insulin. In a clinical study, the mean dose at end of treatment was 0.77 U/kg for LEVEMIR and 0.52 IU/kg for NPH human insulin (see Table 3).
• For patients currently receiving only basal insulin, changing the basal insulin to LEVEMIR can be done on a unit-to-unit basis.
• For insulin-naïve patients with type 2 diabetes who are inadequately controlled on oral antidiabetic drugs, LEVEMIR should be started at a dose of 0.1 to 0.2 U/kg once-daily in the evening or 10 units once- or twice-daily, and the dose adjusted to achieve glycemic targets.
• As with all insulins, close glucose monitoring is recommended during the transition and in the initial weeks thereafter. Dose and timing of concurrent short-acting insulins or other concomitant antidiabetic treatment may need to be adjusted.

HOW SUPPLIED

LEVEMIR is available in the following package sizes: each presentation containing 100 Units of insulin detemir per mL (U-100).

10 mL vial	NDC 0169-3687-12
3 mL PenFill® cartridges*	NDC 0169-3305-11
3 mL InnoLet®	NDC 0169-2312-11
3 mL FlexPen®	NDC 0169-6439-10

*LEVEMIR PenFill^® cartridges are for use with Novo Nordisk 3 mL PenFill^® cartridge compatible insulin delivery devices and NovoFine^® disposable needles.

RECOMMENDED STORAGE

Unused LEVEMIR should be stored between 2° and 8°C (36° to 46° F). Do not freeze. Do not use LEVEMIR if it has been frozen.

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), for up to 42 days, as long as it is kept as cool as possible and away from direct heat and light.

Unpunctured vials can be used until the expiration date printed on the label if they are stored in a refrigerator. Keep unused vials in the carton so they will stay clean and protected from light.

PenFill^® cartridges, FlexPen^® or InnoLet^®:

After initial use, a cartridge (PenFill^®) or a prefilled syringe (including FlexPen^® or InnoLet^®) may be used for up to 42 days if it is kept at room temperature, below 30°C (86°F). In-use cartridges and prefilled syringes in-use must NOT be stored in a refrigerator and must NOT be stored with the needle in place. Keep all cartridges and prefilled syringes away from direct heat and sunlight.

Not in-use (unopened) LEVEMIR PenFill^®, FlexPen^® or InnoLet^® can be used until the expiration date printed on the label if they are stored in a refrigerator. Keep unused cartridges and prefilled syringes in the carton so they will stay clean and protected from light.

The storage conditions are summarized in the following table:

	Not in-use (unopened) Room Temperature (below 30°C)	Not in-use (unopened) Refrigerated	In-use (opened) Room Temperature (below 30°C)
10 mL vial	42 days	Until expiration date	42 days refrigerated/room temperature
3 mL PenFill® cartridges	42 days	Until expiration date	42 days (Do not refrigerate)
3 mL InnoLet®	42 days	Until expiration date	42 days (Do not refrigerate)
3 mL FlexPen®	42 days	Until expiration date	42 days (Do not refrigerate)

Date of issue: May 16, 2007

Version: 3

Novo Nordisk^®, Levemir^®, NovoLog^®, FlexPen^®, InnoLet^®, PenFill^®, and NovoFine^® are registered trademarks owned by Novo Nordisk A/S.

© 2005/2007 Novo Nordisk Inc.

Levemir is covered by US Patent Nos. 5,750,497; 5,866,538; 6,011,007; 6,869,930 and other patents pending.

FlexPen is covered by US Patent Nos. 6,004,297; 6,235,004; 6,582,404 and other patents pending.

Manufactured for:

Novo Nordisk Inc., Princeton, NJ 08540

www.novonordisk-us.com

Manufactured by:

Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark