"Miriam E. Tucker
Medscape Medical News
The U.S. Food and Drug Administration (FDA) will now require a "for single patient use only" warning on all multidose pen devices used for injectable diabetes medications.
DOSAGE AND ADMINISTRATION
Patients treated with LEVEMIR once-daily should administer the dose with the evening meal or at bedtime.
Patients who require twice-daily dosing can administer the evening dose with the evening meal, at bedtime, or 12 hours after the morning dose.
The dose of LEVEMIR must be individualized based on clinical response. Blood glucose monitoring is essential in all patients receiving insulin therapy.
Patients adjusting the amount or timing of dosing with LEVEMIR should only do so under medical supervision with appropriate glucose monitoring [see WARNINGS AND PRECAUTIONS].
In patients with type 1 diabetes, LEVEMIR must be used in a regimen with rapid-acting or short-acting insulin.
LEVEMIR can be injected subcutaneously in the thigh, abdominal wall, or upper arm. As with all insulins, the rate of absorption, and consequently the onset and duration of action, may be affected by exercise and other variables, such as stress, intercurrent illness, or changes in co-administered medications or meal patterns.
When using LEVEMIR with a glucagon-like peptide (GLP)-1 receptor agonist, administer as separate injections. Never mix. It is acceptable to inject LEVEMIR and a GLP-1 receptor agonist in the same body region but the injections should not be adjacent to each other.
Initiation of LEVEMIR Therapy
The recommended starting dose of LEVEMIR in patients with type 1 diabetes should be approximately one-third of the total daily insulin requirements. Rapid-acting or short-acting, pre-meal insulin should be used to satisfy the remainder of the daily insulin requirements.
The recommended starting dose of LEVEMIR in patients with type 2 diabetes inadequately controlled on oral antidiabetic medications is 10 Units (or 0.1-0.2 Units/kg) given once daily in the evening or divided into a twice daily regimen.
The recommended starting dose of LEVEMIR in patients with type 2 diabetes inadequately controlled on a GLP-1 receptor agonist is 10 Units given once daily in the evening.
LEVEMIR doses should subsequently be adjusted based on blood glucose measurements. The dosages of LEVEMIR should be individualized under the supervision of a healthcare provider.
Converting to LEVEMIR from other insulin therapies
If converting from insulin glargine to LEVEMIR, the change can be done on a unit-to-unit basis.
If converting from NPH insulin, the change can be done on a unit-to-unit basis. However, some patients with type 2 diabetes may require more LEVEMIR than NPH insulin, as observed in one trial [see Clinical Studies].
As with all insulins, close glucose monitoring is recommended during the transition and in the initial weeks thereafter. Doses and timing of concurrent rapid-acting or short-acting insulins or other concomitant antidiabetic treatment may need to be adjusted.
Dosage Forms And Strengths
LEVEMIR solution for injection 100 Unit per mL is available as:
- 3 mL LEVEMIR FlexPen®
- 3 mL LEVEMIR FlexTouch®
- 10 mL vial
Storage And Handling
LEVEMIR is available in the following package sizes: each presentation containing 100 Units of insulin detemir per mL (U-100).
3 mL LEVEMIR FlexPen® NDC 0169-6439-10
3 mL LEVEMIR FlexTouch® NDC 0169-6438-10
10 mL vial NDC 0169-3687-12
FlexPen and FlexTouch can be used with NovoFine® or NovoTwist® disposable needles. Each FlexPen or FlexTouch is for use by a single patient. LEVEMIR FlexPen and LEVEMIR FlexTouch should 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 FlexPen, FlexTouch or vial still contains insulin.
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 FlexPen or LEVEMIR FlexTouch:
After initial use, the LEVEMIR FlexPen or 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 FlexPen or LEVEMIR FlexTouch away from direct heat and light at room temperature, below 30°C (86°F). Unrefrigerated LEVEMIR FlexPen or LEVEMIR FlexTouch should be discarded 42 days after they are first kept out of the refrigerator.
The storage conditions are summarized in Table 13:
Table 13: Storage Conditions for LEVEMIR FlexPen,
LEVEMIR FlexTouch, and vial
|Not in-use (unopened) Refrigerated||Not in-use (unopened) Room Temperature (below 30°C)||In-use (opened)|
|3 mL LEVEMIR FlexPen||Until expiration date||42 days*||42 days* Room Temperature (below 30°C) (Do not refrigerate)|
|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)|
|*The total time allowed at room temperature (below 30°C) is 42 days regardless of whether the product is in-use or not in-use.|
Preparation and handling
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].
Manufactured By: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark. Revised: 10/2013
Last reviewed on RxList: 12/2/2013
This monograph has been modified to include the generic and brand name in many instances.
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