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Lantus

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Lantus

Lantus

INDICATIONS

LANTUS is indicated to improve glycemic control in adults and children with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus.

Important Limitations of Use

  • LANTUS is not recommended for the treatment of diabetic ketoacidosis. Intravenous short-acting insulin is the preferred treatment for this condition.

DOSAGE AND ADMINISTRATION

Dosing

LANTUS is a recombinant human insulin analog for once daily subcutaneous administration with potency that is approximately the same as the potency of human insulin. LANTUS exhibits a relatively constant glucose-lowering profile over 24 hours that permits once-daily dosing.

LANTUS may be administered at any time during the day. LANTUS should be administered subcutaneously once a day at the same time every day. The dose of LANTUS 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 LANTUS, should only do so under medical supervision with appropriate glucose monitoring [see WARNINGS AND PRECAUTIONS]

In patients with type 1 diabetes, LANTUS must be used in regimens with short-acting insulin.

The intended duration of activity of LANTUS is dependent on injection into subcutaneous tissue [see CLINICAL PHARMACOLOGY]. LANTUS should not be administered intravenously or via an insulin pump. Intravenous administration of the usual subcutaneous dose could result in severe hypoglycemia [see WARNINGS AND PRECAUTIONS].

As with all insulins, injection sites should be rotated within the same region (abdomen, thigh, or deltoid) from one injection to the next to reduce the risk of lipodystrophy [See ADVERSE REACTIONS].

In clinical studies, there was no clinically relevant difference in insulin glargine absorption after abdominal, deltoid, or thigh subcutaneous administration. As for 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 drugs or meal patterns.

Initiation of LANTUS therapy

The recommended starting dose of LANTUS in patients with type 1 diabetes should be approximately one-third of the total daily insulin requirements. Short-acting, premeal insulin should be used to satisfy the remainder of the daily insulin requirements.

The recommended starting dose of LANTUS in patients with type 2 diabetes who are not currently treated with insulin is 10 units (or 0.2 Units/kg) once daily, which should subsequently be adjusted to the patient's needs.

The dose of LANTUS should be adjusted according to blood glucose measurements. The dosage of LANTUS should be individualized under the supervision of a healthcare provider in accordance with the needs of the patient.

Converting to LANTUS from other insulin therapies

If changing from a treatment regimen with an intermediate- or long-acting insulin to a regimen with LANTUS, the amount and timing of shorter-acting insulins and doses of any oral anti-diabetic drugs may need to be adjusted.

  • If transferring patients from once-daily NPH insulin to once-daily LANTUS, the recommended initial LANTUS dose is the same as the dose of NPH that is being discontinued.
  • If transferring patients from twice-daily NPH insulin to once-daily LANTUS, the recommended initial LANTUS dose is 80% of the total NPH dose that is being discontinued. This dose reduction will lower the likelihood of hypoglycemia [see WARNINGS AND PRECAUTIONS].

HOW SUPPLIED

Dosage Forms And Strengths

LANTUS solution for injection 100 Units per mL is available as:

  • 10 mL Vial (1000 Units/10 mL)
  • 3 mL Cartridge systems for use only in OptiClik® (300 Units/3 mL)
  • 3 mL SoloStar® disposable insulin device (300 Units/3 mL)

Storage And Handling

LANTUS solution for injection 100 units per mL (U-100) is available as:

Dosage Unit/Strength Package size NDC # 00886
10 mL vials
100 Units/mL Pack of 1 2220-33
3 mL cartridge system*
100 Units/mL package of 5 2220-52
3 mL SoloStar® disposable insulin device
100 Units/mL package of 5 2220-60
*Cartridge systems are for use only in OptiClik® (Insulin Delivery Device)

Needles are not included in the packs. BD Ultra-Fine™ needlesto be used in conjunction with SoloStar and OptiClik are sold separately and are manufactured by BD.

Storage

LANTUS should not be stored in the freezer and should not be allowed to freeze. Discard LANTUS if it has been frozen.

Unopened Vial/Cartridge system/SoloStar disposable insulin device

Unopened LANTUS vials, cartridge systems and SoloStar device should be stored in a refrigerator, 36°F - 46°F (2°C - 8°C). Discard after the expiration date.

Open (In-Use) Vial

Vials must be discarded 28 days after being opened. If refrigeration is not possible, the open vial can be kept unrefrigerated for up to 28 days away from direct heat and light, as long as the temperature is not greater than 86°F (30°C).

Open (In-Use) Cartridge system

The opened (in-use) cartridge system in OptiClik should NOT be refrigerated but should be kept at room temperature (below 86°F [30°C]) away from direct heat and light. The opened (in-use) cartridge system in OptiClik must be discarded 28 days after being opened. Do not store OptiClik , with or without cartridge system, in a refrigerator at any time.

Open (In-Use) SoloStar disposable insulin device

The opened (in-use) SoloStar should NOT be refrigerated but should be kept at room temperature (below 86°F [30°C]) away from direct heat and light. The opened (in-use) SoloStar device must be discarded 28 days after being opened.

These storage conditions are summarized in the following table:

  Not in-use (unopened) Refrigerated Not in-use (unopened) Room Temperature In-use (opened) (See Temperature Below)
10 mL Vial Until expiration date 28 days 28 days Refrigerated or room temperature
3 mL Cartridge system Until expiration date 28 days 28 days Refrigerated or room temperature
3 mL Cartridge system® inserted into OptiClik 28 days Room temperature only (Do not refrigerate)
3 mL SoloStar® disposable insulin device Until expiration date 28 days 28 days Room temperature only (Do not refrigerate)

Preparation and handling

Parenteral drug products should be inspected visually prior to administration whenever the solution and the container permit. LANTUS must only be used if the solution is clear and colorless with no particles visible.

Mixing and diluting: LANTUS must NOT be diluted or mixed with any other insulin or solution [See WARNINGS AND PRECAUTIONS].

Vial: The syringes must not contain any other medicinal product or residue.

Cartridge system/SoloStar: If OptiClik, the Insulin Delivery Device used with the LANTUS cartridge system, or SoloStar disposable insulin device, malfunctions, LANTUS may be drawn from the cartridge system or from SoloStar into a U-100 syringe and injected.

sanofi-aventis U.S. LLC Bridgewater, NJ 08807, Rev. June 2009

Last reviewed on RxList: 6/17/2013
This monograph has been modified to include the generic and brand name in many instances.

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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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