LANTUS is indicated for once-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.

LANTUS is a recombinant human insulin analog. Its potency is approximately the same as human insulin. It 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. For patients adjusting timing of dosing with LANTUS, see WARNINGS and PRECAUTIONS, Hypoglycemia. LANTUS is not intended for intravenous administration (see PRECAUTIONS). Intravenous administration of the usual subcutaneous dose could result in severe hypoglycemia. The desired blood glucose levels as well as the doses and timing of antidiabetes medications must be determined individually. Blood glucose monitoring is recommended for all patients with diabetes. The prolonged duration of activity of LANTUS is dependent on injection into subcutaneous space.

As with all insulins, injection sites within an injection area (abdomen, thigh, or deltoid) must be rotated from one injection to the next.

In clinical studies, there was no 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.

LANTUS is not the insulin of choice for the treatment of diabetes ketoacidosis. Intravenous short-acting insulin is the preferred treatment.

Pediatric Use

LANTUS can be safely administered to pediatric patients ≥ 6 years of age. Administration to pediatric patients < 6 years has not been studied. Based on the results of a study in pediatric patients, the dose recommendation for changeover to LANTUS is the same as described for adults in DOSAGE AND ADMINISTRATION, Changeover to LANTUS.

Initiation of LANTUS Therapy

In a clinical study with insulin naïve patients with type 2 diabetes already treated with oral antidiabetes drugs, LANTUS was started at an average dose of 10 IU once daily, and subsequently adjusted according to the patient's need to a total daily dose ranging from 2 to 100 IU.

Changeover to LANTUS

If changing from a treatment regimen with an intermediate- or long-acting insulin to a regimen with LANTUS, the amount and timing of short-acting insulin or fast-acting insulin analog or the dose of any oral antidiabetes drug may need to be adjusted. In clinical studies, when patients were transferred from once-daily NPH human insulin or ultralente human insulin to once-daily LANTUS, the initial dose was usually not changed. However, when patients were transferred from twice-daily NPH human insulin to LANTUS once daily, to reduce the risk of hypoglycemia, the initial dose (IU) was usually reduced by approximately 20% (compared to total daily IU of NPH human insulin) and then adjusted based on patient response (see PRECAUTIONS, Hypoglycemia).

A program of close metabolic monitoring under medical supervision is recommended during transfer and in the initial weeks thereafter. The amount and timing of short-acting insulin or fast- acting insulin analog may need to be adjusted. This is particularly true for patients with acquired antibodies to human insulin needing high-insulin doses and occurs with all insulin analogs. Dose adjustment of LANTUS and other insulins or oral antidiabetes drugs may be required; for example, if the patient's timing of dosing, weight or lifestyle changes, or other circumstances arise that increase susceptibility to hypoglycemia or hyperglycemia (see PRECAUTIONS, Hypoglycemia).

The dose may also have to be adjusted during intercurrent illness (see PRECAUTIONS, Intercurrent Conditions).

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 PRECAUTIONS, General).

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.

LANTUS 100 units per mL (U-100) is available in the following package size:

10 mL vials (NDC 0088-2220-33)
3 mL cartridge system*, package of 5 (NDC 0088-2220-52)

Needles are not included in the packs.

BD Ultra-Fine™ needles^‡ to be used in conjunction with SoloStar and OptiClik are sold separately and are manufactured by BD.

*Cartridge systems are for use only in OptiClik® (Insulin Delivery Device) 3 mL SoloStar® disposable insulin device, package of 5 (NDC 0088-2220-60)
^‡ The brands listed are the trademarks of their respective owners and are not trademarks of sanofi-aventis U.S. LLC

Storage

Unopened Vial/Cartridge system/SoloStar® disposable insulin device

Unopened LANTUS vials, cartridge systems and SoloStar® should be stored in a refrigerator, 36°F - 46°F (2°C - 8°C). LANTUS should not be stored in the freezer and it should not be allowed to freeze. Discard if it has been frozen.

Open (In-Use) Vial

Opened vials, whether or not refrigerated, must be used within 28 days after the first use. They must be discarded if not used within 28 days. 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® kept at room temperature must be discarded after 28 days. 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 ® kept at room temperature must be discarded after 28 days.

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

These storage conditions are summarized in the following table:

Rev. March 2007. Sanofi-aventis U.S. LLC Bridgewater, NJ 08807. Country of Origin: Germany. www.lantus.com. OptiClik® and SoloStar® are a registered trademark of sanofi-aventis U.S. LLC. FDA Rev date: 4/25/2007

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