LANTUS SOLOSTAR
Generic Name: Insulin Glargine
Strength & Packaging: 100 IU/mL, 1 pre-filled pen of 3 mL
Dosage Form: Sterile solution for subcutaneous injection in a SoloStar prefilled pen
Category: Long-acting insulin analog for blood glucose control. Official labeling describes Lantus SoloStar as insulin glargine injection 100 units/mL (U-100) in a 3 mL single-patient-use prefilled pen.

Product Name & Packaging

Product Name: Lantus SoloStar
Generic Name: Insulin Glargine
Strength: 100 IU/mL (U-100)
Presentation: 3 mL pre-filled SoloStar pen
Total Content per Pen: 300 units per 3 mL pen
Pack Format for this listing: 1 pre-filled pen of 3 mL
Official U.S. labeling identifies the product form as a 3 mL single-patient-use SoloStar prefilled pen; carton counts may vary by market.

Description

Lantus SoloStar contains insulin glargine, a long-acting human insulin analog used to improve glycemic control in people with diabetes mellitus. It is designed for once-daily subcutaneous administration and provides basal insulin coverage as part of an individualized diabetes treatment plan. It is not recommended for the treatment of diabetic ketoacidosis.

Indications

Indicated for:

Improvement of glycemic control in adult patients with diabetes mellitus
Improvement of glycemic control in pediatric patients with diabetes mellitus

Limitation of use:

Not recommended for the treatment of diabetic ketoacidosis.

Dosage & Administration

Administration: Subcutaneous injection into the abdomen, thigh, or deltoid once daily, at any time of day, but at the same time every day. Injection sites should be rotated within the same region to reduce the risk of lipodystrophy and localized cutaneous amyloidosis. Lantus should not be diluted or mixed with any other insulin or solution and should not be given intravenously or via an insulin pump.

Dose individualization:
Dosage should be individualized based on metabolic needs, blood glucose monitoring results, glycemic goals, type of diabetes, and prior insulin use. In type 1 diabetes, the recommended starting dose is approximately one-third of the total daily insulin requirement, with the remainder provided as short-acting mealtime insulin. In type 2 diabetes patients not currently using insulin, the recommended starting dose is 0.2 units/kg or up to 10 units once daily.

Mechanism of Action

The primary activity of insulin glargine is the regulation of glucose metabolism. Like other insulins, it lowers blood glucose by stimulating peripheral glucose uptake, particularly in skeletal muscle and fat, and by inhibiting hepatic glucose production. It also inhibits lipolysis and proteolysis while enhancing protein synthesis.

Precautions

Important precautions:

Never share a Lantus SoloStar pen between patients, even if the needle is changed, due to the risk of blood-borne pathogen transmission.
Hypoglycemia is the most important risk and may be life-threatening; closer glucose monitoring is needed when changing dose, regimen, meals, activity, or concomitant medicines.
Severe hypersensitivity reactions, including anaphylaxis, can occur.
All insulins, including Lantus, may cause hypokalemia, which can be life-threatening in at-risk patients.
Repeated injections into areas of lipodystrophy or localized cutaneous amyloidosis may alter absorption and lead to poor glycemic control.

Side Effects

Most common adverse reaction:

Hypoglycemia

Other commonly associated adverse effects include:

Allergic reactions
Injection site reactions
Lipodystrophy
Pruritus
Rash
Edema
Weight gain

Injection site reactions reported with Lantus include redness, pain, itching, urticaria, edema, and inflammation.

Storage

Storage:

Unused pens: Store in a refrigerator at 2°C to 8°C (36°F to 46°F). Do not freeze. Protect from direct heat and light.
In-use SoloStar pen: Store at room temperature below 30°C (86°F) for up to 28 days. Do not refrigerate after first use. Store with the pen cap on, keep away from heat and light, and do not store with the needle attached.