SEMGLEE

SEMGLEE- insulin glargine injection, solution
Mylan Specialty L.P.

1 INDICATIONS AND USAGE

SEMGLEE is indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus.

Limitations of Use

SEMGLEE is not recommended for the treatment of diabetic ketoacidosis.

2 DOSAGE AND ADMINISTRATION

2.1 Important Administration Instructions

Administer SEMGLEE subcutaneously once daily at any time of day but at the same time every day.
Prior to initiation of SEMGLEE, train patients on proper use and injection technique.
Patient should follow the Instructions for Use to correctly administer SEMGLEE.
Administer SEMGLEE subcutaneously into the abdominal area, thigh, or deltoid, and rotate injection sites within the same region from one injection to the next to reduce the risk of lipodystrophy and localized cutaneous amyloidosis. Do not inject into areas of lipodystrophy or localized cutaneous amyloidosis [see Warnings and Precautions (5.2), Adverse Reactions (6)].
During changes to a patient’s insulin regimen, increase the frequency of blood glucose monitoring [see Warnings and Precautions (5.2)].
Visually inspect SEMGLEE vials and prefilled pens for particulate matter and discoloration prior to administration. Only use if the solution is clear and colorless with no visible particles.
The SEMGLEE prefilled pen dials in 1-unit increments.
Use SEMGLEE prefilled pen with caution in patients with visual impairment who may rely on audible clicks to dial their dose.
Refrigerate unused (unopened) SEMGLEE vials and prefilled pens.
Do not administer intravenously or via an insulin pump.
Do not dilute or mix SEMGLEE with any other insulin or solution.
The SEMGLEE prefilled pen is for single patient use only [see Warnings and Precautions (5.1)].

2.2 General Dosing Instructions

Individualize and adjust the dosage of SEMGLEE based on the individual’s metabolic needs, blood glucose monitoring results and glycemic control goal.
Dosage adjustments may be needed with changes in physical activity, changes in meal patterns (i.e., macronutrient content or timing of food intake), during acute illness, or changes in renal or hepatic function. Dosage adjustments should only be made under medical supervision with appropriate glucose monitoring [see Warnings and Precautions (5.2)].

2.3 Initiation of SEMGLEE Therapy

Type 1 Diabetes

In patients with type 1 diabetes, SEMGLEE must be used concomitantly with short-acting insulin. The recommended starting dose of SEMGLEE 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.

Type 2 Diabetes

The recommended starting dose of SEMGLEE in patients with type 2 diabetes who are not currently treated with insulin is 0.2 units/kg or up to 10 units once daily. One may need to adjust the amount and timing of short- or rapid-acting insulins and dosages of any oral antidiabetic drugs.

2.4 Changing to SEMGLEE from Other Insulin Therapies

If changing patients from once-daily insulin glargine, 300 units/mL, to once-daily SEMGLEE, the recommended initial SEMGLEE dose is 80% of the insulin glargine, 300 units/mL dose that is being discontinued. This dose reduction will lower the likelihood of hypoglycemia [see Warnings and Precautions (5.3)].
If changing from a treatment regimen with an intermediate or long-acting insulin to a regimen with SEMGLEE, a change in the dose of the basal insulin may be required and the amount and timing of the shorter-acting insulins and doses of any oral antidiabetic drugs may need to be adjusted.
If changing patients from once-daily NPH insulin to once-daily SEMGLEE, the recommended initial SEMGLEE dose is the same as the dose of NPH that is being discontinued.
If changing patients from twice-daily NPH insulin to once-daily SEMGLEE, the recommended initial SEMGLEE dosage is 80% of the total NPH dose that is being discontinued. This dosage reduction will lower the likelihood of hypoglycemia [see Warnings and Precautions (5.3)].

3 DOSAGE FORMS AND STRENGTHS

Injection: 100 units per mL (U-100) clear and colorless solution available as:

10 mL multiple-dose vial
3 mL single-patient-use prefilled pen

4 CONTRAINDICATIONS

SEMGLEE is contraindicated:

during episodes of hypoglycemia [see Warnings and Precautions (5.3)].
in patients with hypersensitivity to insulin glargine products or any of the excipients in SEMGLEE [see Warnings and Precautions (5.5)].

5 WARNINGS AND PRECAUTIONS

5.1 Never Share a SEMGLEE Prefilled Pen, Syringe, or Needle Between Patients

SEMGLEE prefilled pens must never be shared between patients, even if the needle is changed. Patients using SEMGLEE vials must never re-use or share needles or syringes with another person. Sharing poses a risk for transmission of blood-borne pathogens.

5.2 Hyperglycemia or Hypoglycemia with Changes in Insulin Regimen

Changes in an insulin regimen (e.g., insulin strength, manufacturer, type, injection site or method of administration) may affect glycemic control and predispose to hypoglycemia [see Warnings and Precautions (5.3)] or hyperglycemia. Repeated insulin injections into areas of lipodystrophy or localized cutaneous amyloidosis have been reported to result in hyperglycemia; and a sudden change in the injection site (to unaffected area) has been reported to result in hypoglycemia [see Adverse Reactions (6)].

Make any changes to a patient’s insulin regimen under close medical supervision with increased frequency of blood glucose monitoring. Advise patients who have repeatedly injected into areas of lipodystrophy or localized cutaneous amyloidosis to change the injection site to unaffected areas and closely monitor for hypoglycemia. For patients with type 2 diabetes, dosage adjustments of concomitant oral and antidiabetic products may be needed.

5.3 Hypoglycemia

Hypoglycemia is the most common adverse reaction associated with insulins, including insulin glargine products. Severe hypoglycemia can cause seizures, may be life-threatening or cause death. Hypoglycemia can impair concentration ability and reaction time; this may place an individual and others at risk in situations where these abilities are important (e.g., driving or operating other machinery).

Hypoglycemia can happen suddenly, and symptoms may differ in each individual and change over time in the same individual. Symptomatic awareness of hypoglycemia may be less pronounced in patients with longstanding diabetes, in patients with diabetic nerve disease, in patients using medications that block the sympathetic nervous system (e.g., beta-blockers) [see Drug Interactions (7)] , or in patients who experience recurrent hypoglycemia.

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