Semglee Dosing Schedule: Once Daily, FDA Label | Dose Track
[Dosing schedule · Semglee]

Semglee dosing schedule

insulin glargine-yfgn 100 units/mL · once-daily injection under the skin, U-100 vial or prefilled pen · Label checked

Short answer: The Semglee label gives one injection under the skin once a day, at any time of day but at the same time every day. In type 1 diabetes it starts at about one-third of total daily insulin, with short-acting mealtime insulin for the rest. In type 2 diabetes not on insulin it starts at 0.2 units/kg or up to 10 units once daily. The label has no missed-dose rule.

This is what the FDA label says. Follow your prescriber. Your prescriber may use a different dose or pace than the label's standard schedule.

What Semglee is approved for: Semglee is a long-acting insulin approved to improve blood sugar control in adults and children with diabetes (section 1). It is not recommended for treating diabetic ketoacidosis.

Source
SEMGLEE (insulin glargine-yfgn) injection, for subcutaneous use, prescribing information, Patient Information and Instructions for Use. Biocon Biologics. DailyMed, version published April 17, 2026. DailyMed setid 8cf5544f-87d6-468b-f6ae-898b1fdb5d80

How is Semglee taken?

Semglee is injected under the skin of the abdomen, thigh or deltoid (upper arm) once a day at the same time every day, rotating sites within the same region. In type 1 diabetes it is always used with a short-acting insulin. It is not diluted or mixed with any other insulin or solution, and not given into a vein or by insulin pump (sections 2.1 and 2.2).

It comes as U-100 (100 units/mL) in a 10 mL multiple-dose vial and a 3 mL prefilled pen that dials in 1-unit steps (sections 2.1 and 3).

What is the Semglee dosing schedule on the label?

The table below is the label's schedule, from the Dosage and Administration section. Numbers are copied exactly; the section is in brackets.

Built from the text of sections 2.2 to 2.4 [Section 2.2]
SituationWhat the label says
When to injectOnce daily at any time of day, at the same time every day
Type 1 diabetes, starting doseAbout one-third of total daily insulin; short-acting premeal insulin for the rest
Type 2 diabetes, not on insulin, starting dose0.2 units/kg or up to 10 units once daily
Switching from once-daily insulin glargine 300 units/mL80% of the glargine 300 units/mL dose being stopped
Switching from once-daily NPHSame dose as the NPH being stopped
Switching from twice-daily NPH80% of the total NPH dose being stopped
Storage table from section 16.2 [Section 16.2]
PresentationUnopened, refrigerated 36-46 FUnopened, room temp up to 86 FIn use (opened)
10 mL multiple-dose vialUntil expiration date28 days28 days, refrigerated or room temperature
3 mL prefilled penUntil expiration date28 days28 days, room temperature only (do not refrigerate)

Other dosing rules on the label

  • Section 2.2

    The dose is individualized by metabolic needs, glucose monitoring and glucose goal. Changes may be needed with changes in activity, meals, acute illness or kidney or liver function, and are made only under medical supervision with glucose monitoring.

  • Section 2.4

    The label recommends dose adjustments when switching to Semglee from other insulins to lower the risk of low blood sugar.

  • Section 2.1

    Glucose is monitored more often during any change to the insulin regimen. The solution should be clear and colorless. The label advises caution with the pen for people with poor vision who rely on its clicks.

  • Section 16.2

    Semglee is never frozen and is thrown away if it has been. It is protected from direct heat and light.

What does the label say about a missed dose?

  • No rule

    The Semglee label gives no missed-dose rule. Neither the prescribing information nor the Patient Information says what to do if a dose is missed; the label says Semglee is injected once daily at the same time every day.

More on this: missed a dose of Semglee.

What does the label say about switching?

  • Section 2.4

    From once-daily insulin glargine 300 units/mL, Semglee starts at 80% of that dose. From once-daily NPH, it starts at the same dose. From twice-daily NPH, it starts at 80% of the total NPH dose.

  • Section 5.2

    Any change of insulin strength, maker, type, site or method is made under close medical supervision with more frequent glucose checks. In type 2 diabetes, doses of other diabetes medicines may need adjusting.

How can Dose Track follow this schedule?

In Dose Track you set up Semglee as a protocol with the dose and schedule your prescriber gave you. A protocol can hold dose steps, each with its own dose and length in days or weeks, so a step-up plan like the one on the label can be entered once and the app moves to the next step on its own. Reminders follow the schedule, and every dose is logged with the date and time, so you can see which step you are on and when your last dose was. The app follows what you enter; it does not choose or change a dose.

This page is what the FDA label says, in plain words. It is not medical advice. Follow your prescriber, and ask them or your pharmacist about anything here.

Dosing schedules for similar medicines

Frequently asked questions

What is the starting dose of Semglee?+
In type 2 diabetes not on insulin, 0.2 units/kg or up to 10 units once daily. In type 1 diabetes, about one-third of total daily insulin, with short-acting insulin before meals for the rest (section 2.3).
What time of day is Semglee taken?+
Any time of day, but at the same time every day, once daily (section 2.2).
What if I miss a dose of Semglee?+
The Semglee label gives no missed-dose rule. Neither the prescribing information nor the Patient Information says what to do if a dose is missed.
How do you switch from insulin glargine 300 units/mL to Semglee?+
The label says that switching from once-daily insulin glargine 300 units/mL to Semglee starts at 80% of the dose being stopped (section 2.4).
How long does an opened Semglee pen or vial last?+
28 days. An in-use pen stays at room temperature and is not refrigerated; an in-use vial can be refrigerated or at room temperature (section 16.2).