Short answer: The Lyumjev label has a missed-dose rule in section 2.3: patients who forget a mealtime dose monitor their glucose level to decide if an insulin dose is needed, then resume their usual dosing schedule at the next meal. The Patient Information has no separate missed-dose instruction. Lyumjev is injected at the start of a meal or within 20 minutes after starting one.
| Situation | What the label says |
|---|---|
| Timing | At the start of a meal or within 20 minutes after starting a meal (2.2) |
| Forgot a mealtime dose | Monitor glucose level to decide if an insulin dose is needed (2.3) |
| Next dose | Resume the usual dosing schedule at the next meal (2.3) |
| Skipped-dose plan | Prescribers instruct patients on handling an inadequate or skipped insulin dose (17) |
| Patient Information | No separate missed-dose instruction |
Section 2.3: "Instruct patients who forget a mealtime dose to monitor their glucose level to decide if an insulin dose is needed, and to resume their usual dosing schedule at the next meal."
The rule applies to both Lyumjev U-100 and U-200. The Patient Information and Instructions for Use do not repeat it.
No. It gives no amount and no time limit. Section 17 tells prescribers to teach patients how to handle special situations, including an inadequate or skipped insulin dose and an accidental extra dose, so that plan comes from your diabetes team.
Section 5.3 says low blood sugar (hypoglycemia) is the most common adverse reaction associated with insulins, including Lyumjev, and that severe hypoglycemia may be life-threatening.
No. Lyumjev (insulin lispro-aabc) and Humalog (insulin lispro) have separate labels. The Humalog label has no missed-dose rule; the Lyumjev label does. Humalog is timed within 15 minutes before a meal or right after it, Lyumjev at the start of a meal or within 20 minutes after starting it.
This page summarizes FDA labeling. It is not personalized medical advice; confirm what to do with your prescriber or pharmacist.