Insulin icodec
AWIQLI
What it isA once-weekly basal insulin-receptor agonist whose albumin binding provides basal insulin replacement across a full week; adults with type II diabetes.
Why this oneSeven basal injections collapse into one, which is the entire value proposition for adherence and for supervised or assisted dosing.
What limits itHypoglycemia can be prolonged, and weekly dosing makes administration errors and dose changes slow to correct.
FDA-approved for
- diabetes mellitus (2026)
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Type 2 diabetes mellitus — glycemic control | Adults, insulin-naive | 70 units SC once weekly (same day each week) | Individualize; titrate to glycemic goal | 700 units per single injection (split larger doses into two injections) |
| Type 2 diabetes — switching from daily basal insulin | Adults | Week 1 (one time): 1.5 x total daily basal dose x 7, rounded to nearest 10 units, SC | Week 2: total daily basal dose x 7 (rounded to nearest 10 units); Week 3+: titrate to goal | 700 units per single injection |
Titration Weekly dosing; when switching from daily basal insulin, titrate from Week 3 onward based on metabolic needs and glucose monitoring
Renal No dose adjustment needed (including ESRD); intensify glucose monitoring and adjust individually — higher hypoglycemia risk
Hepatic No dose adjustment needed (mild-severe studied); intensify glucose monitoring and adjust individually
Instructions
- SC only into thigh, upper arm, or abdomen; rotate sites within region; do not inject into lipodystrophy/localized cutaneous amyloidosis
- Do NOT give IM, IV, or in an insulin pump; do not dilute or mix; do not transfer from pen to syringe (overdose risk)
- Pen delivers in 10-unit increments, up to 700 units per injection
- First dose when switching: day after last daily basal insulin dose; monitor glucose closely and adjust concurrent rapid/short-acting insulin or other antidiabetics
- Missed dose: give within 4 days ASAP and resume weekly schedule from that day; if >4 days, skip and dose on the regular day; increase glucose monitoring
- Do not adjust dose during acute illness or short-term diet/activity changes (long half-life) — adjust glucose intake or other glucose-lowering medication instead
- Check product label before each injection; inspect solution (clear/colorless); never share pens even with needle changed
Contraindications
- During episodes of hypoglycemia
Cautions
- Medication errors/accidental overdose — mix-ups with other insulins and once-weekly injectables have caused serious hypoglycemia; never withdraw from pen with a syringe
- Hypoglycemia — most common reaction, may be life-threatening; long-acting effect can delay recovery; higher risk with renal/hepatic impairment, hypoglycemia unawareness, regimen changes
- Hyper- or hypoglycemia with changes in insulin regimen — make changes under close supervision with increased glucose monitoring
- Severe hypersensitivity including anaphylaxis — discontinue, monitor, treat
- Hypokalemia — may be life-threatening; monitor potassium in at-risk patients
- Fluid retention and heart failure with concomitant thiazolidinediones — consider TZD dose reduction/discontinuation
- Never share an Awiqli FlexTouch pen between patients
- Elderly: conservative initial dosing/titration; hypoglycemia harder to recognize
Adverse reactions
- Hypoglycemia (most common)
- Hypersensitivity reactions (urticaria, face/lip swelling)
- Injection site reactions
- Lipodystrophy
- Pruritus
- Rash
- Edema
- Weight gain
Pregnancy No human data; poorly controlled diabetes itself carries maternal/fetal risk; no adverse developmental effects in rats/rabbits at exposures ~ equal to human 230 U/week
Lactation No data on presence in human milk — weigh benefits of breastfeeding against clinical need and potential infant risk
NO BOXED WARNINGS
Classes and tags
Clinical profile
Mechanism of action: Insulin icodec ballicule
