Dulaglutide

The reviewed U.S. product is a prescription subcutaneous injection. This profile supplies no obesity, type 1 diabetes, ketoacidosis or pediatric cardiovascular-prevention regimen.

Use on the same weekly day, at any time, with or without food. Inject under the skin of the abdomen, thigh or upper arm; rotate sites. Do not give intravenously or intramuscularly. Do not mix with insulin; separate injections may use the same body region but not adjacent sites. Take a missed dose only if ≥72 hours remain until the next dose; otherwise skip and resume the usual day. A day change requires ≥72 hours since the last dose. Do not give two doses within 3 days.

Personal or family history of medullary thyroid carcinoma (MTC), multiple endocrine neoplasia syndrome type 2 (MEN 2), or a previous serious hypersensitivity reaction to dulaglutide or a component.

Dulaglutide caused thyroid C-cell tumors in rats. Whether it causes these tumors, including MTC, in humans is unknown. The warning includes MTC/MEN 2 contraindications and thyroid-symptom counseling; it does not establish human causation.

Common reactions include nausea, diarrhea, vomiting, abdominal pain and reduced appetite; dyspepsia and fatigue are also reported. Postmarketing reports include serious allergy, kidney injury, ileus/intestinal obstruction or severe constipation, and pulmonary aspiration. Spontaneous reports cannot establish frequency or causation. Overdose may cause gastrointestinal symptoms and hypoglycemia; seek urgent advice/Poison Help for supportive treatment and glucose monitoring.

• Consider lowering insulin or insulin-secretagogue doses to reduce hypoglycemia; monitor glucose and symptoms.
• Dulaglutide slows gastric emptying and can reduce the absorption rate of oral medicines. The effect is greatest after the first dose and diminishes with repeated doses.
• At 1.5 mg, studied oral drugs showed no clinically relevant absorption changes; experience at 3 mg/4.5 mg is limited. Monitor levels/effects of narrow-therapeutic-index medicines such as warfarin. Do not assume every oral medicine is unaffected.

Human pregnancy data are insufficient; animal findings indicate potential fetal risk. Use during pregnancy only if benefit justifies risk, while addressing risks of poorly controlled diabetes. Human milk, infant-effect and milk-production data are unavailable; weigh breastfeeding benefits, maternal need and possible infant effects with the clinician.

Glycemic efficacy/safety is established from age 10; below 10 it is not established. Pediatric maximum is 1.5 mg weekly. Trials found no overall safety/efficacy difference in older adults, but assess individual comorbidity and treatment tolerance.

No dose adjustment is recommended for renal impairment, including end-stage renal disease; use caution in ESRD and monitor renal function when gastrointestinal effects cause volume depletion. Hepatic impairment does not require a labeled numeric adjustment, but clinical experience is limited: use cautiously across degrees of hepatic impairment.

GLP-1 receptor activation increases intracellular cAMP and glucose-dependent insulin secretion, suppresses glucagon and slows gastric emptying.

Time to peak concentration

24–72 hours; median 48 hours after subcutaneous dosing.

Steady state

About 2–4 weeks of weekly dosing.

Elimination half-life

Approximately 5 days.

Metabolism

Presumed general protein catabolism to amino acids.

Follow glucose/HbA1c and hypoglycemia risk according to the treatment plan. Assess nausea, hydration and weight/appetite tolerance before escalation. Check renal function with persistent vomiting/diarrhea or other fluid-loss reactions; monitor retinopathy when previously present. Review planned anesthesia/deep sedation and new oral or glucose-lowering medicines. The label does not require routine calcitonin/thyroid ultrasound screening.

A clinician should demonstrate the exact pen. Check dose, expiry, damage and clear/colorless solution without particles. Wash hands; keep the pen locked while removing the base cap, do not replace the cap or touch the needle. Place the clear base flat/firm against skin, unlock, press the green button and hold the base until the second loud click (about 5–10 seconds); a visible gray plunger confirms delivery. Use once and immediately place in a sharps container. Obtain trained help for vision problems. A pen dropped on a hard surface should be replaced. Report severe abdominal pain, allergy, persistent gastrointestinal symptoms or vision changes promptly.

Ingredient / route

Dulaglutide · subcutaneous injection.

Presentation

Clear, colorless solution; disposable prefilled single-dose pen.

Manufacturer

Eli Lilly and Company.

Example NDC

0002-1433-80 · carton of four pens.

U.S. status

Prescription biologic (BLA labeling); no stock claim.

Single-dose pens

0.75 mg, 1.5 mg, 3 mg and 4.5 mg; each dose in 0.5 mL.

Four-pen carton examples

0.75 mg: 0002-1433-80; 1.5 mg: 0002-1434-80; 3 mg: 0002-2236-80; 4.5 mg: 0002-3182-80.

Pediatric restriction

Only the 0.75 mg and 1.5 mg labeled regimens apply from age 10.

Refrigerate at 2–8°C. A pen may be kept at room temperature below 30°C for a total of 14 days. Do not freeze; discard a frozen pen. Keep in the original carton, protect from direct heat/light and handle glass parts carefully. Keep away from children and follow local sharps-disposal requirements.