doo-la-GLOO-tide

Therapeutic Classification: antidiabetics

Pharmacologic Classification:

• Type 2 diabetes (as adjunct to diet and exercise).
• To reduce the risk of major cardiovascular events in patients with type 2 diabetes who have established cardiovascular disease or multiple risk factors for cardiovascular disease.

• Acts as an acylated human glucagon-like peptide-1 (GLP-1, an incretin) receptor agonist; increases intracellular cyclic AMP (cAMP) leading to insulin release when glucose is elevated, which then subsides as blood glucose decreases toward euglycemia. Also decreases glucagon secretion and delays gastric emptying.

• Improved glycemic control.
• Reduction in risk of cardiovascular death, nonfatal MI, or nonfatal stroke.

Absorption: 0.75 mg dose: 65% absorbed following SUBQ administration; 1.5 mg dose: 47% absorbed following SUBQ administration.

Distribution: Unknown.

Metabolism/Excretion: Degraded by protein catabolic processes.

Half-life: 5 days.

(↓ in A_1c)

Contraindicated in:

• Hypersensitivity
• Personal or family history of medullary thyroid carcinoma
• Multiple Endocrine Neoplasia syndrome type 2
• History of pancreatitis
• Type 1 diabetes
• Diabetic ketoacidosis
• Severe gastrointestinal disease (including severe gastroparesis).

Use Cautiously in:

• History of angioedema or anaphylaxis to another GLP-1 receptor agonist
• Hepatic/renal impairment
• Diabetic retinopathy (may ↑ risk of complications)
• OB: Use during pregnancy only if potential maternal benefit justifies potential fetal risk
• Lactation: Use while breastfeeding only if potential maternal benefit justifies potential risk to infant
• Pedi: Children <10 yr (safety and effectiveness not established).

Derm: pruritus, rash.

Endo: THYROID C-CELL TUMORS.

GI: abdominal pain, nausea, vomiting, ↓ appetite, cholecystitis, cholelithiasis, constipation, diarrhea, dyspepsia, PANCREATITIS.

GU: acute renal failure.

Local: injection site reactions.

Neuro: fatigue.

Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS AND ANGIOEDEMA).

Drug-Drug:

• Concurrent use with insulin or agents that increase insulin secretion including sulfonylureas may ↑ the risk of serious hypoglycemia; use cautiously and consider dose ↓ of insulin or agents increasing insulin secretion.
• May alter absorption of concomitantly administered oral medications due to delayed gastric emptying.

Type 2 Diabetes

• SC (Adults): 0.75 mg once weekly; after ≥4 wk, may ↑ to 1.5 mg once weekly to obtain glycemic control; if additional glycemic control still needed, may then ↑ to 3 mg once weekly after ≥4 wk; if additional glycemic control still needed, may then ↑ to 4.5 mg once weekly after ≥4 wk.
• SC (Children ≥10 yr): 0.75 mg once weekly; after ≥4 wk, may ↑ to 1.5 mg once weekly to obtain glycemic control.

Risk Reduction of Major Cardiovascular Events

• SC (Adults): 0.75 mg once weekly; after ≥4 wk, may ↑ to 1.5 mg once weekly to obtain glycemic control; if additional glycemic control still needed, may then ↑ to 3 mg once weekly after ≥4 wk; if additional glycemic control still needed, may then ↑ to 4.5 mg once weekly after ≥4 wk.

• Solution for injection (single-dose, prefilled pens): 0.75 mg/0.5 mL; 1.5 mg/0.5 mL; 3 mg/0.5 mL; 4.5 mg/0.5 mL;

• Observe patient taking concurrent insulin for signs and symptoms of hypoglycemic reactions (sweating, hunger, weakness, dizziness, tremor, tachycardia, anxiety, headache, blurred vision, slurred speech, irritability).
• If thyroid nodules or elevated serum calcitonin are noted, patient should be referred to an endocrinologist.
• Monitor for pancreatitis (persistent severe abdominal pain, sometimes radiating to the back, with or without vomiting). If pancreatitis is suspected, discontinue dulaglutide; if confirmed, do not restart dulaglutide.

• Monitor serum A_1c periodically during therapy to evaluate effectiveness.
  • May ↑ lipase and pancreatic amylase.

• Do not confuse Trulicity with Toujeo, Tradjenta, or Tresiba.
• Patients stabilized on a diabetic regimen who are exposed to stress, fever, trauma, infection, or surgery may require administration of insulin.
• SC: Administer once weekly at any time of the day, without regard to food. Day of wk may be changed as long as at least 72 hr before next dose. Inject into abdomen, thigh, or upper arm. Solution should be clear and colorless; do not administer solutions that are discolored or contain particulate matter.

• Instruct patient on use of pen and to take dulaglutide as directed. Follow manufacturer's instructions for pen use. Pen should never be shared between patients, even if needle is changed. Store pen in refrigerator; do not freeze. After initial use, pen may be stored at room temperature up to 14 days. Advise patient to read the Medication Guide before starting dulaglutide and with each Rx refill in case of changes.
• Take missed dose as soon as remembered as long as 3 days (72 hr) until next scheduled dose. If less than 3 days until next scheduled dose, skip and take next scheduled dose.
• Inform patient that nausea is the most common side effect, but usually decreases over time.
• Advise patient taking insulin and dulaglutide to never mix insulin and dulaglutide together. Give as 2 separate injections. Both injections may be given in the same body area, but should not be given right next to each other.
• Explain to patient that this medication controls hyperglycemia but does not cure diabetes. Therapy is long-term.
• Review signs of hypoglycemia and hyperglycemia with patient. If hypoglycemia occurs, advise patient to take a glass of orange juice or 2–3 tsp of sugar, honey, or corn syrup dissolved in water and notify health care professional.
• Encourage patient to follow prescribed diet, medication, and exercise regimen to prevent hypoglycemic or hyperglycemic episodes.
• Instruct patient in proper testing of serum glucose and ketones. These tests should be closely monitored during periods of stress or illness, and health care professional should be notified if significant changes occur.
• Advise patient to notify health care professional if changes in vision occur during therapy.
• Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking any new medications.
• Advise patient to notify health care professional immediately if signs of pancreatitis (nausea, vomiting, abdominal pain) or hypersensitivity (swelling of face, lips, tongue or throat, problems breathing or swallowing, severe rash or itching, fainting or feeling dizzy, very rapid heartbeat) occur.
• Inform patient of risk of benign and malignant thyroid C-cell tumors. Advise patient to notify health care professional if symptoms of thyroid tumors (lump in neck, hoarseness, trouble swallowing, shortness of breath) or if signs of allergic reaction (swelling of face, lips, tongue, or throat; fainting or feeling dizzy; very rapid heartbeat; problems breathing or swallowing; severe rash or itching) occur.
• Advise patient to inform health care professional of medication regimen before treatment or surgery.
• Advise patient to carry a form of sugar (sugar packets, candy) and identification describing disease process and medication regimen at all times.
• Rep: Insulin is the preferred method of controlling blood glucose during pregnancy. Counsel female patients to notify health care professional if pregnancy is planned or suspected or if breastfeeding.
• Emphasize the importance of routine follow-up exams.

• Improved glycemic control.
• Reduction in risk of cardiovascular death, nonfatal MI, or nonfatal stroke.

Trulicity

NDC Code^*

• 0002- Eli Lilly and Company
  • 0002-1433- Trulicity
    • 0002-1433-61- 2 SYRINGE in 1 CARTON (0002-1433-61) >.5 mL in 1 SYRINGE

• 0002- Eli Lilly and Company
  • 0002-1433- Trulicity
    • 0002-1433-80- 4 SYRINGE in 1 CARTON (0002-1433-80) >.5 mL in 1 SYRINGE (0002-1433-01)

• 0002- Eli Lilly and Company
  • 0002-1434- Trulicity
    • 0002-1434-61- 2 SYRINGE in 1 CARTON (0002-1434-61) >.5 mL in 1 SYRINGE

• 0002- Eli Lilly and Company
  • 0002-1434- Trulicity
    • 0002-1434-80- 4 SYRINGE in 1 CARTON (0002-1434-80) >.5 mL in 1 SYRINGE (0002-1434-01)

• 50090- A-S Medication Solutions
  • 50090-3483- Trulicity
    • 50090-3483-0- 4 SYRINGE in 1 CARTON (50090-3483-0) >.5 mL in 1 SYRINGE

• 50090- A-S Medication Solutions
  • 50090-3484- Trulicity
    • 50090-3484-0- 4 SYRINGE in 1 CARTON (50090-3484-0) >.5 mL in 1 SYRINGE