dulaglutide

Therapeutic Classification: antidiabetics

Pharmacologic Classification: glucagon like peptide 1 glp 1 receptor agonists

REMS

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.

Therapeutic effects:

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 A1c)

ROUTE	ONSET	PEAK	DURATION
SUBQ	within 4 wk	13 wk	unknown

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 GI 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);
Undergoing elective surgery or procedure requiring general anesthesia or deep sedation;
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, cholecystitis, cholelithiasis, constipation, diarrhea, dyspepsia, PANCREATITIS

GU: acute renal failure

Local: injection site reactions

Metab: ↓appetite

Neuro: fatigue

Resp: aspiration

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 concurrently 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 (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 hypoglycemia (sweating, hunger, weakness, dizziness, tremor, tachycardia, anxiety, headache, blurred vision, slurred speech, irritability).
If thyroid nodules or ↑ serum calcitonin are noted, refer patient to endocrinology.
Monitor for pancreatitis (persistent severe abdominal pain that may radiate to back, with or without vomiting). If pancreatitis suspected, discontinue dulaglutide; if confirmed, do not restart.

Lab Test Considerations:

Monitor A1c periodically during therapy to evaluate effectiveness.
- May ↑ lipase and amylase.

Do not confuse Trulicity with Tanzeum, 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 day, without regard to food. Day of wk may be changed as long as ≥72 hr before next dose. Inject into abdomen, thigh, or upper arm. Solution is clear and colorless; do not administer if discolored or contains particulates.

Instruct patient on manufacturer's instructions for use of pen and to take dulaglutide as directed. 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; if ≤72 hr until next scheduled dose, omit and take next dose as scheduled.
Inform patient that nausea is the most common side effect but usually ↓ over time.
Advise patient to never mix insulin and dulaglutide together. Both injections may be given in the same body area but not 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. If hypoglycemia occurs, advise patient to take a glass of orange juice or 2–3 teaspoons 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 hypoglycemia or hyperglycemia.
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 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 procedures or surgery due to ↑ risk of aspiration with general or deep sedation.
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. Advise women of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding.
Emphasize importance of routine follow-up exams.

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

NDC Code

0002- Eli Lilly and Company
- 0002-1401-
  - 0002-1401-71- 9 TRAY in 1 BOX (0002-1401-71) / 160 SYRINGE in 1 TRAY / .5 mL in 1 SYRINGE

0002- Eli Lilly and Company
- 0002-1402-
  - 0002-1402-71- 9 TRAY in 1 BOX (0002-1402-71) / 160 SYRINGE in 1 TRAY / .5 mL in 1 SYRINGE

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)

0002- Eli Lilly and Company
- 0002-2236- Trulicity
  - 0002-2236-61- 2 SYRINGE in 1 CARTON (0002-2236-61) / .5 mL in 1 SYRINGE

0002- Eli Lilly and Company
- 0002-2236- Trulicity
  - 0002-2236-80- 4 SYRINGE in 1 CARTON (0002-2236-80) / .5 mL in 1 SYRINGE (0002-2236-01)

0002- Eli Lilly and Company
- 0002-3182- Trulicity
  - 0002-3182-61- 2 SYRINGE in 1 CARTON (0002-3182-61) / .5 mL in 1 SYRINGE

0002- Eli Lilly and Company
- 0002-3182- Trulicity
  - 0002-3182-80- 4 SYRINGE in 1 CARTON (0002-3182-80) / .5 mL in 1 SYRINGE (0002-3182-01)

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

50090- A-S Medication Solutions
- 50090-5467- Trulicity
  - 50090-5467-0- 4 SYRINGE in 1 CARTON (50090-5467-0) / .5 mL in 1 SYRINGE

50090- A-S Medication Solutions
- 50090-6453- TRULICITY
  - 50090-6453-0- 4 SYRINGE in 1 CARTON (50090-6453-0) / .5 mL in 1 SYRINGE

50090- A-S Medication Solutions
- 50090-6456- TRULICITY
  - 50090-6456-0- 4 SYRINGE in 1 CARTON (50090-6456-0) / .5 mL in 1 SYRINGE

50090- A-S Medication Solutions
- 50090-6571- TRULICITY
  - 50090-6571-0- 4 SYRINGE in 1 CARTON (50090-6571-0) / .5 mL in 1 SYRINGE

50090- A-S Medication Solutions
- 50090-7589- TRULICITY
  - 50090-7589-0- 4 SYRINGE in 1 CARTON (50090-7589-0) / .5 mL in 1 SYRINGE

54568- Eli Lilly Italia SPA
- 54568-001-
  - 54568-001-02- 24 CARTON in 1 BOX (54568-001-02) / 4 TRAY in 1 CARTON / 160 SYRINGE in 1 TRAY / .5 mL in 1 SYRINGE

54568- Eli Lilly Italia SPA
- 54568-001-
  54568-001-04- 5 TRAY in 1 BOX (54568-001-04) / 45 SYRINGE in 1 TRAY / .5 mL in 1 SYRINGE

54568- Eli Lilly Italia SPA
- 54568-001-
  54568-001-05- 36 SYRINGE in 1 TRAY (54568-001-05) / .5 mL in 1 SYRINGE

54568- Eli Lilly Italia SPA
- 54568-003-
  54568-003-02- 24 CARTON in 1 BOX (54568-003-02) / 4 TRAY in 1 CARTON / 160 SYRINGE in 1 TRAY / .5 mL in 1 SYRINGE

54568- Eli Lilly Italia SPA
- 54568-003-
  54568-003-05- 640 SYRINGE in 1 BOX (54568-003-05) / .5 mL in 1 SYRINGE

54568- Eli Lilly Italia SPA
- 54568-004-
  54568-004-02- 24 CARTON in 1 BOX (54568-004-02) / 4 TRAY in 1 CARTON / 160 SYRINGE in 1 TRAY / .5 mL in 1 SYRINGE

62195- Vetter Pharma Fertigung GmbH & Co. KG
- 62195-433-
  62195-433-01- 9 TRAY in 1 BOX (62195-433-01) / 160 SYRINGE in 1 TRAY / .5 mL in 1 SYRINGE

62195- Vetter Pharma Fertigung GmbH & Co. KG
- 62195-434-
  62195-434-01- 9 TRAY in 1 BOX (62195-434-01) / 160 SYRINGE in 1 TRAY / .5 mL in 1 SYRINGE

62381- Lilly France
- 62381-1433-
  62381-1433-1- 45 SYRINGE in 1 TRAY (62381-1433-1) / .5 mL in 1 SYRINGE

62381- Lilly France
- 62381-1434-
  62381-1434-1- 45 SYRINGE in 1 TRAY (62381-1434-1) / .5 mL in 1 SYRINGE

63419- Eli Lilly Kinsale Limited
- 63419-0525-
  63419-0525-3- 2 BOTTLE in 1 BOX (63419-0525-3) / 3692 g in 1 BOTTLE

63419- Eli Lilly Kinsale Limited
- 63419-0525-
  63419-0525-5- 6 BOTTLE in 1 BOX (63419-0525-5) / 800 g in 1 BOTTLE

63419- Eli Lilly Kinsale Limited
- 63419-0525-
  63419-0525-6- 2 BOTTLE in 1 BOX (63419-0525-6) / 135 g in 1 BOTTLE

63419- Eli Lilly Kinsale Limited
- 63419-0525-
  63419-0525-8- 6 BOTTLE in 1 BOX (63419-0525-8) / 800 g in 1 BOTTLE

63419- Eli Lilly Kinsale Limited
- 63419-0525-
  63419-0525-9- 6 BOTTLE in 1 BOX (63419-0525-9) / 800 g in 1 BOTTLE

73212- Qingdao Biopeptek Co., Ltd.
- 73212-100-
  73212-100-01- 1 g in 1 BOTTLE (73212-100-01)

73212- Qingdao Biopeptek Co., Ltd.
- 73212-100-
  73212-100-05- 5 g in 1 BOTTLE (73212-100-05)

73212- Qingdao Biopeptek Co., Ltd.
- 73212-100-
  73212-100-10- 10 g in 1 BOTTLE (73212-100-10)

73212- Qingdao Biopeptek Co., Ltd.
- 73212-100-
  73212-100-11- 50 g in 1 BOTTLE (73212-100-11)

73212- Qingdao Biopeptek Co., Ltd.
- 73212-100-
  73212-100-12- 100 g in 1 BOTTLE (73212-100-12)

84772- Guangdong HEC Bio&Pharm Co., Ltd.
- 84772-002-
  84772-002-01- 1 BAG in 1 CARTON (84772-002-01) / 20 g in 1 BAG

84772- Guangdong HEC Bio&Pharm Co., Ltd.
- 84772-002-
  84772-002-02- 1 BAG in 1 CARTON (84772-002-02) / 50 g in 1 BAG

84772- Guangdong HEC Bio&Pharm Co., Ltd.
- 84772-002-
  84772-002-03- 1 BAG in 1 CARTON (84772-002-03) / 100 g in 1 BAG

84772- Guangdong HEC Bio&Pharm Co., Ltd.
- 84772-002-
  84772-002-04- 1 BAG in 1 CARTON (84772-002-04) / 150 g in 1 BAG

84772- Guangdong HEC Bio&Pharm Co., Ltd.
- 84772-002-
  84772-002-05- 1 BAG in 1 CARTON (84772-002-05) / 180 g in 1 BAG

84772- Guangdong HEC Bio&Pharm Co., Ltd.
- 84772-002-
  84772-002-06- 1 BAG in 1 CARTON (84772-002-06) / 200 g in 1 BAG

84772- Guangdong HEC Bio&Pharm Co., Ltd.
- 84772-002-
  84772-002-07- 1 BAG in 1 CARTON (84772-002-07) / 250 g in 1 BAG

85512- Qingdao Qinzeyuan Biotechnology Co., Ltd
- 85512-1121-
  85512-1121-1- 1 g in 1 BOTTLE (85512-1121-1)

85512- Qingdao Qinzeyuan Biotechnology Co., Ltd
- 85512-1121-
  85512-1121-2- 5 g in 1 BOTTLE (85512-1121-2)

85512- Qingdao Qinzeyuan Biotechnology Co., Ltd
- 85512-1121-
  85512-1121-3- 10 g in 1 BOTTLE (85512-1121-3)

85512- Qingdao Qinzeyuan Biotechnology Co., Ltd
- 85512-1121-
  85512-1121-4- 50 g in 1 BOTTLE (85512-1121-4)

85512- Qingdao Qinzeyuan Biotechnology Co., Ltd
- 85512-1121-
  85512-1121-5- 100 g in 1 BOTTLE (85512-1121-5)

85710- Intellective Biologics (Suzhou) Co., Ltd.
- 85710-001-
  85710-001-02- 2 mL in 1 TUBE (85710-001-02)

85710- Intellective Biologics (Suzhou) Co., Ltd.
- 85710-001-
  85710-001-05- 5 mL in 1 TUBE (85710-001-05)

85710- Intellective Biologics (Suzhou) Co., Ltd.
- 85710-001-
  85710-001-15- 15 mL in 1 TUBE (85710-001-15)

85710- Intellective Biologics (Suzhou) Co., Ltd.
- 85710-001-
  85710-001-30- 30 mL in 1 BOTTLE (85710-001-30)

85710- Intellective Biologics (Suzhou) Co., Ltd.
- 85710-001-
  85710-001-50- 50 mL in 1 TUBE (85710-001-50)

85710- Intellective Biologics (Suzhou) Co., Ltd.
- 85710-001-
  85710-001-60- 60 mL in 1 BOTTLE (85710-001-60)

85710- Intellective Biologics (Suzhou) Co., Ltd.
- 85710-001-
  85710-001-91- 125 mL in 1 BOTTLE (85710-001-91)

85710- Intellective Biologics (Suzhou) Co., Ltd.
- 85710-001-
  85710-001-92- 250 mL in 1 BOTTLE (85710-001-92)

85710- Intellective Biologics (Suzhou) Co., Ltd.
- 85710-001-
  85710-001-93- 500 mL in 1 BOTTLE (85710-001-93)

85710- Intellective Biologics (Suzhou) Co., Ltd.
- 85710-001-
  85710-001-94- 1000 mL in 1 BOTTLE (85710-001-94)

85710- Intellective Biologics (Suzhou) Co., Ltd.
- 85710-001-
  85710-001-95- 2000 mL in 1 BOTTLE (85710-001-95)

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Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇

Action ⬆ ⬇

Pharmacokinetics ⬆ ⬇

Time/Action Profile ⬆ ⬇

Contraind./Precautions ⬆ ⬇

Adv. Reactions/Side Effects ⬆ ⬇

Interactions ⬆ ⬇

Route/Dosage ⬆ ⬇

Availability ⬆ ⬇

Assessment ⬆ ⬇

Implementation ⬆ ⬇

Patient/Family Teaching ⬆ ⬇

Evaluation/Desired Outcomes ⬆ ⬇

US Brand Names ⬆ ⬇

Code ⬆