Dosing & Uses
Dosage Forms & Strengths
SC solution
- Available in single-dose pen
- 0.75mg/0.5mL
- 1.5mg/0.5mL
- 3mg/0.5mL
- 4.5mg/0.5mL
Diabetes Mellitus Type 2
Indicated as once-weekly SC injection adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (T2DM)
It is also indicated to reduce risk of major adverse cardiovascular (CV) events (CV death, nonfatal MI, or nonfatal stroke) in adults with T2DM who have established CV disease or multiple CV risk factors
Initial: 0.75 mg SC once weekly
May increase dose to 1.5 mg once weekly for additional glycemic control
If additional glycemic control needed, increase to 3 mg once weekly after at least 4 weeks on the 1.5-mg dose
If additional glycemic control needed, increase to maximum dose of 4.5 mg once weekly after at least 4 weeks on the 3-mg dose
Dosage Modifications
Renal impairment (any severity): No dosage adjustment required
Hepatic impairment (any severity): No dosage adjustment required; owing to limited data, caution advised
Dosing Considerations
Not recommended as first-line therapy for patients inadequately controlled on diet and exercise
Has not been studied with a history of pancreatitis; consider another antidiabetic therapy
Not for treatment of type 1 diabetes mellitus or diabetic ketoacidosis
Not for patients with preexisting severe GI disease
Diabetes Mellitus Type 2
Indicated an adjunct to diet and exercise to improve glycemic control in patients aged ≥10 years with type 2 diabetes mellitus (T2DM)
Initial: 0.75 mg SC once weekly
If additional glycemic control needed, increase to 1.5 mg once weekly after at least 4 weeks on the 0.75-mg dose
Not to exceed 1.5 mg/week
Dosage Modifications
Renal impairment (any severity): No dosage adjustment required
Hepatic impairment (any severity): No dosage adjustment required; owing to limited data, caution advised
Dosing Considerations
Limitations of use
- Not studied in patients with history of pancreatitis; consider other antidiabetic therapies for such patients
- Do not used for type 1 DM
- Not studied with severe gastrointestinal disease (eg, severe gastroparesis)
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (0)
Monitor Closely (59)
- acarbose
dulaglutide, acarbose. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Antidiabetic agents are often used in combination; dosage adjustments may be required when initiating or discontinuing antidiabetic agents.
- alogliptin
dulaglutide, alogliptin. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Antidiabetic agents are often used in combination; dosage adjustments may be required when initiating or discontinuing antidiabetic agents.
- canagliflozin
dulaglutide, canagliflozin. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Antidiabetic agents are often used in combination; dosage adjustments may be required when initiating or discontinuing antidiabetic agents.
- carbamazepine
dulaglutide, carbamazepine. Other (see comment). Use Caution/Monitor. Comment: Dulaglutide slows gastric emptying and may impact absorption of concomitantly administered oral medications; be particularly cautious when coadministered with drugs that have a narrow therapeutic index.
- chlorpropamide
dulaglutide, chlorpropamide. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Antidiabetic agents are often used in combination; dosage adjustments may be required when initiating or discontinuing antidiabetic agents.
- clonidine
dulaglutide, clonidine. Other (see comment). Use Caution/Monitor. Comment: Dulaglutide slows gastric emptying and may impact absorption of concomitantly administered oral medications; be particularly cautious when coadministered with drugs that have a narrow therapeutic index.
- cyclosporine
dulaglutide, cyclosporine. Other (see comment). Use Caution/Monitor. Comment: Dulaglutide slows gastric emptying and may impact absorption of concomitantly administered oral medications; be particularly cautious when coadministered with drugs that have a narrow therapeutic index.
- dapagliflozin
dulaglutide, dapagliflozin. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Antidiabetic agents are often used in combination; dosage adjustments may be required when initiating or discontinuing antidiabetic agents.
- digoxin
dulaglutide, digoxin. Other (see comment). Use Caution/Monitor. Comment: Dulaglutide slows gastric emptying and may impact absorption of concomitantly administered oral medications; be particularly cautious when coadministered with drugs that have a narrow therapeutic index.
- disopyramide
dulaglutide, disopyramide. Other (see comment). Use Caution/Monitor. Comment: Dulaglutide slows gastric emptying and may impact absorption of concomitantly administered oral medications; be particularly cautious when coadministered with drugs that have a narrow therapeutic index.
- empagliflozin
dulaglutide, empagliflozin. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Antidiabetic agents are often used in combination; dosage adjustments may be required when initiating or discontinuing antidiabetic agents.
- ethosuximide
dulaglutide, ethosuximide. Other (see comment). Use Caution/Monitor. Comment: Dulaglutide slows gastric emptying and may impact absorption of concomitantly administered oral medications; be particularly cautious when coadministered with drugs that have a narrow therapeutic index.
- fosphenytoin
dulaglutide, fosphenytoin. Other (see comment). Use Caution/Monitor. Comment: Dulaglutide slows gastric emptying and may impact absorption of concomitantly administered oral medications; be particularly cautious when coadministered with drugs that have a narrow therapeutic index.
- glimepiride
dulaglutide, glimepiride. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Antidiabetic agents are often used in combination; dosage adjustments may be required when initiating or discontinuing antidiabetic agents.
- glipizide
dulaglutide, glipizide. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Antidiabetic agents are often used in combination; dosage adjustments may be required when initiating or discontinuing antidiabetic agents.
- glyburide
dulaglutide, glyburide. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Antidiabetic agents are often used in combination; dosage adjustments may be required when initiating or discontinuing antidiabetic agents.
- insulin aspart
dulaglutide, insulin aspart. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Antidiabetic agents are often used in combination; dosage adjustments may be required when initiating or discontinuing antidiabetic agents.
- insulin aspart protamine/insulin aspart
dulaglutide, insulin aspart protamine/insulin aspart. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Antidiabetic agents are often used in combination; dosage adjustments may be required when initiating or discontinuing antidiabetic agents.
- insulin degludec
dulaglutide, insulin degludec. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Antidiabetic agents are often used in combination; dosage adjustments may be required when initiating or discontinuing antidiabetic agents.
- insulin degludec/insulin aspart
dulaglutide, insulin degludec/insulin aspart. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Antidiabetic agents are often used in combination; dosage adjustments may be required when initiating or discontinuing antidiabetic agents.
- insulin detemir
dulaglutide, insulin detemir. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Antidiabetic agents are often used in combination; dosage adjustments may be required when initiating or discontinuing antidiabetic agents.
- insulin glargine
dulaglutide, insulin glargine. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Antidiabetic agents are often used in combination; dosage adjustments may be required when initiating or discontinuing antidiabetic agents.
- insulin glulisine
dulaglutide, insulin glulisine. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Antidiabetic agents are often used in combination; dosage adjustments may be required when initiating or discontinuing antidiabetic agents.
- insulin inhaled
dulaglutide, insulin inhaled. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Antidiabetic agents are often used in combination; dosage adjustments may be required when initiating or discontinuing antidiabetic agents.
- insulin isophane human/insulin regular human
dulaglutide, insulin isophane human/insulin regular human. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Antidiabetic agents are often used in combination; dosage adjustments may be required when initiating or discontinuing antidiabetic agents.
- insulin lispro
dulaglutide, insulin lispro. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Antidiabetic agents are often used in combination; dosage adjustments may be required when initiating or discontinuing antidiabetic agents.
- insulin lispro protamine/insulin lispro
dulaglutide, insulin lispro protamine/insulin lispro. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Antidiabetic agents are often used in combination; dosage adjustments may be required when initiating or discontinuing antidiabetic agents.
- insulin NPH
dulaglutide, insulin NPH. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Antidiabetic agents are often used in combination; dosage adjustments may be required when initiating or discontinuing antidiabetic agents.
- insulin regular human
dulaglutide, insulin regular human. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Antidiabetic agents are often used in combination; dosage adjustments may be required when initiating or discontinuing antidiabetic agents.
- levothyroxine
dulaglutide, levothyroxine. Other (see comment). Use Caution/Monitor. Comment: Dulaglutide slows gastric emptying and may impact absorption of concomitantly administered oral medications; be particularly cautious when coadministered with drugs that have a narrow therapeutic index.
- linagliptin
dulaglutide, linagliptin. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Antidiabetic agents are often used in combination; dosage adjustments may be required when initiating or discontinuing antidiabetic agents.
- lithium
dulaglutide, lithium. Other (see comment). Use Caution/Monitor. Comment: Dulaglutide slows gastric emptying and may impact absorption of concomitantly administered oral medications; be particularly cautious when coadministered with drugs that have a narrow therapeutic index.
- lonapegsomatropin
lonapegsomatropin decreases effects of dulaglutide by Other (see comment). Use Caution/Monitor. Comment: Closely monitor blood glucose when treated with antidiabetic agents. Lonapegsomatropin may decrease insulin sensitivity, particularly at higher doses. Patients with diabetes mellitus may require adjustment of their doses of insulin and/or other antihyperglycemic agents.
lonapegsomatropin decreases effects of dulaglutide by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Growth hormone (GH) analogs may decrease insulin sensitivity, particularly at higher doses. Antidiabetic agents may require dose adjustment after initiating growth hormone. - metformin
dulaglutide, metformin. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Antidiabetic agents are often used in combination; dosage adjustments may be required when initiating or discontinuing antidiabetic agents.
- miglitol
dulaglutide, miglitol. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Antidiabetic agents are often used in combination; dosage adjustments may be required when initiating or discontinuing antidiabetic agents.
- minoxidil
dulaglutide, minoxidil. Other (see comment). Use Caution/Monitor. Comment: Dulaglutide slows gastric emptying and may impact absorption of concomitantly administered oral medications; be particularly cautious when coadministered with drugs that have a narrow therapeutic index.
- nateglinide
dulaglutide, nateglinide. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Antidiabetic agents are often used in combination; dosage adjustments may be required when initiating or discontinuing antidiabetic agents.
- phenobarbital
dulaglutide, phenobarbital. Other (see comment). Use Caution/Monitor. Comment: Dulaglutide slows gastric emptying and may impact absorption of concomitantly administered oral medications; be particularly cautious when coadministered with drugs that have a narrow therapeutic index.
- phenytoin
dulaglutide, phenytoin. Other (see comment). Use Caution/Monitor. Comment: Dulaglutide slows gastric emptying and may impact absorption of concomitantly administered oral medications; be particularly cautious when coadministered with drugs that have a narrow therapeutic index.
- pioglitazone
dulaglutide, pioglitazone. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Antidiabetic agents are often used in combination; dosage adjustments may be required when initiating or discontinuing antidiabetic agents.
- pramlintide
dulaglutide, pramlintide. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Antidiabetic agents are often used in combination; dosage adjustments may be required when initiating or discontinuing antidiabetic agents.
- prazosin
dulaglutide, prazosin. Other (see comment). Use Caution/Monitor. Comment: Dulaglutide slows gastric emptying and may impact absorption of concomitantly administered oral medications; be particularly cautious when coadministered with drugs that have a narrow therapeutic index.
- primidone
dulaglutide, primidone. Other (see comment). Use Caution/Monitor. Comment: Dulaglutide slows gastric emptying and may impact absorption of concomitantly administered oral medications; be particularly cautious when coadministered with drugs that have a narrow therapeutic index.
- procainamide
dulaglutide, procainamide. Other (see comment). Use Caution/Monitor. Comment: Dulaglutide slows gastric emptying and may impact absorption of concomitantly administered oral medications; be particularly cautious when coadministered with drugs that have a narrow therapeutic index.
- quinidine
dulaglutide, quinidine. Other (see comment). Use Caution/Monitor. Comment: Dulaglutide slows gastric emptying and may impact absorption of concomitantly administered oral medications; be particularly cautious when coadministered with drugs that have a narrow therapeutic index.
- quinine
dulaglutide, quinine. Other (see comment). Use Caution/Monitor. Comment: Dulaglutide slows gastric emptying and may impact absorption of concomitantly administered oral medications; be particularly cautious when coadministered with drugs that have a narrow therapeutic index.
- repaglinide
dulaglutide, repaglinide. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Antidiabetic agents are often used in combination; dosage adjustments may be required when initiating or discontinuing antidiabetic agents.
- rosiglitazone
dulaglutide, rosiglitazone. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Antidiabetic agents are often used in combination; dosage adjustments may be required when initiating or discontinuing antidiabetic agents.
- saxagliptin
dulaglutide, saxagliptin. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Antidiabetic agents are often used in combination; dosage adjustments may be required when initiating or discontinuing antidiabetic agents.
- sirolimus
dulaglutide, sirolimus. Other (see comment). Use Caution/Monitor. Comment: Dulaglutide slows gastric emptying and may impact absorption of concomitantly administered oral medications; be particularly cautious when coadministered with drugs that have a narrow therapeutic index.
- sitagliptin
dulaglutide, sitagliptin. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Antidiabetic agents are often used in combination; dosage adjustments may be required when initiating or discontinuing antidiabetic agents.
- somapacitan
somapacitan decreases effects of dulaglutide by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Growth hormone (GH) analogs may decrease insulin sensitivity, particularly at higher doses. Antidiabetic agents may require dose adjustment after initiating growth hormone.
- somatrogon
somatrogon decreases effects of dulaglutide by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Growth hormone (GH) analogs may decrease insulin sensitivity, particularly at higher doses. Antidiabetic agents may require dose adjustment after initiating growth hormone.
- somatropin
somatropin decreases effects of dulaglutide by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Growth hormone (GH) analogs may decrease insulin sensitivity, particularly at higher doses. Antidiabetic agents may require dose adjustment after initiating growth hormone.
- tacrolimus
dulaglutide, tacrolimus. Other (see comment). Use Caution/Monitor. Comment: Dulaglutide slows gastric emptying and may impact absorption of concomitantly administered oral medications; be particularly cautious when coadministered with drugs that have a narrow therapeutic index.
- theophylline
dulaglutide, theophylline. Other (see comment). Use Caution/Monitor. Comment: Dulaglutide slows gastric emptying and may impact absorption of concomitantly administered oral medications; be particularly cautious when coadministered with drugs that have a narrow therapeutic index.
- tolazamide
dulaglutide, tolazamide. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Antidiabetic agents are often used in combination; dosage adjustments may be required when initiating or discontinuing antidiabetic agents.
- tolbutamide
dulaglutide, tolbutamide. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Antidiabetic agents are often used in combination; dosage adjustments may be required when initiating or discontinuing antidiabetic agents.
- valproic acid
dulaglutide, valproic acid. Other (see comment). Use Caution/Monitor. Comment: Dulaglutide slows gastric emptying and may impact absorption of concomitantly administered oral medications; be particularly cautious when coadministered with drugs that have a narrow therapeutic index.
Minor (0)
Adverse Effects
>10%
Nausea (12.4-21.1%)
Increased amylase (20%)
Increased lipase (14%)
Diarrhea (7-12.6%)
1-10%
Abdominal pain (6.5-9.4%)
Vomiting (5.6-9.3%)
Decreased appetite (4.9-8.6%)
Fatigue (4.2-5.6%)
Dyspepsia (2.3-5.8%)
Constipation (3.7-3.9%)
Severe hypoglycemia with prandial insulin (2.7-3.4%)
Flatulence (1.4-3.4%)
Sinus tachycardia (2.8-3%)
Abdominal distension (2.3-2.9%)
Gastroesophageal reflux disease (1.7-2%)
AV block (0.9-1.7%)
Eructation (0.6-1.6%)
<1%
Hypersensitivity, sometimes severe (eg, severe urticaria, systemic rash, facial edema, lip swelling)
Injection-site reactions
Pancreatitis
Cholelithaisis and cholecystitis
Postmarketing Reports
Gastrointestinal: Ileus
Hepatobiliary: Cholecystitis, cholelithiasis requiring cholecystectomy, cholestasis, elevation of liver enzymes, hepatitis
Hypersensitivity: Anaphylactic reactions, angioedema
Renal: Acute renal failure or worsening of chronic renal failure, sometimes requiring hemodialysis
Warnings
Black Box Warnings
Risk of thyroid C-cell tumors
- Causes thyroid C-cell tumors in rodents; human risk could not be determined
- Contraindicated in patients with personal or family history of medullary thyroid carcinoma (MTC) or in patients with multiple endocrine neoplasia syndrome type 2 (MEN-2)
- Counsel patients regarding potential risk of MTC with therapy and inform them of symptoms of thyroid tumors (e.g., mass in the neck, dysphagia, dyspnea, persistent hoarseness); routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients receiving therapy
Contraindications
Hypersensitivity to drug or excipients
Personal or family history of medullary thyroid carcinoma (MTC)
Multiple endocrine neoplasia type 2 (MEN-2)
Cautions
Systemic hypersensitivity reactions reported; anaphylaxis and angioedema reported with other GLP-1 receptor agonists; use caution in a patient with a history of angioedema or anaphylaxis with another GLP-1 receptor agonist; unknown whether such patients will be predisposed to anaphylaxis with drug; discontinue if such reactions occur
Acute renal failure and worsening of chronic renal failure (some requiring hemodialysis) reported with treatment with glucagonlike peptide-1 (GLP-1) receptor agonists
May be associated with GI adverse reactions, sometimes severe; counsel patients to take precautions to avoid fluid depletion; has not been studied in patients with severe GI disease, including severe gastroparesis
Acute events of gallbladder disease such as cholelithiasis or cholecystitis reported in GLP-1 receptor agonist trials and postmarketing; serious events of acute cholecystitis reported; if cholelithiasis is suspected, gallbladder studies and appropriate clinical follow-up are indicated
Diabetic retinopathy complications
- The REWIND CV outcomes trial (n = 9901; median follow up 5.4 yr) was conducted in patients with T2DM with established CV disease or multiple CV risk factors
- Secondary composite endpoints showed diabetic retinopathy complications occurred in 1.9% of patients treated with dulaglutide compared with 1.5% treated with placebo
- Diabetic retinopathy complications were higher among patients with history of diabetic retinopathy at baseline (dulaglutide 8.5%, placebo 6.2%) compared with those without baseline history (dulaglutide 1%, placebo 1%)
- Rapid improvement in glucose control has been associated with a temporary worsening of diabetic retinopathy
- Monitor for diabetic retinopathy progression in patients who have a history of diabetic retinopathy
Medullary thyroid carcinoma (MTC)
- Nonclinical studies in rodents showed increased incidence of thyroid C-cell tumors (see Black Box Warnings and Contraindications)
- Routine serum calcitonin or thyroid ultrasound monitoring is of uncertain value for early detection of MTC in patients treated with dulaglutide
- Significantly elevated serum calcitonin may indicate MTC; patients with MTC usually have values >50 ng/L; evaluate patient further if serum calcitonin elevated
- Evaluate patients with thyroid nodules noted on physical examination or neck imaging
Pancreatitis
- Acute pancreatitis reported (rare); after initiation of therapy
- Observe for signs and symptoms of pancreatitis, including persistent severe abdominal pain, sometimes radiating to the back, which may or may not be accompanied by vomiting
- Discontinue if pancreatitis suspected and do not restart if confirmed; initiate appropriate management
- Therapy has not been evaluated in patients with a prior history of pancreatitis; consider other antidiabetic therapies in patients with a history of pancreatitis
Drug interaction overview
-
Insulin secretagogues (eg, sulfonylureas) or insulin
- When initiating dulaglutide, consider reducing dosage of concomitantly administered insulin or insulin secretagogues to reduce risk of hypoglycemia
- Patients receiving drug in combination with an insulin secretagogue (eg, sulfonylurea) or insulin may have an increased risk of hypoglycemia, including severe hypoglycemia
- The risk of hypoglycemia may be lowered by a reduction in the dose of sulfonylurea (or other concomitantly administered insulin secretagogues) or insulin; inform patients using these concomitant medications of risk of hypoglycemia and educate them on signs and symptoms of hypoglycemia
-
Oral medications
- Dulaglutide delays gastric emptying and, thus has potential to reduce rate of absorption of concomitantly administered oral medications
- Delay in gastric emptying is dose-dependent, but is attenuated with the recommended dose escalation to higher dulaglutide
- Delay is largest after the first dose and diminishes with subsequent doses
- In clinical pharmacology studies, dulaglutide 1.5 mg did not affect the absorption of the tested orally administered medications to a clinically relevant degree
- Limited experience with use of concomitant medications in clinical trials with 3-mg and 4.5-mg doses
- Monitor drug levels of oral medications with a narrow therapeutic index (eg, warfarin) when concomitantly administered
Pregnancy & Lactation
Pregnancy
Limited data in pregnant women are not sufficient to determine a drug associated risk for major birth defects and miscarriage
There are clinical considerations regarding the risks of poorly controlled diabetes in pregnancy (eg, diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, stillbirth, delivery complications)
Should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus
Animal studies
- Based on animal reproduction studies, there may be risks to the fetus from exposure to dulaglutide during pregnancy
- In pregnant rats and rabbits administered dulaglutide during organogenesis, early embryonic deaths, fetal growth reductions, and fetal abnormalities occurred at systemic exposures at least 13 to 14-times human exposure at the maximum recommended human dose (MRHD) of 1.5 mg/week
Clinical considerations
- Poorly controlled diabetes in pregnancy increases maternal risk for diabetic ketoacidosis, preeclampsia, spontaneous abortions, preterm delivery, and delivery complications
- Poorly controlled diabetes increases fetal risk for major birth defects, stillbirth, and macrosomia-related morbidity
Lactation
There are no data on presence of dulaglutide in human milk, the effects on breastfed infant, or effects on milk production
Consider developmental and health benefits of breastfeeding along with mother’s clinical need for therapy and any potential adverse effects on breastfed infant from therapy or from underlying maternal condition
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Incretin mimetic; analogue of human glucagonlike peptide-1 (GLP-1); acts as GLP-1 receptor agonist to increase insulin secretion in the presence of elevated blood glucose; delays gastric emptying to decrease postprandial glucose; also decreases glucagon secretion
Absorption
Peak plasma concentration: 114 ng/mL
AUC: 14,000 ng•h/mL
Absolute bioavailability
- 65% (0.75 mg/dose)
- 47% (1.5 mg/dose)
- Absolute SC bioavailability for 3 mg and 4.5 mg doses estimated to be similar to 1.5 mg, although not been specifically studied
- Concentrations increased approximately proportional to dose from 0.75-4.5 mg
Distribution
Vd: 3.09 L (central); 5.98 L (peripheral)
Metabolism
Thought to be degraded into its component amino acids by general protein catabolism pathways
Elimination
Half-life: ~5 days
Clearance: 0.142 L/hr
Administration
SC Preparation
Inspect visually before use; solution should appear clear and colorless; do not use if particulate matter or coloration observed
SC Administration
Administer once weekly at any time of day
May take with or without food
Inject SC in abdomen, thigh, or upper arm; rotate injection site with each dose
If needed, can change day of weekly administration if last dose was administered ≥3 days before
Coadministration with insulin
- When using with insulin, administer as separate injections and never mix
- May inject dulaglutide and insulin in same body region, but injections should not be adjacent to each other
Missed dose
- ≥3 days until next scheduled dose: Administer as soon as possible
- <3 days until next scheduled dose: Skip missed dose; administer next dose on regularly scheduled day
- In each case, patients can then resume their regular once weekly dosing schedule
Storage
Refrigerate at 36-46ºF (2-8ºC)
May be kept at room temperature, not to exceed 86ºF (30ºC) for total of 14 days
Do not freeze; do not use if it has been frozen
Protect from light
Storage in original carton recommended until time of administration
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Trulicity subcutaneous - | 1.5 mg/0.5 mL injection |  | |
| Trulicity subcutaneous - | 1.5 mg/0.5 mL injection |  | |
| Trulicity subcutaneous - | 0.75 mg/0.5 mL injection |  | |
| Trulicity subcutaneous - | 3 mg/0.5 mL injection |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
dulaglutide subcutaneous
DULAGLUTIDE - INJECTION
(DOO-la-GLOO-tide)
COMMON BRAND NAME(S): Trulicity
WARNING: This medication can cause a certain type of thyroid tumor (thyroid C-cell tumors) in rats. It is unknown if this medication can cause similar tumors in humans. Talk with your doctor about the benefits and risks of treatment with this medication. Do not use this medication if you have a certain inherited disease (multiple endocrine neoplasia syndrome type 2 or MEN 2) or if you have a personal/family history of a certain type of cancer (medullary thyroid carcinoma). While using this medication, tell your doctor right away if you notice any signs or symptoms of thyroid tumors, including unusual growth or lump in the neck, difficulty swallowing, shortness of breath, unusual/lasting hoarseness.
USES: Dulaglutide is used with a proper diet and exercise program to control high blood sugar in people with type 2 diabetes. Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems. This medication is also used to lessen the risk of a major cardiovascular event (such as heart attack or stroke) in people who already have, or are at high risk for heart/blood vessel disease.Dulaglutide is similar to a natural hormone in your body (incretin). It works by causing insulin release in response to high blood sugar (such as after a meal) and by decreasing the amount of sugar your liver makes.Dulaglutide is not a substitute for insulin if you need insulin treatment.
HOW TO USE: Read the Medication Guide and Instructions for Use provided by your pharmacist before you start using dulaglutide and each time you get a refill. If you have any questions, ask your doctor or pharmacist.Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Before injecting each dose, clean the injection site with rubbing alcohol. Change the injection site each time to lessen injury under the skin.Inject this medication under the skin in the thigh, abdomen, or upper arm as directed by your doctor, usually once every 7 days. Do not inject into a vein or muscle. It may be used with or without meals.If you are also using insulin, give dulaglutide and insulin as separate injections. Do not mix them. You may inject these medications in the same area of the body, but the injection sites should not be next to each other.Do not share your pen device with another person, even if the needle is changed. You may give other people a serious infection, or get a serious infection from them. Learn how to store and discard medical supplies safely.Use this medication regularly to get the most benefit from it. To help you remember, use it on the same day each week. It may help to mark your calendar with a reminder. Carefully follow the medication treatment plan, meal plan, and exercise program your doctor has recommended.The dosage is based on your medical condition, age, and response to treatment. Your doctor will start you on a low dose first to decrease your risk of stomach/abdominal side effects, and gradually increase your dose. Follow your doctor's instructions carefully.Tell your doctor if your condition does not improve or if it worsens (such as if your blood sugar remains high or increases).
SIDE EFFECTS: See also Warning section.Nausea, diarrhea, vomiting, abdominal pain, stomach upset, decreased appetite, tiredness, or weakness may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: slow/irregular heartbeat, signs of kidney problems (such as change in the amount of urine), vision changes.Vomiting/diarrhea that doesn't stop may result in dehydration and kidney problems. Contact your doctor promptly if you notice any symptoms of dehydration, such as unusual decreased urination, unusual dry mouth/thirst, fast heartbeat, or dizziness/lightheadedness.Get medical help right away if you have any very serious side effects, including: signs of pancreas or gallbladder disease (such as nausea/vomiting that doesn't stop, severe stomach/abdominal pain).Although dulaglutide by itself usually does not cause low blood sugar (hypoglycemia), low blood sugar may occur if this drug is prescribed with other diabetes medications. Talk with your doctor or pharmacist about whether the dose(s) of your other diabetes medication(s) needs to be lowered. Drinking large quantities of alcohol, not getting enough calories from food, or doing unusually heavy exercise may also lead to low blood sugar. Symptoms may include sudden sweating, shaking, fast heartbeat, hunger, blurred vision, dizziness, or tingling hands/feet. It is a good habit to carry glucose tablets or gel to treat low blood sugar. If you don't have these reliable forms of glucose, rapidly raise your blood sugar by eating a quick source of sugar such as table sugar, honey, or candy, or drink fruit juice or non-diet soda. Tell your doctor right away about the reaction and the use of this product. To help prevent low blood sugar, eat meals on a regular schedule, and do not skip meals. Check with your doctor or pharmacist to find out what you should do if you miss a meal.Symptoms of high blood sugar (hyperglycemia) include thirst, increased urination, confusion, drowsiness, flushing, rapid breathing, and fruity breath odor. If these symptoms occur, tell your doctor right away. Your dosage may need to be increased.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: See also Warning section.Before using dulaglutide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, disease of the pancreas (pancreatitis), gallbladder disease, stomach/intestinal disorders (such as gastroparesis), a certain eye problem (diabetic retinopathy).You may experience blurred vision, dizziness, or drowsiness due to extremely low or high blood sugar. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely.Limit alcohol while taking this medication because it can increase your risk of developing low blood sugar.It may be harder to control your blood sugar when your body is stressed (such as due to fever, infection, injury, or surgery). Consult your doctor because this may require a change in your treatment plan, medications, or blood sugar testing.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.Pregnancy may cause or worsen diabetes. Discuss a plan with your doctor for managing your blood sugar while pregnant. Your doctor may change your diabetes treatment during your pregnancy (such as diet and medications including insulin).It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Beta-blocker medications (such as metoprolol, propranolol, glaucoma eye drops such as timolol) may prevent the fast/pounding heartbeat you would usually feel when your blood sugar falls too low (hypoglycemia). Other symptoms of low blood sugar, such as dizziness, hunger, or sweating, are unaffected by these drugs.Many drugs can affect your blood sugar, making it harder to control. Before you start, stop, or change any medication, talk with your doctor or pharmacist about how the medication may affect your blood sugar. Check your blood sugar regularly as directed and share the results with your doctor. Tell your doctor right away if you have symptoms of high or low blood sugar. (See also Side Effects section.) Your doctor may need to adjust your diabetes medication, exercise program, or diet.
OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: Do not share this medication with others.Attend a diabetes education program to learn more about how to manage your diabetes with medications, diet, exercise, and regular medical exams.Learn the symptoms of high and low blood sugar and how to treat low blood sugar. Check your blood sugar regularly as directed.Lab and/or medical tests (such as kidney function, fasting blood glucose, hemoglobin A1c, eye exams) should be done while you are using this medication. Keep all medical and lab appointments.
MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is within 3 days of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.
STORAGE: Store in the refrigerator. Do not freeze. This medication may also be stored at room temperature but must be used within 2 weeks. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).
Information last revised November 2022. Copyright(c) 2023 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
Adding plans allows you to compare formulary status to other drugs in the same class.
To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.
Adding plans allows you to:
- View the formulary and any restrictions for each plan.
- Manage and view all your plans together – even plans in different states.
- Compare formulary status to other drugs in the same class.
- Access your plan list on any device – mobile or desktop.
