Dulaglutide

Dulaglutide is a prescription medication used to treat the symptoms of Diabetes Mellitus Type 2. 

• Dulaglutide is available under the following different brand names: Trulicity

Adult dosage

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

Adult dosage: 

• Initial: 0.75 mg SC once weekly
• may increase dose to 1.5 mg once weekly for additional glycemic control
• if additional glycemic control is needed, increase to 3 mg once weekly after at least 4 weeks on the 1.5 mg dose
• if additional glycemic control is needed, increase to maximum dose of 4.5 mg once weekly after at least 4 weeks on the 3 mg dose
• Safety and efficacy not established for pediatric patients

Dosage Considerations – Should be Given as Follows: 

• See "Dosages."

Common side effects of Dulaglutide include:

• nausea, 
• vomiting, 
• stomach pain, 
• diarrhea, and
• loss of appetite

Serious side effects of Dulaglutide include:

• hives, 
• difficulty breathing, 
• swelling of the face, lips, tongue, or throat, 
• lightheadedness, 
• severe pain in the upper stomach spreading to the back, 
• nausea, 
• vomiting, 
• swelling or a lump in the neck, 
• trouble swallowing, 
• hoarse voice, 
• shortness of breath, 
• headache, 
• hunger, 
• weakness, 
• sweating, 
• confusion, 
• irritability, 
• dizziness, 
• fast heart rate, 
• feeling jittery, 
• little or no urination, 
• swelling in the feet or ankles, and
• tiredness

Rare side effects of Dulaglutide include:

• none 

This is not a complete list of side effects and other serious side effects or health problems may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them.  Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first

• Dulaglutide has severe interactions with no other drugs.
• Dulaglutide has serious interactions with no other drugs.
• Dulaglutide has moderate interactions with at least 57 other drugs.
• Dulaglutide has minor interactions with no other drugs. 

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drugs interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use.  Keep a list of all your medications with you, and share this information with your doctor and pharmacist.  Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns.

Contraindications

• Hypersensitivity
• Personal or family history of medullary thyroid carcinoma (MTC)
• Multiple endocrine neoplasia type 2 (MEN-2)

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Dulaglutide?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Dulaglutide?”

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
• Diabetic retinopathy complications
• The REWIND CV outcomes trial (n = 9901; median follow up 5.4 years) 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 over 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
  • 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 and Lactation

• 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
• 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