Diabetes:
Indications for TRULICITY:
As adjunct to diet and exercise, to improve glycemic control in adults with type 2 diabetes mellitus (T2DM). To reduce the risk of major cardiovascular (CV) events (eg, CV death, non-fatal MI or non-fatal stroke) in adults with T2DM and established CV disease or multiple CV risk factors.
Limitations of Use:
Not studied in patients with history of pancreatitis. Not for treating type 1 diabetes or diabetic ketoacidosis. Not a substitute for insulin. Not recommended in patients with pre-existing severe GI disease.
Adult:
Give by SC inj in the abdomen, thigh, or upper arm any time of the day, with or without food. ≥18yrs: initially 0.75mg once weekly; may increase to 1.5mg once weekly if inadequate response. If additional glycemic control is needed: increase to 3mg once weekly after ≥4 weeks on the 1.5mg dose; increase to max 4.5mg once weekly after ≥4 weeks on the 3mg dose.
Children:
<18yrs: not recommended.
Contraindications:
History (personal or family) of medullary thyroid carcinoma. Multiple endocrine neoplasia syndrome type 2.
Boxed Warning:
Risk of thyroid C-cell tumors.
Warnings/Precautions:
Risk of thyroid C-cell tumors; inform patients of potential risk and symptoms. History of pancreatitis; consider other antidiabetics. Monitor for pancreatitis; discontinue if suspected; do not restart if confirmed. History of diabetic retinopathy; monitor for progression. History of anaphylaxis or angioedema with other GLP-1 receptor agonist. Monitor renal function when initiating or escalating dose, and in renally-impaired patients reporting severe GI reactions. ESRD. Hepatic impairment. Pregnancy. Nursing mothers.
Pharmacologic Class:
Glucagon-like peptide-1 (GLP-1) receptor agonist.
Interactions:
Concomitant insulin: administer as separate injections not adjacent to each other. Increased risk of hypoglycemia with concomitant insulin secretagogues (eg, sulfonylureas) or insulin; may need lower dose of these. May affect absorption of concomitant oral drugs (delayed gastric emptying); monitor drugs with narrow therapeutic index.
Adverse Reactions:
Nausea, diarrhea, vomiting, abdominal pain, decreased appetite; pancreatitis, hypersensitivity reactions (discontinue if occur), acute kidney injury.
Generic Availability:
NO
How Supplied:
Single-dose pen—4
