INDICATIONS

TRULICITY^® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Limitations Of Use

• TRULICITY is not recommended as a first-line therapy for patients who have inadequate glycemic control on diet and exercise because of the uncertain relevance of rodent C-cell tumor findings to humans. Prescribe TRULICITY only to patients for whom the potential benefits outweigh the potential risk.
• TRULICITY has not been studied in patients with a history of pancreatitis. Consider other antidiabetic therapies in patients with a history of pancreatitis.
• TRULICITY should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. TRULICITY is not a substitute for insulin.
• TRULICITY has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis. The use of TRULICITY is not recommended in patients with pre-existing severe gastrointestinal disease

DOSAGE AND ADMINISTRATION

Dosage

The recommended initiating dose of TRULICITY is 0.75 mg once weekly. The dose may be increased to 1.5 mg once weekly for additional glycemic control. The maximum recommended dose is 1.5 mg once weekly.

Administer TRULICITY once weekly, any time of day, with or without food. TRULICITY should be injected subcutaneously in the abdomen, thigh, or upper arm.

If a dose is missed, instruct patients to administer as soon as possible if there are at least 3 days (72 hours) until the next scheduled dose. If less than 3 days remain before the next scheduled dose, skip the missed dose and administer the next dose on the regularly scheduled day. In each case, patients can then resume their regular once weekly dosing schedule.

The day of weekly administration can be changed if necessary as long as the last dose was administered 3 or more days before.

Concomitant Use With An Insulin Secretagogue (E.g., Sulfonylurea) Or With Insulin

When initiating TRULICITY, consider reducing the dosage of concomitantly administered insulin secretagogues (e.g., sulfonylureas) or insulin to reduce the risk of hypoglycemia.

Important Administration Instructions

Prior to initiation of TRULICITY, patients should be trained by their healthcare professional on proper injection technique. Training reduces the risk of administration errors such as improper injection site, needle sticks, and incomplete dosing. Refer to the accompanying Instructions for Use for complete administration instructions with illustrations. The instructions can also be found at www.primemedsstore.com.

When using TRULICITY with insulin, instruct patients to administer as separate injections and to never mix the products. It is acceptable to inject TRULICITY and insulin in the same body region but the injections should not be adjacent to each other.

When injecting in the same body region, advise patients to use a different injection site each week. TRULICITY must not be administered intravenously or intramuscularly. TRULICITY solution should be visually inspected for particulate matter and discoloration prior to administration.

HOW SUPPLIED

Dosage Forms And Strengths

• Injection: 0.75 mg/0.5 mL solution in a single-dose pen
• Injection: 1.5 mg/0.5 mL solution in a single-dose pen

Each TRULICITY single-dose pen is packaged in a cardboard outer carton.

Carton Of 4 Single-Dose Pens

• 0.75 mg/0.5 mL solution in a single-dose pen (NDC 0002-1433-80)
• 1.5 mg/0.5 mL solution in a single-dose pen (NDC 0002-1434-80)

Storage And Handling

• Store TRULICITY in the refrigerator at 36°F to 46°F (2°C to 8°C). Do not use TRULICITY beyond the expiration date.
• If needed, each single-dose pen can be kept at room temperature, not to exceed 86°F (30°C) for a total of 14 days.
• Do not freeze TRULICITY. Do not use TRULICITY if it has been frozen.
• TRULICITY must be protected from light. Storage of TRULICITY in the original carton is recommended until time of administration.
• Discard the TRULICITY single-dose pen after use in a puncture-resistant container.

Manufactured by: Eli Lilly and Company Indianapolis, IN 46285, USA. Revised: Jan 2019

SIDE EFFECTS

The following serious reactions are described below or elsewhere in the prescribing information:

• Risk of Thyroid C-cell Tumors
• Pancreatitis
• Hypoglycemia with Concomitant Use of Insulin Secretagogues or Insulin
• Hypersensitivity Reactions
• Acute Kidney Injury
• Severe Gastrointestinal Disease

Clinical Studies Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.