TANZEUM is a GLP-1 receptor agonist, a recombinant fusion protein comprised of 2 tandem copies of modified human GLP-1 genetically fused in tandem to human albumin. The human GLP-1 fragment sequence 7 – 36 has been modified with a glycine substituted for the naturally-occurring alanine at position 8 in order to confer resistance to dipeptidylpeptidase IV (DPP-IV) mediated proteolysis. The human albumin moiety of the recombinant fusion protein, together with the DPP-IV resistance, extends the half-life allowing once-weekly dosing. TANZEUM has a molecular weight of 72,970 Daltons.
TANZEUM is produced by a strain of Saccharomyces cerevisiae modified to express the therapeutic protein.
TANZEUM 30-mg Pen for injection (for subcutaneous use) contains 40.3 mg lyophilized albiglutide and 0.65 mL Water for Injection diluent designed to deliver a dose of 30 mg in a volume of 0.5 mL after reconstitution.
TANZEUM 50-mg Pen for injection (for subcutaneous use) contains 67 mg lyophilized albiglutide and 0.65 mL Water for Injection diluent designed to deliver a dose of 50 mg in a volume of 0.5 mL after reconstitution.
The lyophilized powder of both dose strengths is white to yellow in color and the solvent is a clear and colorless solution. The reconstituted solution is yellow in color.
Inactive ingredients include 153 mM mannitol, 0.01% (w/w) polysorbate 80, 10 mM sodium phosphate, and 117 mM trehalose dihydrate. TANZEUM does not contain a preservative.
| Mechanism of Action:
TANZEUM is an agonist of the GLP-1 receptor and augments glucose-dependent insulin secretion. TANZEUM also slows gastric emptying.
| INDICATIONS AND USAGE:
TANZEUM is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Limitations of Use:
•TANZEUM is not recommended as first-line therapy for patients inadequately controlled on diet and exercise [see Warnings and Precautions ].
•TANZEUM has not been studied in patients with a history of pancreatitis [see Warnings and Precautions]. Consider other antidiabetic therapies in patients with a history of pancreatitis.
TANZEUM is not indicated in the treatment of patients with type 1 diabetes mellitus or for the treatment of patients with diabetic ketoacidosis. TANZEUM is not a substitute for insulin in these patients.
•TANZEUM has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis. The use of TANZEUM is not recommended in patients with pre-existing severe gastrointestinal disease [see Adverse Reactions ].
•TANZEUM has not been studied in combination with prandial insulin.
USE IN SPECIFIC POPULATIONS ————————————-
Medullary Thyroid Carcinoma
| WARNINGS AND PRECAUTIONS:
| ADVERSE REACTIONS:
Adverse reactions, reported in 10% of patients treated with TANZEUM and more frequently than in patients on placebo, were upper respiratory tract infection, diarrhea, nausea, and injection site reaction.
To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
See PACKAGE INSERT for PATIENT COUNSELING INFORMATION and Medication Guide.
| DOSAGE AND ADMINISTRATION:
The recommended dosage of TANZEUM is 30 mg once weekly given as a subcutaneous injection in the abdomen, thigh, or upper arm region. The dosage may be increased to 50 mg once weekly if the glycemic response is inadequate.
TANZEUM may be administered at any time of day without regard to meals. Instruct patients to administer TANZEUM once a week on the same day each week. The day of weekly administration may be changed if necessary as long as the last dose was administered 4 or more days before.
If a dose is missed, instruct patients to administer as soon as possible within 3 days after the missed dose. Thereafter, patients can resume dosing on their usual day of administration. If it is more than 3 days after the missed dose, instruct patients to wait until their next regularly scheduled weekly dose.
Concomitant Use with an Insulin Secretagogue (e.g., Sulfonylurea) or with Insulin
Dosage in Patients with Renal Impairment
Reconstitution of the Lyophilized Powder
Preparing Pen for Injection
1. Slowly and gently rock the Pen side-to-side 5 additional times to mix the reconstituted solution.
See Dosage and Administration for important administration instructions, including the injection procedure.
Alternate Method of Reconstitution (Healthcare Professional Use Only)
Healthcare professionals may utilize the following alternate method of reconstitution. Because this method relies on appropriate swirling and visual inspection of the solution, it should only be performed by healthcare professionals.
1. Follow Step A (Inspect Your Pen and Twist Pen to Mix Your Medication) in the Instructions for Use. Make sure you have:
a. Inspected the Pen for  in number window and expiration date.
2. Hold the Pen with the clear cartridge pointing up and maintain this orientation throughout the reconstitution.
a. For 30-mg Pen: Complete dissolution usually occurs within 2 minutes but may take up to 5 minutes, as confirmed by visual inspection for a clear yellow solution free of particles.
5. After reconstitution, continue to follow the steps in the Instructions for Use, starting at Step B: Attach the Needle.
Important Administration Instructions
•The pen should be used within 8 hours of reconstitution prior to attaching the needle.
When using TANZEUM with insulin, instruct patients to administer as separate injections and to never mix the products. It is acceptable to inject TANZEUM 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. TANZEUM must not be administered intravenously or intramuscularly.
| DOSAGE FORMS AND STRENGTHS:
TANZEUM is supplied as follows:
•For injection: 30-mg lyophilized powder in a single-dose Pen (pen injector) for reconstitution.
Storage and Handling
•Prior to dispensing: Store Pens in the refrigerator at 36°F to 46°F (2°C to 8°C). Pens may be stored refrigerated until the expiration date.
National Institutes of Health, U.S. National Library of Medicine, DailyMed Database.
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