Description
Tanzeum (albiglutide) is a glucagon-like peptide-1 (GLP-1) receptor agonist formerly indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Albiglutide is a recombinant fusion protein consisting of two copies of modified human GLP-1 linked to human albumin, prolonging its half-life and allowing for once-weekly subcutaneous dosing. It exerts its glucose-lowering effect by enhancing glucose-dependent insulin secretion, suppressing inappropriate glucagon secretion, and slowing gastric emptying.
Note: As of July 2018, Tanzeum was withdrawn from the U.S. market by the manufacturer (GlaxoSmithKline) due to commercial reasons, not safety or efficacy concerns. It is no longer available for prescribing in most regions.
Fact Table |
Formula | C2538H3892N746O781S40 |
License | US FDA (withdrawn) |
Bioavailability | Approximately 89% |
Legal status | Rx-only (withdrawn) |
Chemical Name | Albiglutide |
Elimination half-life | ~5 days |
Dosage (Strength) | 30 mg or 50 mg once weekly (subcutaneous) |
Pregnancy | Consult a doctor (Category C) |
Brands | Tanzeum (US), Eperzan (EU) |
Protein binding | Not applicable (large protein) |
PubChem CID | 56843311 |
MedlinePlus | a614034 |
ChEBI | 134722 |
ATC code | A10BJ04 |
DrugBank | DB09045 |
KEGG | D10333 |
Routes of administration | Subcutaneous injection |
Directions
When it was available, Tanzeum was administered via subcutaneous injection once weekly, at any time of day, with or without meals. The recommended starting dose was 30 mg once weekly, which could be increased to 50 mg if additional glycemic control was needed. The injection was delivered using a single-dose reconstitutable pen, requiring mixing just prior to administration. It was injected into the abdomen, thigh, or upper arm, with rotation of sites to reduce local reactions.
Ingredients
Each Tanzeum pen contained:
- Albiglutide (30 mg or 50 mg per dose)
- Sodium phosphate monobasic monohydrate
- Sodium phosphate dibasic heptahydrate
- Water for injection (for reconstitution)
Contraindications
Tanzeum was contraindicated in patients with:
- Personal or family history of medullary thyroid carcinoma (MTC)
- Patients with multiple endocrine neoplasia syndrome type 2 (MEN 2)
- Known hypersensitivity to albiglutide or any excipients in the formulation
Cautions
As with other GLP-1 receptor agonists, Tanzeum carried a boxed warning regarding the potential risk of thyroid C-cell tumors, based on rodent studies (not confirmed in humans). It was not recommended as first-line therapy for type 2 diabetes. Caution was advised in patients with pancreatitis, gastrointestinal disease, or renal impairment. Monitoring was advised for signs of thyroid nodules, hypersensitivity reactions, and hypoglycemia, particularly when used with insulin or sulfonylureas.
Side Effects
Common side effects of Tanzeum included:
- Upper respiratory tract infection
Serious adverse effects included:
- Hypersensitivity reactions (e.g., angioedema)
- Thyroid C-cell tumors (based on animal data)
IMPORTANT NOTE:
The above information is intended to increase awareness of health information and does not suggest treatment or diagnosis. This information is not a substitute for individual medical attention and should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. See your health care professional for medical advice and treatment.
Product Code : 14598