TANZEUM
Clinical safety rating: caution
Comprehensive clinical and safety monograph for TANZEUM (TANZEUM).
Tanzeum (albiglutide) is a glucagon-like peptide-1 (GLP-1) receptor agonist that increases insulin secretion, decreases glucagon secretion, slows gastric emptying, and promotes satiety.
| Metabolism | Albiglutide is metabolized via proteolysis into small peptides and amino acids; not metabolized by CYP450 enzymes. |
| Excretion | Renal (79% as unchanged drug), biliary/fecal (minor, ~1%) |
| Half-life | Terminal elimination half-life approximately 5 days (range 4-6 days), supporting weekly subcutaneous dosing |
| Protein binding | Albumin, ~99% |
| Volume of Distribution | ~0.07 L/kg (low Vd, indicating limited extravascular distribution) |
| Bioavailability | Subcutaneous: ~90% |
| Onset of Action | Subcutaneous: Steady-state achieved after 4-5 weeks; initial glucose-lowering effects observed within 2-4 weeks |
| Duration of Action | ~7 days (once-weekly dosing); clinical effect persists with repeated administration due to long half-life |
Subcutaneous injection: 300 mg every 4 weeks. Administer as 3 consecutive injections of 100 mg each in the same body region (abdomen, thigh, or upper arm).
| Dosage form | INJECTABLE |
| Renal impairment | No dose adjustment required for mild to moderate renal impairment (eGFR ≥30 mL/min/1.73 m²). Not recommended in severe renal impairment (eGFR <30 mL/min/1.73 m²) or ESRD due to limited data. |
| Liver impairment | No dose adjustment required for mild hepatic impairment (Child-Pugh class A). Not studied in moderate (Child-Pugh class B) or severe (Child-Pugh class C) hepatic impairment; use with caution. |
| Pediatric use | Safety and efficacy not established in pediatric patients (<18 years). No recommended dose. |
| Geriatric use | No specific dose adjustment recommended based on age alone. Consider renal function and comorbidities in elderly patients; monitor for adverse effects. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for TANZEUM (TANZEUM).
| Breastfeeding | Unknown if excreted in human breast milk. M/P ratio not available. Caution recommended; manufacturer advises against use while breastfeeding due to potential for hypoglycemia in the infant. |
| Teratogenic Risk | FDA Pregnancy Category C. First trimester: Animal studies show increased fetal resorptions and skeletal variations at exposures 30 times the human dose. No adequate human studies. Second and third trimesters: Risk of fetal hypoglycemia and potential for increased fetal growth due to maternal glucose control changes. |
■ FDA Black Box Warning
There is no black box warning for Tanzeum.
| Serious Effects |
["Personal or family history of medullary thyroid carcinoma","Multiple endocrine neoplasia syndrome type 2 (MEN-2)","Hypersensitivity to albiglutide or any product components"]
| Precautions | ["Risk of acute pancreatitis","Hypoglycemia when used with sulfonylureas or insulin","Renal impairment, including acute renal failure","Gastrointestinal adverse reactions, including nausea, vomiting, diarrhea","Thyroid C-cell tumor risk (observed in animal studies); contraindicated in patients with personal or family history of medullary thyroid carcinoma or MEN-2"] |
Loading safety data…
| Fetal Monitoring |
| Monitor maternal blood glucose levels frequently. Assess fetal growth and well-being via ultrasound every 4-6 weeks during second and third trimesters. Perform fetal non-stress tests or biophysical profiles if gestational diabetes is uncontrolled or if other risk factors present. |
| Fertility Effects | No human data on fertility effects. Animal studies show no adverse effects on fertility at doses up to 30 times the human clinical dose. |