Albiglutide (Tanzeum): Dosing Protocols
Dosing guidelines, reconstitution, and administration information
๐TL;DR
- โข1 dosing protocols documented
- โขReconstitution instructions included
- โขStorage: Unreconstituted pens were stored refrigerated at 2-8 degrees C. Pens could be stored at room temperature (up to 30 degrees C) for up to 4 weeks before use. After reconstitution, the solution was to be administered within 8 hours. Room temperature stability was a notable advantage over some competing products.
Protocol Quick-Reference
Type 2 diabetes mellitus (FDA-approved 2014, withdrawn 2017)
Dosing
Amount
30-50 mg
Frequency
Once weekly
Duration
Ongoing (long-term use)
Administration
Route
SCSchedule
Once weekly
Timing
Start at 30 mg weekly; increase to 50 mg weekly if glycemic response is inadequate after at least 4 weeks. Product discontinued in 2017.
Cycle
Duration
Ongoing
Repeatable
Yes
โ๏ธ Suggested Bloodwork (4 tests)
HbA1c
When: Baseline
Why: Baseline glycemic control assessment
HbA1c
When: 12 weeks
Why: Assess glycemic response and need for dose escalation
Renal function panel
When: Baseline
Why: Baseline kidney function assessment
Lipid panel
When: Baseline
Why: Baseline cardiovascular risk assessment
๐ก Key Considerations
- โProduct withdrawn from market in July 2017: dosing information is historical only
- โRequired reconstitution from lyophilized powder with approximately 15-minute wait time
- โDemonstrated cardiovascular benefit (22% MACE reduction) in HARMONY Outcomes trial, published after withdrawal
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| Purpose | Dose | Frequency | Duration | Notes |
|---|---|---|---|---|
| Once weekly | Product is no longer manufactured or available. Dosing information is provided for historical and educational purposes only. |
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๐Reconstitution Instructions
Tanzeum was supplied as a lyophilized powder in a single-dose pen that required reconstitution before injection. The reconstitution process involved twisting the pen to mix the powder with diluent, waiting approximately 15 minutes for dissolution, then twisting again to complete mixing. The reconstituted solution could be administered at room temperature. The complex reconstitution process was cited as a factor limiting patient and prescriber adoption.
Recommended Injection Sites
- โAbdomen
- โThigh
- โUpper arm
๐งStorage Requirements
Unreconstituted pens were stored refrigerated at 2-8 degrees C. Pens could be stored at room temperature (up to 30 degrees C) for up to 4 weeks before use. After reconstitution, the solution was to be administered within 8 hours. Room temperature stability was a notable advantage over some competing products.
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Before You Begin
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Historical Dosing Information#
Albiglutide (Tanzeum) was withdrawn from the worldwide market in July 2017. The dosing information below is provided for historical and educational purposes only. This product is no longer manufactured or available for clinical use.
FDA-Approved Dosing#
Albiglutide was approved at the following doses for type 2 diabetes mellitus:
- Starting dose: 30 mg subcutaneously once weekly
- Maximum dose: 50 mg subcutaneously once weekly
- Dose escalation: Increase to 50 mg weekly if glycemic response was inadequate after at least 4 weeks
The once-weekly dosing was enabled by the albumin fusion technology, which extended the half-life to approximately 5 days.
Administration#
Tanzeum was provided as a single-dose pen device containing lyophilized powder and diluent. The reconstitution process was notably more complex than the pre-filled pens used by competing GLP-1 agonists:
- Twist the pen to mix powder with diluent
- Wait approximately 15 minutes for dissolution
- Twist again to complete mixing
- Inspect for particulate matter
- Inject subcutaneously within 8 hours of reconstitution
This ~15-minute reconstitution process was a significant disadvantage compared to the ready-to-use pens of liraglutide and semaglutide, and was cited as a factor in low prescriber and patient adoption.
Storage#
- Before reconstitution: Refrigerate at 2-8 degrees C; can be stored at room temperature (up to 30 degrees C) for up to 4 weeks
- After reconstitution: Use within 8 hours; may be kept at room temperature
- Room temperature stability was a practical advantage for patients without consistent refrigerator access
Clinical Trial Dosing Context#
In the HARMONY clinical trial program, the 30 mg and 50 mg weekly doses were the primary doses studied. The HARMONY Outcomes cardiovascular trial used 30 mg weekly with optional uptitration to 50 mg, consistent with the approved labeling.
Dosing Context#
Albiglutide (Tanzeum) belongs to the Metabolic category of research peptides. Dosing protocols for Albiglutide (Tanzeum) are derived from available clinical trial data. These protocols are provided for research reference only and do not constitute medical advice. Actual dosing decisions should be made by qualified healthcare providers based on individual patient factors.
Research Protocols#
The following dosing protocols have been documented in clinical research for Albiglutide (Tanzeum):
undefined#
Dose: undefined
Frequency: Once weekly
Duration: undefined
Product is no longer manufactured or available. Dosing information is provided for historical and educational purposes only.
Reconstitution and Preparation#
Tanzeum was supplied as a lyophilized powder in a single-dose pen that required reconstitution before injection. The reconstitution process involved twisting the pen to mix the powder with diluent, waiting approximately 15 minutes for dissolution, then twisting again to complete mixing. The reconstituted solution could be administered at room temperature. The complex reconstitution process was cited as a factor limiting patient and prescriber adoption.
Injection Sites#
Recommended injection sites for Albiglutide (Tanzeum) include:
- Abdomen
- Thigh
- Upper arm
Site rotation is recommended to minimize local tissue reactions and ensure consistent absorption.
Storage Requirements#
Unreconstituted pens were stored refrigerated at 2-8 degrees C. Pens could be stored at room temperature (up to 30 degrees C) for up to 4 weeks before use. After reconstitution, the solution was to be administered within 8 hours. Room temperature stability was a notable advantage over some competing products.
Related Reading#
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Medical Disclaimer
This website is for educational and informational purposes only. The information provided is not intended to diagnose, treat, cure, or prevent any disease. Always consult with a qualified healthcare professional before using any peptide or supplement.