Albiglutide Dosage

Applies to the following strengths: 30 mg; 50 mg

Usual Adult Dose for:

Diabetes Type 2

Additional dosage information:

Renal Dose Adjustments
Liver Dose Adjustments
Precautions
Dialysis
Other Comments

Usual Adult Dose for Diabetes Type 2

Initial dose: 30 mg subcutaneously once a week

If glycemic response is inadequate, may increase to 50 mg subcutaneously once a week

Maintenance dose: 30 or 50 mg subcutaneously once a week

Comments:

This drug is not recommended as first-line therapy because of uncertain relevance of the rodent C-cell tumor findings to humans; prescribe only to patients for whom the potential benefits are considered to outweigh the potential risk.
This drug has not been studied in patients with a history of pancreatitis; consider alternative therapies
The dose of concomitantly administered insulin or insulin secretagogues may need to be reduced when starting therapy in order to decrease the risk of hypoglycemia.
This drug has not been studied in combination with prandial insulin.

Use: As an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus.

Renal Dose Adjustments

Mild, moderate, or severe renal impairment (eGFR 15 to 89 mL/min/1.73m2): No adjustment recommended; use caution when initiating or escalating doses

eGFR less than 15 mL/min/1.73m2: No data available

Monitor renal function in patients with renal impairment reporting severe adverse gastrointestinal reactions

Liver Dose Adjustments

No dose adjustment recommended

Precautions

The US FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for Albiglutide. It includes communication plan. For additional information: www.fda.gov/REMS

US BOXED WARNING: RISK OF THYROID C-CELL TUMORS

Carcinogenicity of this drug could not be assessed in rodents, but other glucagon-like peptide-1 (GLP-1) receptor agonists have caused thyroid C-cell tumors in rodents at clinically relevant exposures. Human relevance of GLP-1 receptor agonist induced C-cell tumors in rodents has not been determined. It is unknown whether this drug causes thyroid C-cell tumor, including medullary thyroid carcinoma (MTC) in humans.
This drug is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN2). Counsel patients regarding the potential risk of MTC with the use of this drug and inform them of the symptoms of thyroid tumors (e.g., mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine serum calcitonin or thyroid ultrasound monitoring is of uncertain value for early detection of MTC in patients treated with this drug.

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

For subcutaneous use only into the abdomen, thigh, or upper arm region; do not give IV or IM
Administer subcutaneously once a week at any time of the day, without regard to meals; give on the same day each week
Never share a pen between patients, even if the needle is changed, due to risk for transmission of blood-borne pathogens

Missed dose:

If a dose is missed, administer as soon as possible if it is within 3 days of the missed dose, then resume usual dosing schedule
If a dose is missed, and it is more than 3 days after the missed dose, skip the missed dose and resume usual dosing schedule

Administration day may be changed if the last dose was administered 4 or more days earlier

Storage requirements: Store in original carton until use; do not freeze; discard if frozen

Unopened (not in use): Store in the refrigerator (36F to 46F [2C to 8C])
Pens may be kept at room temperature below 86F (30C) for up to 4 weeks
Once reconstituted, must use within 8 hours

Reconstitution/preparation techniques:

The lyophilized powder contained within the Pen must be reconstituted prior to administration
Patients should receive proper training from their healthcare provider prior to first use
Product labeling should be consulted for specific instructions; instructions may also be found at www.TANZEUM.com

General:

This drug has not been studied in patients with a history of pancreatitis, alternative therapy should be considered in these patients.
This drug should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis; this drug is not a substitute for insulin.
This drug is not recommended as a first-line therapy in patients with type 2 diabetes mellitus as the relevance of rat thyroid C-cell tumor findings to humans is uncertain.
Routine serum calcitonin or thyroid ultrasound monitoring is of uncertain value for early detection of MTC in patients treated with this drug.
This drug has not been studied in combination with prandial insulin.
This drug has not been studied in patients with severe gastrointestinal disease and is not recommended in these patients.

Monitoring:

Blood glucose and hemoglobin A1C measurements should be measured periodically to assess efficacy.
Observe for signs and symptoms of pancreatitis.
Observe for signs and symptoms of thyroid tumors.
Renal: Monitor renal function in renally impaired patients reporting adverse gastrointestinal reactions

Patient advice:

Patients should understand the potential risk of medullary thyroid cancer with the use of this drug and should be instructed to report symptoms of thyroid tumors (e.g., mass in the neck, dysphagia, dyspnea, persistent hoarseness).
Patients should be familiar with proper use, storage, and disposal of pen.
Patients should be familiar with self-management practices of diabetes including recognition and management of hypoglycemia and precautions necessary to avoid hypoglycemia while engaged in hazardous activities such as driving and using machines.
Patients should be advised to never share a pen with another person, even if the needle is changed as sharing needles or syringes with another person carries a risk for transmission of blood-borne pathogens
If using this drug together with insulin, administer as separate injections. Injections may be administered in the same body region but should not be adjacent to each other; patients should be instructed to rotate injections sites.
Patients should be instructed to stop this drug and contact their healthcare provider for the occurrence of severe abdominal pain that may radiate to the back with or without vomiting.
Patients should be instructed to seek medical advice during periods of stress, such as fever, trauma, infection, or surgery as medical management of diabetes may change.
Inform patients that hypersensitivity reactions may occur; patients should be instructed to contact their health care professional.
Patients should understand the relationship of dehydration and gastrointestinal side effects and the importance of maintaining adequate hydration during therapy.