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Albiglutide Dosage

Applies to the following strength(s): 30 mg ; 50 mg

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Usual Adult Dose for Diabetes Type 2

Initial dose: 30 mg subcutaneously once a week
-May increase to 50 mg subcutaneously once a week based on individual glycemic response
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.
-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:
-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 once a week at any time of the day, without regard to meals; give on the same day each week
-May change day of administration if the last dose was administered 4 or more days earlier.
-If a dose is missed, administer as soon as possible within 3 days after the missed dose
-If administered within 3 days of missed dose, resume dosing on usual day.
-If more than 3 days have elapsed after the missed dose, wait until the next regularly scheduled weekly dose.
-Never share a pen between patients, even if the needle is changed; do not reuse or share needles or syringes between patients as this presents a risk for transmission of blood-borne pathogens

Storage requirements:
-Store in original carton until use.
-Unopened Pens should be stored in the refrigerator (36F to 46F [2C to 8C]); pens may be kept at room temperature below 86F (30C) for up to 4 weeks
-Do not freeze pens; if liquid in pens is frozen, pen should be discarded
-Once reconstituted, must use within 8 hours

Reconstitution/preparation techniques: The lyophilized powder contained within the Pen must be reconstituted prior to administration. See Patient Instructions for Use for complete administration instructions with illustrations.

General:
-Routine serum calcitonin or thyroid ultrasound monitoring is of uncertain value for early detection of MTC in patients treated with this drug.
-This drug is not recommended as first-line therapy for patients inadequately controlled on diet and exercise because of the uncertain relevance of the rodent C-cell tumor findings to humans.
-This drug has not been studied in patients with a history of pancreatitis; consider alternative antidiabetic therapy in patients with a history of pancreatitis.
-This drug in not a substitute for insulin and should not be used in treating type 1 diabetes mellitus or the treatment of diabetic ketoacidosis.
-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:
-Renal: Renal function in patients with renal impairment reporting adverse gastrointestinal reactions
-Immunologic: Signs and symptoms of hypersensitivity reactions
-Metabolic: Hypoglycemia

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.
-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.

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