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Albiglutide

Pronunciation

(al bi GLOO tide)

Index Terms

  • Tanzeum

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Pen-injector, Subcutaneous [preservative free]:

Tanzeum: 30 mg (1 ea); 50 mg (1 ea) [contains polysorbate 80]

Brand Names: U.S.

  • Tanzeum

Pharmacologic Category

  • Antidiabetic Agent, Glucagon-Like Peptide-1 (GLP-1) Receptor Agonist

Pharmacology

Albiglutide is an agonist of human glucagon-like peptide-1 (GLP-1) receptor and augments glucose-dependent insulin secretion and slows gastric emptying.

Distribution

Vd: 11 L

Metabolism

Degradation to small peptides and individual amino acids by proteolytic enzymes.

Time to Peak

3 to 5 days

Half-Life Elimination

~5 days

Use: Labeled Indications

Diabetes mellitus, type 2: Adjunct to diet and exercise to improve glycemic control in the treatment of type 2 diabetes mellitus (noninsulin dependent, NIDDM)

Contraindications

Severe hypersensitivity to albiglutide or any component of the formulation; history of or family history of medullary thyroid carcinoma (MTC); patients with multiple endocrine neoplasia syndrome type 2 (MEN2)

Dosing: Adult

Diabetes mellitus, type 2: SubQ: 30 mg once weekly; may increase to 50 mg once weekly if inadequate glycemic response. Titration to 50 mg once weekly occurred at week 12 in a monotherapy trial and after a minimum of 4 weeks in combination therapy trials.

Missed doses: If a dose is missed, administer as soon as possible within 3 days after the missed dose; dosing can then be resumed on the usual day of administration. If more than 3 days have passed since the dose was missed, omit the missed dose and resume administration at the next regularly scheduled weekly dose.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Renal Impairment

No dosage adjustment necessary; use caution when initiating or escalating doses.

Dosing: Hepatic Impairment

There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied); however, changes in hepatic function are not likely to have an effect on elimination.

Reconstitution

Reconstitute powder with the diluent contained in the pen device. Refer to manufacturer’s product labeling for full reconstitution instructions. Administer within 8 hours of reconstitution.

Administration

Do not inject intravenously or intramuscularly. Inject subcutaneously into the upper arm, thigh, or abdomen; when administering within the same body region, use a different injection site each week. Administer once weekly on the same day each week, without regard to meals or time of day. The day of weekly administration may be changed, as long as the last dose was administered ≥4 days before. Use immediately after attaching and priming the needle; solution can clog the needle if allowed to dry in the primed needle. If using concomitantly with insulin, administer as separate injections (do not mix); may inject in the same body region as insulin, but not adjacent to one another.

Dietary Considerations

Individualized medical nutrition therapy (MNT) based on ADA recommendations is an integral part of therapy.

Storage

Store unused pens at 2°C to 8°C (36°F to 46°F); may be stored at room temperature (≤30°C [86°F]) for ≤4 weeks prior to reconstitution. Do not freeze. Use within 8 hours of reconstitution.

Drug Interactions

Alpha-Lipoic Acid: May enhance the hypoglycemic effect of Antidiabetic Agents. Monitor therapy

Androgens: May enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Exceptions: Danazol. Monitor therapy

Hyperglycemia-Associated Agents: May diminish the therapeutic effect of Antidiabetic Agents. Monitor therapy

Hypoglycemia-Associated Agents: Antidiabetic Agents may enhance the hypoglycemic effect of Hypoglycemia-Associated Agents. Monitor therapy

Insulin: GLP-1 Agonists may enhance the hypoglycemic effect of Insulin. Management: Consider insulin dose reductions when used in combination with glucagon-like peptide-1 agonists. Avoid the use of lixisenatide in patients receiving both basal insulin and a sulfonylurea. Consider therapy modification

MAO Inhibitors: May enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Monitor therapy

Pegvisomant: May enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Monitor therapy

Quinolone Antibiotics: May enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Quinolone Antibiotics may diminish the therapeutic effect of Blood Glucose Lowering Agents. Specifically, if an agent is being used to treat diabetes, loss of blood sugar control may occur with quinolone use. Monitor therapy

Salicylates: May enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Monitor therapy

Selective Serotonin Reuptake Inhibitors: May enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Monitor therapy

Sulfonylureas: GLP-1 Agonists may enhance the hypoglycemic effect of Sulfonylureas. Management: Consider sulfonylurea dose reductions when used in combination with glucagon-like peptide-1 agonists. Avoid the use of lixisenatide in patients receiving both basal insulin and a sulfonylurea. Consider therapy modification

Thiazide and Thiazide-Like Diuretics: May diminish the therapeutic effect of Antidiabetic Agents. Monitor therapy

Adverse Reactions

Reactions reported from monotherapy and combination therapy.

>10%:

Endocrine & metabolic: Hypoglycemia (combination therapy; 3% to 17%)

Gastrointestinal: Diarrhea (13%), nausea (11%)

Local: Injection site reaction (11% to 18%, including erythema at injection site [2%], hypersensitivity reaction at injection site [1%], rash at injection site [1%], itching at injection site)

Respiratory: Upper respiratory tract infection (14%)

1% to 10%:

Cardiovascular: Atrial fibrillation (1%)

Endocrine & metabolic: Increased gamma-glutamyl transferase (2%)

Gastrointestinal: Gastroesophageal reflux disease (4%), vomiting (4%)

Immunologic: Antibody development (non-neutralizing; 6%)

Infection: Influenza (5%)

Neuromuscular & skeletal: Arthralgia (7%), back pain (7%)

Respiratory: Cough (7%), pneumonia (2%)

<1% (Limited to important or life-threatening): Appendicitis, atrial flutter, hypersensitivity, increased serum ALT, increased serum bilirubin, pancreatitis

ALERT: U.S. Boxed Warning

Risk of thyroid tumors:

Carcinogenicity of albiglutide 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 albiglutide causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans.

Albiglutide is contraindicated in patients with a personal or family history of MTC or in patients with multiple endocrine neoplasia type 2 (MEN2). Counsel patients regarding the potential risk of MTC with the use of albiglutide and inform them of the symptoms of thyroid tumors (eg, 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 albiglutide.

Warnings/Precautions

Concerns related to adverse effects:

• Hypersensitivity reactions: Serious hypersensitivity reactions (including pruritus, rash, and dyspnea) have been reported with use; discontinue therapy in the event of a hypersensitivity reaction; treat appropriately and monitor patients until signs and symptoms resolve.

• Pancreatitis: Cases of acute pancreatitis have been reported; monitor for signs and symptoms of pancreatitis (eg, persistent severe abdominal pain which may radiate to the back and which may or may not be accompanied by vomiting). If pancreatitis is suspected, discontinue use. Do not resume unless an alternative etiology of pancreatitis is confirmed. Consider antidiabetic therapies other than albiglutide in patients with a history of pancreatitis.

• Thyroid tumors: [US Boxed Warning] Thyroid C-cell tumors have developed in animal studies with glucagon-like peptide-1 (GLP-1) receptor agonists; it is not known if albiglutide causes thyroid C-cell tumor, including medullary thyroid carcinoma (MTC) in humans. Routine monitoring of serum calcitonin or using thyroid ultrasound monitoring is of uncertain value for early detection of MTC in patients treated with albiglutide. Patients should be counseled on the potential risk of MTC with the use of albiglutide and informed of symptoms of thyroid tumors (eg, neck mass, dysphagia, dyspnea, persistent hoarseness). Use is contraindicated in patients with a personal or a family history of MTC and in patients with multiple endocrine neoplasia syndrome type 2 (MEN2). Cases of MTC in humans have been reported in patients treated with the GLP-1 receptor agonist liraglutide. Consultation with an endocrinologist is recommended in patients with thyroid nodules on physical examination or neck imaging and patients who develop elevated calcitonin concentrations.

Disease-related concerns:

• Gastrointestinal disease: Use is not recommended in patients with preexisting severe gastrointestinal disease.

• Renal impairment: Use with caution in patients with renal impairment, particularly during initiation of therapy and dose escalation. Acute renal failure and chronic renal failure exacerbation (sometimes requiring hemodialysis) have been reported; some cases have been reported in patients with no known preexisting renal disease. Reports primarily occurred in patients with nausea/vomiting/diarrhea or dehydration.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

• Insulin: Concomitant use of insulin may increase the risk of hypoglycemia; dosage reduction of insulin may be required. Concurrent use with prandial insulin therapy has not been evaluated.

• Insulin secretagogues: Concomitant use of an insulin secretagogue (eg, sulfonylurea) may increase the risk of hypoglycemia; dosage reduction of secretagogues may be required.

• Oral medications: Due to its effects on gastric emptying, albiglutide may reduce the rate and extent of absorption of orally-administered drugs; use with caution in patients receiving medications with a narrow therapeutic window or that require rapid absorption from the GI tract.

Other warnings/precautions:

• Appropriate use: Diabetes mellitus: Not recommended for first-line therapy in patients inadequately controlled on diet and exercise alone. Do not use in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis; not a substitute for insulin.

• Patient education: Diabetes self-management education (DSME) is essential to maximize the effectiveness of therapy.

Monitoring Parameters

Plasma glucose, HbA1c (at least twice yearly in patients who have stable glycemic control and are meeting treatment goals; quarterly in patients not meeting treatment goals or with therapy change [ADA 2016a]), renal function, signs/symptoms of pancreatitis

Pregnancy Risk Factor

C

Pregnancy Considerations

Adverse events have been observed in some animal reproduction studies. Because of the long washout period, consider stopping albiglutide at least 1 month before a planned pregnancy.

In women with diabetes, maternal hyperglycemia can be associated with congenital malformations as well as adverse effects in the fetus, neonate, and the mother (ACOG 2005; ADA 2015; Kitzmiller 2008; Metzger 2007). To prevent adverse outcomes, prior to conception and throughout pregnancy maternal blood glucose and HbA1c should be kept as close to target goals as possible but without causing significant hypoglycemia (ACOG 2013; ADA 2015; Blumer 2013; Kitzmiller 2008). Prior to pregnancy, effective contraception should be used until glycemic control is achieved (Kitzmiller 2008). Other agents are currently recommended to treat diabetes in pregnant women (ACOG 2013; Blumer 2013).

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience diarrhea, nausea, injection site irritation, back pain, joint pain, cough, or rhinitis. Have patient report immediately to prescriber signs of thyroid cancer (new lump or swelling in the neck, pain in the front of the neck, persistent cough, persistent change in voice like hoarseness, or difficulty swallowing or breathing), signs of pancreatitis (severe abdominal pain, severe back pain, severe nausea, or vomiting), severe dizziness, passing out, urinary retention, change in amount of urine passed, or signs of low blood sugar (dizziness, headache, fatigue, feeling weak, shaking, tachycardia, confusion, increased hunger, or sweating) (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

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