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 monitoring of serum calcitonin or using thyroid ultrasound monitoring is of uncertain value for early detection of MTC in patients treated with albiglutide.
Note: Tanzeum has been discontinued in the United States for >1 year. Due to lack of additive glycemic benefit, avoid concomitant use with a dipeptidyl peptidase-4 inhibitor (ADA/EASD [Davies 2018]). May require a dose reduction of insulin and/or insulin secretagogues (sulfonylureas, meglitinides) to avoid hypoglycemia.
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.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
eGFR ≥15 to 89 mL/minute/1.73 m2: No dosage adjustment necessary; use caution when initiating or escalating doses.
eGFR <15 mL/minute/1.73 m2: There are no dosage adjustments provided in the manufacturer's labeling.
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.
Refer to adult dosing.
No
Tanzeum has been discontinued in the US for >1 year.
An FDA-approved patient medication guide, which is available with the product and as follows, must be dispensed with this medication:
Tanzeum: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125431s019lbl.pdf#page=36
SubQ: 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.
Diabetes mellitus, type 2: Adjunct to diet and exercise to improve glycemic control in the treatment of type 2 diabetes mellitus
Tanzeum [DSC] may be confused with Toujeo, Tradjenta, Tresiba, Trulicity
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. 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%: Angioedema, appendicitis, atrial flutter, constipation, hypersensitivity reaction, increased heart rate (1-2 bpm), increased serum ALT, increased serum bilirubin, pancreatitis
Prior serious hypersensitivity (eg, angioedema) 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)
Concerns related to adverse effects:
• Hypersensitivity reactions: Serious hypersensitivity reactions (including angioedema, generalized pruritus and rash with 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. Use in patients with prior serious hypersensitivity reactions to albiglutide is contraindicated. Use with caution in patients with history of anaphylaxis or angioedema to other GLP-1 receptor agonists; potential for cross-sensitivity is unknown.
• Gallbladder disease: Use of GLP-1 agonists may increase risk of gallbladder and bile duct disease (Faillie 2016).
• 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.
• Renal effects: Worsening renal failure and acute kidney injury (some requiring hemodialysis) have been reported; some cases have been reported in patients with no known preexisting renal disease and without gastrointestinal adverse reactions. Monitor for dehydration associated with gastrointestinal effects and avoid fluid depletion.
• 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:
• Bariatric surgery:
- Dehydration: Evaluate, correct, and maintain postsurgical fluid requirements and volume status prior to initiating therapy, and closely monitor the patient for the duration of therapy; acute and chronic kidney failure exacerbation may occur. A majority of cases occurred in patients with nausea, vomiting, diarrhea, and/or dehydration. Nausea is common and fluid intake may be more difficult after gastric bypass, sleeve gastrectomy, and gastric band (Mechanick 2020).
- Excessive glucagon-like peptide-1 exposure: Closely monitor for efficacy and assess for signs and symptoms of pancreatitis if therapy is initiated after surgery; gastric bypass and sleeve gastrectomy (but not gastric band) significantly increase endogenous postprandial glucagon-like peptide-1 (GLP-1) concentrations (Korner 2009; Peterli 2012). Administration of exogenous GLP-1 agonists may be redundant to surgery effects.
• Gastrointestinal disease: Use is not recommended in patients with preexisting severe gastrointestinal disease.
• Renal impairment: Use with caution in patients with renal impairment and/or in patients with severe GI symptoms, particularly during initiation of therapy and dose escalation.
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.
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Alpha-Lipoic Acid: May enhance the hypoglycemic effect of Antidiabetic Agents. Risk C: Monitor therapy
Androgens: May enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Risk C: Monitor therapy
Beta-Blockers (Beta1 Selective): May enhance the hypoglycemic effect of Antidiabetic Agents. Risk C: Monitor therapy
Beta-Blockers (Nonselective): May enhance the hypoglycemic effect of Antidiabetic Agents. Beta-Blockers (Nonselective) may diminish the therapeutic effect of Antidiabetic Agents. Risk C: Monitor therapy
Bortezomib: May enhance the therapeutic effect of Antidiabetic Agents. Bortezomib may diminish the therapeutic effect of Antidiabetic Agents. Risk C: Monitor therapy
Direct Acting Antiviral Agents (HCV): May enhance the hypoglycemic effect of Antidiabetic Agents. Risk C: Monitor therapy
Etilefrine: May diminish the therapeutic effect of Antidiabetic Agents. Risk C: Monitor therapy
Guanethidine: May enhance the hypoglycemic effect of Antidiabetic Agents. Risk C: Monitor therapy
Hyperglycemia-Associated Agents: May diminish the therapeutic effect of Antidiabetic Agents. Risk C: Monitor therapy
Hypoglycemia-Associated Agents: Antidiabetic Agents may enhance the hypoglycemic effect of Hypoglycemia-Associated Agents. Risk C: Monitor therapy
Insulins: Glucagon-Like Peptide-1 Agonists may enhance the hypoglycemic effect of Insulins. Management: Consider insulin dose reductions when used in combination with glucagon-like peptide-1 agonists. Risk D: Consider therapy modification
Liraglutide: May enhance the adverse/toxic effect of Glucagon-Like Peptide-1 Agonists. Risk X: Avoid combination
Maitake: May enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Risk C: Monitor therapy
Meglitinides: Glucagon-Like Peptide-1 Agonists may enhance the hypoglycemic effect of Meglitinides. Management: Consider meglitinide dose reductions when used in combination with glucagon-like peptide-1 agonists, particularly when also used with basal insulin. Risk D: Consider therapy modification
Monoamine Oxidase Inhibitors: May enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Risk C: Monitor therapy
Norethindrone: May diminish the therapeutic effect of Albiglutide. Albiglutide may increase the serum concentration of Norethindrone. Risk C: Monitor therapy
Pegvisomant: May enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Risk C: Monitor therapy
Prothionamide: May enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Risk C: Monitor therapy
Quinolones: May enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Quinolones may diminish the therapeutic effect of Agents with Blood Glucose Lowering Effects. Specifically, if an agent is being used to treat diabetes, loss of blood sugar control may occur with quinolone use. Risk C: Monitor therapy
Ritodrine: May diminish the therapeutic effect of Antidiabetic Agents. Risk C: Monitor therapy
Salicylates: May enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Risk C: Monitor therapy
Selective Serotonin Reuptake Inhibitors: May enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Risk C: Monitor therapy
Semaglutide: May enhance the adverse/toxic effect of Glucagon-Like Peptide-1 Agonists. Risk X: Avoid combination
Sincalide: Drugs that Affect Gallbladder Function may diminish the therapeutic effect of Sincalide. Management: Consider discontinuing drugs that may affect gallbladder motility prior to the use of sincalide to stimulate gallbladder contraction. Risk D: Consider therapy modification
Sulfonylureas: Glucagon-Like Peptide-1 Agonists may enhance the hypoglycemic effect of Sulfonylureas. Management: Consider sulfonylurea dose reductions when used in combination with glucagon-like peptide-1 agonists. Risk D: Consider therapy modification
Thiazide and Thiazide-Like Diuretics: May diminish the therapeutic effect of Antidiabetic Agents. Risk C: Monitor therapy
Glucagon-like peptide-1 (GLP-1) receptor agonists are not recommended for patients with type 2 diabetes mellitus planning to become pregnant. Patients who could become pregnant should use effective contraception during therapy. Transition to a preferred therapy should be initiated prior to conception and contraception should be continued until glycemic control is achieved (ADA 2021; Alexopoulos 2019; Egan 2020)
Because of the long washout period, consider stopping albiglutide at least 1 month before a planned pregnancy.
Adverse events have been observed in some animal reproduction studies.
Poorly controlled diabetes during pregnancy can be associated with an increased risk of adverse maternal and fetal outcomes, including diabetic ketoacidosis, preeclampsia, spontaneous abortion, preterm delivery, delivery complications, major malformations, stillbirth, and macrosomia (ACOG 201 2018). 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 (ADA 2021; Blumer 2013).
Agents other than albiglutide are currently recommended to treat diabetes mellitus in pregnancy (ADA 2021).
It is not known if albiglutide is present in breast milk. The manufacturer recommends a decision be made whether to discontinue breastfeeding or to discontinue the drug, taking into account the importance of treatment to the mother.
Individualized medical nutrition therapy (MNT) based on ADA recommendations is an integral part of therapy.
Plasma glucose; renal function; signs/symptoms of pancreatitis; signs/symptoms of gallbladder disease; signs/symptoms of dehydration.
HbA1c: Monitor at least twice yearly in patients who have stable glycemic control and are meeting treatment goals; monitor quarterly in patients in whom treatment goals have not been met, or with therapy change. Note: In patients prone to glycemic variability (eg, patients with insulin deficiency), or in patients whose HbA1c is discordant with serum glucose levels or symptoms, consider evaluating HbA1c in combination with blood glucose levels and/or a glucose management indicator (ADA 2021; KDIGO 2020).
Recommendations for glycemic control in patients with diabetes:
Nonpregnant adults (ADA 2021):
HbA1c: <7% (a more aggressive [<6.5%] or less aggressive [<8%] HbA1c goal may be targeted based on patient-specific characteristics). Note: In patients using a continuous glucose monitoring system, a goal of time in range >70% with time below range <4% is recommended and is similar to a goal HbA1c <7%.
Preprandial capillary blood glucose: 80 to 130 mg/dL (more or less stringent goals may be appropriate based on patient-specific characteristics).
Peak postprandial capillary blood glucose (~1 to 2 hours after a meal): <180 mg/dL (more or less stringent goals may be appropriate based on patient-specific characteristics).
Older adults (≥65 years of age) (ADA 2021):
Note: Consider less strict targets in patients who are using insulin and/or insulin secretagogues (sulfonylureas, meglitinides) (ES [LeRoith 2019]).
HbA1c: <7% to 7.5% (healthy); <8% to 8.5% (complex/intermediate health). Note: Individualization may be appropriate based on patient and caregiver preferences and/or presence of cognitive impairment. In patients with very complex or poor health (ie, limited remaining life expectancy), consider making therapy decisions based on avoidance of hypoglycemia and symptomatic hyperglycemia rather than HbA1c level.
Preprandial capillary blood glucose: 80 to 130 mg/dL (healthy); 90 to 150 mg/dL (complex/intermediate health); 100 to 180 mg/dL (very complex/poor health).
Bedtime capillary blood glucose: 80 to 180 mg/dL (healthy); 100 to 180 mg/dL (complex/intermediate health); 110 to 200 mg/dL (very complex/poor health).
Classification of hypoglycemia (ADA 2021):
Level 1: 54 to 70 mg/dL; hypoglycemia alert value; initiate fast-acting carbohydrate (eg, glucose) treatment.
Level 2: <54 mg/dL; threshold for neuroglycopenic symptoms; requires immediate action.
Level 3: Hypoglycemia associated with a severe event characterized by altered mental and/or physical status requiring assistance.
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.
Half-life elimination: ~5 days
Time to peak, plasma: 3 to 5 days
Pen-injector (Tanzeum Subcutaneous)
30 mg (per each): $156.60
50 mg (per each): $156.60
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