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Note: This document contains side effect information about albiglutide. Some of the dosage forms listed on this page may not apply to the brand name Tanzeum.In Summary
Common side effects of Tanzeum include: injection site reaction, diarrhea, and nausea. Other side effects include: vomiting. See below for a comprehensive list of adverse effects.For the Consumer
Applies to albiglutide: subcutaneous powder for solution
Subcutaneous route (Powder for Solution)
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 syndrome type 2 (MEN 2). Counsel patients about the potential risk of MTC with the use of albiglutide and inform them of the symptoms of thyroid tumors (e.g., mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or thyroid ultrasound monitoring is of uncertain value for early detection of MTC.
Along with its needed effects, albiglutide (the active ingredient contained in Tanzeum) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking albiglutide:
Incidence not known
Some side effects of albiglutide may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
For Healthcare Professionals
Applies to albiglutide: subcutaneous powder for injectionGeneral
The most commonly reported adverse reactions have included diarrhea, nausea, and injection site reactions which have included rash, erythema, or itching at the injection site.Gastrointestinal
The incidence of pancreatitis (adjudicated as likely to be related to therapy) in clinical trials was 0.3% compared with 0% for placebo and 0.1% for comparators (e.g., liraglutide, pioglitazone, glimepiride, sitagliptin, and insulin glargine) with or without background antidiabetic therapy (e.g. metformin)
Gastrointestinal events occurred more frequently with this drug than comparators (38% versus 32%). Diarrhea (13% vs 9%), nausea (12% vs 11%), vomiting (5% vs 4%), and constipation (5% vs 4%) were the most commonly reported, and the majority of events occurred within the first 6 months.
Very common (10% or more): Diarrhea (13.1%), nausea (11.1%),
Common (1% to 10%): Vomiting, gastroesophageal reflux disease, dyspepsia, constipation
Uncommon (0.1% to 1%): Appendicitis, acute pancreatitis, intestinal obstructionHypersensitivity
Frequency not reported: Pruritus, rash, dyspnea
Postmarketing reports: AngioedemaOncologic
Medullary thyroid cancer (MTC) was diagnosed in 1 patient receiving this drug and 1 patient receiving placebo across 8 phase 3 clinical trials; both of these patients had markedly elevated serum calcitonin levels at baseline. MTC has been reported in patients treated with liraglutide, another GLP-1 receptor agonist. The data is insufficient to establish or exclude a causal relationship between MTC and GLP-1 receptor use in humans.
Very rare (less than 0.01%): Medullary thyroid cancerLocal
Very common (10% or more): Injection site reaction (up to 15%)
Common (1% to 10%): Injection site hematoma, erythema, rash, and/or pruritus
Uncommon (0.1% to 1%): Injection site hypersensitivity and/or hemorrhageMetabolic
Very common (10% or more): Hypoglycemia (when used in combination with insulin or sulfonylurea)
Common (1% to 10%): Hypoglycemia (when used as monotherapy in combination with metformin or pioglitazone)
Frequency not reported: Decreased appetiteRenal
Acute renal failure has been reported and may have been the result of dehydration. Postmarketing reports of acute renal failure and worsening chronic renal failure, sometimes requiring hemodialysis, have been reported. Some of these reports have been in patients without known kidney disease. A majority of patients had experienced nausea, vomiting, diarrhea, or dehydration.
Frequency not reported: Acute renal failure
Postmarketing reports: Acute renal failure, worsening of chronic renal failure, sometimes requiring hemodialysisMusculoskeletal
Very common (10% or more): Back pain (6.7%), arthralgia (6.6%)Other
Very common (10% or more): Influenza (5.2%)Respiratory
Very common (10% or more): Upper respiratory tract infection (14.2%), cough (6.9%), sinusitis (6.2%)
Common (1% to 10%): PneumoniaCardiovascular
Common (1% to 10%): Atrial fibrillation
Uncommon (0.1% to 1%): Atrial flutter
Frequency not reported: Increased heart rateHepatic
Common (1% to 10%): Increased ALT, gamma glutamyltransferaseImmunologic
In a pooled trials, 116 (5.5%) of 2,098 patients exposed to this drug tested positive for anti-albiglutide (the active ingredient contained in Tanzeum) antibodies at any time during the trials. None of these antibodies were shown to neutralize the activity of albiglutide in an in vitro bioassay.
Very common (10% or more): Positive test for anti-albiglutide antibodies
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