Data from FDA (Food and Drug Administration, USA) - Curated by EPG Health - Last updated 31 December 2017

Indication(s)

1 INDICATIONS AND USAGE TANZEUM is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies (14)]. Limitations of Use: •TANZEUM 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. Prescribe TANZEUM only to patients for whom the potential benefits are considered to outweigh the potential risk [see Warnings and Precautions (5.1)]. •TANZEUM has not been studied in patients with a history of pancreatitis [see Warnings and Precautions (5.2)]. Consider other antidiabetic therapies in patients with a history of pancreatitis. •TANZEUM is not indicated in the treatment of patients with type 1 diabetes mellitus or for the treatment of patients with diabetic ketoacidosis. TANZEUM is not a substitute for insulin in these patients. •TANZEUM has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis. The use of TANZEUM is not recommended in patients with pre-existing severe gastrointestinal disease [see Adverse Reactions (6.1)]. •TANZEUM has not been studied in combination with prandial insulin. TANZEUM is a GLP-1 receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. (1) Limitations of Use: •Not recommended as first-line therapy for patients inadequately controlled on diet and exercise. (1, 5.1) •Has not been studied in patients with a history of pancreatitis. Consider other antidiabetic therapies in patients with a history of pancreatitis. (1, 5.2) •Not for treatment of type 1 diabetes mellitus or diabetic ketoacidosis. (1) •Not for patients with pre-existing severe gastrointestinal disease. (1) •Has not been studied in combination with prandial insulin. (1)

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Advisory information

contraindications
4 CONTRAINDICATIONS • Medullary Thyroid Carcinoma TANZEUM is contraindicated in patients with a personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) [see Warnings and Precautions (5.1)]. • Hypersensitivity TANZEUM is contraindicated in patients with a prior serious hypersensitivity reaction to albiglutide or to any of the product components. Serious hypersensitivity reactions including angioedema have been reported with TANZEUM [see Warnings and Precautions (5.4)]. •TANZEUM is contraindicated in patients with a personal or family history of medullary thyroid carcinoma or in patients with Multiple Endocrine Neoplasia syndrome type 2. (4) •TANZEUM is contraindicated in patients with a prior serious hypersensitivity reaction to albiglutide or any of the product components. (4, 5.4)
Adverse reactions
6 ADVERSE REACTIONS The following serious reactions are described below or elsewhere in the prescribing information: •Risk of Thyroid C-Cell Tumors [see Warnings and Precautions (5.1)] •Acute Pancreatitis [see Warnings and Precautions (5.2)] •Hypoglycemia with Concomitant Use of Insulin Secretagogues or Insulin [see Warnings and Precautions (5.3)] •Hypersensitivity Reactions [see Warnings and Precautions (5.4)] •Renal Impairment [see Warnings and Precautions (5.5)] Adverse reactions reported in ≥5% of patients treated with TANZEUM and more frequently than in patients on placebo were upper respiratory tract infection, diarrhea, nausea, injection site reaction, cough, back pain, arthralgia, sinusitis, and influenza. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. Pool of Placebo-Controlled Trials The data in Table 1 are derived from 4 placebo-controlled trials. TANZEUM was used as monotherapy in 1 trial and as add-on therapy in 3 trials [see Clinical Studies (14)]. These data reflect exposure of 923 patients to TANZEUM and a mean duration of exposure to TANZEUM of 93 weeks. The mean age of participants was 55 years, 1% of participants were 75 years or older and 53% of participants were male. The population in these studies was 48% white, 13% African/African American, 7% Asian, and 29% Hispanic/Latino. At baseline, the population had type 2 diabetes for an average of 7 years and had a mean HbA1c of 8.1%. At baseline, 17% of the population in these studies reported peripheral neuropathy and 4% reported retinopathy. Baseline estimated renal function was normal or mildly impaired (eGFR >60 mL/min/1.73 m2) in 91% of the study population and moderately impaired (eGFR 30 to 60 mL/min/1.73 m2) in 9%. Table 1 shows common adverse reactions excluding hypoglycemia associated with the use of TANZEUM in the pool of placebo-controlled trials. These adverse reactions were not present at baseline, occurred more commonly on TANZEUM than on placebo, and occurred in at least 5% of patients treated with TANZEUM. Table 1. Adverse Reactions in Placebo-Controlled Trials Reported in ≥5% of Patients Treated with TANZEUMa Adverse Reaction Placebo (n = 468) % TANZEUM (n = 923) % Upper respiratory tract infection 13.0 14.2 Diarrhea 10.5 13.1 Nausea 9.6 11.1 Injection site reactionb 2.1 10.5 Cough 6.2 6.9 Back pain 5.8 6.7 Arthralgia 6.4 6.6 Sinusitis 5.8 6.2 Influenza 3.2 5.2 a Adverse reactions reported include those occurring with the use of glycemic rescue medications which included metformin (17% for placebo and 10% for TANZEUM) and insulin (24% for placebo and 14% for TANZEUM). b See below for other events of injection site reactions reported. Gastrointestinal Adverse Reactions: In the pool of placebo-controlled trials, gastrointestinal complaints occurred more frequently among patients receiving TANZEUM (39%) than patients receiving placebo (33%). In addition to diarrhea and nausea (see Table 1), the following gastrointestinal adverse reactions also occurred more frequently in patients receiving TANZEUM: vomiting (2.6% versus 4.2% for placebo versus TANZEUM), gastroesophageal reflux disease (1.9% versus 3.5% for placebo versus TANZEUM), and dyspepsia (2.8% versus 3.4% for placebo versus TANZEUM). Constipation also contributed to the frequently reported reactions. In the group treated with TANZEUM, investigators graded the severity of GI reactions as “mild” in 56% of cases, “moderate” in 37% of cases, and “severe” in 7% of cases. Discontinuation due to GI adverse reactions occurred in 2% of individuals on TANZEUM or placebo. Injection Site Reactions: In the pool of placebo-controlled trials, injection site reactions occurred more frequently on TANZEUM (18%) than on placebo (8%). In addition to the term “injection site reaction” (see Table 1), the following other types of injection site reactions also occurred more frequently on TANZEUM: injection site hematoma (1.9% versus 2.1% for placebo versus TANZEUM ), injection site erythema (0.4% versus 1.7% for placebo versus TANZEUM), injection site rash (0% versus 1.4% for placebo versus TANZEUM), injection site hypersensitivity (0% versus 0.8% for placebo versus TANZEUM), and injection site hemorrhage (0.6% versus 0.7% for placebo versus TANZEUM). Injection site pruritus also contributed to the frequently reported reactions. The majority of injection site reactions were judged as “mild” by investigators in both groups (73% for TANZEUM versus 94% for placebo). More patients on TANZEUM than on placebo: discontinued due to an injection site reaction (2% versus 0.2%), experienced more than 2 reactions (38% versus 20%), had a reaction judged by investigators to be “moderate” or “severe” (27% versus 6%), and required local or systemic treatment for the reactions (36% versus 11%). Pool of Placebo- and Active-Controlled Trials The occurrence of adverse reactions was also evaluated in a larger pool of patients with type 2 diabetes participating in 7 placebo- and active-controlled trials. These trials evaluated the use of TANZEUM as monotherapy, as add-on therapy to oral antidiabetic agents, and as add-on therapy to basal insulin [see Clinical Studies (14)]. In this pool, a total of 2,116 patients with type 2 diabetes were treated with TANZEUM for a mean duration of 75 weeks. The mean age of patients treated with TANZEUM was 55 years, 1.5% of the population in these studies was 75 years or older and 51% of participants were male. Forty-eight percent of patients were white, 15% African/African American, 9% Asian, and 26% were Hispanic/Latino. At baseline, the population had diabetes for an average of 8 years and had a mean HbA1c of 8.2%. At baseline, 21% of the population reported peripheral neuropathy and 5% reported retinopathy. Baseline estimated renal function was normal or mildly impaired (eGFR >60 mL/min/1.73 m2) in 92% of the population and moderately impaired (eGFR 30 to 60 mL/min/1.73 m2) in 8% of the population. In the pool of placebo- and active-controlled trials, the types and frequencies of common adverse reactions excluding hypoglycemia were similar to those listed in Table 1. Other Adverse Reactions Hypoglycemia: The proportion of patients experiencing at least one documented symptomatic hypoglycemic episode on TANZEUM and the proportion of patients experiencing at least one severe hypoglycemic episode on TANZEUM in clinical trials [see Clinical Studies (14)] is shown in Table 2. Hypoglycemia was more frequent when TANZEUM was added to sulfonylurea or insulin [see Warnings and Precautions (5.3)]. Table 2. Incidence (%) of Hypoglycemia in Clinical Trials of TANZEUMa TANZEUM Monotherapyb Placebo 30 mg Weekly (52 Weeks) n = 101 n = 101 Documented symptomaticc 2% 2% Severed - - In Combination with Metformin Trial Placebo TANZEUM (104 Weeks)e n = 101 n = 302 Documented symptomatic 4% 3% Severe - - In Combination with Pioglitazone ± Placebo TANZEUM Metformin (52 Weeks) n = 151 n = 150 Documented symptomatic 1% 3% Severe - 1% In Combination with Metformin and Placebo TANZEUM Sulfonylurea (52 Weeks) n = 115 n = 271 Documented symptomatic 7% 13% Severe - 0.4% In Combination with Insulin Lispro TANZEUM Insulin Glargine (26 Weeks) n = 281 n = 285 Documented symptomatic 30% 16% Severe 0.7% - In Combination with Insulin Glargine TANZEUM Metformin ± Sulfonylurea (52 Weeks) n = 241 n = 504 Documented symptomatic 27% 17% Severe 0.4% 0.4% In Combination with OADs in Renal Sitagliptin TANZEUM Impairment (26 Weeks) n = 246 n = 249 Documented symptomatic 6% 10% Severe 0.8% - OAD = Oral antidiabetic agents. a Data presented are to the primary endpoint and include only events occurring on-therapy with randomized medications and excludes events occurring after use of glycemic rescue medications (i.e., primarily metformin or insulin). b In this trial, no documented symptomatic or severe hypoglycemia was reported for TANZEUM 50 mg and these data are omitted from the table. c Plasma glucose concentration ≤70 mg/dL and presence of hypoglycemic symptoms. d Event requiring another person to administer a resuscitative action. e Rate of documented symptomatic hypoglycemia for active controls 18% (glimepiride) and 2% (sitagliptin). Pneumonia: In the pool of 7 placebo- and active-controlled trials, the adverse reaction of pneumonia was reported more frequently in patients receiving TANZEUM (1.8%) than in patients in the all-comparators group (0.8%). More cases of pneumonia in the group receiving TANZEUM were serious (0.4% for TANZEUM versus 0.1% for all comparators). Atrial Fibrillation/Flutter: In the pool of 7 placebo- and active-controlled trials, adverse reactions of atrial fibrillation (1.0%) and atrial flutter (0.2%) were reported more frequently for TANZEUM than for all comparators (0.5% and 0%, respectively). In both groups, patients with events were generally male, older, and had underlying renal impairment or cardiac disease (e.g., history of arrhythmia, palpitations, congestive heart failure, cardiomyopathy, etc.). Appendicitis: In the pool of placebo- and active-controlled trials, serious events of appendicitis occurred in 0.3% of patients treated with TANZEUM compared with 0% among all comparators. Consistent with the high homology of albiglutide with human GLP-1, the majority of patients (approximately 79%) with anti-albiglutide antibodies also tested positive for anti-GLP-1 antibodies; none were neutralizing. A minority of patients (approximately 17%) who tested positive for anti-albiglutide antibodies also transiently tested positive for antibodies to human albumin. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, the incidence of antibodies to albiglutide cannot be directly compared with the incidence of antibodies of other products. Liver Enzyme Abnormalities: In the pool of placebo- and active-controlled trials, a similar proportion of patients experienced at least one event of alanine aminotransferase (ALT) increase of 3-fold or greater above the upper limit of normal (0.9% and 0.9% for all comparators versus TANZEUM). Three subjects on TANZEUM and one subject in the all-comparator group experienced at least one event of ALT increase of 10-fold or greater above the upper limit of normal. In one of the 3 cases an alternate etiology was identified to explain the rise in liver enzyme (acute viral hepatitis). In one case, insufficient information was obtained to establish or refute a drug-related causality. In the third case, elevation in ALT (10 times the upper limit of normal) was accompanied by an increase in total bilirubin (4 times the upper limit of normal) and occurred 8 days after the first dose of TANZEUM. The etiology of hepatocellular injury was possibly related to TANZEUM but direct attribution to TANZEUM was confounded by the presence of gallstone disease diagnosed on ultrasound 3 weeks after the event. Gamma Glutamyltransferase (GGT) Increase: In the pool of placebo-controlled trials, the adverse event of increased GGT occurred more frequently in the group treated with TANZEUM (0.9% and 1.5% for placebo versus TANZEUM). Heart Rate Increase: In the pool of placebo-controlled trials, mean heart rate in patients treated with TANZEUM was higher by an average of 1 to 2 bpm compared with mean heart rate in patients treated with placebo across study visits. The long-term clinical effects of the increase in heart rate have not been established [see Warnings and Precautions (5.6)]. 6.2 Immunogenicity Consistent with the potentially immunogenic properties of protein and peptide pharmaceuticals, patients treated with TANZEUM may develop anti-albiglutide antibodies. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, the incidence of antibodies to albiglutide in the studies described below cannot be directly compared with the incidence of antibodies in other studies or to other products. In the pool of 7 placebo- and active-controlled trials, 116 (5.5%) of 2,098 patients exposed to TANZEUM tested positive for anti-albiglutide antibodies at any time during the trials. None of these antibodies were shown to neutralize the activity of albiglutide in an in vitro bioassay. 6.3 Postmarketing Experience The following adverse reactions have been identified during post-approval use of TANZEUM. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Angioedema.

Usage information

Dosing and administration
2 DOSAGE AND ADMINISTRATION •Administer once weekly at any time of day, without regard to meals. (2.1) •Inject subcutaneously in the abdomen, thigh, or upper arm. (2.1) •Initiate at 30 mg subcutaneously once weekly. Dose can be increased to 50 mg once weekly in patients requiring additional glycemic control. (2.1) •If a dose is missed, administer within 3 days of missed dose. (2.1) •See Full Prescribing Information and Patient Instructions for Use for reconstitution of lyophilized powder and administration. (2.4, 2.5, 17) 2.1 Dosage The recommended dosage of TANZEUM is 30 mg once weekly given as a subcutaneous injection in the abdomen, thigh, or upper arm region. The dosage may be increased to 50 mg once weekly if the glycemic response is inadequate. TANZEUM may be administered at any time of day without regard to meals. Instruct patients to administer TANZEUM once a week on the same day each week. The day of weekly administration may be changed if necessary as long as the last dose was administered 4 or more days before. If a dose is missed, instruct patients to administer as soon as possible within 3 days after the missed dose. Thereafter, patients can resume dosing on their usual day of administration. If it is more than 3 days after the missed dose, instruct patients to wait until their next regularly scheduled weekly dose. 2.2 Concomitant Use with an Insulin Secretagogue (e.g., Sulfonylurea) or with Insulin When initiating TANZEUM, consider reducing the dosage of concomitantly administered insulin secretagogues (e.g., sulfonylureas) or insulin to reduce the risk of hypoglycemia [see Warnings and Precautions (5.3)]. 2.3 Reconstitution of the Lyophilized Powder The lyophilized powder contained within the Pen must be reconstituted prior to administration. See Patient Instructions for Use for complete administration instructions with illustrations. The instructions may also be found at www.TANZEUM.com. Instruct patients as follows: Pen Reconstitution a)Hold the Pen body with the clear cartridge pointing up to see the [1] in the number window. b)To reconstitute the lyophilized powder with the diluent in the Pen, twist the clear cartridge on the Pen in the direction of the arrow until the Pen is felt/heard to “click” into place and the [2] is seen in the number window. This mixes the diluent with the lyophilized powder. c)Slowly and gently rock the Pen side-to-side 5 times to mix the reconstituted solution of TANZEUM. Advise the patient to not shake the Pen hard to avoid foaming. d)Wait 15 minutes for the 30-mg Pen and 30 minutes for the 50-mg Pen to ensure that the reconstituted solution is mixed. Preparing Pen for Injection e)Slowly and gently rock the Pen side-to-side 5 additional times to mix the reconstituted solution. f)Visually inspect the reconstituted solution in the viewing window for particulate matter. The reconstituted solution will be yellow in color. After reconstitution, use TANZEUM within 8 hours. g)Holding the Pen upright, attach the needle to the Pen by pushing it straight down until there is a click and the needle snaps into place. Gently tap the clear cartridge to bring large bubbles to the top. See Dosage and Administration (2.5) for important administration instructions, including the injection procedure. Alternate Method of Reconstitution (Healthcare Professional Use Only) The Patient Instructions for Use provide directions for the patient to wait 15 minutes for the 30-mg Pen and 30 minutes for the 50-mg Pen after the lyophilized powder and diluent are mixed to ensure reconstitution. Healthcare professionals may utilize the following alternate method of reconstitution. Because this method relies on appropriate swirling and visual inspection of the solution, it should only be performed by healthcare professionals. a)Follow Step A (Inspect Your Pen and Mix Your Medication) in the Instructions for Use. Make sure you have: •Inspected the Pen for [1] in the number window and expiration date. •Twisted the clear cartridge until [2] appears in the number window and a “click” is heard. This combines the medicine powder and liquid in the clear cartridge. b)Hold the Pen with the clear cartridge pointing up and maintain this orientation throughout the reconstitution. c)Gently swirl the Pen in small circular motions for at least one minute. Avoid shaking as this can result in foaming, which may affect the dose. d)Inspect the solution, and if needed, continue to gently swirl the Pen until all the powder is dissolved and you see a clear yellow solution that is free of particles. A small amount of foam, on top of the solution at the end of reconstitution, is normal. •For 30-mg Pen: Complete dissolution usually occurs within 2 minutes but may take up to 5 minutes, as confirmed by visual inspection for a clear yellow solution free of particles. •For 50-mg Pen: Complete dissolution usually occurs within 7 minutes but may take up to 10 minutes. e)After reconstitution, continue to follow the steps in the Instructions for Use, starting at Step B: Attach the Needle. 2.4 Important Administration Instructions Instruct patients as follows: •The pen should be used within 8 hours of reconstitution prior to attaching the needle. •After attaching the supplied needle, remove air bubbles by slowly twisting the Pen until you see the [3] in the number window. At the same time, the injection button will be automatically released from the bottom of the Pen. •Use immediately after the needle is attached and primed. The product can clog the needle if allowed to dry in the primed needle. •After subcutaneously inserting the needle into the skin in the abdomen, thigh, or upper arm region, press the injection button. Hold the injection button until you hear a “click” and then hold the button for 5 additional seconds to deliver the full dose. When using TANZEUM with insulin, instruct patients to administer as separate injections and to never mix the products. It is acceptable to inject TANZEUM and insulin in the same body region but the injections should not be adjacent to each other. When injecting in the same body region, advise patients to use a different injection site each week. TANZEUM must not be administered intravenously or intramuscularly.
Use in special populations
8 USE IN SPECIFIC POPULATIONS • Pregnancy: TANZEUM may cause fetal harm; only use if potential benefit justifies potential risk to fetus. (8.1) • Acute Kidney Injury: No dosage adjustment recommended. Monitor renal function in patients with renal impairment reporting severe adverse gastrointestinal reactions. (5.5, 8.6) 8.1 Pregnancy Pregnancy Category C There are no adequate and well-controlled studies of TANZEUM in pregnant women. Nonclinical studies have shown reproductive toxicity, but not teratogenicity, in mice treated with albiglutide at up to 39 times human exposure resulting from the maximum recommended dose of 50 mg/week, based on AUC [see Nonclinical Toxicology (13.1, 13.3)]. TANZEUM should not be used during pregnancy unless the expected benefit outweighs the potential risks. Due to the long washout period for TANZEUM, consider stopping TANZEUM at least 1 month before a planned pregnancy. There are no data on the effects of TANZEUM on human fertility. Studies in mice showed no effects on fertility [see Nonclinical Toxicology (13.1)]. The potential risk to human fertility is unknown. 8.3 Nursing Mothers There are no adequate data to support the use of TANZEUM during lactation in humans. It is not known if TANZEUM is excreted into human milk during lactation. Given that TANZEUM is an albumin-based protein therapeutic, it is likely to be present in human milk. Decreased body weight in offspring was observed in mice treated with TANZEUM during gestation and lactation [see Nonclinical Toxicology (13.3)]. A decision should be made whether to discontinue nursing or to discontinue TANZEUM, taking into account the importance of the drug to the mother and the potential risks to the infant. 8.4 Pediatric Use Safety and effectiveness of TANZEUM have not been established in pediatric patients (younger than 18 years). 8.5 Geriatric Use Of the total number of patients (N = 2,365) in 8 Phase III clinical trials who received TANZEUM, 19% (n = 444) were 65 years and older, and <3% (n = 52) were 75 years and older. No overall differences in safety or effectiveness were observed between these patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out. 8.6 Renal Impairment Of the total number of patients (N = 2,365) in 8 Phase III clinical trials who received TANZEUM, 54% (n = 1,267) had mild renal impairment (eGFR 60 to 89 mL/min/1.73 m2), 12% (n = 275) had moderate renal impairment (eGFR 30 to 59 mL/min/1.73 m2), and 1% (n = 19) had severe renal impairment (eGFR 15 to <30 mL/min/1.73 m2). No dosage adjustment is required in patients with mild (eGFR 60 to 89 mL/min/1.73 m2), moderate (eGFR 30 to 59 mL/min/1.73 m2), or severe (eGFR 15 to <30 mL/min/1.73 m2) renal impairment. Efficacy of TANZEUM in patients with type 2 diabetes and renal impairment is described elsewhere [see Clinical Studies (14.3)]. There is limited clinical experience in patients with severe renal impairment (19 subjects). The frequency of GI events increased as renal function declined. For patients with mild, moderate, or severe impairment, the respective event rates were: diarrhea (6%, 13%, 21%), nausea (3%, 5%, 16%), and vomiting (1%, 2%, 5%). Therefore, caution is recommended when initiating or escalating doses of TANZEUM in patients with renal impairment and/or in those reporting severe gastrointestinal symptoms [see Warnings and Precautions (5.5), Clinical Pharmacology (12.3)].
Pregnancy and lactation
8.3 Nursing Mothers There are no adequate data to support the use of TANZEUM during lactation in humans. It is not known if TANZEUM is excreted into human milk during lactation. Given that TANZEUM is an albumin-based protein therapeutic, it is likely to be present in human milk. Decreased body weight in offspring was observed in mice treated with TANZEUM during gestation and lactation [see Nonclinical Toxicology (13.3)]. A decision should be made whether to discontinue nursing or to discontinue TANZEUM, taking into account the importance of the drug to the mother and the potential risks to the infant.

Interactions

7 DRUG INTERACTIONS TANZEUM did not affect the absorption of orally administered medications tested in clinical pharmacology studies to any clinically relevant degree [see Clinical Pharmacology (12.3)]. However, TANZEUM causes a delay of gastric emptying, and thereby has the potential to impact the absorption of concomitantly administered oral medications. Caution should be exercised when oral medications are concomitantly administered with TANZEUM. TANZEUM delays gastric emptying. May impact absorption of concomitantly administered oral medications. (7)

More information

Category Value
Authorisation number BLA125431
Agency product number 5E7U48495E
Orphan designation No
Product NDC 0173-0867,0173-0866
Date Last Revised 20-12-2017
Type HUMAN PRESCRIPTION DRUG
Marketing authorisation holder GlaxoSmithKline LLC
Warnings WARNING: RISK OF THYROID C-CELL 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 TANZEUM causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans [see Warnings and Precautions (5.1), Nonclinical Toxicology (13.1)]. • TANZEUM 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 regarding the potential risk of MTC with the use of TANZEUM 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 using thyroid ultrasound monitoring is of uncertain value for early detection of MTC in patients treated with TANZEUM [see Contraindications (4.1), Warnings and Precautions (5.1)]. WARNING: RISK OF THYROID C-CELL TUMORS See full prescribing information for complete boxed warning. • 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 TANZEUM causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans. (5.1 , 13.1 ) • TANZEUM 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 regarding the potential risk of MTC and symptoms of thyroid tumors. (4.1, 5.1)