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Tanzeum
Overview
What is Tanzeum?
TANZEUM is a GLP-1 receptor agonist, a recombinant fusion protein comprised of 2 tandem copies of modified human GLP-1 genetically fused in tandem to human albumin. The human GLP-1 fragment sequence 7 – 36 has been modified with a glycine substituted for the naturally-occurring alanine at position 8 in order to confer resistance to dipeptidylpeptidase IV (DPP-IV) mediated proteolysis. The human albumin moiety of the recombinant fusion protein, together with the DPP-IV resistance, extends the half-life allowing once-weekly dosing. TANZEUM has a molecular weight of 72,970 Daltons.
TANZEUM is produced by a strain of modified to express the therapeutic protein.
TANZEUM 30-mg Pen for injection (for subcutaneous use) contains 40.3 mg lyophilized albiglutide and 0.65 mL Water for Injection diluent designed to deliver a dose of 30 mg in a volume of 0.5 mL after reconstitution.
TANZEUM 50-mg Pen for injection (for subcutaneous use) contains 67 mg lyophilized albiglutide and 0.65 mL Water for Injection diluent designed to deliver a dose of 50 mg in a volume of 0.5 mL after reconstitution.
The lyophilized powder of both dose strengths is white to yellow in color and the solvent is a clear and colorless solution. The reconstituted solution is yellow in color.
Inactive ingredients include 153 mM mannitol, 0.01% (w/w) polysorbate 80, 10 mM sodium phosphate, and 117 mM trehalose dihydrate. TANZEUM does not contain a preservative.
What does Tanzeum look like?
What are the available doses of Tanzeum?
For injection: 30 mg or 50 mg in a single-dose Pen. ()
What should I talk to my health care provider before I take Tanzeum?
How should I use Tanzeum?
TANZEUM is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
Limitations of Use:
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.
What interacts with Tanzeum?
Sorry No Records found
What are the warnings of Tanzeum?
Sorry No Records found
What are the precautions of Tanzeum?
Sorry No Records found
What are the side effects of Tanzeum?
Sorry No records found
What should I look out for while using Tanzeum?
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).
TANZEUM is contraindicated in patients with a prior serious hypersensitivity reaction to albiglutide or to any of the product components.
What might happen if I take too much Tanzeum?
No data are available with regard to overdosage in humans. Anticipated symptoms of an overdose may be severe nausea, vomiting, and headache.
In the event of an overdose, appropriate supportive treatment should be initiated as dictated by the patient’s clinical signs and symptoms. A prolonged period of observation and treatment for these symptoms may be necessary, taking into account the half-life of TANZEUM (5 days).
How should I store and handle Tanzeum?
Chlorthalidone tablets, USP 25 mg are available as follows:Yellow, round, tablets, debossed MP 30Chlorthalidone tablets, USP 50 mg are available as follows:Green, round, tablets, debossed MP 43Store at 20° to 25°C (68° to 77°F).[See USP Controlled Room Temperature]DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Chlorthalidone tablets, USP 25 mg are available as follows:Yellow, round, tablets, debossed MP 30Chlorthalidone tablets, USP 50 mg are available as follows:Green, round, tablets, debossed MP 43Store at 20° to 25°C (68° to 77°F).[See USP Controlled Room Temperature]DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Chlorthalidone tablets, USP 25 mg are available as follows:Yellow, round, tablets, debossed MP 30Chlorthalidone tablets, USP 50 mg are available as follows:Green, round, tablets, debossed MP 43Store at 20° to 25°C (68° to 77°F).[See USP Controlled Room Temperature]DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Chlorthalidone tablets, USP 25 mg are available as follows:Yellow, round, tablets, debossed MP 30Chlorthalidone tablets, USP 50 mg are available as follows:Green, round, tablets, debossed MP 43Store at 20° to 25°C (68° to 77°F).[See USP Controlled Room Temperature]DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Chlorthalidone tablets, USP 25 mg are available as follows:Yellow, round, tablets, debossed MP 30Chlorthalidone tablets, USP 50 mg are available as follows:Green, round, tablets, debossed MP 43Store at 20° to 25°C (68° to 77°F).[See USP Controlled Room Temperature]DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Chlorthalidone tablets, USP 25 mg are available as follows:Yellow, round, tablets, debossed MP 30Chlorthalidone tablets, USP 50 mg are available as follows:Green, round, tablets, debossed MP 43Store at 20° to 25°C (68° to 77°F).[See USP Controlled Room Temperature]DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Chlorthalidone tablets, USP 25 mg are available as follows:Yellow, round, tablets, debossed MP 30Chlorthalidone tablets, USP 50 mg are available as follows:Green, round, tablets, debossed MP 43Store at 20° to 25°C (68° to 77°F).[See USP Controlled Room Temperature]DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Chlorthalidone tablets, USP 25 mg are available as follows:Yellow, round, tablets, debossed MP 30Chlorthalidone tablets, USP 50 mg are available as follows:Green, round, tablets, debossed MP 43Store at 20° to 25°C (68° to 77°F).[See USP Controlled Room Temperature]DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Chlorthalidone tablets, USP 25 mg are available as follows:Yellow, round, tablets, debossed MP 30Chlorthalidone tablets, USP 50 mg are available as follows:Green, round, tablets, debossed MP 43Store at 20° to 25°C (68° to 77°F).[See USP Controlled Room Temperature]DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
TANZEUM is an agonist of the GLP-1 receptor and augments glucose-dependent insulin secretion. TANZEUM also slows gastric emptying.
Non-Clinical Toxicology
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).TANZEUM is contraindicated in patients with a prior serious hypersensitivity reaction to albiglutide or to any of the product components.
Chlorthalidone may add to or potentiate the action of other antihypertensive drugs. Potentiation occurs with ganglionic peripheral adrenergic blocking drugs.
Medication such as digitalis may also influence serum electrolytes. Warning signs, irrespective of cause, are: dryness of mouth, thirst, weakness, lethargy, drowsiness, restlessness, muscle pains or cramps, muscular fatigue, hypotension, oliguria, tachycardia, and gastrointestinal disturbances such as nausea and vomiting.
Insulin requirements in diabetic patients may be increased, decreased, or unchanged. Higher dosage of oral hypoglycemic agents may be required. Latent diabetes mellitus may become manifest during chlorthalidone administration.
Chlorthalidone and related drugs may increase the responsiveness to tubocurarine.
Chlorthalidone and related drugs may decrease arterial responsiveness to norepinephrine. This diminution is not sufficient to preclude effectiveness of the pressor agent for therapeutic use.
Carcinogenicity of albiglutide could not be assessed in rodents due to the rapid development of drug-clearing, anti-drug antibodies . Other GLP-1 receptor agonists have caused dose-related and treatment–duration-dependent thyroid C-cell tumors (adenomas or carcinomas) in rodents. 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 MTC, in humans .
Across 8 Phase III clinical trials , MTC was diagnosed in 1 patient receiving TANZEUM and 1 patient receiving placebo. Both patients had markedly elevated serum calcitonin levels at baseline. Cases of MTC in patients treated with liraglutide, another GLP-1 receptor agonist, have been reported in the postmarketing period; the data in these reports are insufficient to establish or exclude a causal relationship between MTC and GLP-1 receptor agonist use in humans.
TANZEUM is contraindicated in patients with a personal or family history of MTC or in patients with MEN 2. Counsel patients regarding the potential risk for MTC with the use of TANZEUM and inform them of symptoms of thyroid tumors (e.g., a mass in the neck, dysphagia, dyspnea, or persistent hoarseness).
Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with TANZEUM. Such monitoring may increase the risk of unnecessary procedures, due to the low specificity of serum calcitonin testing for MTC and a high background incidence of thyroid disease. Significantly elevated serum calcitonin may indicate MTC and patients with MTC usually have calcitonin values >50 ng/L. If serum calcitonin is measured and found to be elevated, the patient should be further evaluated. Patients with thyroid nodules noted on physical examination or neck imaging should also be further evaluated.
The following serious reactions are described below or elsewhere in the prescribing information:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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