Albiglutide (Tanzeum)

Trade Name : Tanzeum

GlaxoSmithKline LLC

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Strength 30 mg/.5mL

ALBIGLUTIDE Glucagon-like Peptide-1 (GLP-1) Agonists [MoA],GLP-1 Receptor Agonist [EPC]

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Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Albiglutide (Tanzeum) which is also known as Tanzeum and Manufactured by GlaxoSmithKline LLC. It is available in strength of 30 mg/.5mL per ml. Read more

Albiglutide (Tanzeum) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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No data

No data

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. (n n- Array
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. (, )

TANZEUM is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus n
Arrayn- Limitations of Use:
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. ()
Limitations of Use:

1n- 5.1
1n- 5.2

No data

2.4n- 2.5n- 17

TANZEUM is supplied as follows:
For injection: 30 mg or 50 mg in a single-dose Pen. ()

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. n n

4n- 5.4

No data

Thyroid C-Cell Tumors:
Acute Pancreatitis:
Hypoglycemia:
Hypersensitivity Reactions:
Acute Kidney Injury:
Macrovascular Outcomes:

The following serious reactions are described below or elsewhere in the prescribing information:
Adverse reactions reported in u22655% 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. ()
To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or

TANZEUM did not affect the absorption of orally administered medications tested in clinical pharmacology studies to any clinically relevant degree . 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. ()

No data

Pregnancy:
Acute Kidney Injury:

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 patientu2019s 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 (5u00a0days).

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 u2013 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 72,970u00a0Daltons.
TANZEUM is produced by a strain of modified to express the therapeutic protein.
TANZEUM 30-mg Pen for injection (for subcutaneous use) contains 40.3u00a0mg lyophilized albiglutide and 0.65u00a0mL Water for Injection diluent designed to deliver a dose of 30u00a0mg in a volume of 0.5u00a0mL after reconstitution.
TANZEUM 50-mg Pen for injection (for subcutaneous use) contains 67u00a0mg lyophilized albiglutide and 0.65u00a0mL Water for Injection diluent designed to deliver a dose of 50u00a0mg in a volume of 0.5u00a0mL 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 153u00a0mM mannitol, 0.01% (w/w) polysorbate 80, 10u00a0mM sodium phosphate, and 117u00a0mM trehalose dihydrate. TANZEUM does not contain a preservative.

No data

No data

TANZEUM has been studied as monotherapy and in combination with metformin, metformin and a sulfonylurea, a thiazolidinedione (with and without metformin), and insulin glargine (with or without oral anti-diabetic drugs). The efficacy of TANZEUM was compared with placebo, glimepiride, pioglitazone, liraglutide, sitagliptin, insulin lispro, and insulin glargine.
Trials evaluated the use of TANZEUM 30u00a0mg and 50u00a0mg. Five of the 8 trials allowed optional uptitration of TANZEUM from 30u00a0mg to 50u00a0mg if glycemic response with 30 mg was inadequate.
In patients with type 2 diabetes mellitus, TANZEUM produced clinically relevant reduction from baseline in HbA1c compared with placebo. No overall differences in glycemic effectiveness or body weight were observed across demographic subgroups (age, gender, race/ethnicity, duration of diabetes).

No data

Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use). The Medication Guide is contained in a separate leaflet that accompanies the product.
Trademark is owned by or licensed to the GSK group of companies.
Manufactured by n
Wilmington, DE 19808
U.S. Lic. No. 1727
Marketed by n
Research Triangle Park, NC 27709
u00a92017 GSK group of companies or its licensor.
TNZ:8PI

This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: December 2017

INSTRUCTIONS FOR USE
TANZEUM (TAN-zee-um)
(albiglutide)
for injection, for subcutaneous use
TANZEUM (albiglutide) Pen 30 mg
Before you Begin: Wash Your Hands, Gather and Inspect Your Supplies
Step A
Inspect Your Pen and Mix Your Medicine
Inspect Your Pen
Twist Pen to Mix Your Medicine
Wait for Medicine to Dissolve
Step B
Attach the Needle and Prepare the Pen for Injection
After the 15 minute wait, wash your hands and finish the rest of the steps right away.
Inspect Your Dissolved Medicine
Attach the Needle
Tap for Air Bubbles
Twist Pen to Prime the Needle
Step C
Remove Both Needle Caps and Inject Your Medicine
Remove Needle Caps
Inject the Medicine
Disposing of Your Used Pens and Needles
General Information About the Safe and Effective Use of TANZEUM
Frequently Asked Questions
Medicine Dosing
What if I need to take my medicine on a different day of the week?
What if I forget to take the medicine on the day I am supposed to?
Storage
How should I store my medicine?
Number Window
Are the Numbers 1, 2, and 3 used to select my dose of medicine?
Number 1:n- 1
Number 2:n- 15
Number 3:
Step A: Inspect Your Pen and Mix Your Medicine
What if I do not wait 15 minutes after turning the pen to the Number 2?
What if I leave my pen for more than 15 minutes after turning the pen to the Number 2 in Step A?
Step B: Attach the Needle and Prepare Pen for Injection
What if I leave my pen with the needle attached at Step B, and come back later to finish Step C?
What if I do not attach the needle at Step B as instructed?
What if I do not hear the u201cclicku201d when the 2 or when the 3 is moved into the Number Window?
Step C: Remove Both Needle Caps and Inject Your Medicine
After I turn the pen to Number 3 (Step B), there are still some small air bubbles remaining. Can I still use the pen?
After I give my medicine, there is some liquid still seen in the clear cartridge.
How should I dispose of the pen?
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Revised: September 2016
INSTRUCTIONS FOR USE
TANZEUM (TAN-zee-um)
(albiglutide)
for injection, for subcutaneous use
TANZEUM (albiglutide) Pen 50 mg
Before you Begin: Wash Your Hands, Gather and Inspect Your Supplies
Step A
Inspect Your Pen and Mix Your Medicine
Inspect Your Pen
Twist Pen to Mix Your Medicine
Wait for Medicine to Dissolve
Step B
Attach the Needle and Prepare the Pen for Injection
After the 30 minute wait, wash your hands and finish the rest of the steps right away.
Inspect Your Dissolved Medicine
Attach the Needle
Tap for Air Bubbles
Twist Pen to Prime the Needle
Step C
Remove Both Needle Caps and Inject Your Medicine
Remove Needle Caps
Inject the Medicine
Disposing of Your Used Pens and Needles
General Information About the Safe and Effective Use of TANZEUM
Frequently Asked Questions
Medicine Dosing
What if I need to take my medicine on a different day of the week?
What if I forget to take the medicine on the day I am supposed to?
Storage
How should I store my medicine?
Number Window
Are the Numbers 1, 2, and 3 used to select my dose of medicine?
Number 1:n- 1
Number 2:n- 30
Number 3:
Step A: Inspect Your Pen and Mix Your Medicine
What if I do not wait 30 minutes after turning the pen to the Number 2?
What if I leave my pen for more than 30 minutes after turning the pen to the Number 2 in Step A?
Step B: Attach the Needle and Prepare Pen for Injection
What if I leave my pen with the needle attached at Step B, and come back later to finish Step C?
What if I do not attach the needle at Step B as instructed?
What if I do not hear the u201cclicku201d when the 2 or when the 3 is moved into the Number Window?
Step C: Remove Both Needle Caps and Inject Your Medicine
After I turn the pen to Number 3 (Step B), there are still some small air bubbles remaining. Can I still use the pen?
After I give my medicine, there is some liquid still seen in the clear cartridge.
How should I dispose of the pen?
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Revised: September 2016

PRINCIPAL DISPLAY PANEL
NDC 0173-0866-35
Arrayn- Tanzeumn
Arrayn- (albiglutide)
Rx Only
Once-weekly
30mg
Each prefilled pen will deliver one 30-mg dose in 0.5 mL.
For subcutaneous use only.
Contents:
Dispense the enclosed Medication Guide to each patient.
To fully dissolve the medicine the 30-mg pen must sit upright in a cup for 15 minutes.
u00a92016 the GSK group of companies
Made in Germany
Rev. 11/16
10004929-03

PRINCIPAL DISPLAY PANEL
NDC 0173-0867-35
Arrayn- Tanzeumn
Arrayn- (albiglutide)
Rx Only
Once-weekly
50mg
Each prefilled pen will deliver one 50-mg dose in 0.5 mL.
For subcutaneous use only.
Contents:
Dispense the enclosed Medication Guide to each patient.
To fully dissolve the medicine the 50-mg pen must sit upright in a cup for 30 minutes.
THE 50-MG PEN HAS A DIFFERENT WAIT TIME
IMPORTANT
TO FULLY DISSOLVE THE MEDICINE THE MUST SIT UPRIGHT IN A CUP FOR n
u00a92016 the GSK group of companies
Made in Germany
Rev. 11/16
10004925-03

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Albiglutide (Tanzeum)

Trade Name : Tanzeum

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Albiglutide (Tanzeum)

Trade Name : Tanzeum

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

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Canadian DIN

Swiss Drugs

NZ Drugs

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