Coagulation Factor Xiii A-Subunit (Recombinant) (Tretten)

Trade Name	TRETTEN
Active Ingredient
Power
Type / form	Tablets
Status
Manufacturer	Novo Nordisk

Storage and handling for TRETTEN

Disclaimer

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Coagulation Factor Xiii A-Subunit (Recombinant) (Tretten) which is also known as TRETTEN and Manufactured by Novo Nordisk. It is available in strength of per ml. Read more

Coagulation Factor Xiii A-Subunit (Recombinant) (Tretten) 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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About GNH

GNH India a Global Orphan Drug specialist renowned for its adherence to stringent quality standards. GNH India holds ISO 9001:2015 certification and WHO Good Storage and Distribution Practices (GSDP) compliance, ensuring the highest levels of safety and reliability in our operations.

No data

TRETTEN, Coagulation Factor XIII A-Subunit (Recombinant), is indicated for routine prophylaxis for bleeding in patients with congenital factor XIII A-subunit deficiency.
TRETTEN is not for use in patients with congenital factor XIII Bu2011subunit deficiency
TRETTEN, Coagulation Factor XIII A-Subunit (Recombinant), is indicated for routine prophylaxis of bleeding in patients with congenital factor XIII A-subunit deficiency. ()
TRETTEN is not for use in patients with congenital factor XIII Bu2011subunit deficiency. ()

For intravenous use only.
For intravenous use only.
Dose:
Rate: Do not exceed 1-2 mL per minute. ()

TRETTEN, Coagulation Factor XIII A-Subunit (Recombinant), is available as a white lyophilized powder in single-use vial containing nominally 2500 IU per vial (2000 u2013 3125 IU) of recombinant coagulation factor XIII A-subunit. The actual amount of TRETTEN in IU is stated on each carton and vial.
After reconstitution with the provided Sterile Water for Injection, each vial contains 667-1042 IU/mL recombinant coagulation factor XIII A-subunit.

TRETTEN is contraindicated in patients who have known hypersensitivity to the active substance or to any of the excipients n
Hypersensitivity to the active substance or to any of the excipients. ()

No data

The most common adverse reactions reported in clinical trials (u22651%), were headache, pain in the extremities, injection site pain, and increase in fibrin D dimer levels.
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
During clinical development, TRETTEN was administered to 77 subjects with congenital factor XIII A-subunit deficiency (3:2, male: female ratio) for a total of 1990 doses. Fifty subjects (65%) were between the ages of 18 and 77 years (received 1338 doses), 21 subjects (27%) were between the ages of 6 and less than 18 years old (received 560 doses), and 6 subjects (8%) were less than 6 years old (received 92 doses). Subjects were exposed for up to 4.5 years.
Of the 77 subjects, 68 received 1979 monthly doses of 35 IU/kg of TRETTEN for routine prophylaxis of bleeding. Eleven single doses of TRETTEN have been administered to nine subjects for pharmacokinetic investigations.
The adverse drug reactions reported included headache, pain in the extremities, pain at the injection site, and increase in fibrin D dimer levels (without evidence of thromboembolic events).
Immunogenicity
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, comparison of the incidence of antibodies to TRETTEN with the incidence of antibodies to other products may be misleading.
Transient non-neutralizing antibodies were seen in one out of 50 healthy subjects after one dose, four out of 77 trial subjects (age < 18 years) with congenital factor XIII A-subunit deficiency after one or two doses (3 discontinued from the trial), and in one subject (age < 18 years) in a post marketing safety study after 3.5 years of treatment. In two subjects, the non-neutralizing antibodies disappeared after continued treatment with TRETTEN. In all cases, the non-neutralizing antibodies were found to be of no clinical significance. No subjects developed neutralizing antibodies (inhibitors) against TRETTEN during clinical trials.
The most common adverse reactions reported in the clinical trials (u22651%) were headache, pain in the extremities, injection site pain, D dimer increase. n
To report SUSPECTED ADVERSE REACTIONS, contact Novo Nordisk Inc. at 1-844-873-8836 or FDA at 1-800-FDA-1088 or n

Thrombosis may occur if TRETTEN is administered concomitantly with factor VIIa n

u00a0
7

No data

One subject accidentally received a dose 2.3 times the recommended dose. No clinical signs and symptoms were observed.

TRETTEN, Coagulation Factor XIII A-Subunit (Recombinant), is a recombinant human factor XIII-A homodimer composed of two factor XIII (FXIII) A-subunits. The FXIII A-subunit is a 731 amino acid chain with an acetylated N-terminal serine. When FXIII is activated by thrombin, a 37 amino acid peptide is cleaved from the N-terminus of the Au2011subunit.
TRETTEN is manufactured as an intracellular, soluble protein in yeast (Saccharomyces cerevisiae) production strain containing the episomal expression vector, pD16. It is subsequently isolated by homogenization of cells and purification by several chromatography steps, including hydrophobic interaction and ion exchange chromatography. No human or animal derived products are used in the manufacturing process.
TRETTEN is supplied as a sterile, white lyophilized powder in a single use vial. Table 1 and Table 2 list the vial content of reconstituted TRETTEN and the diluent, respectively.
u00a0*Values are given per 3 mL reconstituted TRETTEN.
After reconstitution with 3.2 mL sterile water for injection, each vial contains 667-1042 IU/mL of recombinant coagulation factor XIII A-subunit. The reconstituted solution has a pH of approximately 8.0. The formulation contains no preservative and must only be administered intravenously.

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No data

To establish the efficacy of TRETTEN for the prevention of bleeding in patients with congenital FXIII A-subunit deficiency, a multi-center, open-label, non-controlled trial was conducted for 52 weeks in forty-one (41)subjects u2265 6 years. All subjects received monthly doses of TRETTEN at 35IU/kg. Bleeding episodes that required treatment with a FXIII-containing product were observed to evaluate the efficacy of monthly replacement therapy with TRETTEN on prevention of bleeding episodes.
Subjects with congenital FXIII A-subunit deficiency confirmed by genotyping were included. Subjects who before entering the trial had received regular replacement therapy were to have initiated regular replacement therapy at least 6 months prior to screening and were to have a documented history of at least one treatment-requiring bleeding episode before initiation of regular replacement therapy or a documented family history of FXIII congenital deficiency. Subjects who before entering the trial had only received on-demand treatment were to have a documented history of at least two treatment-requiring bleeding episodes within 12 months of the screening visit. Severe bleeders as defined by a documented history of u22652 treatment requiring bleedings per year during regular FXIII replacement therapy were excluded.
During the prophylaxis treatment period with TRETTEN (434subject months), five bleeding episodes treated with FXIII-containing products were observed in four subjects. All five were associated with trauma. When calculated for all 41 subjects, this translated into a mean annual rate of bleeding episodes that required treatment of 0.14 [95% CI:0.058- 0.332] per subject year, which was statistically significantly lower than the historic bleeding rate of 1.68 per subject year for on-demand treatment. The age-adjusted rate of bleeding episodes that required treatment during the TRETTEN treatment period was 0.05 [95% CI: 0.0094 - 0.2501] per subject year with a model-based estimate corresponding to the mean age of 26.4 years. The mean annual bleeding rate in subjects below 18 years of age was higher compared to that in adults (0.362 versus 0.040 bleeds/subject/year). Table 5 below lists the estimated bleeding rates by age.
Thirty-four (34) of the 41 subjects and an additional 21 new subjects were enrolled in an ongoing second trial. During a total treatment period of 107.5 subject years (mean of 1.95 years per subject), 5 subjects experienced 6 bleeds that required treatment with a FXIII-containing product. The mean annual rate of bleeding episodes that required treatment was determined to be 0.056 per subject year. The age-adjusted rate of bleeding episodes that required treatment during the TRETTEN treatment period was 0.022 per subject year [95% CI:0.0045; 0.1023] with a model-based estimate corresponding to a mean age of 29.5 years. The annual mean bleeding rate in subjects below age 18 was higher compared to that in adults (0.127 versus 0.026 bleeds/subject/year) with some overlap of the respective 95% confidence intervals. Table 6 lists the estimated bleeding rates by age.

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How Supplied
TRETTEN, Coagulation Factor XIII A-Subunit (Recombinant), is supplied as a white, lyophilized powder in single-use vial along with the diluent (Sterile Water for Injection) vial.
The actual amount of TRETTEN in international units (IU) is stated on each carton and vial. TRETTEN and the sterile water vials provided in the package are not made with natural rubber latex.
Storage and Handling

License Number: 1261
Patent information: http://novonordisk-us.com/patients/products/product-patents.html
Novo Nordisk is a registered trademark of Novo Nordisk A/S
TRETTEN is a registered trademark of Novo Nordisk Health Care AG
u00a9 2013-2016 Novo Nordisk
For Information contact:
Novo Nordisk Inc.
800 Scudders Mill Road
Plainsboro, NJ 08536
Manufactured by:
Novo Nordisk A/S
DK-2880 Bagsvaerd, Denmark

TRETTENn
Coagulation Factor XIII A-Subunit (Recombinant)
This leaflet summarizes important information about TRETTEN. Please read it carefully before using TRETTEN and each time you get a refill because there may be new information provided. This information does not take the place of talking with your healthcare provider, and it does not include all of the important information about TRETTEN. If you have any questions after reading this, ask your healthcare provider.
What is TRETTEN?
TRETTEN is an injectable medicine used to prevent bleeding in adults and children who have congenital factor XIII (FXIII) A-subunit deficiency. TRETTEN is man-made and does not contain animal or human materials.
Who should use TRETTEN?
You should use TRETTEN if you have ever had allergic (hypersensitivity) reactions, including severe, whole body reaction (anaphylaxis) to TRETTEN or any of the ingredients.
What should I tell my healthcare provider before TRETTEN is given?
Tell your healthcare provider about all of your medical conditions, including:
Tell your healthcare provider about all of the medicines you take, including all prescription and non-prescription medicines such as over-the-counter medicines, supplements, or herbal remedies.
How is TRETTEN given?
TRETTEN is given as an injection into your vein (intravenous injection). These injections are given once a month. Your dose will depend on your body weight. Use the dose that your healthcare provider has prescribed for you based on your weight.
Before injecting TRETTEN, it must be dissolved (reconstituted) using the sterile water that is provided in the package. Throw away any TRETTEN left in the vial after you inject your dose because it may become unsterile.
What are the possible side effects of TRETTEN?
Call your healthcare provider or go to the emergency department right away if you have any of the following symptoms after using TRETTEN:
Other possible side effects may include:
These are not all the possible side effects of TRETTEN. Tell your healthcare provider about any side effect that bothers you or that does not go away. You can also report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088.
How should I store TRETTEN?
It is important to store TRETTEN correctly.
What else should I know about TRETTEN?
Do not use TRETTEN for a condition for which it is not prescribed. Do not share TRETTEN with other people, even if they have the same symptoms that you have.
Talk to your healthcare provider if you would like more information.
TRETTEN ingredients include:
TRETTEN and the sterile water vials provided in the package are not made with natural rubber latex.
This Patient Package Insert has been approved by the US Food and Drug Administration
Revised: 12/2013
Version: 1
Novo Nordisk is a registered trademark of Novo Nordisk A/S
TRETTEN is a registered trademark of Novo Nordisk Health Care AG
u00a9 2013 Novo Nordisk
For Information contact:
Novo Nordisk Inc.
800 Scudders Mill Road
Plainsboro, NJ 08536
www.novonordisk-us.com
1-844-TRETTEN
Manufactured by:
Novo Nordisk A/S
DK-2880 Bagsvaerd, Denmark

2500 IU
TRETTENn
Coagulation Factor XIII A-Subunit (Recombinant)
For intravenous administration only
For human use only
Contains no preservative
Rx only

2500 IU
TRETTENn
Coagulation Factor XIII A-Subunit (Recombinant)
For intravenous administration only
Store refrigerated at 2-8u00b0C (36-46u00b0F)
Reconstitute with 3.2 mL sterile water for injection only
Rx only
Novo Nordisk Inc.
1-844-TRETTEN
Expiry/Lot/rFXIII IU per vial:

3.2 mL
Sterile Water for Injection
For reconstitution of TRETTENn
Coagulation Factor XIII A-Subunit (Recombinant)
Store at 2-25u00b0C (36-77u00b0F)
Novo Nordisk Inc.
1-844-TRETTEN
Expiry/Lot/: