Tretten

Last updated on RxList: 12/4/2020
Tretten Side Effects Center

What Is Tretten?

Tretten [(catridecacog) Coagulation Factor XIII A-Subunit (Recombinant)] is a recombinant human blood factor XIII-A2 homodimer composed of two factor XIII (FXIII) A-subunits used for routine prevention for bleeding in patients with congenital factor XIII A-subunit deficiency. Tretten is not for use in patients with congenital factor XIII B-subunit deficiency.

What Are Side Effects of Tretten?

Common side effects of Tretten include:

  • headache
  • pain in the extremities
  • injection site pain
  • increase in fibrin D dimer levels
  • arthritis
  • itching
  • joint pain or
  • skin redness.

Dosage for Tretten

The dose of Tretten for routine prophylaxis for bleeding in patients with congenital factor XIII (FXIII) A-subunit deficiency is 35 international units (IU) per kilogram body weight once monthly to achieve a target trough level of FXIII activity at or above 10% using a validated assay.

What Drugs, Substances, or Supplements Interact with Tretten?

Tretten may interact with factor VIIa. Tell your doctor all medications and supplements you use.

Tretten During Pregnancy and Breastfeeding

During pregnancy, Tretten should be used only if prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Tretten [(catridecacog) Coagulation Factor XIII A-Subunit (Recombinant)] Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Tretten Professional Information

SIDE EFFECTS

The most common adverse reactions reported in clinical trials (≥1%), were headache, pain in the extremities, injection site pain, and increase in fibrin D dimer levels.

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 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 nonneutralizing antibodies were found to be of no clinical significance. No subjects developed neutralizing antibodies (inhibitors) against TRETTEN during clinical trials.

Read the entire FDA prescribing information for Tretten (Catridecacog Coagulation Factor XIII A-Subunit (Recombinant) )

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© Tretten Patient Information is supplied by Cerner Multum, Inc. and Tretten Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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