On-demand Trial Results: Efficacy in Women and Girls

Among women and girls in the study, 97.7% of analyzed bleeds were treated successfully with COAGADEX

62.5% (10/16) of subjects enrolled in Study TEN01 were women and girls aged 14 to 58 years

80% (8/10) of the women and girls had a history of heavy menstrual bleeding

graphic - 80%

40% (4/10) of the women and girls had a history of anemia

graphic - 40%

The majority of analyzed bleeds were covert while an additional 46% were due to heavy menstrual bleeding

A total of 267 COAGADEX infusions were administered in the women and girls cohort (178 for on-demand treatment and 89 for preventative treatment). A total of 149 bleeds were treated with COAGADEX, of which 132 bleeds were selected by the data review committee for inclusion in the primary efficacy analysis*
- 46% (61/132) of analyzed bleeds in women were due to heavy menstrual bleeding
- 94.3% (67/71) of the remaining bleeds were covert
- 97.7% of bleeds analyzed had a treatment response that was rated as excellent or good

Type of Bleed Assessed

Chart - Type of Bleed Assessed

Non-Menstrual Bleeds Covert % vs. Overt %

Chart - Non-Menstrual Bleeds

In clinical studies, the most common adverse events (frequency ≥5% of subjects) with COAGADEX were infusion site erythema, infusion site pain, fatigue and back pain.

*The 132 bleeds included in the analysis were classified as due to heavy menstrual bleeding (n=61), covert (n=67), and overt (n=4).

Reference: Kulkarni R, James AH, Norton M, Shapiro M. J Thromb Haemost. 2018;16:849-857.

Indications and Usage for COAGADEX

COAGADEX, a plasma-derived blood coagulation factor X concentrate, is indicated in adults and children with hereditary factor X deficiency for:

Routine prophylaxis to reduce the frequency of bleeding episodes
On-demand treatment and control of bleeding episodes
Perioperative management of bleeding in patients with mild and moderate hereditary factor X deficiency

Limitation of Use

Perioperative management of bleeding in major surgery in patients with severe hereditary factor X deficiency has not been studied.

Contraindication for COAGADEX

COAGADEX is contraindicated in patients with known hypersensitivity to any of the components of the product.

Important Safety Information for COAGADEX

Allergic type hypersensitivity reactions, including anaphylaxis, are possible with COAGADEX. If symptoms occur, patients should discontinue use of the product immediately, contact their physician, and administer appropriate treatment.

The formation of neutralizing antibodies (inhibitors) to factor X is a possible complication in the management of individuals with factor X deficiency. Carefully monitor patients taking COAGADEX for the development of inhibitors by appropriate clinical observations and laboratory tests.

COAGADEX is made from human plasma and may contain infectious agents, e.g. viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent. No cases of transmission of viral diseases, vCJD or CJD, have been associated with the use of COAGADEX.

In clinical studies, the most common adverse reactions (frequency ≥5% of subjects) with COAGADEX were infusion site erythema, infusion site pain, fatigue and back pain.

Please see complete Prescribing Information for COAGADEX.