COAGADEX Replaces Exactly What’s Missing—Factor X

COAGADEX is the first and only treatment specifically for hereditary factor X deficiency. With COAGADEX, you get the factor X you need—without a lot of extra clotting factors.

Here, you can:

What Is COAGADEX?

  • COAGADEX is the first and only treatment specifically for hereditary factor X deficiency.
  • People with hereditary factor X deficiency don’t have enough factor X in their blood. COAGADEX replaces exactly what’s missing—factor X.
  • COAGADEX can be taken in different ways—routinely to help prevent bleeding, with surgery to help prevent bleeding, or as needed if bleeding starts.
Coagadex: Coagulation Factor X (Human) packaging and vial

Why Choose COAGADEX?

Doctors and patients may choose COAGADEX for many reasons—

Proven Effective

Stopped 98% of bleeds along with a no bleeding illustration icon

COAGADEX stopped 98% of bleeds in a medical study of adults and older children with hereditary factor X deficiency.

In a medical study of adults and children (12 years of age or older) with hereditary factor X deficiency:

  • COAGADEX stopped 98% of bleeds and most bleeds were stopped with just one dose.
  • 91% of the adults and children in the study thought COAGADEX was “excellent” in stopping their bleeds.
  • In this study, COAGADEX was given as needed for treatment of bleeds and for short-term prevention of bleeding.

High Purity

94% Factor X along with a Factor X vial illustration icon

COAGADEX is high-purity (94%), so you get the factor X you need—without a lot of extra clotting factors.

COAGADEX is the first and only product made specifically for factor X deficiency.

  • There are no other therapies approved for the treatment of factor X deficiency. Some patients use treatments that include clotting factors other than factor X. Too many of the other clotting factors can increase the risk for blood clots that may block blood vessels and cause serious side effects. Examples are stroke or a blood clot in the leg.

Rated Excellent

Rated "excellent" by 100% of doctors along with a doctor illustration icon

100% of doctors rated COAGADEX as “excellent” in preventing or reducing the number of bleeds in younger children.

In another medical study that included only children up to 11 years of age with hereditary factor X deficiency, COAGADEX was tested to see how well it could reduce or prevent bleeds.

  • 100% of doctors who had patients in the study rated COAGADEX as “excellent” in preventing bleeds or reducing the number of bleeds for all children in the study.

Recommended by Experts

#1 Recommend along with a blue ribbon illustration icon

COAGADEX is the #1 recommended treatment by medical experts including a national organization for rare bleeding disorders.1–3

How Does COAGADEX Work?

COAGADEX contains factor X to replace the factor X that is missing in people with hereditary factor X deficiency. The factor X in COAGADEX helps the body form clots to stop bleeding.

  1. Bleeding begins (like from a cut in the skin)
  2. The body tries to make a clot to stop the bleeding
  3. The body needs factor X to help make the clot
  4. WITHOUT COAGADEX

    • Without factor X, the body has trouble making a clot
    • With no clot, the body keeps bleeding or is very slow to stop it

    WITH COAGADEX

    • COAGADEX replaces the missing factor X (Factor X icon)
    • COAGADEX helps the body make a clot to stop the bleeding

Treatment With COAGADEX

COAGADEX can be used in different ways to treat hereditary factor X deficiency.

  • The type of treatment needed depends on how often you have symptoms and how severe they are.
  • Talk with your doctor to find what is best for you.
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Routine: COAGADEX is given at regular times as directed by your doctor to help prevent bleeds. For example, some patients take it 2 times a week.

  • Usually taken at home.
  • Factor X levels are kept at near normal levels all the time to help prevent bleeding before it happens.
  • Factor X levels should be monitored by your doctor and doses should be adjusted accordingly.
Doctor icon

Surgical: COAGADEX is given with surgery.

  • Often given in a hospital or clinic.
  • Factor X levels are increased to help prevent bleeding during and after surgery.
  • After surgery, patients can change to routine therapy, or treatment as needed.
Blood droplet and hand icon

As needed (on-demand): COAGADEX is given as needed for an accident, injury, or unexpected bleeding.

  • Can be given in a hospital or clinic, or at home.
  • Factor X levels are increased to help stop bleeding.

Patient and Caregiver Stories—Finding More Freedom With COAGADEX

Photograph of Adrian, who has factor X deficiency

Adrian’s Story:

“I encourage everyone to be their own advocate, seek out help when needed, and find the treatment that is right for them.”

Read More

Photograph of Maritza, who has factor X deficiency

Maritza’s Story:

“For 23 years I had nothing. Now I do have something—and it’s made just for me.”

Read More

Photograph of Carly, mother to Ariel who has factor X deficiency

Carly’s Story:

“It helped my daughter’s self-esteem and confidence to know that she now has a treatment specifically approved for her disease.”

Read More

Photograph of Pam, whose son, Reece has factor X deficiency

Pam’s Story:

“My son wants others to know that ‘really, and truly…if you take your medicine, you can live a normal life.’”

Read More

Talking With Your Doctor About COAGADEX

  • If you have been diagnosed with hereditary factor X deficiency, take time before your visit to think about your treatment. For example, are you:
    • Thinking about starting COAGADEX?
    • On another medicine, but thinking about trying COAGADEX?
    • Wanting to take COAGADEX to help prevent bleeds?
  • Use our Doctor Discussion Guide to help you with your questions.
  • Print your answers and show your Doctor Discussion Guide to your doctor.

HEMOPHILIA TREATMENT CENTERS

Some people with factor X deficiency receive care at a hemophilia treatment center (HTC). Visit Savings and Support to learn more about HTCs.

How Is COAGADEX Given?

COAGADEX is given as a liquid through a needle in a vein. This is called an intravenous infusion, or IV.

  • At first, COAGADEX is often given in a doctor’s office or infusion center. A nurse will prepare the dose and give the medicine to you.
  • In some cases, a nurse may be able to come to your home to give you COAGADEX. If interested, you or your caregiver may be able to learn how to give COAGADEX yourself. A nurse will provide training. It may take a few doses before you feel ready to give COAGADEX without the nurse.
Learn how to mix (reconstitute) COAGADEX

COAGADEX safety

COAGADEX was approved by the United States Food and Drug Administration (FDA) in 2015 as the first and only treatment specifically for hereditary factor X deficiency.

  • Some people have side effects from COAGADEX. In clinical trials, the most common side effects of COAGADEX were redness of the skin at the infusion site, pain at the infusion site, tiredness (fatigue), and back pain.
  • There are other possible side effects of COAGADEX. Tell your doctor about any side effects that bother you or do not go away.
COAGADEX replaces exactly what’s missing—factor X.
Talk with your doctor to learn more about COAGADEX.

References: 1. Shapiro A. Expert Opin Drug Metab Toxicol. 2017;13:97-104. 2. Giangrande P, Seitz R, Behr-Gross ME, et al. Haemophilia. 2014;20:322-325. 3. National Hemophilia Foundation. MASAC Recommendations concerning products licensed for the treatment of hemophilia and other bleeding disorders. MASAC document 263. https://www.hemophilia.org/Researchers-Healthcare-Providers/Medical-and-Scientific-Advisory-Council-MASAC/MASAC-Recommendations/MASAC-Recommendations-Concerning-Products-Licensed-for-the-Treatment-of-Hemophilia-and-Other-Bleeding-Disorders. Revised August 2020. Accessed October 22, 2020.

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 who have had life-threatening hypersensitivity reactions to COAGADEX.

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.