Coagadex

Last updated on RxList: 1/15/2021
Coagadex Side Effects Center

What Is Coagadex?

Coagadex (Coagulation Factor X [Human]) is a plasma-derived human blood coagulation factor indicated in adults and children (aged 12 years and above) with hereditary Factor X deficiency for on-demand treatment and control of bleeding episodes, and perioperative management of bleeding in patients with mild hereditary Factor X deficiency.

What Are Side Effects of Coagadex?

Common side effects of Coagadex include:

  • infusion site redness and pain,
  • back pain, and
  • fatigue.

Dosage for Coagadex

The dosage and duration of treatment with Coagadex depend on the severity of the Factor X deficiency, on the location and extent of the bleeding and on the patient's clinical condition.

What Drugs, Substances, or Supplements Interact with Coagadex?

Coagadex may interact with other plasma products that may contain Factor X, and direct and indirect Factor Xa inhibitors. Tell your doctor all medications and supplements you use.

Coagadex During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Coagadex; it is unknown if it would affect a fetus. It is unknown if Coagadex passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Coagadex (Coagulation Factor X [Human]) 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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Coagadex Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives, itching, tingling; wheezing, tightness in your chest, difficult breathing; fast heartbeats; feeling like you might pass out; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • burning, stinging, redness, or swelling where the medicine was injected;
  • fever or chills, cough, body aches, lack of energy;
  • new or worsened bleeding; or
  • continued bleeding after treatment.

Common side effects may include:

  • feeling tired;
  • back pain; or
  • pain or redness where the medicine was injected.

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.

Read the entire detailed patient monograph for Coagadex (Coagulation Factor X Lyophilized Powder )

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Coagadex Professional Information

SIDE EFFECTS

The most common adverse drug reactions (frequency ≥ 5% of subjects) observed in clinical trials were infusion site erythema, infusion site pain, fatigue, and back pain.

Clinical Trials Experience

As 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 trial of another drug and may not reflect the rates observed in clinical practice.

During the clinical development of COAGADEX involving three multicenter, open-label, non-randomized clinical studies, 27 individual subjects with hereditary Factor X deficiency received at least one dose of COAGADEX.

Sixteen subjects aged 12 to 58 years with moderate to severe hereditary Factor X deficiency (basal FX:C < 5 IU/dL) received doses of COAGADEX for pharmacokinetic evaluation, on-demand treatment for control of bleeding episodes, and/or perioperative management of minor surgical or dental procedures. A total of 468 infusions were administered, including 242 for on-demand treatment and control of bleeding episodes, 6 for perioperative management and 31 for PK assessments. Spontaneous, traumatic and menorrhagic bleeding episodes were treated with an on-demand dose of 25 IU/kg for up to 2 years.

Two subjects aged 55 and 59 years with mild hereditary Factor X deficiency (basal FX:C 6 IU/dL and 8 IU/dL) received COAGADEX for perioperative management of four major surgical procedures. There were 40 exposure days to COAGADEX.

Six adverse reactions were reported in 2 of the 18 subjects. These were infusion site erythema (2 reports in 1 subject [5.6%]), fatigue (2 reports in 1 subject [5.6%]), back pain (1 report [5.6%]) and infusion site pain (1 report [5.6%]).

In a separate study, nine children (aged 2 to 11 years), of whom four were less than 6 years of age, received 537 (mean 59.7) doses of COAGADEX as routine prophylaxis of bleeding episodes during a period of at least 6 months. In addition, 22 infusions were given to treat a bleed, equivalent to 2.1 bleeds per subject per year. There were no adverse drug reactions in this study.

Immunogenicity

All subjects (adults and children) underwent Factor X inhibitor testing (inhibitor screen and Nijmegen-Bethesda assay) at baseline, end of study and at 3-monthly intervals in between. For subjects who underwent surgery, inhibitor testing was done pre-surgery and on discharge. All inhibitor tests were negative. Additionally, comparison of pharmacokinetic (PK) parameters at the repeat PK assessment with those at first dose did not suggest development of any inhibitors to Factor X.

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, it may be misleading to compare the incidence of antibodies to COAGADEX in the studies described above with the incidence of antibodies in other studies or to other products.

Read the entire FDA prescribing information for Coagadex (Coagulation Factor X Lyophilized Powder )

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

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