Coagadex

Coagadex is part of the drug class:

• Blood coagulation factors

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• anticoagulant (blood thinner) medications that are Factor Xa inhibitors, such as fondaparinux (Arixtra), apixaban (Eliquis), edoxaban (Savaysa), or rivaroxaban (Xarelto)

This is not a complete list of Coagadex drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Coagadex including the following:

Allergic reactions. You can have an allergic reaction to Coagadex. Stop treatment and call your healthcare provider right away if you have any of the following symptoms:

• difficulty breathing
• chest tightness
• swelling of the face, lips, arms, or legs
• rash or hives

Antibody formation. Your body can also make antibodies, called “inhibitors,” against Coagadex, which may stop Coagadex from working properly. Your healthcare provider may give you blood tests to check for inhibitors.

Infections that may be transmitted from Coagadex. Coagadex is made from human blood and may contain infectious agents, such as viruses, that can be transmitted while using this medication and cause diseases. Report any symptom that concerns you to your healthcare provider.

You should not receive Coagadex if you are allergic (hypersensitive) to any of the ingredients in Coagadex.

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

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

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.

General

Coagulation factor X human is available in the following dosage form(s) and strength(s):

Coagulation factor X human is available as a lyophilized powder for reconstitution in single-use vials containing nominally (approximately) 250 IU or 500 IU of factor X activity. When reconstituted using the sterile water for injection supplied with the kit, the final concentration is approximately 100 IU/mL).1

Dosage

It is essential that the manufacturer’s labeling be consulted for more detailed information on dosage, preparation, and administration of this drug. Dosage summary:

For intravenous use only after reconstitution.1

• Each vial of coagulation factor X human contains the labeled amount of factor X in international units (IU).1

• The dosage and duration of treatment depend on the severity of the factor X deficiency, on the location and extent of the bleeding and on the patient’s clinical condition.1

• For treatment of bleeding episodes: Use 25 IU per kg body weight, repeated at intervals of 24 hours until the bleed stops.1

• For perioperative management: Pre-surgery, raise plasma factor X levels to 70-90 IU/dL.1

• For perioperative management: Post-surgery, maintain plasma factor X levels at a minimum of 50 IU/dL until the patient is no longer at risk of bleeding due to surgery.1

• For perioperative management: Required dose (IU) = Body weight (kg) × Desired factor X rise (IU/dL or % of normal) × 0.5.1

Specific Drugs

It is essential that the manufacturer’s labeling be consulted for more detailed information on interactions with this drug, including possible dosage adjustments. Interaction highlights:

Drug interaction studies have not been performed. Use with caution in patients who are receiving other plasma products that may contain factor X, (e.g., fresh frozen plasma, prothrombin complex concentrates). Based on the mechanism of action, coagulation factor X human is likely to be counteracted by direct and indirect factor Xa inhibitors.1

Specific Drugs

It is essential that the manufacturer’s labeling be consulted for more detailed information on interactions with this drug, including possible dosage adjustments. Interaction highlights:

Drug interaction studies have not been performed. Use with caution in patients who are receiving other plasma products that may contain factor X, (e.g., fresh frozen plasma, prothrombin complex concentrates). Based on the mechanism of action, coagulation factor X human is likely to be counteracted by direct and indirect factor Xa inhibitors.1

AHFS First Release. For additional information until a more detailed monograph is developed and published, the manufacturer's labeling should be consulted. It is essential that the manufacturer's labeling be consulted for more detailed information on usual uses, dosage and administration, cautions, precautions, contraindications, potential drug interactions, laboratory test interferences, and acute toxicity.

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
• Perioperative management of bleeding in patients with mild hereditary Factor X deficiency

Limitation of Use

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

One case of accidental overdosage was reported in the clinical trials, in which a subject received approximately 80 IU/kg Factor X to treat a bleed. No adverse events were reported relating to this overdose.

Coagadex® (co-ag-a-dex)
Coagulation Factor X (Human)

Important: Do not attempt to give an infusion to yourself unless you have been taught how to by your healthcare provider or hemophilia center.

Always follow the specific instructions given by your healthcare provider. The steps listed below are general guidelines for using Coagadex. If you are unsure of the procedures, please call your healthcare provider before using.

Your healthcare provider will prescribe the dose that you should take. Contact your healthcare provider right away if you accidentally take more than the prescribed dose.

Your healthcare provider may need to take blood tests from time to time.

Talk to your healthcare provider before travelling. Plan to take enough Coagadex for your treatment during this time.

Dispose of all materials, including any leftover reconstituted Coagadex product, in an appropriate container.

When should I inject Coagadex?

Inject Coagadex when the first sign of bleeding occurs, before surgery as a precaution, and before the onset of menstrual bleeding, if appropriate and advised by your healthcare provider.

Repeat the injection at intervals of 24 hours to stop the bleeding. Each individual bleed should be judged on its own severity.

Contact your healthcare provider right away if bleeding does not stop after using Coagadex.

How should I dissolve Coagadex before use?

Coagadex must be dissolved in the sterile water provided with the product using the provided transfer device called Mix2Vial.

To administer this medicine you will also need a syringe and suitable needle (not provided in the Coagadex carton).

See below for step-by-step instructions for reconstituting Coagadex.

If you have to use more than one vial of Coagadex to make up your dose, repeat steps 1 to 5 to reconstitute each vial and draw up all of the solution into one syringe for your injection. You must use a new Mix2Vial to draw the contents of each vial up into the plastic syringe.

How do I inject Coagadex?

Inspect the solution before injection. Do not use if there are any particles in the syringe, or if the solution is cloudy, or if a gel or clot forms.

Do not add the solution to any other fluids and do not mix it together with any other medicine.

To inject the medicine:

• Attach a suitable needle to the syringe containing Coagadex solution.
• Inject the dose at a suggested rate of 10 mL/min, but no more than 20 mL/min into your vein.

Dispose of any solution that remains, along with used syringes, needles and containers. Do not throw it out with the ordinary household trash.

Important: Contact your healthcare provider or local hemophilia treatment center if you experience any problems.

Manufactured by:
Bio Products Laboratory Ltd.,
Elstree,
WD6 3BX,
United Kingdom.

U.S. Distributor:
Bio Products Laboratory USA Inc.,
302 East Pettigrew Street,
Suite C-190,
Durham, NC 27701,
USA

U.S. Licence No: 1811

Coagadex® is a registered trade mark of Bio Products Laboratory Limited. Mix2Vial™ is a trade mark of West Pharmaceutical services.