Coagadex

Coagadex is a prescription medication used to replace the clotting factor that is missing in people with Factor X deficiency. Factor X deficiency is an inherited bleeding disorder that prevents blood from clotting normally. Coagadex is used to treat and control bleeding in patients aged 12 years and over with hereditary Factor X deficiency. 

It belongs to a group of drugs called blood coagulation factors. These drugs work to activate substances in your blood to form clots and decrease bleeding episodes.

This medication is available as a powder for solution to be injected directly into the vein (IV) by a healthcare professional. 

Common side effects of Coagadex include pain and redness at the injection site and fatigue.

Coagadex is a prescription medication control bleeding and prevent bleeding in adults and children (aged 12 years and above) with hereditary Factor X deficiency, an inherited bleeding disorder. 

Your healthcare provider may give you Coagadex when you have surgery.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

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Serious side effects have been reported with Coagadex. See the “Coagadex Precautions” section.

Common side effects of Coagadex include the following:

• redness and pain at injection site
• fatigue
• back pain

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

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Coagadex, there are no specific foods that you must exclude from your diet when receiving this medication.

Before receiving Coagadex, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Coagadex or to any of its ingredients
• are taking anticoagulant medications such as apixaban (Eliquis), edoxaban (Savaysa), fondaparinux (Arixtra), or rivaroxaban (Xarelto)
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed
• have or have had any medical problems
• have any allergies
• have been told you have inhibitors to Factor X

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

Tell your doctor if you are pregnant or plan to become pregnant.

No studies have been done in animals, and no well-controlled studies have been done in pregnant women. Coagadex should be given to a pregnant woman only if clearly needed.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Coagadex crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Coagadex.

Coagadex is available as a powder for solution to be injected directly into the vein (IV) by a healthcare professional. 

You may infuse Coagadex at a hemophilia treatment center, at your healthcare provider’s office or in your home. You should be trained on how to do infusions by your healthcare provider or hemophilia treatment center.

Many people with coagulation factor deficiencies learn to infuse their treatment by themselves or with the help of a family member.

• 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.

Your healthcare provider will tell you how much Coagadex to use based on your weight, the severity of your Factor X deficiency, and where you are bleeding. You may need blood tests done after using Coagadex to be sure that your blood level of Factor X is high enough to clot your blood.

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

You must carefully follow your healthcare provider's instructions regarding the dosing and administration for infusing Coagadex so that your treatment will work best for you.

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. 

If you administer too much Coagadex, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If Coagadex is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Keep Coagadex in its original package to protect it from light.
• Store Coagadex refrigerated [not below 2°C (36°F)] or at room temperature [not to exceed 30°C (86°F)]. Do not freeze.
• Do not use after the expiration date printed on the box. The expiration date refers to the last day of that month.
• Do not use the sterile water if any small bits can be seen in it.
• After reconstitution (mixing with the sterile water), Coagadex must be used within one hour. Discard any Coagadex left in the vial at the end of your infusion.