factor X

What it is used for

COAGADEX is a medicine given as an infusion into the vein 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, control or reduce bleeding in patients with hereditary Factor X deficiency.

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

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, rash or hives.

Common side effects of COAGADEX are infusion site redness, infusion site pain, tiredness, and back pain.

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.

These are not all of the possible side effects of COAGADEX. Tell your healthcare provider about any side effects that bother you or do not go away.

COAGADEX is packaged with a suitable volume (2.5 mL or 5 mL) of Sterile Water for Injection, and one Mix2Vial transfer device.

COAGADEX comes in two different dosage strengths:

Approximately 250 International Units (IU) – to be reconstituted with 2.5 mL of sterile water.

Approximately 500 International Units (IU) - to be reconstituted with 5 mL of sterile water.

The actual strength will be printed on the vial label and on the box. Once dissolved, the concentrations in these two vials will be the same, 100 IU per mL.

Always check the actual dosage printed on the label to make sure you are using the vial size prescribed by your healthcare provider.

Always check the expiration date printed on the box. Do not use the product after the expiration date printed on the box.

The most important thing to know

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

You must carefully follow your healthcare provider's instructions regarding the dose and schedule for infusing COAGADEX so that your treatment will work best for you.

How to take it

You get COAGADEX as an infusion into your vein.

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 or caregiver.

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 from.

You may need blood tests done after using COAGADEX to be sure that the level of Factor X in your blood is high enough to clot your blood.

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

Who should not take it

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

Tell your healthcare provider if you are pregnant or breast-feeding because COAGADEX may not be right for you.

What to say before you start

You should tell your healthcare provider if you:

• Have or have had any medical problems
• Have any allergies
• Take any prescription and non-prescription medicines, including over-the-counter medicines, supplements or herbal medicines
• Are breast-feeding. It is not known if COAGADEX passes into your milk and if it can harm your baby
• Are pregnant or planning to become pregnant. It is not known if COAGADEX may harm your unborn baby
• Have been told you have inhibitors to Factor X

Storing it

• Keep COAGADEX in its original package to protect it from light.
• Store COAGADEX in a refrigerator (not below 36°F [2°C]) or at room temperature (not to exceed 86°F [30°C]). Do not freeze.

What else should I know about COAGADEX?

Medicines are sometimes prescribed for purposes other than those listed here. Do not use COAGADEX for a condition for which it is not prescribed.

Do not share COAGADEX with other people, even if they have the same symptoms or condition that you have.

For further information or if you have any questions about COAGADEX, please contact Kedrion Biopharma, Inc. at the address below or through [email protected].

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

Marketed by: Kedrion Biopharma, Inc. Parker Plaza, 400 Kelby Street, Fort Lee, NJ 07024 United States

U.S. License No: 1811

Version 7