Patient information: uses, side effects, how to take - Coagadex

What is the most important information I need to know about COAGADEX?

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.

What is COAGADEX?

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.

Who should not use COAGADEX?

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 should I tell my healthcare provider before I use COAGADEX?

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

How should I use COAGADEX?

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.

What are the possible side-effects of COAGADEX?

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.

What are the COAGADEX dosage strengths?

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.

How do I store COAGADEX?

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 US_Medicalinfo@kedrion.com.

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

Instructions for Use

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 and when to use COAGADEX. 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 traveling. 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.

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™.

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

Step 1

Bring the vials of COAGADEX and sterile water to room temperature before mixing.
Remove the cap from the vial of COAGADEX and clean the top of the stopper with an alcohol swab.
Repeat this step with the vial of sterile water.

Step 2

Peel back the top of the Mix2Vial package but leave the device in the package.

Step 5

The sterile water will be pulled into the vial of COAGADEX by the vacuum contained within it.
Gently swirl the vial to make sure the powder is thoroughly mixed. Do not shake the vial.
A clear or slightly pearl-like solution should be obtained, usually in less than 1 minute (5 minutes maximum).

Note: If the water is not pulled into the vial of COAGADEX. This indicates a loss of vacuum in the vial. Do not use the product.

Step 3

Place the blue end of the Mix2Vial on the sterile water vial and push straight down until the spike penetrates the rubber stopper and snaps into place.
Remove the plastic outer packaging from the Mix2Vial and discard it. Do not touch the exposed end of the device.

Step 6

Separate the empty sterile water vial and blue part from the clear part by unscrewing counter-clockwise.

Step 7

Draw air into the syringe by pulling the plunger to the required volume of sterile water added.
Connect the syringe to the clear part of the Mix2Vial.
Push the air in the syringe into the vial.

Step 4

Turn the sterile water vial upside down with the device still attached.
Place the clear end of the Mix2Vial on the product vial and push straight down until the spike penetrates the rubber stopper and snaps into place.

Step 8

Immediately invert the COAGADEX vial. The solution will be drawn into the syringe.
Disconnect the filled syringe from the device.
Use the product immediately or within one hour of reconstitution. Do not store the reconstituted product.

Note: If there are any particles in the syringe, or if the solution is cloudy, or if a gel or clot forms, contact the manufacturer to report the batch number printed on the vial.

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 infusion. You must use a new Mix2Vial to draw the contents of each vial up into the plastic syringe.

How do I infuse COAGADEX?

Inspect the solution before infusion. 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 infuse 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.

After infusing the medicine:

After infusion, safely dispose of the needle, tubing, syringe, any unused COAGADEX and other waste materials. Record the infusion in your infusion tracker or calendar.

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

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

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

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