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

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

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

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

What is REBINYN?

REBINYN is an injectable medicine used to replace clotting Factor IX that is missing in patients with hemophilia B. Hemophilia B is an inherited bleeding disorder in all age groups that prevents blood from clotting normally.

REBINYN is used to treat, prevent, or reduce the frequency (number) of bleeding episodes in people with hemophilia B.

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

Who should not use REBINYN?

You should not use REBINYN if you

are allergic to Factor IX or any of the other ingredients of REBINYN
if you are allergic to hamster proteins

If you are not sure, talk to your healthcare provider before using this medicine.

Tell your healthcare provider if you are pregnant or nursing because REBINYN might not be right for you.

What should I tell my healthcare provider before I use REBINYN?

You should tell your healthcare provider if you

Have or have had any medical conditions.
Take any medicines, including non-prescription medicines and dietary supplements.
Are nursing. It is not known if REBINYN passes into breast milk or if it can harm your baby.
Are pregnant or planning to become pregnant. It is not known if REBINYN may harm your unborn baby.
Have been told that you have inhibitors to Factor IX (because REBINYN may not work for you).

How should I use REBINYN?

Treatment with REBINYN should be started by a healthcare provider who is experienced in the care of patients with hemophilia B.

REBINYN is given as an infusion into the vein.

You may infuse REBINYN 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 hemophilia treatment center or healthcare provider. Many people with hemophilia B learn to infuse the medicine by themselves or with the help of a family member.

Your healthcare provider will tell you how much REBINYN to use based on your weight, the severity of your hemophilia B, and where you are bleeding. Your dose will be calculated in international units, IU.

Call your healthcare provider right away if your bleeding does not stop after taking REBINYN.

If your bleeding is not adequately controlled, it could be due to the development of Factor IX inhibitors. This should be checked by your healthcare provider. You might need a higher dose of REBINYN or even a different product to control bleeding. Do not increase the total dose of REBINYN to control your bleeding without consulting your healthcare provider.

Use in children

REBINYN can be used in children. Your healthcare provider will decide the dose of REBINYN you will receive.

If you forget to use REBINYN

If you forget a dose, infuse the missed dose when you discover the mistake. Do not infuse a double dose to make up for a forgotten dose. Proceed with the next infusions as scheduled and speak to your healthcare provider if you have any questions or concerns.

If you stop using REBINYN

Do not stop using REBINYN without consulting your healthcare provider.

If you have any further questions on the use of this product, ask your healthcare provider.

What if I take too much REBINYN?

Always take REBINYN exactly as your healthcare provider has told you. You should check with your healthcare provider if you are not sure. If you infuse more REBINYN than recommended, tell your healthcare provider as soon as possible.

What are the possible side effects of REBINYN?

Common Side Effects Include:

infusion site reaction (bruising, bleeding, swelling, pain, or redness)
itching
rash

Your body can also make antibodies called “inhibitors” against Factor IX, including REBINYN, which may stop REBINYN from working properly. Your healthcare provider may need to test your blood for inhibitors from time to time.

You could have an allergic reaction to coagulation Factor IX products. Call your healthcare provider right away or get emergency treatment right away if you get, for example, any of the following signs of an allergic reaction: hives, chest tightness, wheezing, difficulty breathing, and/or swelling of the face.

You may be at an increased risk of forming blood clots in your body, especially if you have risk factors for developing blood clots. Call your healthcare provider if you have chest pain, difficulty breathing, leg tenderness or swelling.

These are not all of the possible side effects from REBINYN. Ask your healthcare provider for more information. You are encouraged to report side effects to FDA at 1-800-FDA-1088.

Tell your healthcare provider about any side effect that bothers you or that does not go away.

What are the REBINYN dosage strengths?

REBINYN comes in four different dosage strengths. The actual number of international units (IU) of Factor IX in the vial will be imprinted on the label and on the box. The four different strengths are as follows:

Cap Color Indicator	Nominal Strength
Red	500 IU per vial
Green	1000 IU per vial
Yellow	2000 IU per vial
Dark Gray	3000 IU per vial

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

How should I store REBINYN?

Prior to Reconstitution (mixing the dry powder in the vial with the diluent):

Store in original package in order to protect from light. Do not freeze REBINYN.

REBINYN vials can be stored in the refrigerator (36-46°F [2°C – 8°C]) for up to 24 months until the expiration date, or at room temperature (up to 86°F [30°C]) for a single period not more than 6 months.

If you choose to store REBINYN at room temperature:

Note the date that the product is removed from refrigeration on the box.
The total time of storage at room temperature should not be more than 6 months. Do not return the product to the refrigerator.
Do not use after 6 months from this date or the expiration date listed on the vial, whichever is earlier.

Do not use this medicine after the expiration date which is on the outer carton and the vial. The expiration date refers to the last day of that month.

After Reconstitution:

The reconstituted (the final product once the powder is mixed with the diluent) REBINYN should appear clear without visible particles.

The reconstituted REBINYN should be used immediately.

If you cannot use the reconstituted REBINYN immediately, it should be used within 4 hours when stored at or below 86ºF (30°C). Store the reconstituted product in the vial.

Keep this medicine out of the sight and out of reach of children.

What else should I know about REBINYN and hemophilia B?

Medicines are sometimes prescribed for purposes other than those listed here. Do not use REBINYN for a condition for which it is not prescribed. Do not share REBINYN with other people, even if they have the same symptoms that you have.

For more information about REBINYN, please call Novo Nordisk at 1-844-REB-INYN.

Revised: 08/2022

REBINYN^®is a trademark of Novo Nordisk A/S.

For Patent Information, refer to:

http://novonordisk-us.com/products/product-patents.html

Manufactured by:

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsværd, Denmark

For information about REBINYN contact:

Novo Nordisk Inc.

800 Scudders Mill Road

Plainsboro, NJ 08536, USA

Instructions on how to use REBINYN^®MixPro^®

READ THESE INSTRUCTIONS CAREFULLY BEFORE USING REBINYN.

REBINYN is supplied as a powder. Before infusion (administration) it must be mixed (reconstituted) with the liquid diluent supplied in the syringe. The liquid diluent is a histidine solution. The mixed REBINYN must be infused into your vein (intravenous infusion). The equipment in this package is designed to mix and infuse REBINYN.

You will also need an infusion set (tubing and butterfly needle), sterile alcohol swabs, gauze pads, and bandages.

Don’t use the equipment without proper training from your doctor or nurse.

Always wash your hands and ensure that the area around you is clean.

When you prepare and infuse medication directly into the veins, it is important to use a clean and germ free (aseptic) technique. Improper technique can introduce germs that can infect the blood.

Don’t open the equipment until you are ready to use it.

Don’t use the equipment if it has been dropped, or if it is damaged. Use a new package instead.

Don’t use the equipment if it is expired. Use a new package instead. The expiration date is printed on the outer carton and on the vial, the vial adapter and the pre-filled syringe.

Don’t use the equipment if you suspect it is contaminated. Use a new package instead.

Don’t dispose of any of the items until after you have infused the mixed solution.

The equipment is for single use only.

Single-dose container. Discard unused portion.

Content

The package contains:

Vial with REBINYN powder
Vial adapter
Pre-filled syringe with diluent
Plunger rod (placed under the syringe)

1. Prepare the vial and the syringe

Take out the number of REBINYN^®packages you need.
Check the expiry date.
Check the name, strength and color of the package, to make sure it contains the correct product.
Wash your hands and dry them properly using a clean towel or air dry.
Take the vial, the vial adapter and the pre-filled syringe out of the carton. Leave the plunger rod untouched in the carton.
Bring the vial and the pre-filled syringe to room temperature. You can do this by holding them in your hands until they feel as warm as your hands.

Remove the plastic cap from the vial. If the plastic cap is loose or missing, don’t use the vial.
Wipe the rubber stopper with a sterile alcohol swab and allow it to air dry for a few seconds before use to ensure that it is as germ free as possible.
Don’t touch the rubber stopper with your fingers as this can transfer germs.

2. Attach the vial adapter

Remove the protective paper from the vial adapter.

Don’t take the vial adapter out of the protective cap with your fingers. If you touch the spike on the vial adapter germs from your fingers can be transferred.

If the protective paper is not fully sealed or if it is broken, don’t use the vial adapter.

Place the vial on a flat and solid surface.
Turn over the protective cap, and snap the vial adapter onto the vial.
Once attached, don’t remove the vial adapter from the vial.

Lightly squeeze the protective cap with your thumb and index finger as shown. Remove the protective cap from the vial adapter.
Don’t lift the vial adapter from the vial when removing the protective cap.

3. Attach the plunger rod and the syringe

Grasp the plunger rod by the wide top end and take it out of the carton. Don’t touch the sides or the thread of the plunger rod. If you touch the sides or the thread germs from your fingers can be transferred.
Immediately connect the plunger rod to the syringe by turning it clockwise into the rubber plunger inside the pre-filled syringe until resistance is felt.

Remove the syringe cap from the pre-filled syringe by bending it down until the perforation breaks.
Don’t touch the syringe tip under the syringe cap. If you touch the syringe tip germs from your fingers can be transferred.
If the syringe cap is loose or missing, don’t use the pre-filled syringe.

Screw the pre-filled syringe securely onto the vial adapter until resistance is felt.

4. Mix the powder with the diluent

Hold the pre-filled syringe slightly tilted with the vial pointing downwards.
Push the plunger rod to inject all the diluent into the vial.

Keep the plunger rod pressed down and swirl the vial gently until all the powder is dissolved.
Don’t shake the vial as this will cause foaming.
Check the mixed solution. It must be clear and colorless. If you notice visible particles or discoloration, don’t use it. Use a new package instead.

REBINYN is recommended to be used immediately after it is mixed.

If you cannot use the mixed REBINYN solution immediately, it should be used within 4 hours when stored at room temperature at or below 86°F (30°C). Store the reconstituted product in the vial.

Do not freeze mixed REBINYN solution or store it in syringes.

Keep mixed REBINYN solution out of direct light.

If your dose requires more than one vial, repeat step A to J with additional vials, vial adapters and pre-filled syringes until you have reached your required dose.

Keep the plunger rod pushed completely in.
Turn the syringe with the vial upside down.
Stop pushing the plunger rod and let it move back on its own while the mixed solution fills the syringe.
Pull the plunger rod slightly downwards to draw the mixed solution into the syringe.
In case you only need part of the entire vial, use the scale on the syringe to see how much mixed solution you withdraw, as instructed by your doctor or nurse.
While holding the vial upside down, tap the syringe gently to let any air bubbles rise to the top.
Push the plunger rod slowly until all air bubbles are gone.

Unscrew the vial adapter with the vial.

Don’t touch the syringe tip. If you touch the syringe tip germs from your fingers can be transferred.

Caution: The pre-filled diluent syringe is made of glass with an internal tip diameter of 0.037 inches, and is compatible with a standard Luer-lock connector.

Some needleless connectors for intravenous catheters are incompatible with the glass diluent syringes (for example, certain connectors with an internal spike, such as Clave^®/MicroClave^®, InVision-Plus^®, InVision-Plus CS^®, Invision-Plus^®Junior^®, Bionector^®).

The use of these needleless connectors can damage the connector and affect administration.

To administer REBINYN through incompatible needleless connectors, withdraw reconstituted product into a standard 10 mL sterile Luer-lock plastic syringe.

If you have encountered any problems with attaching the pre-filled histidine diluent syringe to any Luer‐lock compatible device, please contact Novo Nordisk at (844) 303-4448.

5. Infuse the mixed solution

REBINYN is now ready to infuse into your vein.

Do not mix REBINYN with any other intravenous infusions or medications.
Infuse the mixed solution slowly over 1 to 4 minutes as instructed by your doctor or nurse.

Infusing the solution via a central venous access device (CVAD) such as a central venous catheter or subcutaneous port:

Use a clean and germ free (aseptic) technique. Follow the instructions for proper use for your connector and central venous access device in consultation with your doctor or nurse.
Infusing into a CVAD may require using a sterile 10 mL plastic syringe for withdrawal of the mixed solution and infusion.
If necessary, use 0.9% Sodium Chloride Injection, USP to flush the CVAD line before or after REBINYN infusion.
The peel-off label found on the REBINYN vial can be used to record the lot number.

Disposal

After infusion, safely dispose of all unused REBINYN solution, the syringe with the infusion set, the vial with the vial adapter, and other waste materials in an appropriate container for throwing away medical waste.
Don’t throw it out with the ordinary household trash.

Don’t disassemble the vial and vial adapter before disposal.

Don’t reuse the equipment.

Important information

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

For full Prescribing Information please read the other insert included in this package.

REBINYN ^®and MixPro ^®are trademarks of Novo Nordisk A/S.

For Patent Information, refer to: http://novonordisk-us.com/patients/products/product-patents.html

Clave^®and MicroClave^®are registered trademarks of ICU Medical Inc.

InVision-Plus^®, InVision-Plus CS^®, Invision-Plus^®Junior^®are registered trademarks of RyMed Technologies, Inc.

Bionector is a registered trademark of Vygon