Consumer Information for: ZINBRYTA

ZINBRYTA™ - Solution for injection, for subcutaneous use, pre-filled syringe
ZINBRYTA™ - Solution for injection, for subcutaneous use, pre-filled pen

ZINBRYTA™ - Solution for injection, for subcutaneous use, pre-filled syringe

Read the Instructions for Use before you start using ZINBRYTA and each time you get a refill of your prescription. There may be new information. This information does not take the place of talking to your doctor or nurse about your medical condition or your treatment.

It is very important that you should receive a blood test to test your liver function before you begin treatment with ZINBRYTA and before your next monthly dose during your treatment with ZINBRYTA, and for 6 months after you have stopped using ZINBRYTA.

Note:

• Before you use the ZINBRYTA pre-filled syringe for the first time, your doctor or nurse should show you or your caregiver how to prepare and inject your ZINBRYTA prefilled syringe the right way.
• If you experience difficulty or have questions about how to inject, call the Biogen ONE® Support Program at 1-855-676-6300.
• ZINBRYTA pre-filled syringe is for use under the skin only (subcutaneous)
• Each ZINBRYTA pre-filled syringe can be used 1 time only. Do not share your ZINBRYTA pre-filled syringe with anyone else. By sharing the needle, you may give an infection to them or get an infection from them.

Supplies needed for your ZINBRYTA injection:

ZINBRYTA pre-filled syringe Figure A

Additional supplies which are not included in the pack (See Figure B):

• Alcohol wipe
• Gauze pad
• Adhesive bandage
• 1 sharps container for throwing away used needles and ZINBRYTA pre-filled syringes. See “Disposing of your used ZINBRYTA pre-filled syringes” at the end of these instructions.
• a well-lit area and a clean, flat surface to work on, like a table

Parts of your ZINBRYTA pre-filled syringe (See Figure C)

Note:

• Before you prepare your injection, take your ZINBRYTA pre-filled syringe out of the refrigerator and let it come to room temperature for at least 30 minutes.
  Do not use external heat sources such as hot water to warm the ZINBRYTA prefilled syringe.
  Do not use more than one pre-filled syringe per calendar month.
• The Finger Flange will allow you to better grip the syringe and should remain attached.

Preparing for Injection

Step 1: Place Supplies and Wash Hands

• Find a well-lit, clean, flat surface to work on, like a table. Collect all the supplies you will need to give yourself or to receive an injection.
• Wash your hands with soap and water and dry thoroughly.

Step 2: Check Your ZINBRYTA Pre-filled Syringe

• Check the expiration date printed on your ZINBRYTA pre-filled syringe (See Figure D).
  Do not use ZINBRYTA pre-filled syringe past the expiration date.
• Check that your ZINBRYTA medicine is colorless or slightly yellow (See Figure E).
  Do not use ZINBRYTA pre-filled syringe if the liquid is cloudy, or has floating particles in it.
• You might see air bubbles in your ZINBRYTA medicine. This is normal and does not need to be expelled prior to your injection.

Giving the Injection Step 3: Choose and Clean the Injection Site ZINBRYTA pre-filled syringe is for subcutaneous injection (injection into skin). ZINBRYTA pre-filled syringe should be injected into the abdomen, thigh, or the back of the upper arm. (See Figure F.) Do not inject directly into your belly button. Do not inject into an area of the body where the skin is irritated, tender, red, bruised, tattooed, infected, or scarred. Choose an injection site and wipe the skin with an alcohol wipe. Let the injection site dry before injecting the dose. Do not touch this area again before giving the injection.
Step 4: Firmly Remove Needle Cover Using one hand, hold the syringe by the glass barrel. Be sure that this hand is not pushing on the Finger Flange. With your other hand, firmly grasp the needle cover and pull it straight off the needle (See Figure G). Use caution when removing the needle cover to avoid getting a needle stick injury. Do not touch the needle. Caution - do not recap the ZINBRYTA pre-filled syringe. You could get a needle stick injury.
Step 5: Gently Pinch the Injection Site Gently pinch the skin around the cleaned injection site using thumb and forefinger to create a slight bulge. (See Figure H.)
Step 6: Inject Medication Hold the ZINBRYTA pre-filled syringe at a 45° - 90° angle to the injection site. Quickly insert the needle straight into the skin fold until the needle is fully under the skin. (See Figure I.) After the needle is in, let go of your skin Do not pull back on the plunger. Slowly push the plunger all the way down until the syringe is empty. (See Figure J.) Do not take your ZINBRYTA prefilled syringe out of the injection site until you have pushed the plunger all the way down.
Step 7: Remove Pre-filled Syringe from Site Pull the needle straight out. (See Figure K.) Caution -do not recap the ZINBRYTA pre-filled syringe. You could get a needle stick injury. Do not reuse the ZINBRYTA pre-filled syringe.

After the Injection

Step 8: Disposing of your used ZINBRYTA Pre-filled Syringe

• Throw away the used ZINBRYTA pre-filled syringe into a special secure container, such as a sharps bin, or according to community guidelines. Check with your doctor, pharmacist or nurse about the right way to throw away the container.
  Do not dispose of your used pre-filled syringe or disposal container in your household trash unless your community guidelines permit this.

Step 9: Care for Injection Site

• If needed, apply a gauze pad or adhesive bandage to the injection site.

General Warnings
Do not reuse your ZINBRYTA pre-filled syringe.
Do not share your ZINBRYTA pre-filled syringe.

• Keep ZINBRYTA pre-filled syringe and all medications out of reach of children.

Storage

• Recommended storage is controlled refrigeration 2°C to 8°C (36°F to 46°F) in the closed original carton to protect from light.
• If needed, ZINBRYTA may be stored in the closed original carton without refrigeration up to 30°C (up to 86°F) for up to 30 days.
  Do not place your ZINBRYTA pre-filled syringe back into the refrigerator after warming to room temperature
  Do not freeze or expose to high temperatures.

ZINBRYTA™ - Solution for injection, for subcutaneous use, pre-filled pen

Read the Instructions for Use before you start using ZINBRYTA and each time you get a refill of your prescription. There may be new information. This information does not take the place of talking to your doctor or nurse about your medical condition or your treatment.

It is very important that you should receive a blood test to test your liver function before you begin treatment with ZINBRYTA and before your next monthly dose during your treatment with ZINBRYTA, and for 6 months after you have stopped using ZINBRYTA.

Note:

• If you experience difficulty or have questions regarding how to use the pen, call Biogen ONE® Support Program at 1-855-676-6300.
• Before you use your pen for the first time, your doctor or nurse should show you or your caregiver how to prepare and inject your pen the right way.
• Your pen is for use under the skin only (subcutaneous).
• Each pen can be used 1 time only.
• Do not share your pen with anyone else to avoid giving an infection to them or getting an infection from them.
• Do not use more than 1 pen per month.
• Do not use your pen if it has been dropped or is visibly damaged.

Supplies needed for your ZINBRYTA Pen injection:

• 1 ZINBRYTA 150 mg Pen (see Figure A)

Before Use - Parts of your ZINBRYTA Pen (see Figure A):

Caution! Do not remove the cap until you are ready to inject. If you remove the cap, do not re-cap the pen. Re-capping could cause the pen to lock.

Additional supplies which are not included in the pack (See Figure B):

Preparing for your injection:

1. Remove your pen from the refrigerator.
   1. Remove your pen from the carton in your refrigerator 30 minutes before giving your injection to allow it to warm to room temperature.
      
      Do not use external heat sources, such as hot water, to warm your pen


2. Collect your supplies and wash your hands
   1. Find a well-lit area and a clean, flat surface to work on, like a table and collect all the supplies you will need to give yourself, or to receive, an injection.
   2. Wash your hands with soap and water.


3. Check your ZINBRYTA Pen (See Figure C)

   Check the injection status window. You should see green stripes. Check the expiration date. Check the medication window and make sure the ZINBRYTA medicine is colorless to slightly yellow. Do not use your pen if: You do not see the green stripes in the injection status window. It is past the expiration date. The liquid is cloudy or has floating particles in it. Note: You might see air bubbles in the medication window. This is normal and will not affect your dose.



4. Choose and clean your injection site

   Choose an injection site in your thigh, abdomen, or the back of your upper arm (See Figure D). Do not inject into an area of your body where the skin is irritated, red, bruised, tattooed, infected, or scarred. Wipe your skin with an alcohol wipe. Do not touch or blow on this area again before giving your injection. Let your injection site dry on its own before injecting your dose.

Giving your injection:

5. Remove the ZINBRYTA Pen cap

   Pull the pen cap straight off and set it aside for disposal after your injection (See Figure E). Your pen is ready to inject. Warning! Do not touch, clean or manipulate the needle cover. You could get a needle stick or the pen may lock. Caution! Do not recap your pen. This could lock the pen.



6. Give your injection

   Hold your pen over your chosen injection site. Make sure you can see the green stripes in the injection status window (See Figure F). Note: Be ready to inject prior to pressing your pen down on your injection site, as the needle cover will lock when it is lifted from the site. Firmly press and hold down your pen on your injection site until you hear the clicking sounds start (See Figure G). Continue to hold your pen firmly down on your injection site until the clicking sounds have stopped (see Figure H). Do not lift your pen off your injection site until the clicking sounds stop and you see green checkmarks in the injection status window.




If you do not hear clicking sounds and/or you do not see green checkmarks in the injection status window after attempting to inject, your pen may have locked and you should call the Biogen ONE^TM Support Program at 1-855-676-6300.

7. Remove your ZINBRYTA Pen from your injection site
   1. After the clicking sound has stopped, lift your pen from your injection site. The needle cover will extend to cover the needle and will lock (See Figure I).

   

8. Check to make sure you have received your full dose of ZINBRYTA (see Figure J)
   1. Check the injection status window. You should see green checkmarks.
   2. Check the medication window. You should see a yellow plunger.

   

After Use – Parts of your ZINBRYTA Pen (see Figure K):

Note: After the pen has been removed from the injection site, the needle cover will lock to protect against needle stick injury. Do not recap your pen.

After your injection:

9. Dispose of your used ZINBRYTA Pens

1. Throw away the used ZINBRYTA pens into a special secure container, such as a sharps bin, or according to community guidelines. Check with your doctor, pharmacist or nurse about the right way to throw away the container.
   
   Do not dispose of your used pens or disposal container in your household trash unless your community guidelines permit this.
   
   Do not recap your ZINBRYTA Pen.

10. Care for injection site

1. Apply a gauze pad or adhesive bandage to the injection site, if needed.

Storage

• Recommended storage is controlled refrigeration 2°C to 8°C (36°F to 46°F) in the closed original carton to protect from light.
• If needed, ZINBRYTA may be stored in the closed original carton without refrigeration up to 30°C (up to 86°F) for up to 30 days.
• Do not place your ZINBRYTA pen back into the refrigerator after warming to room temperature
• Do not freeze or expose to high temperatures.
• Keep ZINBRYTA pen and all medications out of reach of children.

If you want more information about ZINBRYTA:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website; the manufacturer’s website www.biogen.ca, or by calling 1-866-477-3462.

This leaflet was prepared by Biogen Canada Inc.

Last Revised: January 2018