Zinbryta - Instructions for Use
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Zinbryta - Instructions for Use

Manufacture: AbbVie
Country: United States
Condition: Multiple Sclerosis
Class: Interleukin inhibitors
Form: Liquid solution, Subcutaneous (SC)
Ingredients: Daclizumab, Sodium succinate, Anhydrous, Succinic acid, Sodium chloride, Polysorbate 80, Water for injection

Important Information

  • Before you use ZINBRYTA for the first time, your healthcare provider should show you or your caregiver how to prepare and inject your ZINBRYTA prefilled syringe the right way.
  • ZINBRYTA is for use under the skin only (subcutaneous).
  • ZINBRYTA prefilled syringe is for 1 time use only. Do not share your ZINBRYTA prefilled syringe with other people. You may give an infection to them or get an infection from them.
  • Throw away (dispose of) the used ZINBRYTA prefilled syringe right away after use. See “Disposing of used ZINBRYTA prefilled syringes ” at the end of this Instructions for Use.

Supplies needed for your ZINBRYTA prefilled syringe injection (See Figure A):

  • a ZINBRYTA 150 mg prefilled syringe

Additional supplies you will need for your injection (See Figure B):

  • alcohol wipe
  • gauze pad
  • adhesive bandage
  • 1 sharps container for throwing away ZINBRYTA prefilled syringes. See “Disposing of usedZINBRYTA prefilled 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 Prefilled Syringe (See Figure C)


  • Before you prepare your injection, take your ZINBRYTA prefilled 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 inject more than one dose per month.
    • If you miss a dose, take the missed dose as soon as possible but no more than 2 weeks late and take the next dose on schedule. If you have missed your dose by more than 2 weeks, skip the missed dose and take the next dose on schedule.
  • The finger flange will allow you to hold the prefilled syringe more firmly. Do not remove the finger flange.

Preparing for Your Injection

Step 1: Collect your supplies and wash your hands

  • Find a well-lit and clean, flat surface, like a table and collect all the supplies you will need to give yourself or to receive an injection.
  • Wash your hands with soap and water and dry your hands well.
Step 2: Check your ZINBRYTA prefilled syringe
    - Check the expiration date printed on your ZINBRYTA prefilled syringe (See Figure D).
      - Do not use ZINBRYTA prefilled syringe past the expiration date.

    - Check that your ZINBRYTA medicine is clear and colorless to slightly yellow (See Figure E).
      - Do not use ZINBRYTA prefilled 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 will not affect your dose.

Giving Your Injection

Step 3: Choos e and clean your injection site
    - ZINBRYTA prefilled syringe is for use under the skin only (subcutaneous).
    - ZINBRYTA prefilled syringe should be injected into the thigh, abdomen, 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, infected, scarred, or tattooed.

    - 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.

    - Do not take off the ZINBRYTA prefilled syringe needle cover until you are ready to inject.
Step 4: Remove the ZINBRYTA prefilled syringe needle cover
    - With 1 hand, hold your ZINBRYTA prefilled syringe as shown. Do not push on the finger syringe as shown. Do not push on the finger flange. With your other hand, firmly hold the needle cover and pull the needle cover straight off the needle (See Figure G).
      - Throw away the needle cover after your injection. Do not recap your ZINBRYTA prefilled syringe, you could get a needle stick injury.
      - Do not touch the needle.

Step 5: Give your ZINBRYTA prefilled syringe injection
    - See Step 3 for appropriate injection sites.
    - With 1 hand, use your thumb and first finger and pinch the skin around the cleaned injection site (See Figure H).
    - With your other hand, hold your ZINBRYTA prefilled syringe like a pencil. Us e a quick dart-like motion and ins ert the needle at a 90° angle into your skin (See Figure I).
    - After the needle is in, let go of your skin
    - Slowly push the plunger down until the syringe is empty (See Figure J).
      - Do not pull back on the plunger.
      - Do not take your ZINBRYTA prefilled syringe out of your skin until you have slowly pushed the plunger all the way down.

Step 6: Remove the ZINBRYTA prefilled syringe from your injection site
    - Pull the needle straight out of your skin (See Figure K).
      - If you see blood at your injection site, wipe it off with gauze and apply an adhesive bandage.

    - Do not recap the ZINBRYTA prefilled syringe. Recapping the prefilled syringe can lead to a needle stick injury.
    - Do not reuse the ZINBRYTA prefilled syringe.

After Your Injection

Step 7: Disposing of used ZINBRYTA prefilled syringes

  • Put your used ZINBRYTA prefilled syringes in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) loose needles and ZINBRYTA prefilled syringes inyour household trash.
  • If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:
    • made of a heavy-duty plastic,
    • can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
    • upright and stable during use,
    • leak resistant, and
    • properly labeled to warn of hazardous waste inside the container.
  • When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal.
  • Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.

How Should I Store Zinbryta

  • Store ZINBRYTA in the refrigerator between 36°F to 46°F (2°C to 8°C ).
  • Do not freeze ZINBRYTA or expose to temperatures above 86°F (30°C). Do not use ZINBRYTA that has been frozen.
  • Keep ZINBRYTA in the original carton to protect it from light.
  • If you cannot refrigerate ZINBRYTA, you can store ZINBRYTA at room temperature for up to 30 days.
  • If ZINBRYTA has reached room temperature, do not put it back in the refrigerator.
  • Keep ZINBRYTA and all medicines out of the reach of children.

Questions

For product or service related questions, please call 1-800-456-2255 or go to www.Zinbryta.com.

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

Manufactured by: Biogen Inc., Cambridge, MA 02142

2013-2016 Biogen. All rights reserved. 1-800-456-2255 Issued: 05/2016

Principal Display Panel - 150 mg/mL Box Label

NDC 0074-0033-01