Zinbryta - Instructions for Use
|Form:||Liquid solution, Subcutaneous (SC)|
|Ingredients:||Daclizumab, Sodium succinate, Anhydrous, Succinic acid, Sodium chloride, Polysorbate 80, Water for injection|
- 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|
- 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 should be injected into the thigh, abdomen, or the back of the upper arm (See Figure F).
- 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 take off the ZINBRYTA prefilled syringe needle cover until you are ready to inject.
|Step 4: Remove the ZINBRYTA prefilled syringe needle cover|
- Do not touch the needle.
|Step 5: Give your ZINBRYTA prefilled syringe injection|
- With 1 hand, use your thumb and first finger and pinch the skin around the cleaned injection site (See Figure H).
- After the needle is in, let go of your skin
- 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|
- 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.
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