Patient information: uses, side effects, how to take - Dawnzera
Instructions for Use
INSTRUCTIONS FOR USE
DAWNZERA TM[dawn-ZAIR-ah]
(donidalorsen)
injection, for subcutaneous use
This Instructions for Use contains information on how to inject DAWNZERAusing the autoinjector.
Read this Instructions for Use before you start using your DAWNZERA autoinjector and each time you get a refill. There may be new information.This information does not take the place of talking to your healthcare provider about your medical condition or treatment. Your healthcare provider should show you or your caregiver how to use the DAWNZERA autoinjector the right way. If you or your caregiver have any questions, talk to your healthcare provider.
Important information:
DAWNZERA is injected under the skin (subcutaneous use) only.
Each autoinjector contains 1 single-dose and can only be used 1 time.
Do notremove the clear cap until you are ready to inject DAWNZERA (See Step 5).
Do notshare your autoinjector with anyone.
Do notuse if the autoinjector appears damaged.
Storage information:
Store the autoinjector in the refrigerator between 36°F to 46°F (2°C to 8°C) in the original carton.
If needed, DAWNZERA can be storedat room temperature up to 86°F (30°C) in the original carton for up to 6 weeks.
Do notstore DAWNZERA at room temperatures above 86°F.
Throw away the DAWNZERA if kept at room temperature longer than 6 weeks.
Do notfreeze.
Do notexpose the autoinjector to heat.
Protect from direct light.
Keep the autoinjector in the carton until ready to use.
Do notstore the autoinjector with the clear cap removed.
Keep DAWNZERA and all medicine out of the reach of children.
Parts of your DAWNZERA autoinjector
Single-dose autoinjector
Other supplies (not included)
Preparing to inject DAWNZERA
Step 1 Remove from the refrigerator 30 minutes before you inject
- a) Remove the autoinjector from the refrigerator.
- b) Keep the autoinjector in the original cartonand let the autoinjector come to room temperature for 30 minutes before injecting.
Do nottry to speed up the warming process using other heat sources, such as a microwave or hot water.
Step 2 Check the medicine
a)Check the expiration (EXP) date.
b)Check the medicine through the viewing window. The DAWNZERA medicine should be clear and colorless to yellow. There should be no particles. It is normal to see air bubbles in the solution.
Do notuse the autoinjector if the:
clear cap is missing or not attached.
expiration (EXP) date has passed.
medicine looks cloudy, discolored, or has particles.
autoinjector appears damaged.
Step 3 Choose the injection site
a)Choose an injection site on the stomach or the front of the thigh.
- b) Only healthcare providers or caregivers may choose the back of the upper arm.
Do notinject:
within 2 inches of the belly button (navel).
into skin that is bruised, tender, red, or hard.
into scars or damaged skin.
Step 4 Wash hands and clean the injection site
a)Wash your hands with soap and water.
b)Clean the injection site with an alcohol wipe in a circular motion. Let the skin air dry.
Do nottouch the cleaned skin before injecting.
Injecting DAWNZERA
Step 5 Remove and throw away the clear cap
a)Hold the autoinjector by the middle with the clear cap facing away from you.
b)Remove the clear cap by pulling it straight off. Do nottwist it off. The needle is inside the orange needle shield.
c)Throw away the clear cap in the trash or sharps container.
Do not remove the clear cap until right before you inject.
Do notrecap the autoinjector.
Do notpush the orange needle shield against the hand or finger.
Step 6 Begin injection
a)Hold the autoinjector in 1 hand. Place the orange needle shield at a 90 degree angle against your skin. Make sure you can see the viewing window.
b)Push firmly and hold the autoinjector straight against the skin. You will hear a click as the injection starts.
You may hear a second click. This is normal. The procedure is not finished.
c)Hold the autoinjector against the skin for 10 seconds to make sure the full dose has been given.
Do notmove, turn, or change the angle of the autoinjector during the injection.
Step 7 Finish injection
a )Check that the orange plunger rod
has moved down to fill the entire viewing window.
If the orange plunger rod does not fill the viewing window, you may not have received the full dose.
If this happens or if you have other concerns, contact your healthcare provider.
b)Remove the autoinjector by lifting it straight up. After removal from the skin, the orange needle shield locks into place and covers the needle.
c)There may be a small amount of blood or liquid where you injected. This is normal.
If needed, press a cotton ball or gauze on the area and apply a small bandage.
The autoinjector contains 1 dose. Do notreuse the autoinjector.
Step 8 Throwing away autoinjector
a)Put the used autoinjector in a sharps container right away after use.
Do notthrow away the autoinjector in your household trash.
Do notrecycle your used sharps disposal container.
Do notreuse the autoinjector or clear cap.
If you do not have an FDA-cleared sharps 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 labelled 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 autoinjectors.
For more information about safe sharps disposal, and 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 notthrow away your used sharps disposal container in your household trash unless your community guidelines permit this. Do notrecycle your used sharps disposal container.
For more information, go to https://www.DAWNZERA.com or call 1-833-644-6647. If you still have questions, contact your healthcare provider.
Distributed by: Ionis Pharmaceuticals, Inc., Carlsbad, CA 92010
This Instructions for Use has been approved by the U.S. Food and Drug Administration Approved: 08/2025