WEBVTT

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Welcome to this video guide on how

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to use the Skytrofa Auto-injector.

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We're here to make things simple

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and clear so you feel confident using your device.

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Before we get started, do not use the Skytrofa

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Auto-injector for the first time

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until you receive training from a healthcare provider.

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If you do not follow the instructions for the auto-injector,

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you may not get the right dose,

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cause injury or get an infection.

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The auto-injector should only be used

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with Skytrofa cartridges

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and needles that are prescribed by your healthcare provider.

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Do not use your auto-injector

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with other medicines or needles.

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Do not share your auto-injector

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with other people even if the needle has been changed.

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Do not reuse needles.

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If you have any issues while using the Skytrofa

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Auto-injector, click on any

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of the helpful hints throughout this video.

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If you have questions or need extra help Ascendis Pharma

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customer support is just a call away.

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Skytrofa is a prescription medicine for the treatment

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of growth hormone deficiency in adults and children one year

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and older who weigh at least 26 pounds, 11.5 kilograms.

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Don't take Skytrofa if you are allergic to Skytrofa

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or any of its ingredients; if you have a critical illness

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caused by certain types of heart or stomach surgery, trauma,

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or breathing problems;

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if you have eye problems caused by diabetes,

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if you have cancer or other tumors;

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if you are a child with closed bone growth plates;

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or if you are a child with Prader-Willi syndrome

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who is severely obese or has breathing problems.

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Please see important safety information at the end

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of this video and visit Skytrofa.com

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for full prescribing information.

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Inside the Skytrofa Auto-injector box,

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you'll find the auto-injector, power cord

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with USB adapter, Instructions for Use,

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and a Quick Reference Guide.

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Be sure to read everything in the box before proceeding.

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Inside the Skytrofa cartridge

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and needle kit, you'll find four Skytrofa medication

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cartridges, four needles plus two

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extra under the green cover.

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An Ascendis Signature Access Program,

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personalized support brochure, and prescribing information.

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To get ready for your first injection,

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you'll need the auto-injector, a cartridge, needle

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and alcohol wipe, and a sharps container.

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Before your first injection, fully charged the 

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Skytrofa Auto-injector.

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Check the battery icon before each injection.

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A solid green icon means it's fully charged.

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Let's walk through the steps together.

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Take out one cartridge pack and one needle.

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Check the expiration dates on both.

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Don't use them if the expiration date has passed

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or if the packaging is damaged.

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Check the cartridge dose

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to make sure it matches your prescription.

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To open the pack, peel back the label to the stop sign,

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remove the cartridge, and discard

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the orange plug with the package.

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If refrigerated, allow the cartridge

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to sit at room temperature for at least 15 minutes.

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Cartridges can be stored in the refrigerator

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or at room temperature for up to six months if kept

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below 86 degrees Fahrenheit.

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To assemble the needle, remove the protective paper

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and screw the needle straight

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and tight onto the cartridge until it's secure.

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Do not remove the needle cover.

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Place the auto-injector on a flat surface,

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remove the protective cover and press

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and release the green button once to turn it on.

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All lights will turn on and off.

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Then you'll hear two beeps

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and the green top will start flashing.

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With the needle cover still on,

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insert the cartridge. Push it straight down until it clicks,

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then remove your finger. The green mixing icon will light up

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and the green battery icon will now switch off

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telling you that the Skytrofa Auto-injector will start

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automatically mixing the medicine,

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which takes four to eight minutes.

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You'll know mixing is complete when you hear two beeps

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and the entire progress bar flashes.

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Turn the auto-injector up

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and down five to 10 times for the manual mixing.

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Be sure not to touch the green start button.

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Each motion should take no longer than two seconds.

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You will hear a ticking sound with every proper rotation.

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The manual mixing is done when you hear two beeps

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and all of the lights within the progress bar except the

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top light are lit.

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Place the auto-injector upright on a flat surface.

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It will automatically remove excess air.

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When it is completed,

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you will hear two beeps

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and the entire progress bar lights up.

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Pull the needle cover straight up from the cartridge.

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Keep the needle cover for later.

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The green eye icon will light up.

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You can now check the mixed medicine in the inspection

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window on the side of the auto-injector.

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The medicine should look colorless and clear.

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Some air bubbles and foam are okay.

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Do not inject the medicine if you see particles

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or if it's not clear and colorless.

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See the helpful hints. You can inject in the stomach,

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thighs, or buttocks.

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Remember to rotate sites with each injection.

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Wash your hands with soap and water.

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Use an alcohol wipe to clean the injection site.

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Inject directly into the skin.

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Do not touch, fan, or blow on the cleaned area

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before injecting. 

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Firmly press the green top against the skin until it retracts

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and hold for 10 to 15 seconds.

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Do not press the green start button. The medicine

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injects automatically.

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You'll hear steady ticking

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and see the progress bar light up.

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Keep the injector on the skin until the injection finishes

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to ensure a full dose. Wait for two beeps,

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the green top flashes twice,

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and the green checkmark icon confirms

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the injection is complete.

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Carefully remove the auto-injector and place it upright

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on a flat surface. You will hear a

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buzzing or whirring sound

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that means the cartridge is unlocking.

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You are ready to remove the used cartridge when you hear two

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beeps and the green top starts flashing.

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Push the needle cover down to release

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and remove the used cartridge.

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You'll hear a click and the green top will stop flashing.

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Remove the used cartridge by pulling straight up.

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After you remove the cartridge,

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the battery icon will display the battery level

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and the auto-injector will turn off automatically.

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Always check that the cartridge is empty of medicine.

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Dispose of the used cartridge

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and needle in an FDA approved sharps container.

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For more information about safe sharp's disposal, visit

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www.fda.gov/safesharpsdisposal.

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If your weekly dose requires two cartridges,

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take the second injection by repeating steps one through 11

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with a new cartridge and needle.

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Before continuing to step 12. Be sure

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to use a different injection site for the second injection.

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After removal of the used cartridge,

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the battery icon will display the battery level.

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Check if the auto-injector needs charging

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before your next use.

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If the battery icon is solid green,

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the auto-injector is ready to use

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and is good for at least four injections.

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A flashing green battery icon means one injection is still

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possible, but charging is recommended.

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If the battery icon is flashing red, do not attempt

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to use. The auto-injector needs to be charged.

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Make sure that the auto-injector is clean. If it is dirty,

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or if medicine has been spilled onto it,

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clean with a damp cloth.

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Do not place the auto-injector underwater.

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Put the protective cover back on

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and store at room temperature between 59

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and 86 degrees Fahrenheit.

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This video is a quick overview,

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but your Instructions for Use

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and Quick Reference Guide contain detailed information on

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setup, use, cleaning, and storage.

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If you need assistance

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or help with troubleshooting, don't hesitate

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to contact Ascendis Pharma Customer Support at 

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1-844-4ASCENDIS, 1-844-442-7236

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and select option one.

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Indication. Skytrofa is a prescription medicine

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for the treatment of growth hormone deficiency in adults

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and children one year

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and older who weigh at least 26 pounds, 11.5 kilograms.

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Important safety information.

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Don't take Skytrofa if you are allergic to Skytrofa

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or any of its ingredients; if you have a critical illness

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caused by certain types of heart or stomach surgery, trauma

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or breathing problems.

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If you have eye problems caused by diabetes;,

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if you have cancer or other tumors;

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if you are a child with closed bone growth plates;

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or if you are a child with Prader-Willi syndrome

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who is severely obese

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or has breathing problems.

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Skytrofa may cause increased blood sugar levels,

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increased risk of growth of an existing tumor or cancer,

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or increased risk of a previous tumor

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or cancer returning increased pressure in the skull, hip

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and knee pain or limp in children (slipped capital femoral

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epiphysis), which may lead to bone tissue dying due to lack

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of blood supply, (osteonecrosis); worsening of curvature

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of the spine in children scoliosis, severe

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and constant stomach pain, which could be a sign

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of pancreatitis; and loss of fat

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and tissue weakness at the injection site.

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Hormone levels should be monitored during treatment.

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Tell your doctor all medical

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conditions and medicines you take.

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Common side effects in children include viral infection,

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fever, cough, nausea, and vomiting.

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Common side effects in adults include swelling due

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to fluid buildup and low thyroid hormone.

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Talk to your doctor to see if Skytrofa is right for you.

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Visit skytrofa.com for full prescribing information.

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Thank you for watching

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and we hope this guide helps you feel confident using your

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Skytrofa Auto-injector.