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 Auto-injector

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for the first time until you receive training

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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 can only be used 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 with other medicines

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or needles then provided in the sky TR cartridge pack.

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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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Along with the Skytrofa Auto-injector,

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you'll receive a Skytrofa cartridge and needle kit.

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Inside the box you'll find four Skytrofa medication

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cartridges, four needles plus two extra under the green cover,

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an Ascendis

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signature access program, personalized support brochure,

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and prescribing information.

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To get ready for your first injection,

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

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an alcohol wipe, and a sharps container.

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Before your first injection fully charged the Skytrofa

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Auto-injector. Check the battery icon before each injection.

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A solid green icon means it's fully charged

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and will last for three injections.

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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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Do not use the needle if the protective paper is broken,

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not fully sealed or not removed by hand,

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or if the needle is bent.

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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 the

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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 and until it's secure.

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Do not remove the needle cover.

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Do not use the needle if it has touched anything other

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than the injection site.

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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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You'll hear a humming sound

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and the three icons above the green button will light up.

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Then all of the icons will turn off except the battery icon.

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With the needle cover still on,

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push down the cartridge

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with the attached needle straight down into the flashing

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green top until it clicks,

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then remove your finger.

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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 4 to 8 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 5 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 top

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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 or hand sanitizer.

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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. Firmly press the green top against the skin

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until it retracts

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and hold for 10 to 20 seconds.

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The medicine 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 check mark 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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Press down the needle cover into the flashing green top

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until you hear a click

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to remove the cartridge.

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Do not remove the cartridge without using the needle cover.

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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 and needle in an FDA

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approved sharps container.

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For more information about safe sharps disposal, visit

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www.fda.gov/safesharpsdisposal.

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If your weekly dose requires 2 cartridges,

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take the second injection by repeating steps 1 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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A flashing green battery icon means 1 injection is still

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possible, but charging is recommended.

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If the battery icon is flashing orange, 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.

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Do not place the auto-injector under water 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 and wait until dry

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before putting the protective cover back on

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to be ready for the next use.

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It is recommended to 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 or help with troubleshooting,

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don't hesitate to contact Ascendis Pharma Customer Support

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at 1-844-44Ascendis,

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1-844-442-7236

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and select Option 1.

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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 1 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 and children (scoliosis);

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severe 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 sky TRPA is right for you.

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Visit sky trpa.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.