Skytrofa Auto-Injector Instructions For Use Manual
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Skytrofa Auto-Injector Instructions For Use Manual

Single-patient use
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  • Page 1 Instructions for Use Single-patient use...

  • Page 2: How To Use

    Cartridge dose from bar flashes. cartridge. needle. Turn the auto-injector up and down Check cartridge and throw away Turn on the auto-injector Prepare for injection Turn the auto-injector up Check that Press and Choose an injection site: Wash hands.
  • Page 3 structions • Important Information • Before You Begin r Use • Setting Up • Step-by-Step Guide e-patient use • Troubleshooting • Cleaning and Maintenance • Charging and Charger Cable • Storing • Product Safety • Expiration • EMC Compliance Levels •...
  • Page 4 Step-by-step Instructions for the SKYTROFA Auto-Injector Read and follow this Instructions for Use that comes with your auto-injector before you start using it. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.
  • Page 5 Getting Started Page Important Information …………… 4 Before You Begin ………………… 6 Setting Up ………………………… 8...
  • Page 6 The auto-injector should only be used with SKYTROFA cartridges and needles that are prescribed by your healthcare provider. Cartridges and needles come together in the same packaging.
  • Page 7 Do not use your auto-injector with other medicines or needles. Do not share your auto-injector with other people, even if the needle has been changed. You may give other people a serious infection or get a serious infection from them.
  • Page 8 Before You Begin The SKYTROFA Auto-Injector The auto-injector is an electronic, reusable device for people needing injections of SKYTROFA. It automates parts of the procedure for injecting SKYTROFA. The auto-injector is designed for personal home use, so that the injections may be given without the assistance of a medical professional.
  • Page 9 Product Overview Charger USB to Micro-USB Cable Quick Reference Guide Auto-Injector Protective Cover SKYTROFA Auto-Injector Figure A...
  • Page 10 (only use the provided charger). Plug the charger into a power outlet. Connect the Micro-USB (small end of the cable) to the back of the auto-injector. For protection, charge the auto-injector with the protective cover on (see Figure B).
  • Page 11 Fully charge the auto-injector before take 2 hours and 30 minutes. When the battery icon located at the base of the auto-injector (see Figure C) is When it shows constant green, the auto-injector is fully charged and is ready to use after the charging cable is unplugged.
  • Page 12 Gather your supplies and place Supplies needed for an injection: From SKYTROFA Auto-Injector packaging (see Figure A): • 1 SKYTROFA Auto-Injector From SKYTROFA packaging (see Figure D): • 1 SKYTROFA Cartridge Other supplies (not included) (see Figure D): •...
  • Page 13 Supplies Needed for Each Injection Sharps Container Alcohol Wipe SKYTROFA Cartridge Ascendis Pharma Needle B.Braun Figure D...
  • Page 14 Does Your Weekly Dose Require 2 Cartridges? Your healthcare provider may prescribe a dose that requires use of the medicine in 2 cartridges. If you have been prescribed a dose that requires 2 cartridges: • • Then take your second injection by repeating Step 1 to Step 11 with a new cartridge and needle.

  • Page 15: Table Of Contents

    How to Use Step-by-Step Guide Page Prepare …………………………… 14 Mix ………………………………… 20 Inject ……………………………… 26 After Injection …………………… 32...

  • Page 16: Prepare

    Figure E 1.1 Check the expiration date and cartridge dose on the cartridge packaging (see Figure E). Remove the SKYTROFA cartridge from the packaging according to the instructions on its lid. Do not use if the expiration date has passed on the cartridge.
  • Page 17 Figure F 1.3 Screw the needle straight on the cartridge by turning clockwise until there is a (see Figure G). Do not remove the plastic needle cover. You will need it to insert the cartridge into the SKYTROFA Auto-Injector. Figure G...
  • Page 18 Battery icon will light up and green top will Figure H 2.1 Disconnect the auto-injector from the charger when charged. The auto-injector cannot be used • when connected to the charger. 2.2 Find a quiet place where you can give your injection.
  • Page 19 6 minutes, it will turn off. Press the green button to turn it on again. 2.5 Check the battery icon on the base of the auto-injector to see if it is charged. The battery icon is green when the auto-injector is ready to use: Constant Green Battery is fully charged.
  • Page 20 • You will hear a click, the green top icon will light up, and the battery icon will switch off. • The cartridge cannot be inserted when the auto-injector is connected to the charger. from the cartridge (see Figure K).
  • Page 21 An orange plug may need to be removed from the cartridge. Figure L Do not use the auto-injector if you cannot insert the cartridge. Please call Ascendis Pharma Customer Support. For contact information back cover.

  • Page 22: Mix

    (see Figure M). Make sure the auto-injector is • the auto-injector is not upright, the medicine mixing will pause. automatic part of the mixing when you hear 2 loud beeps and the entire...
  • Page 23 If you wait for more than 2 hours before completing the steps for auto-injector will automatically cancel the procedure. If this happens, the cartridge will be released and cannot be used. To remove the cartridge, see Step 10 (page 32).
  • Page 24 Do not press the green button. Figure N 5.1 Turn the auto-injector up and down to mix the medicine by hand. You will hear a ‘tick’ sound each time you turn the auto-injector up and down correctly. To mix the medicine correctly: •...
  • Page 25 If you wait more than 2 hours before preparing and doing the injection (Step 6 to Step 9, pages 24–31), the auto-injector will automatically cancel the procedure. If this happens, the cartridge will be released and cannot be used. To remove the cartridge, see Step 10 (page 32).
  • Page 26 Figure O 6.1 Keep the auto-injector upright for automatic air removal (see Figure O). Wait until you hear 2 loud beeps and the entire progress bar lights up. icon and the progress bar is frozen page 42.
  • Page 27 Pull off the needle cover. Do not twist. Keep needle cover for later. (Eye icon will light up) Figure P 6.2 Pull off the needle cover (see Figure P). The green eye icon will light up. Removing the needle cover will allow you to check the mixed medicine in the inspection window (Step 7 on page 26).

  • Page 28: Inject

    Step 10. Figure Q 7.1 Check the mixed medicine in the inspection window on the side of the auto-injector (see Figure Q). The medicine should look colorless and clear. Some air bubbles are okay. Do not inject the medicine if there...
  • Page 29 If you see visible particles or the medicine is discolored: • Cancel the injection procedure by pressing and holding the green button for 3 seconds. This will unlock the cartridge. Go to Step 10 (page 32). • Get a new cartridge. Follow the instructions beginning at Step 1 (page 14).
  • Page 30 Inject Prepare for injection Front Back Stomach (abdomen) Buttocks Thighs Figure R 8.1 Choose an injection site. There are 3 areas of your body you can inject into (see Figure R): • Stomach (abdomen) • Thighs • Buttocks Change the injection site for every injection.
  • Page 31 8.2 Wash your hands with soap and water (see Figure S). Figure S 8.3 Clean the injection site with an alcohol wipe (see Figure T). Do not inject through clothes. Inject directly into the skin. Do not touch the cleaned area before injecting.
  • Page 32 Inject Inject medicine Press and hold Remove the green top auto-injector against the from skin and injection site for wait until you 10 to 15 seconds hear 2 loud until you hear 2 beeps. loud beeps. (Green top (Green top will...
  • Page 33 2 loud beeps and the green top mark will light up. 9.2 Remove the auto-injector from the skin (see Figure V). • auto-injector makes a buzzing sound as it unlocks the cartridge.

  • Page 34: After Injection

    After Injection Remove cartridge Press needle cover into Remove Press used green top. needle cartridge. cover down to release cartridge. Figure W Figure X Figure Y 10.1 Press the needle cover back on when Be careful when handling needles to reduce the risk of needlestick injury and infection.
  • Page 35 • After you remove the cartridge, the battery icon will display the battery level. The auto-injector turns off automatically. Do not use the auto-injector if you cannot remove the cartridge as instructed. Please call Ascendis Pharma Customer Support. For contact information...
  • Page 36 Figure Z 11.1 Check that the cartridge is empty of medicine (see Figure Z). Do not use the auto-injector if there is medicine left in the cartridge after injection. Please call Ascendis Pharma Customer Support. For contact information back cover.
  • Page 37 If you do not have an FDA-cleared sharps disposal container, you may use a household container that is: • Made of a heavy-duty plastic • puncture-resistant lid without sharps being able to come out • Upright and stable during use •...
  • Page 38 Put on the protective cover. Store at room temperature to be ready for next use. Figure AA 12.1 Make sure that the auto-injector is clean. If it is dirty or if medicine has been spilled onto it, clean with a damp cloth.
  • Page 39 12.3 Charge the auto-injector if the battery the injection. For more information about how to charge the auto-injector page 49. 12.4 Store the auto-injector at room with the protective cover on until the next injection. For more information about how to store the auto-injector 12.5 Write down the date of every weekly...
  • Page 41 Troubleshooting and Car Page Troubleshooting ….…….……… 40 Cleaning and Maintenance …… 48 Charging and Charger Cable … 49 Storing …………………………… 50...

  • Page 42: Troubleshooting

    Troubleshooting - What do you see? icons If you see any of these pages 42– 43. Green battery icon If you see any of these page 44. If you see no icons lighting up at all page 44.
  • Page 43 If you see any of these pages 46–47. Red battery icon If you see this...
  • Page 44 Mixing paused (Step 4 on page 20). If the SKYTROFA Auto-Injector is not in an upright position, mixing or air removal will pause (see Figure AB). Do this: Place the auto-injector in an upright position and the mixing or air removal will continue. Figure AB...
  • Page 45 You hear a repeating warning sound. Injection paused (Step 9 on page 30). If the green top is removed from the skin before completing the injection, the auto-injector will pause the injection (see Figure AC). Do this: Press the green top against skin and the injection will start again.
  • Page 46 You see a constant green battery icon. Battery is fully charged. The auto-injector is ready to use (the battery icon turns off while the auto-injector is in use). Do this: If you are charging the auto-injector, disconnect it from the charger.
  • Page 47 You hear a warning sound. The battery needs charging. Do this: Charge the auto-injector. Insert the charger cable into the auto-injector at rear lower side and connect to a power outlet (see Figure AD). When the auto-injector has charged for 15 minutes ready to use after the charging cable is unplugged.
  • Page 48 15 minutes. Do this: Remove the cartridge and wait for the auto-injector to turn off. Start again with a new, unused cartridge and make sure to screw on the needle straight and tightly.
  • Page 49 The auto-injector is near its expiration. auto-injector expires in 1 month. Do this: The auto-injector can be used as usual for the remaining injections. When there are no more injections left or the expiration date has passed, the auto-injector cannot be used. Please contact a healthcare provider or Ascendis Pharma Customer Support to receive a new auto-injector.

  • Page 50: Cleaning And Maintenance

    Cleaning and Maintenance Cleaning the SKYTROFA Auto-Injector If the auto-injector is dirty or if medicine has been spilled onto it, clean with a damp cloth. Before cleaning, the cartridge must be removed. The green top needs to be cleaned on the outside and on the reachable part of the inside.

  • Page 51: Charging And Charger Cable

    Connect the USB (large end of the cable) to the charger. Plug the charger into a power outlet. Connect the Micro-USB (small end of the cable) to the rear of the auto-injector. For protection, charge the auto-injector with the protective cover on. Read more pages 8–9.

  • Page 52: Storing

    Store with the protective cover on. It is recommended to store the auto-injector at room temperature between use. If the auto-injector is stored at higher or lower temperatures, you should keep it at room temperature for 30 minutes before use with a cartridge.
  • Page 53 Avoid refrigerating or freezing the auto-injector between use. Avoid exposing the auto-injector to direct sunlight and extreme temperatures. For technical details of the conditions under which the auto-injector can be used, stored, and transported pages 60–61.
  • Page 55 Product Information Page Product Safety ……….….……… 54 Expiration ………………………… 56 EMC Compliance Levels ……… 58 Technical Specification ………… 60 Symbols ………………………… 62 Warranty and Disclaimer ……… 64 Parts Overview ………………… 65...

  • Page 56: Product Safety

    Do not use the auto-injector if you think it may be damaged. Do not open or change the auto-injector. The auto-injector comes with a battery that cannot be replaced.
  • Page 57 Do not clean the auto-injector while charging. Keep the auto-injector dry. Do not place the auto-injector in liquid. Do not wash the auto-injector in a dishwasher. Do not expose the auto-injector to extreme temperatures. Keep the auto-injector away from heat and open Keep the auto-injector away from microwave ovens.

  • Page 58: Expiration

    (YYYY), month (MM), and date (DD), printed as YYYY-MM-DD. 1 month left, the auto-injector will indicate this when turned on. Read more page 47. The auto-injector may be used for the injection or after the expiration date, your auto-injector has to be replaced.
  • Page 59 The auto-injector contains electrical and electronic components, including a non-replaceable battery. Do not throw away (dispose) in household trash. When the auto-injector reaches its expiration date, maximum number of injections, or needs replacing, return it to the Ascendis Pharma Customer Support.

  • Page 60: Emc Compliance Levels

    EMC Compliance Levels Electromagnetic Compatibility Basic EMC Standard (EMC) Compliance Levels EMC - RF Field radiated emission in 10 m (maximum): a) 30 MHz to 230 MHz: 4-th Edition b) 230 MHz to 1 GHz: c) Internal source <108 MHz EMC - RF Field radiated 4-th Edition IEC 61000-4-3...
  • Page 61 EMC - Voltage dips and interruptions: 4-th Edition IEC 61000-4-11 EMC - RF Field Immunity to communication equipment, Immunity at 0.3 m separation: 4-th Edition IEC 61000-4-39 ESD immunity: a) ± 8 kV contact 4-th Edition IEC 61000-4-2...

  • Page 62: Technical Specification

    Technical Specification SKYTROFA Auto-Injector Lifetime Expiration date Serial Number Please refer to the bottom side (SN) of your auto-injector, marked after Size 7.09 x 1.46 x 1.06 in (180 x 37 x 27 mm). Weight Display Light-emitting diodes (LED). Power source Mains charger: 100 to 240 V AC.
  • Page 63 Use Conditions for Cartridge with Medicine and Needles The use conditions provided here are for the SKYTROFA Auto-Injector device. The use conditions for SKYTROFA cartridges with medicine and needles may be different. To see the use conditions for cartridges with medicine and needles, please see the information provided with your medicine.

  • Page 64: Symbols

    Manufacturer batch code for Expiration date. YYYY-MM-DD See Instructions for Use. Applied parts SKYTROFA Auto-Injector is a type BF device and provides protection against electrical shock and electrical current leakage. Applied parts on the device are the green top, the housing, and the button.
  • Page 65 59°F 40°C 104°F Storage & Transportation temperature. -10°C 14°F Keep dry. SKYTROFA Auto-Injector complies with the requirements of The Medical and the RoHS (Restriction of Hazardous 2460 SKYTROFA Auto-Injector contains electrical and electronic components, including a battery that cannot be replaced, and must not be disposed of using standard waste collection.

  • Page 66: Warranty And Disclaimer

    For contact information back cover. The expiration date is located at the bottom of the auto-injector and is indicated by year (YYYY), month (MM), and date (DD), printed as YYYY-MM-DD. Disclaimer The correct application of SKYTROFA according to the information provided with your medicine remains your responsibility.
  • Page 67 Pharma Customer Support 1-844-44ASCENDIS (1-844-442-7236) Constant Green Constant Green Battery is fully charged Battery is fully charged The auto-injector is ready to use The auto-injector is ready t Distributed by: Ascendis Pharma, Inc. Flashing Green Flashing Green Palo Alto, CA 94301...

  • Page 68: Parts Overview

    Read more on pages 20–24 and 30–31 roubleshooting) (and pages 42–43 for troubleshooting) Green Button OFA Auto-Injector or to To turn on the SKYTROFA Auto-Injector or to reject mixed medicine Needle SKYTROFA Cartridge d water for injection Contains medicine and water for injection...
  • Page 69 Turn the auto-injector up and down Check cartridge and throw away Turn the auto-injector up and do pages 18–33 (and pages 40–47 for Turn on the auto-injector Prepare for injection Turn on the auto-injector...
  • Page 70 This is your Instructions for Use • For quick overview of steps, read your Quick Reference Guide • For training video, go to www.skytrofa.com Instructions Quick Training for Use Reference Guide Video Ascendis Pharma Customer Support 1-844-44ASCENDIS (1-844-442-7236) Distributed by: Ascendis Pharma, Inc.

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