How to use your Pergoveris pre-filled pen

Transcription

1 How to use your Pergoveris pre-filled pen Information in this user guide is based on the European product information for Pergoveris. It is not country specific and may vary from country to country. Please always refer to the patient leaflet and instructions for use provided in your medicine pack or speak to your doctor before using this User Guide.

2 Getting started with your PERGOVERIS pre-filled pen the PERGOVERIS pre-filled pen The diagram below shows the key components of the Pergoveris pre-filled pen, needle and other items you will need to complete your injection. This document provides a step-by-step guide to self-injecting with your Pergoveris pre-filled pen. 3 This guide is intended only for patients who have been prescribed the Pergoveris pre-filled pen by a doctor experienced in treating fertility disorders Before injecting with your Pergoveris pre-filled pen, please also read the Patient Information Leaflet and Instructions For Use leaflet that come in the pack with your pen. They contain important information about the Pergoveris pre-filled pen, including how to use and store it, and the possible side effects that you may experience If you have any questions about using your Pergoveris pre-filled pen, please speak to your healthcare professional Pen cap 2. Threaded needle connector 3. Reservoir holder 4. Plunger piston 5. Dose feedback window 6. Dose-setting knob 7. Inner needle shield 8. Removable needle 9. Outer needle cap 10. Peel-off seal tab 11. Alcohol swabs 12. Sharps disposable container

3 EXAMINE YOUR MEDICATION Check your medication is within the expiry date you can find this on the pen and the pack. Getting READY Before you get started If you keep your Pergoveris pre-filled pen in the refrigerator, take it out about half an hour before you plan to inject, to allow the medication to adjust to room temperature. This makes it more comfortable to inject than when it is cold. lot: EXP: JUL 2019 LT9Y0003A DO NOT USE IF THE EXPIRY DATE HAS PASSED Wash your hands with soap and water Make sure you have all the items you need for your injection this should include: 1 Pergoveris pre-filled pen Check that the medication in the reservoir holder is clear. 2 One single-use needle 0 3 Alcohol swabs IF THE MEDICATION IS NOT CLEAR OR CONTAINS PARTICLES, DO NOT USE IT. YOU SHOULD CONTACT YOUR HEALTHCARE PROFESSIONAL. You will also need to ask your healthcare professional for a sharps disposal bin, to throw used needles away safely.

4 PREPARE YOUr needle ATTACHING THE NEEDLE PREPARE YOUr PEN Check that the seal on the outer needle cap is intact. If it is damaged or loose, dispose of the needle safely and use a new needle. Your healthcare professional will advise how to dispose of your needles and pens, e.g. in sharps bin. 3. Remove the peel-off seal from the outer needle cap. 0 ATTACH YOUr needle 0 1. First remove the pen cap. 2. Make sure that the dose feedback window is set at 0 The second time you use your pen and for all other injections with the same pen, you should wipe the threaded tip with an alcohol swab and allow it to dry before you attach the needle. There is no need to do this the first time as the pen is sterile. 4. Screw the threaded tip of the pen into the outer needle cap until it is firmly in place. Take care not to screw it in too tightly as it may become difficult to remove the needle after the injection.

5 remove the outer needle cap 5. Remove the outer needle cap by pulling it gently. Put this aside as you will need this later on. Check for air in the system check for drops of fluid The first time you use each of your Pergoveris pre-filled pens, you will need to check for air in the system. You will not need to do this when you reuse the pen. 6. Hold the pen with the needle pointing upwards. Carefully remove the green inner needle shield and dispose of it safely. Hold the pen with the needle pointing upwards and look closely at the tip of the needle for one or more tiny drops of fluid. If you see any, the pen is ready to inject. Go straight to Step 4: Setting the dose.

6 removing air from the system Hold the pen with the needle pointing upwards. Gently tap the reservoir holder. 1. To remove air from the system, turn the dose-setting knob clockwise until 25 is displayed in the dose feedback window. If you go past 25, you can easily turn the knob back the other way to select 25. setting your prescribed dose Your healthcare professional will have told you what dose you need to inject each day The Pergoveris pre-filled pen is available in 3 sizes: 300 IU IU, 450 IU IU and 900 IU IU. The higher number tells you how much follitropin alfa the pen contains e.g the 300 IU IU pen contains 300 IU follitropin alfa and 150 IU lutropin alfa Turn the dose-setting knob clockwise until the dose prescribed by your doctor shows in the dose feedback window. You can adjust the dose in 12.5 IU increments. 3. Press the dose-setting knob as far as it will go. A tiny drop of fluid will appear at the top of the needle. 4. Check that the dose feedback window displays 0 before you move on the next step and set the dose. 0 The number shown in the dose feedback window relates to your dose of follitropin alfa only. The pen is designed to automatically give you the correct dose of lutropin alfa, which is half the amount you see in the dose feedback window e.g if you have been prescribed 150 IU follitropin alfa, you will also get 75 IU lutropin alfa If you go past the dose you require, turn the knob back anti-clockwise to select the correct dose. Always check the dose is the correct prescribed dose before injecting

7 inject your dose injecting your dose 1. Slowly push the needle into the skin completely at a 90 angle. Injection area PREPARE YOUr skin Your healthcare professional will have discussed with you how and where on your body to inject. Choosing a different injection site each day will help to minimize skin irritation. 2. Gently push down on the dose-setting knob as far as it will go and hold it down for at least 5 seconds. The larger the dose, the longer the injection will take. The dose feedback window will return to 0. Clean the skin at the chosen injection site by wiping with an alcohol swab. 3. Pull the needle out of the skin, while keeping the dose-setting knob pressed down.

8 after your injection removing the needle check the full dose has been given the needle must be removed after each injection 0 1. Check the number shown in the dose feedback window has returned to 0 and your full prescribed dose has been given If a number higher than 0 appears in the dose feedback window, this shows the remaining amount of Pergoveris solution that you will need to inject using a new pre-filled pen. 1. Place the outer needle cap on a flat surface. Holding the pen in one hand, push the needle into the outer needle cap. 2. Push the capped needle against a firm surface until you hear a click. complete a partial injection (if required) 50 Repeat steps 1 to 3 to prepare your new pen for injection. Then set the dose on your new pen to match the dose shown on your old pen to complete your full prescribed dose. 3. Hold the outer needle cap and unscrew the needle by turning anti-clockwise. 4. Replace the pen cap NEVER PUT THE PEN CAP BACK ON WITH THE NEEDLE STILL IN PLACE.

9 safety STORING Your Pergoveris pen Always dispose of needles safely as recommended by your healthcare professional. When the pen is empty ask your healthcare professional how to dispose of it safely. It is recommended that your new Pergoveris pre-filled pen should be stored in its original packaging in a refrigerator between 2 C and 8 C and should not be frozen. Please write the date of first use on the Pergoveris pre-filled pen. Once opened, it may be stored for a maximum of 28 days outside of the fridge at room temperature (at or below 25 C). Do not use any medicine left in your pre-filled pen after 28 days. At the end of the treatment any unused solution must be discarded. Do not use Pergoveris after the expiry date which is stated on the cartridge label or carton after EXP. The expiry date refers to the last day of that month. Do not use Pergoveris if you notice any visible signs of deterioration, if the liquid contains particles or is not clear. NEVER REUSE NEEDLES OR SHARE NEEDLES.

10 Frequently asked questions What should I do when I cannot push the dose-setting knob to deliver the dose? If you cannot push the dose-setting knob down, it means your pen is empty so you will not be able to inject using this pen. You may still see a small amount of medication remaining in the pen. This is normal. What do I do if there is not enough Pergoveris remaining in the pen for my prescribed dose? If the dose display shows a number higher than 0 after your injection, this means that the pen is empty and that the complete dose has not been given. If this happens, the number shown in the dose display indicates the missing amount of Pergoveris solution that is needed to complete your dose. This is the dose you need to inject using a new pen. The pen contains two medicines, follitropin alpha and lutropin alpha, but why can I only see one number in the dose feedback window? Pergoveris pre-filled pen contains follitropin alpha and lutropin alpha in a fixed ratio of 2:1. The dose feedback window only shows the dose of follitropin alpha. So the dose of lutropin alpha equivalent to half the number shown in the dose feedback window gets delivered automatically, e.g. if you dial the number in the dose feedback window to 150 IU, you will be getting follitropin alpha 150 IU + lutropin alpha 75 IU. What do I do if I dial the wrong dose? To adjust the dose, simply turn the dose-setting knob either clockwise or anti-clockwise. After confirming the correct dose from the display window, you can proceed with your injection.

11 HOW TO USE YOUR PERGOVERIS PRE-FILLED PEN TREATMENT DIARY A treatment diary is included in the pack with your pen. You can use this to record your daily injection. Here s an example of a treatment diary using the 450 IU IU pen: 1 Treatment Day Number #1 #2 # Date Time Pen Volume Prescribed Dose feedback Window (300 IU IU)/ 0.48 ml Dose (450 IU IU)/ 0.72 ml Amount Set 0 to Inject Amount to Be Set for a Second Injection (900 IU IU)/ 1.44 ml 10/06 19: IU+225 IU 150 IU/ 75IU 150 if 0, if not 0, need second injection injection complete Inject this amount...using new pen 11/06 12/06 19:00 19: IU+225 IU 450 IU+225 IU 150 IU/ 75IU 150 IU/ 75IU 1. Record the treatment day number (column 1), date (column 2), time of your injection (column 3), and volume of your pen (column 4). 2. Record your prescribed dose (column 5). 3. Verify you dialed the right dose before injecting (column 6). 4. After injection, read the number shown in the dose feedback window. if not 0, need second injection Inject this amount...using new pen if not 0, need second injection Inject this amount...using new pen 5. Confirm you receive a complete injection (column 7) OR record the number shown in the dose feedback window if other than 0 (column 8). 6. When needed, inject yourself using a second pen, dialing your remaining dose written in the Amount to Be Set for a Second Injection section (column 8). 7. Record this remaining dose in the Amount Set to Inject section in the next row (column 6) if 0, injection complete if 0, injection complete Before injecting with your Pergoveris pre-filled pen, please also read the Patient Leaflet and Instructions For Use Leaflet that come in the pack with your pen. If you have any questions about using your Pergoveris pre-filled pen, please speak to your healthcare professional. Contact details Doctor : Nurse :

12 NOTES NOTES

13 GBPMLR/PER/0317/0005b Date of preparation: September 2017