Consumer Information for: PERGOVERIS

PERGOVERIS^® - Powder and diluent for injection
PERGOVERIS^® - Solution for Injection in a Pre-filled Pen

PERGOVERIS^® - Powder and diluent for injection

Usual dose

Always take PERGOVERIS exactly as your doctor or Healthcare Professional (HCP) has instructed you. You should check with your doctor or HCP if you are not sure. With professional guidance, you can learn to inject yourself, in the comfort and privacy of your own home.

It is recommended that you inject PERGOVERIS at around the same time each day.

The usual dose is one vial of PERGOVERIS taken every day for up to three weeks. According to your response, your doctor may increase your dose of follitropin alfa usually by 37.5-75 IU at 7 to 14-day intervals.

When the desired response has been obtained, a single injection of hCG is given 24-48 hours after the last injection of PERGOVERIS. It is recommended that you have sexual intercourse on the day of, and the day following administration of the hCG. Alternatively, intrauterine insemination (IUI) or in vitro fertilization (IVF) may be performed.

If an excessive response occurs, treatment should be stopped and hCG withheld (see section SIDE EFFECTS). For the following cycle, your doctor may prescribe follitropin alfa at a lower dose than that used in the previous cycle.

Every treatment is individualized. Yours has been carefully designed for you by your doctor according to your own specific needs. It is very important that you keep your appointments and follow your doctor’s instructions, particularly with regard to the amount and frequency of the medication you are taking.

Route of administration

PERGOVERIS is intended for subcutaneous use that means given by injection just under the skin. Each vial is intended for a single use only.

If you self-administer PERGOVERIS, please read the following instructions carefully:

• Wash your hands. It is important that your hands and the items you use be as clean as possible.
  
• Assemble and lay out on a clean surface everything you need:
  
  • one vial containing PERGOVERIS (powder) (or as instructed by your doctor)
  • one vial of diluent (liquid)
  • three alcohol swabs
  • one syringe
  • one needle for mixing (long)
  • one fine bore needle for subcutaneous injection (short)
  • sharps container (which may be provided by your clinic or pharmacist)

DRAWING UP THE DILUENT FROM THE VIAL

Remove the protective cap from the vial containing the diluent. Use an alcohol swab to clean the rubber stopper and metal ring. Discard the alcohol swab.

Remove the syringe from its package and carefully remove the cap off of the long mixing needle, taking care not to let the needle touch any surface. Pull the plunger back until it is at the line next to the number showing the amount of diluent that you need to draw up as advised by your healthcare provider (for example: 1 cc).

Place the vial of diluent on a clean, flat surface. Push the needle through the center of the rubber stopper on the vial. Then, push the plunger all the way in.

Keeping the needle in the vial, lift the vial and turn it upside down. Check to see that the needle tip is in the liquid. Be sure you completely cover the needle tip with liquid before pulling back on the plunger. Slowly pull the plunger back until you see the required amount of diluent in the syringe. Discard the vial containing any unused diluent into a sharps container. Carefully replace the cap on the needle and place the syringe on a clean surface.

MIXING THEMEDICATION FOR INJECTION

Remove the protective cap from the PERGOVERIS powder vial. Use an alcohol swab to clean the rubber stopper and metal ring. Discard the alcohol swab.

Pick up the syringe containing the diluent and carefully remove the cap. Push the needle through the center of the rubber stopper on the PERGOVERIS powder vial. Slowly inject the diluent into the powder vial by pushing down on the plunger.

Leaving the needle in the vial, gently rotate the vial between your fingers until all of the powder is dissolved. Do not shake. Check that the solution is clear and colorless. Do not use if the solution is cloudy, discolored, or contains particles.

DRAW UP THEMEDICATION

After the powder has dissolved, turn the vial upside down, and gently draw up the entire contents of the vial into the syringe, being careful not to pull the plunger out of the syringe. It may help to slowly tip the vial.

Be sure you completely cover the needle tip with liquid before you pull back the plunger.

CHANGE THE NEEDLE

Hold the syringe with the needle pointing upwards. Create a small airspace at the top of the barrel by gently pulling the plunger back. Carefully recap the needle, then twist and remove the mixing needle. Replace the long mixing needle with the fine-bore, short needle for injection. Twist to attach, and pull to remove the cap.

Hold the syringe with the needle pointing upwards and gently flick the syringe so that, if there are any large air bubbles, they will rise to the top.

If large air bubbles are present, gently push the plunger upwards until a small droplet of liquid appears at the tip of the needle. Replace the cap on the needle. Place the syringe on a clean surface.

Do not worry if you are unable to remove very tiny bubbles; they will do you no harm.

PREPARE THE INJECTION SITE

Select the site of injection (e.g. top of thigh, tummy). Choose a different site each day. Wipe the chosen area with an alcohol swab, cleansing an area of approximately 5 cm x 5 cm (an area about the size of a tea bag). Lay the used side of the swab next to your working surface or on the alcohol swab wrapper.

INJECTING THEMEDICATION

Pick up the syringe and remove the cap from the needle. Using the hand with which you write, hold the syringe like a pencil or as if “throwing a dart”. With your other hand, gently squeeze the skin together to make a little elevation at the injection site. Using a “dart like motion”, insert the needle at a 90◦ angle. (You need very little force but quick action).

Inject the solution by gently pushing on the plunger with your index finger. Take as much time as you need to inject all the solution. As you release the skin from your grip, withdraw the needle by pulling it straight out. Clean the skin with the clean side of the alcohol swab using a circular motion. If there is minor oozing you may need to apply a small amount of pressure.
DISPOSE OF ALL USED ITEMS

Once you have finished your injection, immediately discard the needles and syringe (without recapping the needle) into the disposal container.

Overdose

The effects of an overdose of PERGOVERIS are unknown, nevertheless one might expect ovarian hyperstimulation syndrome to occur, which is further described in section SIDE EFFECTS. However this will only occur if hCG is administered.

Missed Dose

If you missed a dose of PERGOVERIS, do not take a double dose, please contact your doctor.

PERGOVERIS^® - Solution for Injection in a Pre-filled Pen

Usual dose

Always take PERGOVERIS exactly as your doctor or Healthcare Professional (HCP) has instructed you. You should check with your doctor or HCP if you are not sure. With professional guidance, you can learn to inject yourself, in the comfort and privacy of your own home.

It is recommended that you inject PERGOVERIS at around the same time each day.

A treatment regimen commences with the recommended dose of PERGOVERIS containing 150 IU follitropin alfa and 75 IU lutropin alfa. This is one dose from your pre-filled pen. According to your response, your doctor may increase your dose of follitropin alfa usually by 37.5-75 IU at 7 to 14-day intervals.

When the desired response has been obtained, a single injection of hCG is given 24-48 hours after the last injection of PERGOVERIS. It is recommended that you have sexual intercourse on the day of, and the day following administration of the hCG. Alternatively, intrauterine insemination (IUI) or in vitro fertilization (IVF) may be performed.

If an excessive response occurs, treatment should be stopped and hCG withheld (see section SIDE EFFECTS). For the following cycle, your doctor may prescribe follitropin alfa at a lower dose than that used in the previous cycle.

Every treatment is individualized. Yours has been carefully designed for you by your doctor according to your own specific needs. It is very important that you keep your appointments and follow your doctor’s instructions, particularly with regard to the amount and frequency of the medication you are taking.

Route of administration

PERGOVERIS is intended for subcutaneous use that means given by injection just under the skin.

If you self-administer PERGOVERIS, please read the following instructions carefully:

PERGOVERIS Pre-filled Pen and other materials you may need for injection.

1. Before you start using PERGOVERIS pre-filled pen:
   
   • Wash your hands with soap and water. It is important that your hands and items you use be as clean as possible.
     
   • On a clean surface, e.g., clean table or kitchen surface, lay out everything you will need:
     • PERGOVERIS pre-filled pen
     • One removable injection needle
     • Alcohol swabs
     • Sharps disposal container
   • Verify the expiration date on the label. Do not use expired medication.
     
2. Getting your PERGOVERIS pen ready for injection
   
   • Take off the pen cap.
   • Wipe the end of the threaded tip (containing the rubber centre) using an alcohol swab.
   • Verify that the Dose Display is set to “0”. The numbers in the dose feedback window represent the number of International Units or IU and show the dose of follitropin alfa. Your doctor will tell you how many IUs of follitropin alfa to inject each day.
     
   • Prepare your needle for injection:
     • Get a new needle – only use the “single-use” needles supplied
     • Hold the outer needle cap firmly
     • Check that the peel-off seal on the outer needle cap is not damaged or loose:
       
   • Remove the peel-off seal
     
   CAUTION: If the peel-off seal is damaged or loose, do not use the needle. Throw it away in a sharps disposal container. Get a new needle.
3. Attach the needle
   • Screw the threaded tip of the PERGOVERIS pen into the outer needle cap until you feel a light resistance.
     
     
     • Important Note: Do not attach the needle too tightly; the needle could be difficult to remove after the injection.
   
   
   • Remove the outer needle cap by pulling it gently. Put it aside for later use.
     
   • Do not throw away the outer needle cap; you will need it for removing the needle from the pen.
     
   • Hold the PERGOVERIS pen with the needle pointing upwards.
     
   • Carefully remove the green inner shield by pulling it straight off and discard it.
     
     
     • Warning: Do not recap the needle with the green inner shield as this can lead to needle stick.
   • Please note: if this is NOT a brand new PERGOVERIS pen (you have done previous injections with this pen), then proceed to Section 4: “Setting the dose prescribed by your doctor”.
   • If this IS A BRAND NEW PEN that you are using for the first time, look closely at the tip of the needle for a tiny drop of fluid.
     • If you see a tiny drop(s) of fluid, proceed to Section 4 “Setting the dose prescribed by your doctor”.
     • If you do not see a tiny drop(s), please see to Section 7 “Preparing your new PERGOVERIS Pre-filled Pen for first time use”.
   
   
   • Important Note: Only check for drop(s) with a brand new pen. This step is not required if you are doing additional injections using the same pen.
     
4. Setting the dose prescribed by your doctor
   • Turn the dose setting knob forward (or clockwise) until your prescribed dose shows in the Dose Display. Do not push or pull the dose setting knob while you turn it.
     
     • In this example below, it is 150 IU.
       
     • If you have turned the knob past your prescribed dose, turn the knob backwards (or counter-clockwise) to correct the dose.
       
       
       
     • Important Note: Check that the Dose Display shows your prescribed dose before you move on to the next step.
       
5. Injecting the dose
   
   • Choose an injection site in the area your doctor or nurse has told you to give the injection.
     • Note: To minimize skin irritation, select a different injection site each day.
       
   • Clean the skin by wiping the area with an alcohol swab. Allow the site to dry.
   • Set the alcohol wipe to the side.
   • Verify once more that the Dose Display is showing the correct dose. If it is not the correct dose, you must adjust it by turning the dose setting knob either clockwise or counter-clockwise (see Step 4 “Setting your dose prescribed by your doctor”).
   • Inject the dose as you were trained to do by your doctor or nurse
     • Holding the pen in one hand, use your other hand to gently squeeze the skin together to make a raised area at the injection site.
     • Insert the needle at a 90° angle into the skin. You might bend the needle if you do not insert it at a 90o angle.
     • Press the dose knob down as far as it will go and hold it to complete the full injection.
       
   • Hold the dose knob down for a minimum of 5 seconds to ensure you inject the full dose. The larger the dose, the longer it will take to inject.
     
   • Do not release the dose setting knob until you remove the needle from your skin.
     
   • Remove the needle from your skin, release the dose setting knob.
   • The dose number shown in the Dose Display will turn back to 0 to indicate that the complete dose was delivered. If you see a number higher than 0, proceed to Section 6 “After the Injection – Complete a Partial Injection” (only when needed).
6. After the injection
   
   • Verify you have given a complete injection.
   • Check that the dose Display shows 0.
     
     Important Note: If the Dose Display shows a number higher than 0, the PERGOVERIS pen is empty and you have not received your full prescribed dose.
     
     Complete a Partial Injection (only when needed):
   • The Dose Display will indicate the missing amount (in the example below, it is 50 IU), you need to inject using a new pen.
     
   • Repeat Section 1 “Before you start using PERGOVERIS” through Section 2 “Getting your PERGOVERIS pen ready for injection” with a second pen.
     
     
   • For a brand new pen that you are using for the first time, look closely at the tip of the needle for a tiny drop of fluid.
     • If you see a tiny drop(s) of fluid, proceed to Section 4 “Setting the dose prescribed by your doctor”.
     • If you do not see a tiny drop(s), please see Section 7 “Preparing your new PERGOVERIS pen for first time use”.
   • Once your pen is ready, set the dose as described in Section 4 to the missing amount indicated in the Dose Display on your previous pen. Complete your prescribed dose by following steps outlined in Section 5 “Injecting the dose”.
     
     Important Note: Always make sure to use a new needle for each injection.

Removing the needle after each injection:

• Place the outer needle cap on a flat surface.
• Hold the PERGOVERIS pen firmly with one hand, and slip the needle into the outer needle cap. Be careful not to prick yourself with the needle.
• Continue by pushing the capped needle against a firm surface until you hear a “click.”
  
• Grip the outer needle cap and unscrew the needle by turning counter clockwise. Dispose of the used needle safely.
  
• Never reuse any used needle. Never share needles.
• Recap the pen.

Preparing your new PERGOVERIS pen for first time use

• If you do not see a tiny drop(s) at or near the needle tip the first time you use a new pen, you must perform the steps below:
  • Gently turn the dose setting knob clockwise until it reads 25 in the Dose Display. You can turn the dose knob backwards if you turn it past 25.
    
• Hold the pen with the needle pointing upward.
• Tap the reservoir holder gently.
• Press the dose setting knob as far as it will go. A tiny drop of fluid will appear at the tip of the needle. The amount of fluid seen at the needle tip is part of the overfill from the pre-filled pen.
• Verify that the Dose Display reads “0”.
  
• You may need to repeat this step if you do not see a tiny drop of liquid appearing at the tip of the needle.
• Proceed to Section 4 “Setting the dose prescribed by your doctor”.

Storing the PERGOVERIS pen:

• Store the pen in its original packaging in a safe place
• When the pen is empty, ask your pharmacist how to dispose of it.

Important Note: Medicine should not be disposed of via wastewater or household waste.

Overdose

The effects of an overdose of PERGOVERIS are unknown, nevertheless one might expect ovarian hyperstimulation syndrome to occur, which is further described in section SIDE EFFECTS. However this will only occur if hCG is administered.

Missed Dose

If you missed a dose of PERGOVERIS, do not take a double dose, please contact your doctor.