Gonal-F (Emd Serono, A Division of Emd Inc., Canada, 150 Unit): Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What is GONAL-f?

GONAL-f is follicle-stimulating hormone (FSH) with no urinary proteins, which stimulates oocyte (egg) development in women. GONAL-f is a highly purified recombinant human form of FSH, manufactured using the latest technology with proven effectiveness and safety in clinical studies.

What is GONAL-f used for?

GONAL-f is used to stimulate the maturation of follicles in ovulatory patients undergoing Assisted Reproductive Technologies (ART) such as in vitro fertilization (IVF). To complete the maturation of follicles, another hormone, hCG (human chorionic gonadotropin), is given.

GONAL-f is also used to stimulate the maturation of follicules in some patients whose menstrual cycle is either irregular or absent. To complete the maturation of follicles another hormone, hCG, is given.

When should GONAL-f not be used?

GONAL-f should not be used if:

• you are hypersensitive to FSH or to any of the other

  ingredients of GONAL-f

• you have tumours of the hypothalamus and pituitary

  gland

• you are pregnant or breastfeeding

• you have ovarian enlargement or a cyst not due to

  polycystic ovarian disease (PCO)

• you have a gynaecological bleeding of unknown cause
• you have ovarian, uterine or breast cancer.

The medicinal ingredient in GONAL-f:

The medicinal ingredient in GONAL-f is follitropin alpha.

The nonmedicinal ingredients in GONAL-f:

The non-medicinal ingredients in GONAL-f 37.5 IU (2.8 µg), 75 IU (5.5 µg) and 150 IU (11 µg) single dose vials are: sucrose, disodium phosphate dihydrate, methionine, Polysorbate 20 and sodium dihydrogen phosphate monohydrate. GONAL-f may also contain O-phosphoric acid and/or sodium hydroxide used for pH adjustment.

The diluent provided for reconstitution is Sterile Water for Injection, Ph.Eur./USP.

The non-medicinal ingredients in GONAL-f 450 IU (33 µg) and 1050 IU (77 µg) Multi-Dose vials are:

sucrose, disodium phosphate dihydrate, sodium dihydrogen phosphate monohydrate. GONAL-f may also contain O-phosphoric acid and/or sodium hydroxide used for pH adjustment. The diluent provided for reconstitution is Bacteriostatic Sterile Water for Injection (0.9% Benzyl Alcohol), USP.

What dosage forms of GONAL-f are available?

GONAL-f is available as a lyophilized powder for reconstitution in vials.

GONAL-f is available in 37.5 IU (2.8 µg), 75 IU (5.5 µg) and 150 IU (11 µg) single dose vials and in 450 IU (33 µg) and 1050 IU (77 µg) Multi-Dose vials. Depending on the dosage regimen, the 450 IU (33 µg) vial can also be administered as a single dose injection.

Each box for the single doses contains a vial of medication (white powder), a vial or pre-filled syringe of sterile water for injection, Ph.Eur./USP (liquid) and a needle for mixing and a needle for injection. Each box for the Multi-Dose vial contains a vial of medication (white powder), a pre-filled syringe containing bacteriostatic sterile water for injection, USP, as well as injection syringes.

Is there a difference between GONAL-f 37.5 IU (2.8 µg)/75 IU (5.5 µg)/150 IU (11 µg) Single Dose vials and the GONAL-f 450 IU (33 µg)/1050 IU (77 µg) Multi-Dose Vials?

Both products contain the same, highly pure rFSH. However, the 1050 IU (77 µg) multi-dose vial contains the equivalent of fourteen 75 IU (5.5 µg) vials and the 450 IU (33 µg) multi-dose vial contains the equivalent of six 75 IU (5.5 µg) vials. The 450 IU (33 µg) and 1050 IU (77 µg) multi- dose presentations are stable for 28 days after reconstitution when stored at room temperature (at or below 25ºC).

The GONAL-f Multi-Dose vials are over-filled with 43.7 or 87.4 µg of drug in order to deliver approximately 450 IU (33 µg) or 1050 IU (77 µg) in several smaller daily doses, respectively. It is common for a small amount of drug to be left over in each vial that cannot be retrieved with a syringe. This is normal. Any drug remaining in the vial that cannot be withdrawn should be discarded.

How is GONAL-f administered?

GONAL-f cannot be taken orally because it would be digested in the stomach and for this reason, it must be taken by injection. Due to its high level of purity, GONAL-f is approved for subcutaneous injection (just under the skin), which is easier and less painful than intramuscular injections (in the muscle). In fact, with professional guidance, you can learn to inject yourself, in the comfort and privacy of your own home.

How is GONAL-f different from other treatments? Over the years, the gonadotropin drugs used in the treatment of infertility have undergone significant changes and improvements.

Many other products that are not derived from recombinant technology contain FSH and varying amounts of LH and urinary proteins.

GONAL-f is produced through rDNA technology and consists only of highly purified rFSH.

How long will one treatment cycle last?

This depends on the average follicular response to therapy. Every cycle treatment is individualized and your doctor will need to carefully evaluate how you respond.

WARNINGS AND PRECAUTIONS

Treatment increases your risk of developing ovarian hyperstimulation syndrome (OHSS). However, if you follow your doctor’s instructions for the recommended dose and schedule of administration, the occurrence of OHSS is uncommon. GONAL-f treatment seldom causes significant OHSS unless the medicine used to induce final follicular maturation and ovulation (containing human chorionic gonadotropin or hCG) is administered. In cases where OHSS is developing it is recommended to not give hCG, and women should prevent pregnancy at this time by not having sexual intercourse.

Since women with infertility undergoing assisted reproduction, particularly IVF, may have tubal abnormalities, the incidence of ectopic pregnancies (pregnancy in the fallopian tubes) might be increased. Early ultrasound to confirm that a pregnancy is in the uterus is important.

Miscarriages may be higher than in the normal population, but comparable with the rates found in women with fertility problems.

There have been isolated reports of non-serious allergic reactions to GONAL-f. If you had this type of reaction to similar medicines, inform your doctor.

The incidence of multiple births with GONAL-f is no different from any other gonadotropin and is dependent upon the protocol used by the clinic. Your doctor will monitor you closely to help minimize the possibility of a multiple pregnancy. The majority of births (about 80%) are single babies. Of those women who do have multiple births, the majority of these are twins. Only very few women conceive 3 or more babies. Even so, neither single nor multiple births can be guaranteed.

A causal relationship between treatment with fertility drugs and ovarian cancer has not been established.

INTERACTIONS WITH THIS MEDICATION

GONAL-f is often used with other medicines to stimulate ovulation (eg, hCG, LH, clomiphene citrate) which may help the maturation of follicles. If a GnRH agonist or antagonist medicine is also given along with your GONAL-f in your treatment

program, you may be told by your doctor to change your dose of GONAL-f. No other significant interactions with other medicines have been reported.

PROPER USE OF THIS MEDICATION

Always take GONAL-f exactly as your doctor has instructed you. You should check with your health care provider if you are unsure.

Recommended Dose

Every treatment is individualized. Your treatment has been carefully designed for you by your doctor. Over the course of your treatment, doses may range between 75 to 450 IU depending on your specific medical condition and your response to the medicine.

Overdose

What should I do if I accidentally inject more than my prescribed amount of GONAL-F?

The effects of an overdose of GONAL-f are unknown. You should contact your doctor for advice if you take more than your prescribed dose of GONAL-f.

Missed dose

What should I do if I forget to take my GONAL-f? Do not take a double dose to make up for any doses you have missed. Contact your doctor for advice if you forget to take a dose of GONAL-f.

Where should I inject GONAL-f?

The most easily accessible areas for subcutaneous injection are the abdomen and thighs. The absorption of GONAL-f is the same regardless of the injection site selected. You may find the injection is more comfortable if you vary the site each time you inject GONAL-f.

Below is a diagram with shaded areas demonstrating the recommended subcutaneous injection sites.

HOW TO INJECT GONAL-f

A Step by Step Guide

Understandably, you may be a little apprehensive at first about giving yourself an injection. That is why this information has been produced. Refer to it as necessary and follow each instruction step by step. For your convenience, Serono provides a self-injection video for GONAL-f that is available at your clinic. If you have any questions or concerns that are not addressed here, please consult your clinic.

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. If you have concerns regarding your dosage, consult your doctor. Do not adjust your dosage without being instructed to do so. If you forget or miss an injection, do not panic, but you should call your doctor for advice.

The Standard* GONAL-f Care Kit contains the following:

• Patient Information Booklet
• Alcohol wipes

• Needle disposal container. All used needles and vials

  should be discarded into this container. Only close the lid of the needle disposal container when you have completed your entire treatment or when the container is full. Once the lid is closed, the needle disposal container is permanently sealed and cannot be reopened.

• 3 mL syringes with 1½ inch, 21 or 22 gauge needles (for

  mixing-- use with GONAL-f vials)

• ½ inch, 25, 27 or 29 gauge needles (for injection-- use

  with GONAL-f vials)

* Your GONAL-f Care Kit may have been customized by your clinic for your treatment.

IMPORTANT POINTS TO REMEMBER

Always follow the basic principles of self injection:

• It is recommended that you inject GONAL-f at around

  the same time each day.

• Use a clean work surface and clean skin as directed.

• Always check expiry date before use--never use expired

  GONAL-f.

• Check dosage and instructions for mixing.

• Be sure to use the correct strength and correct amount of

  diluent.

• Check medication after reconstitution - do not use if

  medication is cloudy, lumpy or discoloured.

• Alternate injection sites each day.
• Check and record site of injections each day. If you are unsure about the mixing of the solution, or have difficulty with the injections, call your clinic immediately.

*For instructions on how to administer GONAL-f (follitropin alpha for Injection) 450 IU (33 µg) or 1050 IU (77 µg) Multi-Dose vials, please read INSTRUCTIONS FOR USING GONAL-F 450 IU (33 µg) or 1050 IU (77 µg) MULTI-DOSE VIAL.

Please read through the following instructions before you begin, in order to become familiar with self-administration of GONAL-f. If you have been prescribed GONAL-f single-dose vials, but the diluent is in a vial, please see your clinic for the

specific reconstitution steps.

Please note that µg is pronounced "microgram" and is a unit of measure. 1 gram is equivalent to 1 million micrograms.

1. 1.

   GETTING READY

   • On a clean work surface, lay out everything you will need:

     • GONAL-f mono-dose vial(s) of white powder
     • Diluent in pre-filled syringe
     • One needle for reconstitution (mixing)
     • One ½ inch, 25, 27 or 29 gauge needle for injection
     • Two alcohol wipes
     • Needle disposal container
   • If you use your kitchen to prepare the injection, ensure that all medicines and needles are kept well away from food. As for the injection itself, it can be given in any room where you feel comfortable.
2. 2.

   CLEANSE

   • Before you start, wash your hands well with soap and water. It is important that your hands and the items you use be as clean as possible.
   • Needles should not touch any surface except inside the vials and alcohol-cleaned skin; keep them capped prior to use.
   • Make sure you use a new needle each time you inject to avoid contamination.
3. 3.

   PREPARE THE PRE-FILLED SYRINGE OF DILUENT

   • Carefully twist off the cap at the tip of the barrel of the pre-filled syringe.
   • Remove the mixing needle from its package, being careful to keep the protective needle cap in place.
   • Carefully twist the mixing needle onto the barrel of the pre-filled syringe until it is tightened.
   • Carefully lay the syringe down on a flat, clean, surface.

Reconstitution Volumes

Volumes used for reconstitution should be between 0.5 and

1.0 mL; up to 225 IU (16.5 µg) may be dissolved in 0.5 ml of diluent (Sterile Water for Injection, USP). Following reconstitution, the medication in the vials should be used immediately, and any unused solution should be discarded.

1. 4.

   MIXING GONAL-f SINGLE DOSE VIAL(S)

   • You should have a set number of vials, as prescribed by your doctor, containing GONAL-f (white powder).

   • Using your thumb, flip off the plastic cap of the

     GONAL-f vial.

   • Continue to open all vials in this manner, if required.
   • Wipe the rubber stoppers on the top of the vial with an alcohol wipe.
   • Carefully twist the needle cap off the pre-filled syringe labelled "Sterile Water for Injection, USP" prepared in previous step 3.
   • Position the needle in a straight, downward position over the marked centre circle of the rubber stopper on the vial of GONAL-f powder.

INSTRUCTIONS FOR USING GONAL-f (follitropin alpha for Injection) 37.5 IU (2.8 µg), 75 IU (5.5 µg) and 150 IU (11 µg) SINGLE DOSE VIALS

• Keep the needle in a straight, downward position as you

  insert it through the centre circle or it may be difficult to depress the plunger.

• Slowly inject the liquid into the vial by pushing the

  syringe plunger down (volume to be confirmed by your physician). The sterile water and white powder will mix to form a clear liquid.

• Do not shake the vial. If bubbles appear, wait a few

  moments for the bubbles to settle.

• DO NOT USE IF SOLUTION APPEARS CLOUDY,

  LUMPY or DISCOLOURED. Report this and the lot number to your doctor.

• When all of the sterile water (diluent) has been injected

  into the vial, keep the needle in the vial, lift the vial and turn it upside down with the needle pointing toward the ceiling. With the needle tip in the liquid, slowly pull back the plunger until the vial is empty. Be careful not to pull the plunger out of the syringe. Remove the needle from the vial.

• If you have been prescribed more than one vial of

  GONAL-f, repeat the points above using the mixed solution in the syringe to dissolve the next vial. Continue in the same manner until you have the prescribed number of powder vials dissolved in the solution.

• Discard empty vials in the needle disposal container.
• REMOVE AIR BUBBLES AND CHANGE NEEDLE

• Hold the syringe with the needle pointing upwards and

  gently flick the syringe if there are any visible air bubbles. The air bubbles will collect at the top of the syringe. If there are no air bubbles, or if there is no air space at the top of the syringe, pull the plunger back to allow an air space.

• Recap the needle and twist to remove; replace with the ½

  inch, 25, 27 or 29 gauge injection needle with cap. Lay syringe down on the clean surface.

• Do not worry if you are unable to remove very tiny

  bubbles; they will do no harm. When you invert the syringe, the air space will be next to the plunger. This space will ensure that all of the medication has been injected. The air will remain in the needle.

• PREPARE THE INJECTION SITE
• Select the site of injection (e.g. top of thigh, tummy).

• Refer to the injection site diagram in your patient diary

  and record your chosen site of injection.

• Wipe the chosen area with an alcohol wipe, cleansing an

  area of approximately 5 cm x 5 cm.

• Lay the used side of the wipe next to your working

  surface or on the alcohol wipe wrapper.

• INJECTING THE SOLUTION
• Pick up the syringe and remove the cap from the needle.
• Invert the needle and hold 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-

  degree angle. (You need very little force but quick

  action.)

  • Once the needle is inserted into the tissue all the way, inject the solution by pushing gently on the plunger with your thumb or index finger of the hand holding the syringe. Take as much time as you need to inject all the solution.
  • Immediately withdraw the needle and clean the site 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 for a minute.
  1. 8.

     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.
     • Only close the lid of the needle disposal container when you have completed your entire treatment, or when the container is full.
     • Once the lid is closed, the needle disposal container is permanently sealed and cannot be reopened.
     • Take the container to a clinic or pharmacy for proper disposal.

*For instructions on how to administer GONAL-f (follitropin alpha for Injection) 37.5 IU (2.8 µg), 75 IU (5.5 µg) or 150 IU (11 µg), please read "INSTRUCTIONS FOR USING GONAL-f 37.5 IU (2.8 µg), 75 IU (5.5 µg) or 150 IU (11 µg) SINGLE-DOSE VIALS"

GONAL-f 450 IU (33 µg) or 1050 IU (77 µg) Multi-Dose has been prescribed for you by your doctor to treat infertility. To help you prepare and use this medicine, you should read these instructions carefully and ask your doctor to explain anything you do not understand.

1. 1. GETTING READY

Make sure you have all the necessary items listed below before you begin:

• Three alcohol wipes

• Single, prefilled syringe labelled "Bacteriostatic Sterile

  Water for Injection, USP"

• Vial containing GONAL-f 450 IU (33 µg) or 1050 IU

  (77 µg) Multi-Dose (white powder)

• One 27-gauge syringe for injection with unit dose markings from 37.5 IU (2.8 µg) FSH to 600 IU (44 µg) FSH for use with the GONAL-f Multi-Dose vials
• Needle disposal container
• MIXING GONAL-f 450 IU (33 µg) or 1050 IU (77 µg) MULTI-DOSE VIAL
• Wash your hands with soap and water.

• Using your thumb, flip off the plastic cap of the

  GONAL-f 450 IU (33 µg) or 1050 IU (77 µg) Multi INSTRUCTIONS FOR USING GONAL-f (follitropin alpha for Injection) 450 IU (33 µg) or 1050 IU (77 µg) MULTI-DOSE VIALS

Dose vial.

• Wipe the top of the vial stopper with an alcohol wipe.

• Carefully twist the needle cap off the syringe labelled

  "Bacteriostatic Sterile Water for Injection, USP". Do not touch the needle or allow the needle to touch any surface.

• Position the needle of the syringe of bacteriostatic sterile

  water in a straight, downward position over the marked centre circle of the rubber stopper on the vial of GONAL-f 450 IU (33 µg) or 1050 IU (77 µg) Multi-Dose powder.Keep the needle in a straight, downward position as you insert it through the centre circle or it may be difficult to depress the plunger.

• Slowly inject the bacteriostatic sterile water into the vial

  by pushing the syringe plunger down. When all the bacteriostatic sterile water has been injected into the vial, withdraw the syringe and safely dispose of it immediately in your disposal container. Do not use the syringe to inject your dose. The bacteriostatic sterile water and white powder will mix to form a clear liquid.

• Do not shake the vial. If bubbles appear, wait a few

  moments for the bubbles to settle. The liquid drug should be clear.

• DO NOT USE IF SOLUTION APPEARS CLOUDY,

  LUMPY or DISCOLOURED. Report this and the lot number to your doctor.

• Once reconstituted, write the date of reconstitution on

  the vial or box in order to keep track of its 28-day shelf-life.

• DETERMINING YOUR DOSE ON THE INJECTION SYRINGE

Your doctor will instruct you to take a specific dose of GONAL-f 450 IU (33 µg) or 1050 IU (77 µg) Multi-Dose. Your doctor will show you how to locate the syringe marking that corresponds to your prescribed dose.

IMPORTANT: If your doctor instructs you to increase or decrease your dose for one or more days, find the correct dose marking on the injection syringe and make the change as directed. Contact your clinic office if you have questions.

1. 4.

   PREPARING YOUR DOSE

   • Wipe the rubber stopper of the vial of GONAL-f Multi-

     Dose with an alcohol wipe.

   • Carefully pull the cap from the needle for injection. Do

     not touch the needle or allow the needle to touch any surface. Firmly hold the vial of GONAL-f 450 IU (33 µg) or 1050 IU (77 µg) Multi-Dose liquid on a flat surface and insert the needle straight and through the marked center circle of the rubber stopper.

   • Keeping the needle in the vial, lift the vial and turn it

     upside down with the needle pointing toward the ceiling. With the needle tip in the liquid, slowly pull back the plunger until the syringe fills to slightly more than the mark for your prescribed dose. Next, keeping the needle in the vial, slowly adjust the plunger to your prescribed dose-this will clear away any air bubbles.

   • Check that you have the plunger set at your prescribed

     dose.

     IMPORTANT: During your treatment, if you are required to reconstitute another Multi-Dose vial, please read instructions found in the box below and consult your GONAL-f 450 IU (33 µg) or 1050 IU (77 µg) Multi-Dose Patient Record; otherwise, please follow through to the next bullet point.

     • Remove the syringe needle from the vial. Recap the syringe needle. Do not touch the needle or allow the needle to touch any surface. Carefully lay the syringe down on a flat, clean surface. You should now be ready to prepare the injection site and inject your prescribed dose.
     1. 5.

        PREPARE THE INJECTION SITE

        • Select the site of injection (e.g. top of thigh, tummy).
        • Refer to the injection site diagram in your patient diary and record your chosen site of injection.
        • Wipe the chosen area with an alcohol wipe, cleansing an area of approximately 5 cm x 5 cm. Lay the used side of the wipe next to your working surface or on the alcohol wipe wrapper.
     2. 6.

        INJECTING THE SOLUTION

        • Pick up the syringe and remove the cap from the needle.
        • Invert the needle and hold 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-degree angle (You need very little force but quick action).
        • Once the needle is inserted into the tissue all the way, inject the solution by pushing gently on the plunger with your thumb or index finger of the hand holding the syringe. Take as much time as you need to inject all the solution.
        • Immediately withdraw the needle and clean the site 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 for a minute.

If you have used less than 450 IU (33 µg) or 1050 IU (77 µg) but the amount remaining is insufficient to complete your next dose, follow these steps to maintain sterility:

1. 1. Verify the amount remaining in the vial currently in use by referencing your dose log; or, if necessary, by withdrawing the remaining liquid into a syringe for injection, making note of the exact volume, and returning it to the vial.
2. 2. Discard empty syringe.
3. 3.

   Reconstitute the new vial as directed in step "Mixing

   GONAL-f Multi-Dose vials"

4. 4. Calculate the amount to withdraw from the new vial by subtracting the amount left in the current vial from the desired dose (as prescribed by your physician).
5. 5. Use a new syringe for injection to withdraw the calculated amount from new vial.
6. 6. Insert this partially filled new syringe for injection into the previous vial then draw up your complete dose.

IMPORTANT: The injection syringes provided with GONAL-f 450 IU (33 µg) or 1050 IU (77 µg) Multi-Dose are designed for use only with this product. Do NOT use the injection syringes to administer other drugs or hormones. All used syringes should be discarded.

1. 7.

   DISPOSE OF USED ITEMS

   • Once you have finished your injection, immediately

     discard the needles and syringe (without recapping the needle) into the disposal container.

   • Only close the lid of the needle disposal container when

     you have completed your entire treatment, or when the container is full.

   • Once the lid is closed, the needle disposal container is

     permanently sealed and cannot be reopened.

   • Take the container to a clinic or pharmacy for proper

     disposal.

2. 8.

   STORING YOUR VIAL OF GONAL-f [450 IU (33 µg) or 1050 IU (77 µg) MULTI-DOSE] BETWEEN USES

   • After each use, the vial containing GONAL-f 450 IU (33

     µg) and 1050 IU (77 µg) Multi-dose liquid can be stored at room temperature (at or below 25ºC).

   • Do not freeze. Do not store the drug in the syringe.

   • Discard any unused liquid GONAL-f 450 IU (33 µg) or

     1050 IU (77 µg) Multi-Dose after 28 days.

If you are unsure about the mixing of the solution, or have difficulty with the injections, call your clinic office immediately.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Are there any side effects with gonadotropin therapy? Fertility drugs are safe to take with close monitoring by your doctor. As with all medication, there is a potential for side effects. Some patients undergoing gonadotropin therapy may experience some breast tenderness, fatigue, bloating, weight gain, nausea or diarrhea. These are temporary and will resolve once treatment is stopped. Other adverse reactions may include a rash and local swelling at the injection site.

The greatest concern your doctor will have is ovarian hyperstimulation syndrome (OHSS). To avoid the development of OHSS, your doctor will carefully monitor your response to GONAL- f. Ovarian enlargement, sometimes accompanied by abdominal bloating and pain, may occur in about 20% of women taking gonadotropins. This is generally reversed with cessation of treatment and severe life-threatening cases are rare.

A causal relationship between treatment with fertility drugs and ovarian cancer has not been established.

If you experience any unusual symptoms or side-effects, you should report them to your doctor immediately. It is also wise to discuss the possibility of side effects with your doctor before you begin treatment.

HOW TO STORE IT

GONAL-f vials of lyophilized powder are stable when stored at or below room temperature (25ºC) and protected from light.

Do not freeze.

Do not use the product after the expiry date indicated on the label.

Reconstituted Product

Check medication after reconstitution - do not use if medication is cloudy, lumpy or discoloured

GONAL-f 37.5 IU (2.8 µg), 75 IU (5.5 µg) and 150 IU (11 µg) Single Dose Vials

Following reconstitution, the medication in the vials should be used immediately, and any unused solution should be discarded.

GONAL-f 450 IU (33 µg) or 1050 IU (77 µg) Multi-Dose Vial

After each use, the vial containing GONAL-f 450 IU (33 µg) and 1050 IU (77 µg) Multi-dose liquid can be stored at room temperature (at or below 25ºC).

Do not freeze. Do not store the drug in the syringe. Discard any unused liquid GONAL-f 450 IU (33 µg) or 1050 IU (77 µg) Multi-Dose after 28 days.

REPORTING SUSPECTED SIDE EFFECTS

To monitor drug safety, Health Canada collects information on serious and unexpected effects of drugs. If you suspect you have had a serious or unexpected reaction to this drug you may notify Health Canada by:

toll-free telephone: 866-234-2345

toll-free fax 866-678-6789

By email: cadrmp@hc-sc.gc.ca

By regular mail:

National AR Centre

Marketed Health Products Safety and Effectiveness Information Division

Marketed Health Products Directorate

Tunney’s Pasture, AL 0701C

Ottawa ON K1A 0K9

NOTE: Before contacting Health Canada, you should contact your physician or pharmacist.

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be obtained from:

Serono Canada Inc.

2695 North Sheridan Way, Suite 200 Mississauga ON L5K 2N6

Last revised: February 22, 2007