GONAL-f (follitropin alfa for injection) is a fertility medication that contains follicle-stimulating hormone (FSH), which belongs to a group of hormones called “gonadotropins.” They are produced by the pituitary gland in the brain and play a role in the reproductive cycle and fertility.

GONAL-f is used to help eggs develop in women (patients with ovaries) undergoing procedures to help them become pregnant, such as in vitro fertilization (IVF). GONAL-f is also used to help eggs develop in patients with irregular or absent menstrual cycles.

GONAL-f comes as a liquid formulation in a pre-filled, ready-to-use pen.

GONAL-f is available in 3 pre-filled pen formats:

• 300 IU Pen – 300 IU/0.48 ml
• 450 IU Pen – 400 IU/0.72 mL
• 900 IU Pen – 900 IU/1.44 mL

“IU” stands for International Units.

The rubber stopper is latex-free; however, we cannot guarantee that the device has not been exposed to latex.

• Store between 2-25°C (either in the refrigerator or at room temperature) for up to 3 months
  • After first use, the pen may be stored at 25°C (room temperature) for a maximum of 28 days
• Do not use the GONAL-f Pen if the solution contains particles or is not clear
• Do not freeze
• Protect the GONAL-f Pen from light
• Keep in a safe place out of the reach of children
• Do not use after the expiry date

You should dispose of the used needles safely in a sharps container. This container is usually provided by your clinic or pharmacy.

You can dispose of your used GONAL-f Pens in an environmentally responsible manner by participating in the EMD Serono ecoprogram. Download our ecoprogram brochure to learn more.

GONAL-f is given by subcutaneous injection (just under the skin). You can learn to do your own injections in the comfort and privacy of your own home.

The easiest places to give yourself a GONAL-f injection are your abdomen and thighs. You may find the injection is more comfortable if you use a different injection site each time you inject GONAL-f.

Shaded areas show recommended injection sites

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

If you have accidentally injected too much GONAL-f, contact your clinic or another healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms.

IMPORTANT: The maximum dose that can be dialed for the 450 and 900 IU pens is 450 IU, while the maximum dose that can be dialed for the 300 IU pen is 300 IU.

If you dial past your dose, turn the dose setting knob back to the correct dose. To adjust the dose, you can turn the knob either clockwise or counter-clockwise. After confirming the correct dose from the display window, you can proceed with the injection.

When you cannot push the injection button down, it means your pen is empty. You may still see a small amount of medication remaining in the pen – this is normal.

If the dose display shows a number higher than “0” after your injection, this indicates that the pen is empty and that you have not received your full prescribed dose. If this happens, the number shown in the dose display indicates the amount of GONAL-f solution that is still needed to complete your dose. This is the dose you need to inject using a new pen.

Do not use GONAL-f if you:

• Have high levels of FSH in your blood that show your ovaries do not work at all
• Have uncontrolled thyroid or adrenal dysfunction
• Are allergic to recombinant human FSH or to any of the other ingredients of GONAL-f
• Are pregnant or breastfeeding (feeding a baby your own milk)
• Have large ovaries or sacs of fluid (ovarian cysts) not due to polycystic ovarian disease (PCOS)
• Have abnormal bleeding from your uterus or vagina from an unknown cause
• Have tumours of the ovary, uterus, breast/soft chest tissue, or brain (hypothalamus or pituitary gland)

To help avoid side effects and ensure proper use, talk to your doctor or pharmacist before you take GONAL-f. Your fertility should be evaluated by a fertility specialist before you start treatment.

Tell your doctor about any health conditions or problems you may have, including:

• Porphyria: Using GONAL-f may increase your risk of a sudden attack

Other warnings you should know about:

• Overstimulation of the ovary: This may occur during FSH therapy, resulting in temporary enlargement of the ovaries and/or ovarian hyperstimulation syndrome (OHSS)
• Breathing and blood clotting problems: Using gonadotropin can increase the risk of such conditions, including collapsed lung, extreme shortness of breath, worsening of asthma, and blood clots which can cause serious issues such as blockage in the lungs, arms or legs, heart attack, or stroke
• Reproductive issues: Incidence of reproductive issues is increased compared with natural conception; these include ectopic pregnancy (a pregnancy that occurs outside of the uterus) or being pregnant with more than one child (i.e., a multiple pregnancy, usually twins)

Refer to the GONAL-f package insert for more information about these warnings, including what to watch for and what to do if you experience signs or symptoms of these conditions.

Fertility drugs are safe to take with close monitoring by your doctor. As with all medications, there may be side effects. Common side effects include:

• Ovarian cysts
• Mild to moderate ovarian enlargement
• Breast (chest) tenderness
• Mild to moderate ovarian hyperstimulation syndrome (OHSS)
• Mild to severe injection site reaction (such as pain, redness, bruising, swelling, and/or irritation)
• Headache
• Stomach pain or bloating
• Feeling sick (nausea), vomiting, diarrhea

This is not a complete list of side effects. Refer to the package insert for more information about possible side effects with GONAL-f, including serious side effects.

If you experience any unusual symptoms or side effects while taking GONAL-f, report them to your doctor or pharmacist immediately.

GONAL-f is often used with other medicines to help eggs develop. If you are also taking a gonadotropin-releasing hormone (GnRH) agonist or antagonist as part of your treatment program, your doctor may adjust your GONAL-f dose. No other significant interactions with other medicines have been reported.