Pergoveris (follitropin alfa/lutropin alfa) is a fertility medication that contains follicle-stimulating hormone (FSH) and luteinizing hormone (LH), which belong 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.

Pergoveris is used to stimulate the production of eggs in women (patients with ovaries ) with significant FSH and LH deficiency who are undergoing procedures to help them become pregnant, such as in vitro fertilization (IVF).

Pergoveris comes as a liquid formulation for injection in a pre-filled, ready-to-use pen.

Pergoveris is available in 3 pre-filled pen formats.

• 300 IU Pen – contains 300 IU r-hFSH/150 IU r-hLH in 0.48 mL
• 450 IU Pen – contains 450 IU r-hFSH/225 IU r-hLH in 0.72 mL
• 900 IU Pen – contains 900 IU r-hFSH/450 IU r-hLH in 1.44 mL

“IU” stands for International Units; “r-hFSH” stands for follicle-stimulating hormone; “r-hLH” stands for luteinizing hormone.

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

• Before first use: store between 2-8°C (in the refrigerator)
• Once opened: store at or below 25°C (in the refrigerator or at room temperature), for a maximum of 28 days
• Do not freeze
• Store in original package to protect from light
• Do not use after expiry date
• Do not use if you notice any visible signs of deterioration or if the liquid contains particles or is not clear
• Never store pen with needle still attached
• Keep out of reach of children

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 Pergoveris Pens in an environmentally responsible manner by participating in the EMD Serono ecoprogram. Download our ecoprogram brochure to learn more.

Pergoveris 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.

Choose an injection site on your body as directed by your clinic. The easiest places to give yourself a Pergoveris injection are your abdomen and thighs. You may find the injection is more comfortable and you experience less skin irritation if you select a different injection site each day.

Shaded areas show recommended injection sites

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

If you have accidentally injected too much Pergoveris, contact your clinic or another healthcare professional, hospital emergency department, or regional Poison Control Centre immediately, even if there are no symptoms.

If you dial past your prescribed dose, simply turn the knob backwards (or counter-clockwise) to the correct dose. 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 that cannot be used – 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 Pergoveris solution that is still needed to complete your dose. This is the dose you need to inject using a new pen.

Do not use Pergoveris if:

• You are allergic to FSH, LH, or any of the other ingredients of this medicine
• You have ovarian dysfunction or egg doesn’t release with normal levels of LH and FSH
• You have an uncontrolled thyroid or adrenal function
• You have a brain tumour (in your hypothalamus or pituitary gland)
• You have large ovaries or sacs of fluid within your ovaries (ovarian cysts) of unknown origin
• You have unexplained vaginal bleeding
• You have sex hormone–dependent tumours of the reproductive system and accessory organs
• You are currently pregnant or breastfeeding (feeding a baby your own milk)

Pergoveris should not be used if you have a condition that would make a normal pregnancy impossible, such as:

• Premature menopause
• Malformation of reproductive organs
• Specific tumours of the uterus, including severe uterine fibroids

To help avoid side effects and ensure proper use, talk to your doctor or pharmacist before you take Pergoveris.

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

• Porphyria: Using Pergoveris may increase your risk of a sudden attack

Other warnings you should know about:

• Ovarian hyperstimulation syndrome (OHSS): Treatment with Pergoveris increases the risk of developing OHSS
• Thromboembolic events: Treatment with gonadotropins, like pregnancy itself, can increase the risk of thromboembolic events (formation of a blood clot in a vein or artery) in individuals at higher risk due to personal or family history
• Reproductive issues: Incidence of reproductive issues is increased compared with natural conception; these include ectopic pregnancy (a pregnancy that occurs outside of the uterus) in patients with a history of disease or scarring of the Fallopian tubes, miscarriage, or being pregnant with more than one child (i.e., a multiple pregnancy, usually twins)
• Tumours of the ovary and other reproductive organs: There have been reports of both benign and malignant tumours in women who have undergone multiple drug regimens for infertility

Refer to the Pergoveris 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.

As with all medications, Pergoveris may cause side effects. The most common side effects include:

• Abdominal pain
• Pelvic pain
• Breast (chest) pain
• Constipation
• Painful menstruation
• Stomach or intestinal gas
• Headache
• Nausea
• Reactions at the injection site (pain, redness, itching, bruising, swelling, and/or irritation)

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

If you experience any of the conditions listed above or any unexpected side effect while taking Pergoveris, contact your doctor or pharmacist.

Reactions between Pergoveris and other drugs have not been established. Nevertheless, tell your doctor or pharmacist if you are taking (or have recently taken) any other medicines, including over-the-counter products, vitamins, minerals, natural supplements, or alternative medicines.