Pergoveris ® 300 Iu/150 Iu/0,48 ml Solution

What Pergoveris is

Pergoveris contains two different active substances called “follitropin alfa” and “lutropin alfa”. Both belong to the family of hormones called “gonadotropins”, which are involved in reproduction and fertility.

What Pergoveris is used for

This medicine is used to stimulate the development of follicles (each containing an egg) in your ovaries. This is to help you get pregnant. It is for use in adult women (18 years old or above) who have low levels (severe deficiency) of “follicle stimulating hormone” (FSH) and “luteinising hormone” (LH). These women are usually infertile.

How Pergoveris works

The active substances in Pergoveris are copies of the natural hormones FSH and LH. In your body:

• FSH stimulates the production of eggs
• LH stimulates the release of the eggs.

By replacing the missing hormones, Pergoveris allows women with low levels of FSH and LH to develop a follicle. This will then release an egg, after an injection of the hormone “human chorionic gonadotropin (hCG)”. This helps the women to become pregnant.

You and your partner's fertility should be evaluated before the treatment is started by a doctor experienced in treating fertility problems.

Do not use Pergoveris

• if you are allergic to follicle stimulating hormone (FSH), luteinising hormone (LH) or any of the other ingredients of this medicine (listed in section 6)
• if you have a brain tumour (in your hypothalamus or pituitary gland)
• if you have large ovaries or sacs of fluid within your ovaries (ovarian cysts) of unknown origin
• if you have unexplained vaginal bleeding
• if you have cancer in your ovaries, womb or breasts
• if you have a condition that would make a normal pregnancy impossible, such as an early menopause, malformed sex organs or benign tumours of the womb.

Do not use this medicine if any of the above apply to you. If you are not sure, talk to your doctor, pharmacist or nurse before using this medicine.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using Pergoveris.

Porphyria

Talk to your doctor before you start your treatment. If you or any member of your family have porphyria (an inability to breakdown porphyrins that may be passed on from parents to children).

Tell your doctor straight away if:

• your skin becomes fragile and easily blistered, especially skin that has been frequently exposed to sunlight.
• you have stomach, arm or leg pain.

In case of above events your doctor may recommend that you stop treatment.

Do not share medicines prescribed for you with any other person. Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Using this medicine

• Pergoveris is intended to be given by injection just under the skin (subcutaneously). To minimise skin irritation, select a different injection site each day.
• Your doctor or nurse will show you how to use the Pergoveris pre-filled pen to inject the medicine.
• If they are satisfied that you can administer Pergoveris safely, you can then prepare and inject the medicine yourself at home.
• If you administer Pergoveris to yourself, please carefully read and follow section “Instructions for Use”.

Your doctor will tell you how long your treatment with Pergoveris will last.

How much to use

A treatment regimen commences with the recommended dose of Pergoveris containing 150 International Units (IU) of follitropin alfa and 75 IU of lutropin alfa every day. According to your response, your doctor may decide to add every day a dose of a licensed follitropin alfa preparation to your Pergoveris injection. In this case, the follitropin alfa dose is usually increased every 7 or every 14 days by 37,5 to 75 IU.

Treatment is continued until you get the desired response. This is when you have developed a suitable follicle, as assessed using ultrasound scans and blood tests. This may take up to 5 weeks.

When you get the desired response, you will be given a single injection of human chorionic gonadotropin (hCG) 24 to 48 hours after your last Pergoveris injection. The best time to have sex is on the day of the hCG injection and the day after. Alternatively, intrauterine insemination (IUI) may be performed.

If your body responds too strongly, your treatment will be stopped and you will not be given any hCG (see in section 2. under ”Ovarian hyperstimulation syndrome (OHSS)”). In this case, your doctor will give you a lower follitropin alfa dose in the following cycle.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Not all side effects reported for Pergoveris are included in this leaflet. Should your general health worsen or if you experience any untoward effects while using Pergoveris, please consult your health care provider for advice.

Most serious side effects

Contact your doctor straight away if you notice any of the below listed side effects. The doctor might ask you to stop using Pergoveris.

Allergic reactions

Allergic reactions such as rash, red skin, hives, swelling of your face with difficulty breathing can sometimes be serious. This side effect is very rare.

Ovarian hyperstimulation syndrome (OHSS)

• Lower abdominal pain together with nausea or vomiting. These may be the symptoms of ovarian hyperstimulation syndrome (OHSS). Your ovaries may have over-reacted to the treatment and formed large sacs of fluid or cysts (see in section 2. under “Ovarian hyperstimulation syndrome (OHSS)”). This side effect is common. If this happens, your doctor will need to examine you as soon as possible.
• The OHSS may become severe with clearly enlarged ovaries, decreased urine production, weight gain, difficulty in breathing and/or possible fluid accumulation in your stomach or chest. This side effect is uncommon (may affect up to 1 in 100 people).
• Complications of OHSS such as twisting of ovaries or blood clotting occur rarely (may affect up to 1 in 1,000 people).
• Serious blood clotting problems (thromboembolic events) usually with severe OHSS are found very rarely. This could cause chest pain, breathlessness, stroke or heart attack. In rare cases this can also happen independently of OHSS (see in section 2. under “Blood clotting problems (thromboembolic events)”).

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the label and the carton after EXP. The expiry date refers to the last day of that month.

Store in a refrigerator (2 °C - 8 °C). Do not freeze. Store in the original package in order to protect from light. Once opened, the pre-filled pen may be stored for a maximum of 28 days outside of the refrigerator (at 25 °C). Do not use Pergoveris if you notice any visible signs of deterioration, if the liquid contains particles or is not clear. Return all unused medicine to your pharmacist.

After the injection, dispose of the used needle safely. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.