How does it work?

Puregon injections contain the active ingredient follitropin beta, which is synthetic version of a natural sex hormone called follicle stimulating hormone (FSH). It is used in the treatment of infertility.

FSH directly affects the ovaries in women and the testicles in men.

In the ovaries in women, FSH increases the number of growing follicles and stimulates their development. Within the follicles are the developing eggs. FSH also increases the production of oestrogen, and under the influence of this hormone, the largest follicle continues to develop. Follitropin beta has the same effects as the natural hormone.

This medicine is used to stimulate the development of follicles and eggs in women who are having difficulties getting pregnant due to problems with ovulation. It is used for women who have tried treatment with clomifene, eg Clomid, when this has been unsuccessful. When the follicle has developed appropriately, another medicine called human chorionic gonadotrophin (HCG), eg Choragon, is given. This causes ovulation to happen.

This medicine can also be used to stimulate multiple follicles and eggs to develop in women who are having assisted conception treatments such as in-vitro fertilisation (IVF). The eggs are harvested and fertilised in a test tube and the resulting embryo is then implanted in the womb.

In men, FSH is involved in the production and development of sperm in the testicles. This medicine is used to increase sperm production in men who have a low sperm count as a result of low hormone levels. It is also used in combination with human chorionic gonadotrophin HCG, which increases the production of testosterone in the testicles and helps the FSH to work.

Treatment with Puregon is started under the supervision of a specialist trained in the treatment of fertility problems. The injection is administered either under the skin (subcutaneously) or into a muscle (intramuscularly). If you are going to administer the injections yourself, your doctor will show you how to inject them under the skin.

What is it used for?

• Stimulating the production of eggs in women having treatment for infertility caused by problems with ovulation.
• Stimulating the production of eggs in women having assisted reproduction treatments such as in-vitro fertilisation (IVF).
• Infertility in men caused by low hormone levels that have resulted in a low sperm count.

Warning!

• Before treatment is started your doctor will want to check the functioning of your adrenal glands and thyroid gland, and that you do not have tumours of the pituitary or hypothalamic glands in the brain, or higher than normal blood levels of a hormone called prolactin, all of which can affect fertility.
• In women, before treatment is started your doctor will need to check the functioning of your ovaries using ultrasound and a blood test to measure your oestrogen levels. During treatment, these tests, as well as tests to measure the level of oestrogen in your urine, will need to be carried out at regular intervals until the follicles develop.
• This medicine can cause over-stimulation of the ovaries that can be dangerous (ovarian hyperstimulation syndrome or OHSS). For this reason, it is important to tell your doctor immediately if you experience pain or swelling of the abdomen, weight gain, difficulty breathing, increased thirst, decreased urine output, nausea, vomiting and diarrhoea during treatment.
• If during treatment your blood or urine tests show high levels of oestrogen, or if an ultrasound scan shows excessive development of follicles in your ovaries, this indicates that your ovaries may be overstimulated, which could lead to OHSS. Treatment with this medicine should be stopped immediately and you should not have sex, or use barrier contraception for at least four days.
• If this treatment does result in pregnancy, there are a few risks that you should be aware of. You should discuss these with your doctor before starting treatment. Pregnancy following treatment with Puregon is more likely to result in a multiple pregnancy (twins or more) than if you had conceived naturally. This carries an increased risk of problems for the mother during the pregnancy, and at or around the time of birth. There is a greater risk of miscarriage or abortion in women having fertility treatment than in the general population. There may also be a slightly higher risk of your baby being born with physical defects. There is a slightly higher risk of an ectopic pregnancy (where a fertilised egg implants outside the uterus) after IVF treatment than in the general population.

Use with caution in

• Women with polycystic ovary syndrome (PCOS).
• Women at risk of blood clots in the blood vessels (thromboembolism, eg deep vein thrombosis or pulmonary embolism), for example due to a personal or family history, or severe obesity.
• Hereditary blood disorders called porphyrias.
• People allergic to the antibiotics streptomycin or neomycin.

Not to be used in

• Men and women with tumours of the pituitary or hypothalamic glands in the brain.
• Men with prostate or testicular cancer.
• Women with breast, uterine or ovarian cancer.
• Women with vaginal bleeding of unknown cause.
• Women with ovarian cysts or enlarged ovaries, not due to polycystic ovary syndrome (PCOS).
• Women whose ovaries are not functioning properly.
• Women with blocked fallopian tubes, unless having IVF.
• Women with a physical defect of the reproductive organs (uterus, fallopian tubes, ovaries and/or cervix).
• Women who have had a premature menopause or hysterectomy.
• Women with uterine fibroids that may cause problems with a pregnancy.
• Men whose testicles are not functioning properly.

This medicine should not be used if you are allergic to one orany of its ingredients. Please inform your doctor or pharmacist if you havepreviously experienced such anallergy.

If you feel you haveexperienced an allergic reaction, stop using this medicine and inform yourdoctor or pharmacist immediately.

Pregnancy and breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

• This medicine must not be used in women who are already pregnant or breastfeeding. Seek further medical advice from your doctor.

Side effects

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here does not mean that all people using this medicine will experience that or any side effect.

• Pain, bruising, itching and inflammation at the injection site in men and women.
• Allergic skin reactions, such as redness, rash, hives (urticaria) and itching in men and women.
• Headache in women.
• Nausea in women.
• Pelvic pain in women.
• Abdominal pain and bloating in women.
• Enlargement of the ovaries in women.
• Over-stimulation of the ovaries in women (ovarian hyperstimulation syndrome), causing the production of many eggs (see warning section above).
• Breast tenderness, pain and enlargement in women.
• Blood clot formation in a vein (thromboembolism), usually of the leg (deep vein thrombosis) in women.
• Breast enlargement in men.
• Acne in men.

The side effects listed above may not include all of the side effects reported by the medicine's manufacturer.

For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

How can this medicine affect other medicines?

You should tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while having treatment with this one, to make sure that the combination is safe.

If this medicine is used in combination with other medicines that stimulate ovulation, eg clomifene, there may be an increased risk of over-stimulation of the ovaries.

Other medicines containing the same active ingredient

There are currently no other medicines available in the UK that contain follitropin beta as the only active ingredient.