Puregon - follitropin beta

What is Puregon?

Puregon is a powder and solvent to be mixed to make a solution for injection. It is also available as a solution for injection in a vial or cartridge. Puregon contains the active substance follitropin beta.

What is Puregon used for?

Puregon is used for the treatment of infertility in women under the following conditions:

  1. women with anovulation (ie where ovulation is absent) who do not respond to treatment with clomiphene citrate (another medicine that stimulates ovulation).
  2. women undergoing fertility treatments (assisted reproduction techniques, such as in vitro fertilization). The administration of Puregon serves to stimulate the ovaries to produce more than one egg at a time.

Puregon can also be used in humans to stimulate sperm production in the presence of hypogonadotrophic hypogonadism (a rare hormonal deficiency disease).

Puregon can only be obtained with a prescription.

How is Puregon used?

Treatment with Puregon should be supervised by a doctor who has experience in treating fertility problems. Puregon is given as a 'subcutaneous' (under the skin) or intramuscular injection. The powder must be mixed immediately before use with the supplied solvent. Injections can be performed by the patient or by their relative. Puregon should only be administered by individuals who have received instructions from their doctor or who have access to expert advice. The dosage and frequency of administration of Puregon depend on its use (see above) and the patient's response to treatment. For a complete description of the doses, see the package leaflet.

How does Puregon work?

The active ingredient in Puregon, follitropin beta, is a copy of the natural follicle-stimulating hormone (FSH). In the body, FSH regulates reproductive function: in women it stimulates the production of eggs and in men it stimulates the production of sperm by the testicles. In the past, FSH used as a medicine was extracted from urine. The follitropin beta present in Puregon is produced with a method known as "recombinant DNA technology": that is, it is obtained from a cell in which a gene (DNA) has been introduced which makes it capable of producing human FSH.

What studies have been performed on Puregon?

The use of Puregon in women undergoing fertility treatment was studied in 981 patients. The main measures of effectiveness were the number of eggs recovered and the rate of evolutionary pregnancies. Puregon has been studied in 172 anovulatory women to determine how many treatment cycles were needed to determine ovulation in these patients. In humans, the use of Puregon has been studied to observe its effect on sperm production in 49 patients. In all the studies Puregon was compared to the natural FSH hormone extracted from urine.

What benefit has Puregon shown during the studies?

Puregon was as effective as the comparison product in all studies. Puregon was as effective as urinary FSH as a fertility treatment in ovulation and sperm production.

What is the risk associated with Puregon?

The most commonly reported side effects are reaction and pain at the injection site. In 4% of women treated with Puregon in clinical studies, signs and symptoms of ovarian hyperstimulation syndrome (eg, feeling of nausea, increased body weight and diarrhea) have been reported. Ovarian hyperstimulation syndrome occurs in cases of hyper ovary reaction to treatment. Physicians and patients should be aware of this possibility. For the full list of all side effects reported with Puregon, see the Package Leaflet.

Puregon should not be used in people who may be hypersensitive (allergic) to follitropin beta or any of the other ingredients. Puregon should not be used in patients with ovarian, breast, uterine, testicular, pituitary, or hypothalamus tumors. It must not be used in men with testicular failure. In women, it must not be used in the presence of ovarian failure, increased ovarian volume or the presence of cysts not due to polycystic ovarian disease, or vaginal bleeding. For the complete list of limitations, see the package leaflet.

Why has Puregon been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Puregon's benefits outweigh its risks for women in treating infertility, and in men for the spermatogenesis deficiency due to hypogonadotropic hypogonadism. The committee recommended that Puregon be given marketing authorization.

More information on Puregon:

On 3 May 1996, the European Commission issued a marketing authorization for Puregon, valid throughout the European Union. The marketing authorization holder is NV Organon. The marketing authorization was renewed on 3 May 2001 and 3 May 2006.

For the full EPAR for Puregon, click here.

Last update of this summary: 03-2009.