What is Pergoveris?
Pergoveris is a powder and solvent for solution for injection. Contains the active ingredients follitropin alfa and lutropin alfa.
What is Pergoveris used for?
Pergoveris is indicated to stimulate the development of follicles (structures containing an egg cell) in the ovaries. It is indicated in women with severe impairment of luteinizing hormone (LH) and follicle stimulating hormone (FSH), which normally have problems with infertility.
The medicine can only be obtained with a prescription.
How is Pergoveris used?
Treatment with Pergoveris should be started under the supervision of a doctor experienced in treating infertility.
Pergoveris is administered once a day until the patient has developed a suitable follicle, assessed by ultrasound monitoring and measuring the estrogen dosage in the blood. This can take up to 5 weeks to achieve this. The recommended starting dose is one vial once a day; however the treatment must be adapted based on the individual response of the patient. If you use less than one vial a day, this dose may not be sufficient to stimulate the development of a mature follicle. If deemed necessary, the dose of follitropin alfa can be increased by adding a distinct preparation, observing an interval of 7-14 days between one increase and another.
The drug should be reconstituted immediately before injection and administered subcutaneously. The first injection must be carried out under the direct supervision of a doctor, but the patient can inject herself if she is well motivated and adequately trained and if she has the possibility of consulting an expert.
How does Pergoveris work?
The active ingredients contained in Pergoveris, follitropin alfa and lutropin alfa, are copies of the natural hormones FSH and LH. In the body, the hormone FSH stimulates the production of egg cells, while the hormone LH stimulates its release. Replacing the insufficient hormones, Pergoveris allows women with FSH and LH deficiency to develop a follicle, from which the egg cell will be expelled after the administration of the human chorionic gonadotropin hormone (hCG), thus favoring pregnancy. The active ingredients in Pergoveris are produced with a method called "recombinant DNA technology", ie they are generated by cells in which genes (DNA) have been introduced that make them capable of producing follitropin alfa and lutropin alfa.
What studies have been carried out on Pergoveris?
Both active substances have already been authorized in the European Union (EU): follitropin alfa as GONAL-f and lutropin alfa as Luveris. Therefore, the company presented, in support of the use of Pergoveris, information from the studies carried out during the development of Luveris. He also carried out "bioequivalence" studies to verify whether the combined injection was assimilated by the body in the same way as the two drugs administered separately.
What benefit has Pergoveris shown during the studies?
In studies conducted during the development of Luveris, the combination of follitropin alfa and lutropin alfa at the same doses present in Pergoveris produced active follicles. Bioequivalence studies have confirmed that Pergoveris was absorbed by the body as the active ingredients administered separately, producing similar concentrations of follitropin alfa and lutropin alfa in the blood.
What is the risk associated with Pergoveris?
The most frequent side effects with Pergoveris (seen in more than 1 patient in 10) are headache, mild to severe reactions at the site of administration (pain, redness, hematoma, swelling or irritation) and ovarian cysts (accumulation of liquid substances in the ovaries). Rarely, treatment can cause ovarian hyperstimulation, which can lead to serious medical conditions or multiple pregnancies (two or three fetuses). The response of the ovaries must be carefully monitored during treatment with Pergoveris; where necessary, therapy should be suspended. For the full list of all side effects reported with Pergoveris, see the Package Leaflet.
Pergoveris should not be used in people who may be hypersensitive (allergic) to follitropin alfa, lutropin alfa or to any of the other ingredients of the medicine. Furthermore, Pergoveris should not be used in patients with:
- cases of tumors of the hypothalamus and pituitary gland (hypophysis);
- ovarian enlargement or ovarian cysts not due to polycystic ovary syndrome;
- gynecological bleeding whose cause is not known;
- cancer of the ovaries, uterus or breast.
Pergoveris should not be used in women who cannot be pregnant, such as women whose ovaries are not functioning properly, suffering from malformations of sexual organs or fibroids of the uterus.
Why has Pergoveris been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that the benefits of Pergoveris outweigh its risks for stimulation of follicular development in women with severe LH and FSH insufficiency and therefore recommended issuing authorization in trade of the product.
Other information about Pergoveris:
On 25 June 2007, the European Commission granted a marketing authorization valid for Pergoveris, valid throughout the European Union, to Serono Europe Limited.
The full EPAR for Pergoveris can be found here.
Last update of this summary: 05-2007
