Pergoveris is a powder and solvent that are made up into a solution for injection. It contains the active substances follitropin alfa and lutropin alfa.
|Table of Contents|
|What is it used for?|
|How is it used?|
|How does it work?|
|How has it been studied?|
|What benefits has it shown during the studies?|
|What is the risk associated?|
|Why has it been approved?|
Pergoveris is used to stimulate the development of follicles (structures containing an egg) in the ovaries. It is for use in women who have severe deficiency (low levels) of luteinising hormone (LH) and follicle-stimulating hormone (FSH). These women are usually infertile.
The medicine can only be obtained with a prescription.
Treatment with Pergoveris should be initiated under the supervision of a doctor who has experience in the treatment of fertility problems.
Pergoveris is given once a day until the patient has developed a suitable follicle, as assessed using ultrasound scans and by measuring blood oestrogen levels. This may take up to 5 weeks. The recommended starting dose is one vial once a day, but this should be tailored according to the patient?s response. Using less than one vial a day may not be sufficient to stimulate development of a follicle. If necessary, the dose of follitropin alfa can be increased by adding it as a separate medicine, with 7 to 14 days between each dose increase.
The medicine is made up immediately before being injected under the skin. The first injection must be carried out under direct medical supervision, but the patient can inject herself if she is adequately motivated and properly trained, and has access to expert advice.
The active substances in Pergoveris, follitropin alfa and lutropin alfa, are copies of the natural hormones FSH and LH. In the body, FSH stimulates the production of eggs, and LH stimulates their release. By replacing the missing hormones, Pergoveris allows women with FSH and LH deficiency to develop a follicle, which will release an egg after an injection of the hormone human chorionic gonadotrophin (hCG). This helps the women to become pregnant.
The active substances in Pergoveris are produced using a method called ?recombinant DNA technology?: they are made by cells that have received genes (DNA) that make them able to produce follitropin alfa and lutropin alfa.
Both active substances have already been authorised in the European Union (EU), follitropin alfa as GONAL-f and lutropin alfa as Luveris. Therefore, the company presented information from studies carried out during the development of Luveris to support the use of Pergoveris. It also carried out ?bioequivalence? studies to establish whether the combined injection was treated by the body in the same way as the two medicines given separately.
In the studies carried out during the development of Luveris, the combination of follitropin alfa and lutropin alfa at the same doses as in Pergoveris produced active follicles. The bioequivalence studies confirmed that Pergoveris was treated by the body in the same way as the two active substances given separately, producing similar blood levels of follitropin alfa and lutropin alfa
The most common side effects with Pergoveris (seen in more than 1 patient in 10) are headache, mild to severe injection site reaction (pain, redness, bruising, swelling or irritation at the site of injection) and ovarian cysts (collections of fluid within the ovaries). Rarely, the treatment can cause overstimulation of the ovaries, which can lead to serious medical problems or multiple pregnancies, such as twins or triplets. The response of the ovaries should be carefully monitored during treatment with Pergoveris, and treatment stopped if necessary. 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 any of the other ingredients. It should also not be used in people who have:
- tumours of the hypothalamus or pituitary gland,
- enlarged ovaries or a cyst on the ovary that is not due to polycystic ovarian disease,
- bleeding from the genital region whose cause is unknown, or,
- cancer of the ovary, womb or breast. Pergoveris should not be used in women who cannot become pregnant, such as women whose ovaries do not function correctly, who have malformations of the sexual organs or who have fibroid tumours of the womb.
The Committee for Medicinal Products for Human Use (CHMP) decided that Pergoveris?s benefits are greater than its risks for the stimulation of follicular development in women with severe LH and FSH deficiency. The Committee recommended that Pergoveris be given marketing authorisation.