About
This is a summary of the European Public Assessment Report (EPAR). It explains how the Committee for Medicinal products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
- What is Pergoveris?
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.
- What is Pergoveris used for?
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.
- How is Pergoveris used?
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.
- How does Pergoveris work?
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.
- How has Pergoveris been studied?
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.
- What benefit has Pergoveris shown during the studies?
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
- What is the risk associated with Pergoveris?
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.
- Why has Pergoveris been approved?
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.
- Other information about Pergoveris
The European Commission granted a marketing authorisation valid throughout the European Union for Pergoveris to Serono Europe Limited on 25 June 2007.
This EPAR was last updated on 14/07/2011 .
More detail is available in the summary of product characteristics
Authorisation details
Product information
Product information
01/07/2011 Pergoveris -EMEA/H/C/000714 -IG/0076/G
Contents
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
Pharmacotherapeutic group
Sex hormones and modulators of the genital system
Therapeutic indication
Pergoveris is indicated for the stimulation of follicular development in women with severe LH and FSH deficiency.
In clinical trials, these patients were defined by an endogenous serum LH level < 1.2 IU/l.
Assessment History
Changes since initial authorisation of medicine
| Name | Language | First published | Last updated |
|---|---|---|---|
| Pergoveris : EPAR - Procedural steps taken and scientific information after authorisation | (English only) | 31/07/2009 | 14/07/2011 |
Initial marketing-authorisation documents
| Name | Language | First published | Last updated |
|---|---|---|---|
| Pergoveris : EPAR - Scientific Discussion | (English only) | 06/08/2007 | |
| Pergoveris : EPAR - Procedural steps taken before authorisation | (English only) | 06/08/2007 |
Authorised
This medicine is approved for use in the European Union
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