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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/422139/2012

EMEA/H/C/00714

EPAR summary for the public

Pergoveris

follitropin alfa / lutropin alfa

This is a summary of the European public assessment report (EPAR) for Pergoveris. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Pergoveris.

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 adult 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.

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© European Medicines Agency, 2012. Reproduction is authorised provided the source is acknowledged.

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 may help these 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 reported with Pergoveris (seen in more than 1 patient in 10) are headache, ovarian cysts and injection site reactions (e.g. pain, itching, redness, bruising, swelling or irritation at the site of injection). Treatment can cause overstimulation of the ovaries (known as ovarian hyperstimulation syndrome, OHSS), which can lead to serious medical problems. Mild or moderate OHSS is common, while severe OHSS is uncommon. Thromboembolism (problems with blood clots in the blood vessels) may occur very rarely, usually associated with severe OHSS. For the full list of all side effects reported with Pergoveris, see the package leaflet.

Pergoveris must not be used in people who are 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 and is of unknown origin,

•    bleeding from the genital region whose cause is unknown,

•    cancer of the ovary, womb or breast.

Pergoveris must not be used when a benefit cannot be obtained, such as in women with primary ovarian failure (when the ovaries stop working before the menopause). It must also not be used in women who have malformations of the sexual organs or fibroid tumours of the womb that would stop them from becoming pregnant.

Why has Pergoveris been approved?

The CHMP decided that Pergoveris's benefits are greater than its risks and recommended that it be given marketing authorisation.

Other information about Pergoveris

The European Commission granted a marketing authorisation valid throughout the European Union for Pergoveris on 25 June 2007.

The full EPAR for Pergoveris can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. For more information about treatment with Pergoveris, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 06-2012.

Pergoveris