Luveris
Authorised
This medicine is authorised for use in the European Union
lutropin alfa
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
This is a summary of the European public assessment report (EPAR) for Luveris. 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 Luveris.
Luveris is a medicine that contains the active substance lutropin alfa. It is available as a powder and solvent that are made up into a solution for injection, and as a solution for injection in a prefilled pen.
Luveris is a fertility treatment. It is used with follicle-stimulating hormone (FSH) to stimulate the development of eggs in the ovaries of adult women who have severe deficiency (very low levels) of luteinising hormone (LH) and FSH.
The medicine can only be obtained with a prescription.
Treatment with Luveris should be carried out by a doctor who has experience in the treatment of fertility problems.
Luveris is given once a day together with FSH. The patient’s response to treatment is monitored to check how the egg development in the ovary is progressing. Doses of FSH are adjusted according to the response, and treatment may continue for up to five weeks. Luveris is given by injection under the skin. The patient may carry out the injection herself if she is well motivated, has been adequately trained and has access to expert advice.
If the powder and solvent are used, they should be mixed together just before use. The resulting solution can be mixed with FSH in the same syringe.
The active substance in Luveris, lutropin alfa, is a copy of the natural hormone LH. In the body, LH causes the release of eggs (ovulation) during the menstrual cycle. FSH, which is used together with Luveris, also stimulates ovulation.
Lutropin alfa is produced by a method known as ‘recombinant DNA technology’: it is made by a cell that has received a gene (DNA), which makes it able to produce human LH.
Luveris, given together with FSH, has been studied in one main study involving 38 women with severe LH and FSH deficiency. Because the number of patients with this condition is low, Luveris was not compared with any other medicines. The main measure of effectiveness was the number of women who produced functional follicles (eggs in the ovaries that are ready for release).
In the main study, 67% of the women who received the approved dose of Luveris (75 International Units) together with FSH produced functional follicles (6 out of 9). Higher doses were no more effective than this dose.
The most common side effects with Luveris (seen in between 1 and 10 patients in 100) are reactions at the injection site (pain, redness, bruising or swelling), headache,, nausea (feeling sick), vomiting, diarrhoea, abdominal pain and discomfort, pelvic (lower abdominal) pain, mild to moderate ovarian hyperstimulation syndrome, ovarian cyst (development of a fluid-filled cavity in the ovary) and breast pain. Ovarian hyperstimulation syndrome occurs when the ovaries over respond to treatment, especially when medicines to trigger ovulation have been used, and can cause nausea, weight gain and diarrhoea. For the full list of all side effects reported with Luveris, see the package leaflet.
Luveris should not be used in people who may be hypersensitive (allergic) to LH, FSH or any of the other ingredients. It must not be used in women who have tumours of the pituitary gland, hypothalamus (a region of the brain), breast, womb or ovary. It must also not be used when there is enlargement of the ovaries or cysts that are not related to polycystic ovarian disease and are of unknown origin, or unexplained bleeding from the vagina. For the full list of restrictions, see the package leaflet.
The CHMP decided that Luveris’s benefits are greater than its risks and recommended that it be given marketing authorisation.
The European Commission granted a marketing authorisation valid throughout the European Union for Luveris to Merck Serono Europe Limited on 29 November 2000. The marketing authorisation is valid for an unlimited period.
For more information about treatment with Luveris, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Product information
Latest procedure affecting product information:
IA/0100
19/07/2024
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Luveris
- Active substance
- lutropin alfa
- International non-proprietary name (INN) or common name
- lutropin alfa
- Therapeutic area (MeSH)
- Ovulation Induction
- Infertility, Female
- Anatomical therapeutic chemical (ATC) code
- G03GA07
Pharmacotherapeutic group
Sex hormones and modulators of the genital systemTherapeutic indication
Luveris in association with a follicle-stimulating-hormone (FSH) preparation is recommended for the stimulation of follicular development in women with severe luteinising-hormone (LH) and FSH deficiency. In clinical trials, these patients were defined by an endogenous serum LH level <1.2 IU/l.
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