What is Luveris?
Luveris is a medicine that contains the active substance lutropin alfa. It is available as a powder and solvent for the preparation of a solution for injection and a solution for injection contained in a cartridge.
What is Luveris used for?
Luveris is used to treat infertility. Taken together with follicle-stimulating hormone (FSH), it stimulates the maturation of eggs in the ovaries of women suffering from severe insufficiency (very low levels) of luteinizing hormone (LH) and FSH.
The medicine can only be obtained with a prescription .
How is Luveris used?
Luveris treatment should be conducted by doctors experienced in infertility treatment.
Luveris is given together with FSH once a day. Treatment response should be monitored to monitor the development of ovary development in the ovary. The FSH dose should be adjusted based on the patient's response and treatment can last up to five weeks. Luveris is given by subcutaneous injection (under the skin). The injection can be carried out by the patient herself appropriately trained by the doctor and provided that she has the opportunity to consult with an expert.
If the powder and solvent are used, they must be mixed immediately before use. The solution thus produced can be mixed with the FSH in the same syringe. One vial containing powder and the solvent are for single use only, but each solution cartridge contains six doses of Luveris.
How does Luveris work?
The active ingredient in Luveris is lutropin alfa, a replica of the naturally produced LH hormone. When placed in the body, the hormone LH causes the release of the eggs (ovulation) during the menstrual cycle. Luveris is used in combination with FSH, which also stimulates ovulation.
Lutropin alfa is produced by a method called "recombinant DNA technology": that is, it is obtained from a cell in which a gene (DNA) has been introduced that makes it capable of producing human LH.
What studies have been carried out on Luveris?
Luveris, administered with FSH, was the subject of a main study involving 38 women with severe LH and FSH insufficiency. Given the small number of patients suffering from this dysfunction, Luveris was not compared with other medicines. The main parameter for assessing efficacy was the number of women who produced functional follicles (eggs inside the ovaries ready to be released).
What benefit has Luveris shown during the studies?
In the main study, 67% of women taking the approved dose of Luveris (75 international units) in combination with FSH produced functional follicles (6 of 9). Higher doses showed no greater efficacy than this dose.
What is the risk associated with Luveris?
The most common side effects with Luveris (seen in between 1 and 10 patients in 100) are injection site reactions, headache, drowsiness, nausea, abdominal pain, pain in the pelvic region (lower abdomen), ovarian hyperstimulation syndrome (such as nausea, weight gain and diarrhea), ovarian cysts (development of a cavity filled with fluid in the ovaries) and breast pains. Ovarian hyperstimulation syndrome occurs when the ovaries over-treat, especially if medicines have been used to stimulate ovulation. 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 other ingredients in the medicine. It must not be used in women with cancer of the pituitary gland, hypothalamus, breast, uterus or ovaries. It must also not be used in the presence of increased ovarian volume or the presence of cysts that are not due to polycystic ovarian disease, or unexplained vaginal bleeding. For the full list of usage restrictions, see the package leaflet.
Why has Luveris been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Luveris's benefits are greater than its risks in association with an FSH preparation in stimulating follicular development in women with severe LH and FSH insufficiency. The Committee recommended that Luveris be given marketing authorization.
More information about Luveris:
On 29 November 2000, the European Commission issued a marketing authorization valid for Luveris, valid throughout the European Union, to Serono Europe Limited. The marketing authorization was renewed on 29 November 2005.
The full EPAR for Luveris can be found here.
Last update of this summary: 04-2009.
