Luveris - lutropin alfa

What is Luveris?

Luveris is a medicine that contains the active substance lutropin alfa. It is available as a powder and solvent to make up a solution for injection and as a solution for injection in a cartridge.

What is Luveris used for?

Luveris is used in the treatment of infertility. Taken together with follicle-stimulating hormone (FSH), it stimulates the maturation of eggs in the ovaries of women with severe deficiency (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 physicians experienced in infertility treatment.
Luveris is given together with FSH once a day. Response to treatment should be monitored to monitor the evolution of egg development in the ovary. The FSH dose should be adjusted according to the patient's response and treatment may last. up to five weeks. Luveris is given by injection under the skin (under the skin). The injection can be practiced by the patient herself appropriately instructed by the doctor and on condition that she has the possibility to consult with an expert.
If the powder and solvent are used, they must be mixed immediately before use. The resulting solution can be mixed with FSH in the same syringe. One vial of powder and solvent are for single use only, but each cartridge of solution contains six doses of Luveris.

How does Luveris work?

The active substance in Luveris is lutropin alfa, a replica of the naturally produced hormone LH. When released into the body, the hormone LH causes the eggs to be released (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': it is made by a cell that has received a gene (DNA), which makes it capable of producing human LH.

How has Luveris been studied?

Luveris, given with FSH, was the subject of a main study involving 38 women with severe LH and FSH deficiency. Due to the small number of patients with this dysfunction, Luveris was not compared with any other medicines. The main measure of effectiveness 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 out of 9). Higher doses did not show greater efficacy than at this dose.

What is the risk associated with Luveris?

The most common side effects seen with Luveris (seen in 1 to 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 fluid-filled cavity in the ovaries) and breast pain. Ovarian hyperstimulation syndrome occurs when the ovaries over-respond to treatment, especially if they have been used medicines to stimulate ovulation. For the full list of side effects reported with Luveris, see the Package Leaflet.
Luveris must not be used in people who may be hypersensitive (allergic) to "LH," FSH or other ingredients of the medicine. It must not be used in women with cancer of the pituitary gland, hypothalamus, breast, uterus or ovaries. It should also not be used in the presence of ovarian enlargement or the presence of cysts not due to polycystic ovarian disease, or unexplained vaginal bleeding. For the complete list of restrictions on use, 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 combination with an FSH preparation in stimulating follicular development in women with severe LH and FSH deficiency. The committee recommended the granting of a marketing authorization for Luveris.

Other information about Luveris:

On 29 November 2000, the European Commission granted Serono Europe Limited a "Marketing Authorization" for Luveris, valid throughout the European Union. The "Marketing Authorization" was renewed on 29 November 2005.
For the full version of Luveris EPAR click here.

Last update of this summary: 04-2009.


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