What is Rekovelle -Follitropina delta and what is it used for?
Rekovelle is a medicine given to women undergoing fertility treatment, such as in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI). It is used to stimulate the ovaries to produce more than one egg at a time; the egg is then collected and fertilized in the laboratory.
Rekovelle contains the active substance follitropin delta.
How is Rekovelle -Follitropina delta used?
Rekovelle is available as a solution for injection, contained in a cartridge to be used with the Rekovelle injection pen. The medicine can only be obtained with a prescription and treatment should be started under the supervision of a doctor experienced in treating fertility problems.
Rekovelle is administered by subcutaneous injection (under the skin) once a day for several consecutive days during a woman's menstrual cycle beginning on the 2nd or 3rd day of the cycle and continuing until a sufficient number of eggs have been produced. The initial dose of Rekovelle depends on the woman's body weight and the level of the anti-Müllerian hormone (AMH, an indicator of how the ovaries respond to stimulation) in the blood. The dose can then be modified in subsequent cycles based on the woman's response to treatment. After the first injection, the patient or her partner may be able to give the injections independently, provided they are properly instructed and can consult an expert.
For more information, see the package leaflet.
How does Rekovelle -Follitropina delta work?
The active ingredient contained in Rekovelle, follitropin delta, is a copy of the natural hormone called follicle-stimulating hormone (FSH), which plays an essential role in women's fertility by stimulating the production of eggs in the ovaries. Providing additional stimulation with Rekovelle helps to increase the number of eggs produced in the ovaries, which means that more eggs can be collected and fertilized in the laboratory.
What benefit has Rekovelle -Follitropin delta shown during the studies?
Rekovelle was compared with GONAL-f (follitropin alfa), another fertility medicine, in a study of 1 326 women who had undergone controlled ovarian stimulation for IVF or ICSI. The main measure of effectiveness was the percentage of implantation and pregnancy.
The study showed that Rekovelle was as effective as GONAL-f for ovarian stimulation: about 31% of women (204 of 665) treated with Rekovelle reached pregnancy compared to about 32% of women (209 out of 661) treated with Gonal-f. Also the implantation percentages were similar: about 35% with Rekovelle against about 36% with GONAL-f.
What are the risks associated with Rekovelle -Follitropina delta?
The most common side effects of Rekovelle (which may affect up to 10 people in 100) are headache (headache), discomfort and pain in the pelvic area that can result from ovaries, nausea and fatigue, and ovarian hyperstimulation syndrome (OHSS). Ovarian hyperstimulation syndrome occurs when a woman's ovaries respond excessively to treatment, causing symptoms such as vomiting, diarrhea and pain. In severe cases, OHSS can lead to breathing difficulties and blood clotting problems. The frequency of undesirable effects may decrease with repeated therapeutic cycles. For the full list of all side effects reported with Rekovelle, see the package leaflet.
Rekovelle should not be used in women with pituitary or hypothalamus tumors, or with breast, uterine or ovarian cancers. Rekovelle should not be used in the presence of enlarged ovaries or cysts in the ovaries (unless they are caused by polycystic ovarian syndrome) or in the presence of vaginal bleeding without any known cause. For the full list of limitations, see the package leaflet.
Why has Rekovelle -Follitropina delta been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Rekovelle's benefits are greater than its risks and recommended that it be approved for use in the EU.
The CHMP considered Rekovelle effective for the production of several eggs at the same time following the stimulation of women undergoing fertility treatment. The safety profile of Rekovelle was considered acceptable and similar to that of GONAL-f.
What measures are being taken to ensure the safe and effective use of Rekovelle -Follitropina delta?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Rekovelle have been included in the summary of product characteristics and the package leaflet.
More information on Rekovelle -Follitropina delta
For the full EPAR for Rekovelle, consult the website of the Agency: ema.europa.eu/Find medicine / Human medicines / European public assessment reports. For more information about treatment with Rekovelle, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
