What is Bemfola - follitropin alfa used for and what is it used for?
Bemfola is a medicine that contains the active substance follitropin alfa . It is used for the treatment of the following groups of subjects:
- women who cannot ovulate and do not respond to treatment with clomiphene citrate (another medicine that stimulates the ovaries to produce eggs);
- women undergoing assisted reproduction techniques (fertility therapy) such as in vitro fertilization. Bemfola is administered to stimulate the ovaries to produce more than one egg at a time;
- women with severe impairment (very low levels) of luteinizing hormone (LH) and follicle stimulating hormone (FSH). Bemfola is given together with a medicine containing LH to stimulate the eggs to mature in the ovaries;
- men with hypogonadotrophic hypogonadism (a rare disease characterized by hormonal deficit). Bemfola is used together with human chorionic gonadotropin (hCG) to stimulate sperm production.
Bemfola is a "biosimilar" medicine. This means that it should have been similar to a biological medicine (the "reference medicine") that has already been authorized in the European Union (EU). The reference medicine for Bemfola is GONAL-f. For more information on biosimilar medicines, see the questions and answers by clicking here.
How is Bemfola - follitropin alfa used?
Bemfola is available as a solution for injection in a pre-filled 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 disorders.
Bemfola is given by subcutaneous injection once a day. The dosage and frequency of administration of Bemfola depend on the use for which it is intended and the patient's response to treatment. After the first injection, the patient or his partner can give the injections independently, as long as they are properly motivated, educated and with the possibility of having recourse to an expert's advice.
For more information, see the package leaflet.
How does Bemfola - follitropin alfa work?
The active substance in Bemfola, follitropin alfa, is a copy of the natural FSH hormone. In the body, FSH regulates the reproductive function: in women it stimulates the production of eggs in the ovaries, while in humans it stimulates the production of sperm by the testicles.
In the past, FSH used in medicines was extracted from urine. The follitropin alfa contained in the medicinal product Bemfola and in the reference medicinal product is produced by a method known as "recombinant DNA technology": that is, it is obtained from cells in which a gene (DNA) has been introduced that allows them to produce human FSH .
What benefit has Bemfola - follitropin alfa shown during the studies?
Bemfola was compared to GONAL-f in a main study involving 372 women undergoing assisted reproduction techniques. The main measure of effectiveness was the number of eggs collected. Bemfola has been shown to be comparable to the reference medicine, GONAL-f. The study showed that Bemfola was as effective as GONAL-f in stimulating the ovaries during assisted reproduction techniques, since with both medicines an average of 11 eggs were collected.
What is the risk associated with Bemfola - follitropin alfa?
The most common side effects with Bemfola (which may affect more than 1 in 10 people) are reactions at the injection site (pain, erythema, hematoma, swelling or irritation). In women, ovarian cysts (fluid sacs in the ovaries) and headaches are also seen in more than 1 in 10 patients. For the full list of side effects reported with Bemfola, see the package leaflet. Bemfola should not be used in people who are hypersensitive (allergic) to follitropin alfa, FSH or any of the other ingredients. It must not be used in patients with cancer of the pituitary gland or hypothalamus, lungs, uterus or ovaries. It should not be used in patients where an effective response is not possible, such as those with ovarian or testicular insufficiency or in women whose pregnancy is not recommended for medical reasons. In women, Bemfola should not be used in the presence of an ovary or cyst that is not due to polycystic ovarian disease, or unexplained vaginal bleeding. For the full list of limitations, see the package leaflet. In some women the ovaries may over-respond to stimulation. This phenomenon is called "ovarian hyperstimulation syndrome". Physicians and patients should be aware of this possibility. For more information, see the package leaflet.
Why has Bemfola - follitropin alfa been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) has decided that, in accordance with EU requirements for biosimilar medicines, Bemfola has been shown to have a comparable quality, safety and efficacy profile to GONAL-f. Therefore, the CHMP considered that, as in the case of GONAL-f, the benefits outweigh the identified risks and recommended that Bemfola be given marketing authorization. The committee recommended that Bemfola be given marketing authorization.
What measures are being taken to ensure the safe and effective use of Bemfola - follitropin alfa?
A risk management plan has been developed to ensure that Bemfola is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Bemfola, including the appropriate precautions to be followed by healthcare professionals and patients. Further information is available in the summary of the risk management plan.
Other information about Bemfola - follitropin alfa
On 27 March 2014, the European Commission issued a marketing authorization for Bemfola, valid throughout the European Union. For more information about treatment with Bemfola, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. Last update of this summary: 03-2014.
