WHAT İS GONAL -F?
GONAL-F is a medicine containing the active substance follitropin alfa. It is available as a solution for injection in a prefilled pen and as powder and solvent made into a solution for injection.
WHAT İS GONAL -F USED FOR?
GONAL-F is used to treat the following groups:
- Adult women (18 years of age and older) who do not produce eggs and do not respond to treatment with clomiphene citrate (another medicine that stimulates the ovaries to produce eggs);
- Adult women undergoing an assisted reproductive technique (fertility treatment) such as in vitro fertilisation. GONAL -F is administered to stimulate the ovaries to produce more than one egg at a time;
- Adult women with severe deficiencies (very low levels) of luteinizing hormone (LH) and follicle-stimulating hormone (FSH). GONAL –F is given along with a drug containing LH to stimulate eggs to mature in the ovaries;
- Adult men who have hypogonadotrophic hypogonadism (a rare hormone deficiency disorder).
GONAL-F is used together with human chorionic gonadotropin (HCG) to stimulate sperm production.
HOW İS GONAL -F USED?
Treatment with GONAL –F should be performed by a doctor experienced in treating fertility disorders.
GONAL-F is administered once daily by injection under the skin. If the powder is used, it should be mixed with the solvent provided immediately before use. The dose of GONAL -F and the frequency of administration depend on the reason for use and the patient's response to treatment. After the first injection, the patient or their partner can self-administer the injections if they are well motivated, trained and have access to expert advice.
HOW DOES GONAL -F WORK?
The active ingredient in GONAL -F, follitropin alfa, is a copy of the natural hormone FSH. In the body, FSH controls reproductive function in the body: in women, it stimulates the production of eggs; in men, it stimulates the production of sperm in the testicles.
Until now, the FSH used in pharmaceuticals has been derived from urine. The follitropin alfa in GONAL -F is produced by a method known as 'recombinant DNA technology': it is made by a cell that has been given a gene (DNA) that enables it to produce human FSH.
HOW WAS GONAL -F STUDIED?
GONAL-F was studied in 222 women who did not produce eggs or did not respond to clomiphene citrate. It has also been studied in 470 women as part of assisted reproductive techniques. In these studies,
- GONAL-F was compared to human FSH extracted from urine.
- GONAL-F in combination with LH was also studied in 38 women with severe LH and FSH deficiency, and in combination with hCG in 19 men with hypogonadotrophic hypogonadism. Because these conditions are rare, GONAL -F was not compared with other treatments in these studies, and the small number of patients in the studies was considered acceptable.
- In the studies with women, efficacy was measured primarily by the number of eggs retrieved, the number of women who released eggs, and the number of follicles (small sacs containing the eggs) formed in the ovaries. For men, the studies looked at the number of men who started producing sperm within the first 18 months of treatment.
WHAT BENEFIT DID GONAL -F SHOW IN THE STUDIES?
GONAL-F was as effective as human FSH in women who did not produce eggs or did not respond to clomiphene citrate: 84% of women who received GONAL -F produced eggs, compared with 91% of women who received human FSH. GONAL-F was also as effective as human FSH in stimulating the ovaries during assisted reproductive techniques.
GONAL-F was effective in stimulating oocyte formation in women with severe LH and FSH deficiency. In the study in men, GONAL -F in combination with HCG was effective in stimulating sperm production: 63% of men started to produce sperm.
WHAT ARE THE RISKS ASSOCIATED WITH GONAL -F?
The most common side effects of GONAL –F (observed in more than 1 in 10 patients) are injection site reactions (pain, redness, bruising, swelling, or irritation). In women, ovarian cysts (fluid sacs in the ovaries) and headache are also observed in more than 1 in 10 patients. For a complete list of side effects reported in association with GONAL -F, see the package leaflet.
GONAL-F must not be used in individuals who may be hypersensitive (allergic) to follitropin alfa, FSH, or any of the other ingredients. It must not be used in patients with tumours of the pituitary gland or hypothalamus or with breast, uterine, or ovarian cancer. It must not be used if an effective patient response is not possible, such as in patients whose ovaries or testes are not functioning, or in women who are not allowed to become pregnant for medical reasons. In women, GONAL -F should not be used if there is an enlarged ovary or cyst caused by anything other than polycystic ovary disease, or if there is unexplained bleeding from the vagina. See the package insert for a complete list of restrictions.