FOLLISTIM (follitropin beta for injection) is the first recombinant follicle-stimulating hormone (FSH) to receive clearance in the United States for the induction of ovulation in women experiencing anovulation (an absence of ovulation) and in women undergoing assisted reproductive technology (ART) procedures.
FOLLISTIM is a highly purified preparation, with a high level of manufacturing consistency.
These advantages result in a reliable and increased supply of this hormone preparation that can be administered subcutaneously and that has a higher specific activity than other FSH agents, such as urofollitropin and menotropin.
FOLLISTIM was studied in the worlds largest randomized in vitro fertilization (IVF) study ever conducted.(1) The study included 981 women undergoing IVF at 18 centers throughout Europe. The results demonstrated that FOLLISTIM is safe and effective as compared to urofollitropin, the most widely used FSH treatment in the U.S. during 1996.
FOLLISTIM acts like naturally produced FSH by stimulating the development of follicles within the ovary. It binds to the FSH receptors located on the surface of small granulosa cells surrounding the immature follicle and oocyte.
Although FOLLISTIM acts to stimulate the maturation of follicles, it does not induce ovulation. For ovulation to occur, therapy with FOLLISTIM is followed by a single administration of 5,000 to 10,000 IU of human chorionic gonadotropin (hCG).
The dosage range for FOLLISTIM is 150 IU to 600 IU daily, depending on the patient response. FOLLISTIM may be administered either subcutaneously or intramuscularly.
Although FOLLISTIM may cause certain adverse effects, the incidence of these events is relatively low and similar to that of other FSH-containing infertility products.
The following adverse events occurred in one percent or more of the patients treated with FOLLISTIM during clinical trials and are similar in type and frequency to those that occurred with urofollitropin:
- Ovarian hyperstimulation syndrome (OHSS 5.2%)
- Miscarriage (3.2%)
- Ectopic pregnancy (2.2%)
- Abdominal pain (1.9%)
- Vaginal hemorrhage (1.1%)
- Injection site pain (1.0%)
The following adverse events occurred in less than one percent of the patients treated with FOLLISTIM during clinical trials and are similar in type and frequency to those that occurred with urofollitropin:
- Ovarian cysts
- Mild to moderate ovarian enlargement
- Body rashes
(1) A prospective, randomized, assessor-blind, multicentre study comparing recombinant and urinary follicle stimulating hormone in in-vitro fertilization, Human Reproduction, vol.10 no.10 pp. 2534-2540, 1995.