hMG, FSH and LH prepared from human urine collected from postmenopausal women. First extracted in 1953. Injected intra-muscularily or subcutaneously. Generic Brands The more common side effects of preparations containing FSH and LH are:
Preparations of follicle-stimulating hormone mainly include those derived from the urine of menopausal women, as well as recombinant preparations. The recombinant preparations are more pure and more easily administered, but they are more expensive. The urinary preparations are equally effective and less expensive, but are not as convenient to administer as they are available in vials versus injection pens. One study reported that users of the purified urinary FSH preparation Bravelle experienced less injection site pain compared to the recombinant preparation Follistim.
Urinary preparations
Recombinant preparations
The package insert for Gonal-f states that based on physio-chemical tests and bioassays that follitropin beta and follitropin alfa are indistinguishable. Two studies showed no difference. However, a more recent study showed there may be a slight clinical difference, with the alfa form tending towards a higher pregnancy rate and the beta form tending towards a lower pregnancy rate, but with significantly higher estradiol levels. The package insert for Puregon states that structural analysis shows that the amino acid sequence of follitropin beta is identical to that of natural human follicle stimulating hormone. Further, the ogliosaccharide side chains are very similar, but not completely identical to that of natural hFSH. However, these small differences do not affect the bioactivity compared to natural hFSH. Gonal-f was approved for use in the European Union in October 1995.
Biosimilars
Bemfola, Ovaleap Ovaleap was approved for use in the European Union in September 2013. Bemfola was approved for use in the European Union in March 2014.
Side effects of FSH preparations
Side effects of FSH preparations include:
Local irritation at the injection site
Feeling of fullness, bloating, and tenderness in the lower abdomen due to increasing size of the ovaries.
Mood swings
Fatigue
FSH analogues
Merck received approval on February 15, 2010 from the European Commission for ELONVA a long lasting single injection fusion protein lacking LH activity. Only one injection is required for the first seven days, replacing the first seven daily injections of conventional FSH. Initial results demonstrates similar pregnancy rates as daily recombinant FSH injections.
can be recovered from the urine of pregnant women or be produced from recombinant DNA. It acts similarly to LH, but the larger supply makes it less costly; it also has a longer half-life. In veterinary medicine, equine chorionic gonadotropin extracted from pregnant mare serum is used instead on a variety of mammals, sometimes eliciting an immune response in non-horse species. In Women: Used to induce final maturation of follicle and subsequent ovulation. Also used for luteal phase support. Typically a single injection of 10,000 international units is used to induce ovulation. In men: Used to treat select cases of Hypogonadotropic Hypogonadism in adult males. Typical dosages are 500-1000IU three times weekly, or 4,000IU three times weekly for 6-9 months until atrophy is reversed and the dose is reduced to 2,000IU three times weekly. These doses are starting guidelines for treatment, and variable depending on individual response. In off-label use, some urologists prescribe hCG in low doses in combination with Testosterone replacement to preserve fertility. In male children: Also used to treat prepubertal cryptorchidism not due to anatomical obstruction. therapy is usually administered between ages 4 and 9. Recent data has shown that subcutaneous injection works as well as intramuscular injection, however this form of administration is not FDA approved.
