Follicle stimulating hormone

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[edit] BRAND NAMES

[edit] MECHANISM OF ACTION

FSH stimulates the follicles directly and produces ovarian follicular growth and maturation. When sufficient follicular maturation has occurred, hCG must be given to induce ovulation. .

FSH is typically used alone for women who have taken clomiphene and failed. Such women often have polycystic ovaries, which is characterized by high LH and low FSH levels. The standard FSH agent has been urofollitropin (Metrodin, Fertinex, Fostimon), which is a FSH extracted from the urine of postmenopausal women.

Recombinant follicle-stimulating hormone (Puregon, Gonal-F, Follistim) is also available. This is a genetically developed form of the natural FSH, which has no risk for contaminants from urinary proteins or any traces of LH.

[edit] INDICATIONS

  • Induction of ovulation in women who have previously received pituitary suppression
  • Development of multiple follicles as part of an Assisted Reproductive Technology (ART) cycle in ovulatory women who have previously received pituitary suppression

[edit] DOSAGE

Ovulation Induction

  • For women who have received GnRH agonist or antagonist pituitary suppression, a starting dose of 150 International Units per day is administered subcutaneously or intramuscularly for 5 days in the first cycle of treatment.
  • Individualization of dosing after 5 days : Appropriate dose adjustment(s), based on clinical monitoring (including serum estradiol levels and vaginal ultrasound results), should be used to prevent multiple follicular growth and cycle cancellation.
  • Dosage adjustments not to occur more frequently than once every 2 days and not to exceed 75 to 150 International Units per adjustment
  • The lowest dose that will achieve desired results must be used. The maximum, individualized, daily dose is 450 International Units per day.
  • In general, do not exceed 12 days of treatment.
  • When pre-ovulatory conditions are reached, administer human chorionic gonadotropin (hCG) to induce final oocyte maturation and ovulation. The couple must be encourage to have intercourse daily, beginning on the day prior to the administration of hCG and until ovulation becomes apparent.
  • In subsequent cycles of treatment, the starting dose (and dosage adjustments) should be determined based on the history of the ovarian response.


Assisted Reproductive Technology (ART)

  • For patients undergoing IVF who have received GnRH agonist or antagonist pituitary suppression, a starting dose of 225 International Units per day is administered subcutaneously, beginning on cycle day 2 or 3, until sufficient follicular development, as determined by ultrasound in combination with measurement of serum estradiol levels, is attained. In most cases, therapy should not exceed 12 days.
  • Individualization of dosing after 5 days : Appropriate dose adjustment(s), based on the woman’s ovarian response, as determined by ultrasound evaluation of follicular growth and serum estradiol levels
  • Dosage adjustments not to occur more frequently than once every 2 days and not to exceed 75 to 150 International Units per adjustment
  • The lowest dose that will achieve desired results must be used. The maximum, individualized, daily dose is 450 International Units per day.
  • In general, do not exceed 12 days of treatment.
  • Continue treatment until adequate follicular development is evident, and then administer hCG.

[edit] CONTRAINDICATIONS

  • Prior hypersensitivity to Urofollitropins
  • High levels of FSH indicating primary ovarian failure
  • Pregnancy
  • Presence of uncontrolled non-gonadal endocrinopathies
  • Sex hormone dependent tumors of the reproductive tract and accessory organ
  • Tumors of pituitary gland or hypothalamus
  • Abnormal uterine bleeding of undetermined origin
  • Ovarian cysts or enlargement of undetermined origin, not due to polycystic ovary syndrome

[edit] WARNINGS AND PRECAUTIONS

See full prescribing information

  • Abnormal Ovarian Enlargement
  • Ovarian Hyperstimulation Syndrome
  • Pulmonary and Vascular Complications
  • Ovarian Torsion
  • Multi-fetal Gestation and Birth
  • Congenital Malformations
  • Ectopic Pregnancy
  • Spontaneous Abortion
  • Ovarian Neoplasms

[edit] INTERACTIONS

No drug/drug interaction studies have been conducted for Urofollitropin in humans

[edit] PREGNANCY AND LACTATION

  • Pregnancy Category X (US). Do not use Urofollitropin in pregnant women.
  • Nursing Mothers: It is not known whether Urofollitropin is excreted in human milk.

[edit] SIDE EFFECTS

  • The most common adverse reactions (≥5% incidence) in ovulation induction include: headache, hot flashes, Ovarian Hyperstimulation Syndrome, pain, and respiratory disorder
  • The most common adverse reactions (≥2% incidence) in ART include: abdominal cramps, abdominal fullness/enlargement, headache, nausea, Ovarian Hyperstimulation Syndrome, pain, pelvic pain, and post retrieval pain.

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