Indication
Clinical Particulars
Therapeutic indications
In the Female:
Ovulation Induction
FSH administered IM or SC with HCG in a sequential manner, which is indicated for ovulation
induction in patients who have previously received pituitary suppression.
Multi-follicular Development
During ART FSH administered IM in conjunction with HCG is indicated for multiple follicular
developments (controlled ovarian stimulation) during ART cycles in patients who have
previously received pituitary suppression.
Polycystic Ovarian Syndrome (PCOS)
Used to treat Polycystic Ovarian Syndrome (PCOS) related infertility
In the Male: Male infertility treatment in combination with HCG Induction of Spermatogenesis in
men deficient spermatogenesis due to Hypogonadotrophic-hypogonadism.
Dosage & Administration
To prevent painful injections and minimize leakage from the injection site FSH should be slowly
administered intramuscularly or subcutaneously. The subcutaneous injection site should be
alternated to prevent lipoathrophy. Any unused solution should be discarded. Subcutaneous
injection of FSH may be carried out by patient or partner, provided that proper instructions are
given by the physician. Self administration of FSH should only be performed by patients who
are well-motivated, adequately trained and with access to expert advice.
Dosage in Female
There are great inter and intra-individual variations in the response of the ovaries to exogenous
gonadotrophins. This makes it impossible to set a uniform dosage scheme. The dosage should,
therefore, be adjusted individually depending on the ovarian response. This requires
ultrasonography and monitoring of oestradiol levels. There should be consideration to minimize
the risk of unwanted ovarian hyperstimulation. FSH can be given either alone, or in
combination with a GnRH analogue to prevent premature luteinisation. In the later case,
especially when using a GnRH agonist, a higher total treatment dose of FSH may be required
to achieve an adequate follicular response. Clinical experience with FSH is based on up to
three treatment cycles in both indications. Overall experience with IVF indicates that in general
the treatment success rate remains stable during the first four attempts and gradually declines
thereafter.
Ovulation Induction in Women
Starting daily dose of 50 international units (IU) of FSH is administered subcutaneously or
intramuscularly for at least the first 7 days. The dose is increased by 25 or 50 international units
(IU) at weekly intervals until follicular growth and/or serum estradiol levels indicate an adequate
response. When an acceptable pre-ovulatory state is achieved, final oocyte maturation is
achieved with 5000 to 10,000 international units (IU) of human chorionic gonadotropin (HCG).
The woman and her partner should have intercourse daily, beginning on the day prior to the
administration of HCG and until ovulation becomes apparent.
Assisted Reproductive Technology (ART)
In Women; Starting dose of 150 to 225 international units (IU) of FSH is administered
intramuscularly for at least the first 4 days of treatment. Subsequent doses are adjusted based
upon ovarian response as determined by ultrasound evaluation of follicular growth and serum
estradiol levels. Final oocyte maturation is induced with a dose of 5000-10,000 international
units of HCG Oocyte (egg) retrieval is performed 34 to 36 hours later.
Polycystic Ovarian Syndrome (PCOS)
FSH injections are therefore given each morning as an intramuscular injection. It is best to start
with the lowest dose of FSH per day (using 50 IU per day). These doses are used for 4 to 6
days at a time. The ovarian response is determined by measuring oestrogen levels in the
blood. When the oestrogen begins to rise, the FSH is successfully growing an egg or eggs. If
there is no response to a dose of FSH in 5- 6 days of injections the dose will be increased. The
normal dose increments are 75 units, 112 units, 150 units and 225 units per day. Most patients
respond with 75 to 150 IU per day. However it is very important that increments are only made
cautiously.
Dosage in Male
Induction of Spermatogenesis in Men
Pre-treatment with HCG alone (1500 international units (IU) twice weekly) is required. If serum
testosterone levels have not normalized after 8 weeks of HCG treatment, the dose may be
increased to 3000 international units (IU) twice a week. After normalization of serum
testosterone levels, administer 450 international units (IU) per week (225 international units
twice weekly or 150 international units (IU) three times weekly) of FSH subcutaneously with
the same pre-treatment HCG dose used to normalize testosterone level.
Precautions
Special Warnings and Special Precautions for Use
The presence of uncontrolled non gonodalendocrinopathies (e.g. thyroid, adrenal or pituitary
disorders) should be excluded.
? In pregnancies occurring after induction of ovulation with gonadotrophin preparations, there is
an increased risk of multiple gestations (Multiple birth).
? There has been no reports of hypersensitivity to Follicle Stimulating Hormone, but there
remains the possibility of anaphylactic responses.
? The first injection of Follicle Stimulating Hormone should be performed under direct medical
supervision.
? Since infertile women undergoing assisted reproduction, and particularly IVF, often have tubal
abnormalities the incidence of ectopic pregnancies might be increased. Early ultrasound
confirmation that a pregnancy is intrauterine is therefore important.
? Rates of pregnancy loss in women undergoing assisted reproduction techniques are higher
than in the normal population.
? Unwanted ovarian hyperstimulation in the treatment of female patients, ultrasonographic
assessment of follicular development, and determination of oestradiol levels should be
performed prior to treatment and at regular intervals during treatment. Apart from the
development of a high number of follicles, oestradiol levels may rise very rapidly, e.g. more
than a daily doubling for two or three consecutive days, and possibly reaching excessively high
values. The diagnosis of ovarian hyperstimulation may be confirmed by ultrasound
examination. If this unwanted ovarian hyperstimulation occurs (i.e. not as part of controlled
ovarian hyperstimulation in medically assisted reproduction programs), the administration of
Follicle Stimulating Hormone should be discontinued. In that case pregnancy should be
avoided and Human Chorionic Gonadotrophin must be withheld, because it may induce, in
addition to multiple ovulation, the Ovarian Hyperstimulation Syndrome (OHSS).
? In men, semen analysis is recommended 4 to 6 months after the beginning of treatment in
assessing the response.
Pregnancy and Lactation
Category: X (Follicle Stimulating Hormone must not be used during pregnancy and lactation).
