Posology : מינונים

4.2 Posology and method of administration

Treatment with FOSTIMON should be initiated under the supervision of a physician experienced in the treatment of infertility problems.
There are great inter- and intra-individual variations in the response of the ovaries to exogenous gonadotropins. 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 may also include monitoring of oestradiol levels.

Posology
Anovulation (including PCOS):
The objective of a treatment with FOSTIMON is to develop a single mature de Graaf follicle from which the ovum will be released after the administration of human chorionic gonadotrophin (hCG).
FOSTIMON can be administered by daily injection. In menstruating patients the treatment should begin within the first 7 days of the menstrual cycle.
A commonly used regimen starts at 75 to 150 IU of FSH per day and is increased if necessary by 37.5 IU (up to 75 IU), with intervals of 7 or 14 days preferably, in order to achieve an adequate but not excessive response.
The treatment should be adjusted to the individual patient's response, assessed by measuring the follicle size by ultrasonography and/or oestrogen levels.
The daily dose is then maintained until pre-ovulatory conditions are reached. Usually, 7 to 14 days of treatment is sufficient to reach this state.
The administration of FOSTIMON is then discontinued and ovulation can be induced by administering human chorionic gonadotropin (hCG).
If the number of responding follicles is too high or oestradiol levels increase too rapidly, i.e. more than a daily doubling for oestradiol for two or three consecutive days, the daily dose should be decreased. Since follicles of over 14 mm may lead to pregnancies, multiple pre-ovulatory follicles exceeding 14 mm carry the risk of multiple gestations. In that case hCG should be withheld and pregnancy should be avoided in order to prevent multiple gestations. The patient should use a barrier method of contraception or refrain from having coitus until the next menstrual bleeding has started (see section 4.4). The treatment should recommence in the next treatment cycle at a lower dose than in the previous cycle.
Maximum daily dosages of FSH should generally not exceed 225 IU.
If a patient fails to adequately respond after 4 weeks of treatment, the cycle should be abandoned and the patient should recommence at a higher initial dose than in the previous cycle.
Once the ideal response is obtained, a single injection of 5 000 IU to 10 000 IU of hCG should be administered 24 to 48 hours after the last FOSTIMON injection.
The patient is recommended to have coitus on the day of hCG injection and the following day.
Alternatively, intrauterine insemination may be performed.

Controlled ovarian hyperstimulation during ART:
Pituitary down-regulation in order to suppress the endogenous LH peak and to control basal levels of LH is now commonly achieved by administration of a gonadotropin releasing hormone agonist (GnRH agonist).
In a commonly used protocol the administration of FOSTIMON begins approximately two weeks after the start of the agonist treatment, both treatments are then continued until adequate follicular development has been achieved. For example, following two weeks of pituitary down-regulation with agonist, 150 to 225 IU of FSH are administered for the first seven days. The dose is then adjusted according to the patient's ovarian response.
An alternative protocol for superovulation involves the administration of 150 to 225 IU of FSH daily starting on the 2nd or 3rd day of the cycle. The treatment is continued until sufficient follicular development has been achieved (assessed by monitoring of serum oestrogen concentrations and/or ultrasound) with the dose adjusted according to the patient's response (usually not higher than 450 IU daily). Adequate follicular development is usually achieved on average around the tenth day of treatment (5 to 20 days).
When an optimal response is obtained a single injection of 5 000 IU to 10 000 IU of hCG administered 24 to 48 hours after the last FOSTIMON injection, to induce final follicular maturation.
Oocyte retrieval is performed 34-35 hours later.

Method of administration
FOSTIMON is intended for intramuscular or subcutaneous administration.
The powder should be reconstituted immediately prior to use with the solvent provided.

To prevent painful injections and minimize leakage from the injection site FOSTIMON should be slowly administered intramuscularly or subcutaneously. The subcutaneous injection site should be alternated to prevent lipo-atrophy. Any unused solution should be discarded.

Subcutaneous injections can be self-administered by the patient, provided the physician's instructions and recommendations are strictly followed.