Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2017 Publisher: IBSA Farmaceutici Italia S.r.l, Via Martiri di Cefalonia 2, 26900 Lodi Italy
Sterility in women:
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.
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 gonadotropin (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.
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.
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.
No data on acute toxicity of FSH in humans is available, but the acute toxicity of urinary gonadotropin preparations in animal studies has been shown to be very low. Too high a dosage of FSH may lead to hyperstimulation of the ovaries (see section 4.4).
2 years.
After reconstitution, immediate use is recommended.
Do not store above 25°C. Keep the vial and the ampoule in the outer carton, in order to protect from light.
Powder in a vial (type I glass), with a stopper (bromobutylrubber), with a seal (aluminium) and a flip-off cap (plastic) + 1 ml of solvent in an ampoule (type I glass); pack size of 1, 5 and 10 sets.
Not all pack sizes may be marketed.
The solution must be prepared just before injection.
One vial is for single use only. The medicinal product must be reconstituted under aseptic conditions.
Fostimon must only be reconstituted with the solvent provided in the package.
A clean surface should be prepared and hands should first be washed before the solution is reconstituted.
Set out all the following items on the clean surface:
Both intramuscular and subcutaneous routes of administration are possible. If the intramuscular route is preferred appropriate needles will have to be prescribed.
1. Open the solvent ampoule containing the clear liquid.
A coloured mark is indicated on the tip of the solvent ampoule: At this mark the ampoule neck is specifically designed to break more easily. Gently tap the top of the ampoule to dislodge any liquid which may remain in the tip. Firmly press the ampoule above the neck and break it while levering up at the coloured mark. Carefully place the opened ampoule onto the preparation area.
Withdraw the solvent:
Attach the reconstitution needle (long needle) to the syringe. With the syringe in one hand, hold the previously opened solvent ampoule, place the needle into it and withdraw all the solvent. Place the syringe very carefully on the preparation area and avoid touching the needle.
Presentations other than ampoules (prefilled syringe) should be considered for selfadministration by patients, for example FostimonKit.
Prepare the solution for injection:
2. Remove the coloured plastic cap from the powder vial by gently pushing it upwards. Disinfect the top of the rubber stopper by wiping it with an alcohol swab and allow to dry.
3. Pick up the syringe and slowly inject the solvent into the powder vial through the middle of the top of the rubber stopper. Press the plunger down firmly to squirt all the solution onto the powder. Do not shake, but gently roll the vial between the hands until the powder is completely dissolved, taking care to avoid creating a foam.
4. Once the powder is dissolved (which, in general, occurs immediately), slowly draw the solution into the syringe.
Preparation of higher doses, using more than 1 vial of powder.
When reconstituting more than 1 vial of Fostimon, at the end of step 4 above, draw the reconstituted contents of the first vial back into the syringe, and slowly inject into a second vial. Repeat steps 2 to 4 for the second and subsequent vials, and until the contents of the required number of vials equivalent to the prescribed dosage are dissolved (within the limit of the maximum total dosage of 450 IU, corresponding to a maximum of 6 vials of Fostimon 75 IU, or 3 vials of Fostimon 150 IU).
The solution must be clear and colourless.
Any unused product or waste material should be disposed of in accordance with local requirements (once the injection is ended, all the needles and empty ampoules should be disposed of in an appropriate container).
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
