Menopur Dosage/Direction for Use

Treatment with MENOPUR should be initiated under the supervision of a physician experienced in the treatment of fertility problems.
Posology: Dosage regimens described as follows are identical for S.C. and I.M. administration.
There are great inter-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. MENOPUR can be given alone or in combination with a gonadotrophin-releasing hormone (GnRH) agonist or antagonist.
Recommendations about dosage and duration of treatment may change depending on the actual treatment protocol.
Women with anovulation (including, PCOD): The object of MENOPUR therapy is to develop a single Graafian follicle from which the oocyte will be liberated after the administration of human chorionic gonadotrophin (hCG).
MENOPUR therapy should start within the initial 7 days of the menstrual cycle. The recommended initial dose of MENOPUR is 75-150 IU daily, which should be maintained for at least 7 days. Based on clinical monitoring (including ovarian ultrasound alone or in combination with measurement of oestradiol levels) subsequent dosing should be adjusted according to individual patient response. Adjustments in dose should not be made more frequently than every 7 days. The recommended dose increment is 37.5 IU per adjustment, and should not exceed 75 IU. The maximum daily dose should not be higher than 225 IU. If a patient fails to respond adequately after 4 weeks of treatment, that cycle should be abandoned and the patient should recommence treatment at a higher starting dose than in the abandoned cycle.
When an optimal response is obtained, a single injection of 5,000 IU to 10,000 IU hCG should be given 1 day after the last MENOPUR injection. The patient is recommended to have coitus on the day of and the day following hCG administration. Alternatively intrauterine insemination (IUI) may be performed. If an excessive response to MENOPUR is obtained treatment should be stopped and hCG withheld (see Precautions) and the patient should use a barrier method of contraception or refrain from having coitus until the next menstrual bleeding has started.
Women undergoing controlled ovarian hyperstimulation for multiple follicular development for assisted reproductive technologies (ART): In a protocol using down-regulation with a GnRH agonists, MENOPUR therapy should start approximately 2 weeks after the start of agonist treatment. In a protocol using down-regulation with a GnRH antagonist, MENOPUR therapy should start on day 2 or 3 of the menstrual cycle. The recommended initial dose of MENOPUR is 150-225 IU daily for at least the first 5 days of treatment. Based on clinical monitoring (including ovarian ultrasound alone or in combination with measurement of oestradiol levels) subsequent dosing should be adjusted according to individual patient response, and should not exceed more than 150 IU per adjustment. The maximum daily dose given should not be higher than 450 IU daily and in most cases dosing beyond 20 days is not recommended.
When a suitable number of follicles have reached an appropriate size a single injection of up to 10,000 IU hCG should be administered to induce final follicular maturation in preparation for oocyte retrieval. Patients should be followed closely for at least 2 weeks after hCG administration. If an excessive response to MENOPUR is obtained treatment should be stopped and hCG withheld (see Precautions) and the patient should use a barrier method of contraception or refrain from having coitus until the next menstrual bleeding has started.
Women with hypo- or normogonadotropic ovarian insufficiency: The dose of MENOPUR required to induce follicular growth in normo- or hypogonadotrophic women must be adjusted individually for each patient. The amount depends on ovarian reaction and should be checked by ultra‑sound examinations of the ovaries and measuring estradiol levels. If the MENOPUR dosage is too high for the treated individual, multiple uni and bilateral follicle growth can occur.
MENOPUR is administered intramuscularly or subcutaneously and in general, the therapy is begun with a daily dosage of corresponding to 75-150 IU FSH (1-2 vials MENOPUR per day). If there is no ovarian reaction, the dose can be gradually increased until there is evidence of estradiol secretion or follicular growth. The dose of HMG should be maintained until the pre-ovulation estradiol serum level is achieved. The dose should be reduced if the level increases too rapidly.
As a measure of follicle maturity the following values can be taken: total urinary oestrogen: 75-150 micrograms (270-540 nmol)/24 hours; plasma 17 beta-oestradiol: 400-800 picograms/ml (1500-3000 pmol/L).
To induce ovulation, 5,000‑10,000 IU hCG should be administered by intramuscular injection 1‑2 days after the last dose of HMG.
Note: Unintentional hyperstimulation of the ovaries can be induced by the administration of hCG after an excessive dose of MENOPUR. Duration of treatment depends on the individual situation of the patient (estradiol level, ultra‑sound). For intramuscular or subcutaneous injection after dissolving the dry substance in the solvent included.
Paediatric population: There is no relevant use of MENOPUR in the paediatric population.
Method of administration: MENOPUR 75 IU is intended for subcutaneous (S.C.) or intramuscular (I.M.) injection after reconstitution with the solvent provided.
After reconstitution with the solvent provided MENOPUR 600 IU and 1200 IU are intended for subcutaneous (S.C.) injection, as the syringe provided is for S.C. administration only.
The powder should be reconstituted prior to use. In order to avoid the injection of large volume up to 3 vials of the powder may be dissolved in 1 mL of the solvent powder.
Shaking should be avoided. The solution should not be used if it contains particles or if it is not clear.