Folisan Dosage/Direction for Use

Treatment with FOLISAN (r-hFSH) should be initiated under the supervision of a physician experienced in the treatment of fertility disorders.
FOLISAN (r-hFSH) is intended for subcutaneous administration. The powder should be reconstituted immediately prior to use with the solvent provided. In order to avoid the injection of large volumes, up to 3 vials of product may be dissolved in 0.5ml of solvent.
Posology: The dosage recommendations given for FOLISAN (r-hFSH) are those in use for urinary FSH. Clinical assessment of FOLISAN (r-hFSH) indicates that its daily doses, regimens of administration, and treatment monitoring procedures should not be different from those currently used for urinary FSH-containing medicinal products. However, the study reports conclude that FOLISAN (r-hFSH) is more effective than urinary FSH in terms of a lower total dose and shorter treatment period needed to achieve pre-ovulatory. It is advised to adhere to the recommended starting doses indicated as follows.
Women with anovulation (including polycystic ovarian syndrome): FOLISAN (r-hFSH) may be given as a course of daily injections. In menstruating patients treatment should commence within the first 7 days of the menstrual cycle.
Treatment should be tailored to the individual patient's response as assessed by measuring follicle size by ultrasound and/or oestrogen secretion. A commonly used regimen commences at 75-150 IU FSH daily and is increased preferably by 37.5 or 75 IU at 7 or preferably 14 day intervals if necessary, to obtain an adequate, but not excessive, response. The maximal daily dose is usually not higher than 225 IU FSH. If a patient fails to respond adequately after 4 weeks of treatment, that cycle should be abandoned and the patient should undergo further evaluation after which she may 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, up to 10,000 IU HCG should be administered 24-48 hours after the last FOLISAN (r-hFSH) 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 is obtained, treatment should be stopped and HCG withheld (see Special warnings and precautions for use under Precautions). Treatment should recommence in the next cycle at a dose lower than that of the previous cycle.
Women undergoing ovarian stimulation for multiple follicular developments prior to in vitro fertilisation or other assisted reproductive technologies: A commonly used regimen for superovulation involves the administration of 150-225 IU of FOLISAN (r-hFSH) daily, commencing on days 2 or 3 of the cycle. Treatment is continued until adequate follicular development has been achieved (as assessed by monitoring of serum oestrogen concentrations and/or ultrasound examination), with the dose adjusted according to the patient's response, to usually not higher than 450 IU daily. In general adequate follicular development is achieved on average by the tenth day of treatment (range 5 to 20 days).
A single injection of up to 10,000 IU HCG is administered 24-48 hours after the last FOLISAN (r-hFSH) injection to induce final follicular maturation. Down-regulation with a gonadotropin-releasing hormone (GnRH) agonist or antagonist is now commonly used in order to suppress the endogenous LH surge and to control tonic levels of LH. In a commonly used protocol, FOLISAN (r-hFSH) is started approximately 2 weeks after the start of agonist treatment, both being continued until adequate follicular development is achieved. For example, following two weeks of treatment with an agonist, 150-225 IU FOLISAN (r-hFSH) are administered for the first 7 days. The dose is then adjusted according to the ovarian response.
Overall experience with IVF indicates that in general the treatment success rate remains stable during the first four attempts and gradually declines thereafter.
Women with anovulation resulting from severe LH and FSH deficiency: In LH and FSH deficient women (hypogonadotrophic hypogonadism), the objective of FOLISAN (r-hFSH) therapy in association with lutropin alfa is to develop a single mature Graafian follicle from which the oocyte will be liberated after the administration of human chorionic gonadotropin (HCG). FOLISAN (r-hFSH) should be given as a course of daily injections simultaneously with lutropin alfa. Since these patients are amenorrhoeic and have low endogenous oestrogen secretion, treatment can commence at anytime.
A recommended regimen commences at 75 IU of lutropin alfa daily with 75-150 IU FSH. Treatment should be tailored to the individual patient's response as assessed by measuring follicle size by ultrasound and oestrogen response.
If an FSH dose increase is deemed appropriate, dose adaptation should preferably be after 7-14 day intervals and preferably by 37.5-75 IU increments. It may be acceptable to extend the duration of stimulation in any one cycle to up to 5 weeks.
When an optimal response is obtained, a single injection of 5,000 IU up to 10,000 IU HCG should be administered 24-48 hours after the last FOLISAN (r-hFSH) and lutropin alfa injections. The patient is recommended to have coitus on the day of, and on the day following, HCG administration.
Alternatively, IUI may be performed.
Luteal phase support may be considered since lack of substances with luteotrophic activity (LH/HCG) after ovulation may lead to premature failure of the corpus luteum.
If an excessive response is obtained, treatment should be stopped and HCG withheld. Treatment should recommence in the next cycle at a dose of FSH lower than that of the previous cycle.
Special Population: Elderly population: There is no relevant use of FOLISAN (r-hFSH) in the elderly population. Safety and effectiveness of FOLISAN (r-hFSH) in elderly patients have not been established.
Renal or hepatic impairment: Safety, efficacy and pharmacokinetics of FOLISAN (r-hFSH) in patients with renal or hepatic impairment have not been established.
Paediatric population: There is no relevant use of FOLISAN (r-hFSH) in the paediatric population.
Method of administration: FOLISAN (r-hFSH) is intended for subcutaneous administration. The first injection of FOLISAN (r-hFSH) should be performed under direct medical supervision. Self-administration of FOLISAN (r-hFSH) should only be performed by patients who are well motivated, adequately trained and have access to expert advice.
The injection site should be alternated daily.