Concise Prescribing Info
Recombinant-human FSH
Anovulation (including PCOS) in women who have been unresponsive to treatment w/ clomiphene citrate. Stimulation of multifollicular development in patients undergoing superovulation for assisted reproductive technologies (ARD eg, in vitro fertilisation (IVF), gamete intra-fallopian transfer (GIFT) & zygote intra-fallopian transfer (ZIFT). Recommended for the stimulation of follicular development in women w/ severe LH & FSH deficiency.
Dosage/Direction for Use
SC Women w/ anovulation (including PCOS) Individualized dosage. Start w/in initial 7 days of menstrual cycle. Initially 75-150 IU daily, preferably increased by 37.5 or 75 IU at 7 or 14 day intervals. Max: 225 IU daily. Single inj of 5,000-10,000 IU HCG is given 24-48 hr after the last inj when an optimal response is obtained. Women undergoing ovarian stimulation for multiple follicular development prior to in vitro fertilisation or other assisted reproductive technologies Superovulation 150-225 IU commencing on days 2 or 3 of the cycle, continued until adequate follicular development has been achieved. Max: 450 IU daily. Duration: 5-20 days. Single inj of up to 10,000 IU HCG is administered 24-48 hr after the last inj to induce final follicular maturation. Women w/ anovulation resulting from severe LH & FSH deficiency Initially 75 IU of lutropin α daily w/ 75-150 IU FSH. FSH dose may increase after 7-14 day intervals & by 37.5-75 IU increments. Max duration: 5 wk. Single inj of 5,000-10,000 IU HCG is given 24-48 hr after the last FSH & lutropin α inj when an optimal response is obtained. Alternatively, intrauterine insemination (IUI) may be performed.
Hypersensitivity. Tumours of the hypothalamus & pituitary gland; ovarian enlargement or cyst not due to PCOS; gynaecological haemorrhages of unknown aetiology; ovarian, uterine or mammary carcinoma. Primary ovarian failure; malformations of sexual organs incompatible w/ pregnancy; fibroid tumours of the uterus incompatible w/ pregnancy.
Special Precautions
Monitoring of ovarian response w/ ultrasound, alone or preferably in combination w/ measurement of serum oestradiol levels on a regular basis. Closely monitor patients w/ porphyria or a family history of porphyria during treatment. Assess couple's infertility & evaluate for hypothyroidism, adrenocortical deficiency, hyperprolactinemia & pituitary/hypothalamic tumors prior to therapy. Patient undergoing stimulation of follicular growth. Increased ovarian sensitivity when administered w/ lutropin α. Withhold hCG & refrain from coitus or use barrier methods for at least 4 days if ovarian hyperstimulation occurs. Discontinue use if severe ovarian hyperstimulation syndrome (OHSS) occurs. Risk of OHSS, multiple pregnancies, pregnancy loss by miscarriage or abortion, ectopic pregnancy, reproductive system neoplasms, congenital malformation & thromboembolic events. Not to be used during pregnancy. Not indicated during breastfeeding.
Adverse Reactions
Ovarian cysts; mild to severe inj site reaction (eg, pain, redness, bruising, swelling &/or irritation at the inj site); headache. Mild to moderate OHSS; abdominal pain & GI symptoms eg, nausea, vomiting, diarrhoea, abdominal cramps & bloating.
Drug Interactions
Not to be administered as a mixt w/ other medicinal products in the same inj except lutropin α or combination of lutropin α & follitropin α. Concomitant use w/ other medicinal products used to stimulate ovulation (eg, HCG, clomiphene citrate) may potentiate the follicular response; gonadotropin hormone-releasing hormone agonist or antagonist may increase the dose needed to elicit an adequate ovarian response.
MIMS Class
Trophic Hormones & Related Synthetic Drugs
ATC Classification
G03GA05 - follitropin alfa ; Belongs to the class of gonadotropins. Used as ovulation stimulants.
Folisan inj 75 IU
(+ 0.5 mL amp (sterile water for inj)) 1's (Rp550,000/boks)
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