Gonal-f

Gonal-f

follitropin alfa

Manufacturer:

PT. Merck Tbk
Concise Prescribing Info
Contents
Follitropin α (recombinant FSH)
Indications/Uses
Anovulation in women unresponsive to treatment w/ clomiphene citrate. Stimulation of multifollicular development in women undergoing superovulation for assisted reproductive technologies (ART) eg, in vitro fertilization (IVF), gamete intra-fallopian transfer & zygote intra-fallopian transfer. Stimulation of follicular development in women w/ severe LH & FSH deficiency. Stimulation of spermatogenesis in men who have congenital or acquired hypogonadotrophic hypogonadism w/ concomitant HCG therapy.
Dosage/Direction for Use
SC Women w/ anovulation Initially 75-150 IU daily, increased by 37.5 or 75 IU at 7 or 14-day intervals. Max: 225 IU daily. Ovarian stimulation for multiple follicular development prior to IVF or other assisted reproductive technologies 150-225 IU daily, commencing on day 2 or 3 of the cycle. Max: 450 IU daily. Anovulation resulting from severe LH & FSH deficiency 75-150 IU w/ 75 IU of lutropin α daily. Men w/ hypogonadotrophic hypogonadism 150 IU thrice wkly w/ HCG for min of 4 mth, may be continued for at least 18 mth to achieve spermatogenesis.
Contraindications
Hypersensitivity. Hypothalamus or pituitary gland tumours; ovarian enlargement/cyst not due to PCOS; gynaecological haemorrhages of unknown aetiology; ovarian, uterine or mammary carcinoma; primary ovarian failure; malformations of sexual organs & fibroid tumours of the uterus incompatible w/ pregnancy; primary testicular insufficiency.
Special Precautions
Closely monitor patients who have or history of porphyria. Assess for couple's infertility before starting treatment. Evaluate patients for hypothyroidism, adrenocortical deficiency, hyperprolactinemia. May experience ovarian enlargement or develop hyperstimulation in patients undergoing stimulation of follicular growth. Co-administration w/ lutropin α may increase ovarian sensitivity. Ovarian hyperstimulation syndrome. Monitor stimulation cycles by ultrasound scans & oestradiol measurements to identify risk factors early. Increased risk of adverse maternal & perinatal outcomes w/ multiple pregnancy. Carefully monitor ovarian response to minimise risk of multiple pregnancy. Potential risk of multiple births. Pregnancy loss. Ectopic pregnancy. Reproductive system neoplasms. Congenital malformation. Thromboembolic events. Not to be used when an effective response cannot be obtained. Assess response w/ semen analysis for 4-6 mth after the beginning of treatment. Not indicated during breastfeeding. Secretion of prolactin can result in poor prognosis to ovarian stimulation during lactation.
Adverse Reactions
Inj site reactions; headache; ovarian cysts. GI disorders; mild/moderate ovarian hyperstimulation syndrome; acne; gynaecomastia, varicocele; wt gain.
Drug Interactions
Not to be co-administered w/ other medicinal products in the same inj, except lutropin α or combination of lutropin α & follitropin α. May potentiate follicular response w/ other ovulation stimulating agents eg, HCG, clomiphene citrate. Concurrent use of GnRH agonist/antagonist to induce pituitary desensitisation may increase the dosage of GONAL-f 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.
Presentation/Packing
Form
Gonal-f pen 300 IU/0.5 mL
Packing/Price
1's (Rp2,182,950/pre-filled pen)
Form
Gonal-f pen 900 IU/1.5 mL
Packing/Price
1's (Rp6,476,250/pre-filled pen)
Form
Gonal-f inj 75 IU
Packing/Price
(vial) 1's (Rp546,150/vial)
Form
Gonal-f inj 1,050 IU/1.75 mL
Packing/Price
(multidose vial) 1's (Rp7,507,500/vial)
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