Puregon

Puregon

follitropin beta

Manufacturer:

Organon

Distributor:

Zuellig
/
Agencia Lei Va Hong
Concise Prescribing Info
Contents
Follitropin β
Indications/Uses
Female: Treatment of infertility in anovulation (including PCOS) in women who have been unresponsive to clomifene citrate; in controlled ovarian hyperstimulation to induce the development of multiple follicles in medically assisted reproduction programs. Male: Deficient spermatogenesis due to hypogonadotrophic hypogonadism.
Dosage/Direction for Use
SC Female Anovulation Initially 50 IU daily, maintained for at least 7 days. If no ovarian response, gradually increase daily dose until adequate pharmacodynamic response. Maintain daily dose until pre-ovulatory conditions are reached. Controlled ovarian hyperstimulation in medically assisted reproduction programs Initially 100-225 IU for at least the 1st 4 days. Thereafter, adjust dose based upon ovarian response. Male 450 IU per wk, preferably in 3 divided dosage of 150 IU, concomitantly w/ HCG for at least 3-4 mth.
Contraindications
Hypersensitivity. Tumours of the ovary, breast, uterus, testis, pituitary or hypothalamus; primary gonadal failure. Female: Pregnancy; undiagnosed vag bleeding; ovarian cysts or enlarged ovaries not related to PCOS; malformations of the reproductive organs incompatible w/ pregnancy; fibroid tumours of the uterus incompatible w/ pregnancy.
Special Precautions
Alternate inj site to prevent lipoatrophy. May contain traces of streptomycin &/or neomycin that may cause hypersensitivity reactions in susceptible persons. Assess couple's infertility before treatment. Evaluate & give appropriate specific treatment for hypothyroidism, adrenocortical insufficiency, hyperprolactinemia & pituitary or hypothalamic tumours before starting treatment. Contains benzyl alcohol. Female: Monitor ovarian response to reduce risk of ovarian hyperstimulation syndrome (OHSS). Risk of multiple pregnancies & births; ectopic pregnancy; thromboembolic events; ovarian torsion. Rates of pregnancy loss in women undergoing assisted reproduction techniques are higher than in the normal population. Incidence of congenital malformations after assisted reproduction technique may be slightly higher than after spontaneous conceptions. Reports of ovarian & other reproductive system neoplasms in women who have undergone multiple treatment regimens for infertility treatment. Medical conditions that contraindicate pregnancy should also be evaluated before starting treatment. May affect milk production. Male: Patients w/ elevated endogenous FSH levels are unresponsive to Puregon/HCG therapy.
Adverse Reactions
Headache; inj site reaction. Female: Abdominal distension or pain; OHSS; pelvic pain. Male: Acne, rash; epididymal cyst; gynaecomastia.
Drug Interactions
Concomitant use w/ clomifene citrate may enhance follicular response. A higher dose may be needed after pituitary desensitisation induced by a gonadotrophin-releasing hormone (GnRH) agonist.
MIMS Class
Trophic Hormones & Related Synthetic Drugs
ATC Classification
G03GA06 - follitropin beta ; Belongs to the class of gonadotropins. Used as ovulation stimulants.
Presentation/Packing
Form
Puregon soln for inj 300 IU/0.36 mL
Packing/Price
1's
Form
Puregon soln for inj 600 IU/0.72 mL
Packing/Price
1's
Form
Puregon soln for inj 900 IU/1.08 mL
Packing/Price
1's
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