Puregon

Puregon

follitropin beta

Manufacturer:

Organon

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Follitropin β
Indications/Uses
Women: Anovulation including polycystic ovarian syndrome (PCOS) in women who have been unresponsive to treatment w/ clomiphene citrate. Controlled ovarian hyperstimulation to induce development of multiple follicles in medically assisted reproduction programs. Men: Deficient spermatogenesis due to hypogonadotrophic hypogonadism.
Dosage/Direction for Use
Women Anovulation Initially 50 IU daily for 7-14 days. Controlled ovarian hyperstimulation in medically assisted reproduction programs Initially 100-225 IU for at least 1st 4 days. Thereafter, dose may be adjusted individually. Maintenance: 75-375 IU for 6-12 days. Men 450 IU wkly in 3 divided doses of 150 IU each, concomitantly w/ hCG for at least 3-4 mth. May continue for up to ≥18 mth if patient is unresponsive.
Contraindications
Hypersensitivity. Ovarian, breast, uterine, testicular, pituitary or hypothalamic tumours; primary gonadal failure. Women: Undiagnosed vag bleeding; ovarian cysts or enlarged ovaries not related to PCOS. Reproductive organ malformations & uterine fibroid tumors incompatible w/ pregnancy. Pregnancy.
Special Precautions
Hypersensitivity to streptomycin &/or neomycin. Assess couple's infertility & evaluate hypothyroidism, adrenocortical insufficiency, hyperprolactinemia & pituitary or hypothalamic tumors. Avoid use in childn <2 yr. Not to be used in neonates. Women: Increased risk of ectopic pregnancy & congenital malformations. Closely monitor patients & perform ultasonographic assessments of follicular development prior to & at regular intervals during treatment for risk of OHSS development. Ovarian torsion; multiple pregnancies & birth; benign & malignant ovarian & other reproductive system neoplasms. Personal or family history of thromboembolic events, severe obesity or thrombophilia. Evaluate medical conditions contraindicating pregnancy prior to treatment. Not to be used during pregnancy. Lactation. Men: Men w/ elevated endogenous FSH; deficient spermatogenesis due to hypogonadotrophic hypogonadism.
Adverse Reactions
Headache; inj site reactions. Women: Abdominal distension & pain; OHSS, pelvic pain. Men: Acne, rash; epididymal cyst, gynecomastia.
Drug Interactions
Enhanced follicular response w/ clomiphene citrate. Pituitary desensitization induced by 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
6 × 1's
Form
Puregon soln for inj 600 IU/0.72 mL
Packing/Price
6 × 1's
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