Puregon

Puregon

follitropin beta

Manufacturer:

Organon

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Recombinant FSH (follitropin β)
Indications/Uses
Anovulation (including PCOS), in women who have been unresponsive to treatment w/ clomifene citrate. Controlled ovarian hyperstimulation to induce the development of multiple follicles in medically assisted reproduction programs [eg, in vitro fertilization/embryo transfer (IVF/ET), gamete intra-fallopian transfer (GIFT) & intracytoplasmic sperm inj (ICSI)]. Deficient spermatogenesis due to hypogonadotrophic hypogonadism in males.
Dosage/Direction for Use
SC Female Individualized dosage. Anovulation Initially 50 IU daily for at least 7 days. Gradually increase daily dose if there is no ovarian response. Decrease daily dose if the number of responding follicles is too high or estradiol levels increase too rapidly. Controlled ovarian hyperstimulation in medically assisted reproductive program Initially 100-225 IU for at least 1st 4 days. Maintenance dose: 75-375 IU for 6-12 days. Male 450 IU/wk divided in 3 doses of 150 IU concomitantly w/ HCG for at least 3-4 mth.
Contraindications
Hypersensitivity. Ovarian, breast, uterine, testis, pituitary or hypothalamic tumours. Primary gonadal failure. Undiagnosed vag bleeding. Ovarian cysts or enlarged ovaries, not related to PCOS. Reproductive organ malformation; uterine fibroid tumours incompatible w/ pregnancy. Pregnancy.
Special Precautions
Hypersensitivity to streptomycin &/or neomycin. Ovarian hyperstimulation syndrome (OHSS); arterial thromboembolism or VTE; transient LFTs. Ovarian torsion. Potential risk of multiple births prior to treatment. Increased risk of tumors in infertile women. Women w/ risk factors for high ovarian response; thromboembolic events eg, personal or family history, severe obesity or thrombophilia. Men w/ elevated endogenous FSH levels. Assess infertility & evaluate for hypothyroidism, adrenocortical insufficiency, hyperprolactinemia & pituitary or hypothalamic tumors prior to therapy. Monitor patients for at least 2 wk after HCG administration. Perform ultrasound assessments of follicular development prior to & at regular intervals during therapy. Evaluate medical conditions contraindicating pregnancy before starting treatment. Increased incidence of ectopic pregnancies in infertile women undergoing assisted reproductive technology. Lactation.
Adverse Reactions
Headache. Female: Abdominal distension & pain; OHSS, pelvic pain; inj site reaction. Male: Acne, rash; epididymal cyst, gynecomastia; inj site induration.
Drug Interactions
Enhanced follicular response w/ clomifene citrate.
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 100 IU/0.5 mL
Packing/Price
10 × 1's
Form
Puregon soln for inj 300 IU/0.36 mL
Packing/Price
(pen) 1's
Form
Puregon soln for inj 50 IU/0.5 mL
Packing/Price
10 × 1's
Form
Puregon soln for inj 600 IU/0.72 mL
Packing/Price
(pen) 1's
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