PUREGON
FOLLITROPIN BETA · by SEARLE
Composition
lnj50 IU/100 IU: Follitropin beta equiv to 50 IU/100 IU FSH activity.
Indications & Dosage
Anovulation, Infertility in women with proven hypopituitarism or not responded to clomifene: BY SC OR IM INJ: Adults (female): Initially usually 75 - 150 IU daily. Monitor response. Super ovulation treatment for assisted conception (such as in vitro fertilization): BY SC OR IM INJ: Adults:Usually 150- 225 IU dailystarting on day 2 or 3 of cycle usually 2 wk after starting GnRH agonist treatment. Monitor response. See literature. Adjunct to HCG therapy to stimulate spermatogenesis in hypogonadotropic hypogonadism: BY SC INJ: Adults (male):150 IU 3 times a week for a minimum of 4 months. Monitor semen samples after 4-6 months; treatment for 18 months or more may be necessary. Children: Not applicable.
Administration
Administer SC or IM to females, and SC only in males. Inject 1 ml of 0.45 % NS into vial of Follitro-pin Beta. Do not shake.Use immediately after reconstitution.
Contraindications
Ovarian cysts or ovarian enlargement (not caused by polycystic ovarian syndrome), tumours of breast, tumours of hypothalamus, tumours of ovaries, tumours of pituitary, tumours of prostate, tumours of testes, tumours of uterus, vaginal bleeding of unknown cause
Precautions
Acute porphyrias, history of tubal disease. Exclude anatomical abnormalities. Monitor ovarian size and oestrogen response to avoid hyper-stimulation
Pregnancy
Contraindicated in pregnancy.
Lactation
Contraindicated, avoid
Side Effects
Fever, GI disturbances, headache, hypersensitivity reactions, injection site reactions, joint pain, ovarian hyperstimulation, varicocele, acne, gynaecomastia, increased risk of miscarriage, increased risk of multiple pregnancy, weight gain. Rare: Exacerbation or aggravation of asthma, thromboembolism