PUREGON

FOLLITROPIN BETA

Follitropin beta injection is indicated for the development of multiple follicles in ovulatory patients participating in an Assisted Reproductive Technology (ART) program. Follitropin beta is also indicated for the induction of ovulation and pregnancy in anovulatory infertile patients in whom the cause of infertility is functional and not due to primary ovarian failure.

Drugs for Infertility

Follitropin beta is a human FSH preparation of recombinant DNA origin. It stimulates ovarian follicular growth in women who do not have primary ovarian failure.

37.5 IU at wkly intervals. Once follicular growth or serum estradiol levels indicates an adequate response, administer a single dose of hCG (5,000-10,000 IU) after the last dose to induce ovulation. Withhold hCG if the ovaries are abnormally enlarged or if abdominal pain occurs. Max: 300 IU/day. Assisted reproductive technologies: IM or SC admin: 150-225 IU /day for at least 1st 4 days of treatment. Adjust dose based on individual ovarian response. Usual maintenance dose: 75-300 IU for 6-12 days; 375-600 IU for poor responders. Max (clinical studies): 600 IU/day. Upon adequate follicular development, a single dose of hCG (5,000-10,000 IU) is administered for final oocyte maturation. Oocyte retrieval can be done 34-36 hr later. Withhold hCG if ovaries are abnormally enlarged on the last day of follicular treatment.

No drug-drug interaction studies have been performed.

Abnormal genital bleeding of undetermined origin, hormone sensitive malignancies; ovary, breast, uterus, hypothalamus, testes or pituitary gland tumor; ovarian cysts or enlargement not due to the polycystic ovary syndrome; high levels of FSH indicating primary gonadal failure (ovarian or testicular); uncontrolled thyroid or adrenal dysfunction; presence of any cause of infertility other than anovulation; hypersensitivity; pregnancy, lactation

Ovarian cysts, mild to severe inj site reactions, headache, mild to moderate OHSS, abdominal pain, GI disturbances. Rarely, severe OHSS, ovarian torsion, thromboembolism, mild systemic allergic reactions.

Category X: Studies in animals or human beings have demonstrated foetal abnormalities or there is evidence of foetal risk based on human experience or both, and the risk of the use of the drug in pregnant women clearly outweighs any possible benefit. The drug is contraindicated in women who are or may become pregnant.

May lead to OHSS and multiple gestations.

May result in multiple births. Ovarian hyperstimulation syndrome (OHSS), serious pulmonary conditions and thromboembolic events may occur. Evaluate patients for hypothyroidism, adrenocortical deficiency, hyperprolactinaemia, pituitary and hypothalamic tumors before starting therapy.

Store at 2-88C.