Menotropins

MENOPUR ® (menotropins for injection) is a gonadotropin indicated for: Development of multiple follicles and pregnancy in ovulatory women as part of an Assisted Reproductive Technology (ART) cycle. Development of Multiple Follicles and Pregnancy in Ovulatory Women as Part of an Assisted Reproductive Technology (ART) Cycle Prior to initiation of treatment with MENOPUR ® (menotropins for injection): Perform a complete gynecologic and endocrinologic evaluation, and diagnose the cause of infertility Exclude the possibility of pregnancy Evaluate the fertility status of the male partner Exclude a diagnosis of primary ovarian failure

MENOPUR, administered for 7 to 20 days, produces ovarian follicular growth and maturation in women who do not have primary ovarian failure. Treatment with MENOPUR in most instances results only in follicular growth and maturation. When sufficient follicular maturation has occurred, hCG must be given to induce ovulation.

Initial starting dose of the first cycle - 225 International Units per day, administered subcutaneously. Dosage adjustments after 5 days and by no more than 150 International Units at each adjustment. Do not administer doses greater than 450 International Units per day. MENOPUR may be administered together with BRAVELLE ® (urofollitropin for injection, purified). Only the total starting dose of 225 International Units (150 International Units of MENOPUR and 75 International Units of BRAVELLE or 75 International Units of MENOPUR and 150 International Units of BRAVELLE) was studied in a clinical trial.

MENOPUR is contraindicated in women who exhibit: Prior hypersensitivity to MENOPUR or menotropins products or one of their excipients High levels of FSH indicating primary ovarian failure Pregnancy MENOPUR may cause fetal harm when administered to a pregnant woman. MENOPUR is contraindicated in women who are pregnant. If this drug is used during pregnancy, or if the woman becomes pregnant while taking this drug, the woman should be apprised of the potential hazard to a fetus.

MENOPUR should only be used by physicians who are experienced in infertility treatment. MENOPUR contains gonadotropic substances capable of causing in women, Ovarian Hyperstimulation Syndrome (OHSS) with or without pulmonary or vascular complications and multiple births. Gonadotropin therapy requires the availability of appropriate monitoring facilities. Use the lowest effective dose. Abnormal Ovarian Enlargement. Ovarian Hyperstimulation Syndrome (OHSS). Pulmonary and Vascular Complications. Ovarian Torsion. Multi-fetal Gestation and Birth. Congenital Malformation. Ectopic Pregnancy. Spontaneous Abortion. Ovarian Neoplasms

The following serious adverse reactions are discussed elsewhere in the labeling: Abnormal Ovarian Enlargement Ovarian Hyperstimulation Syndrome Atelectasis, acute respiratory distress syndrome and exacerbation of asthma Thromboembolic events Ovarian Torsion Multi-fetal Gestation and Birth Congenital Malformations Ectopic Pregnancy Spontaneous Abortion Ovarian Neoplasms The most common adverse reactions (≥2%) in ART include: abdominal cramps, abdomen enlarged, abdominal pain, headache, injection site pain and reaction, injection site inflammation, OHSS

No drug/drug interaction studies in humans have been conducted for MENOPUR. No drug/drug interaction studies have been conducted for MENOPUR in humans.

Lyophilized powder may be stored refrigerated or at room temperature (3° to 25° C/37° to 77°F) until dispensed. Protect from light.