Overview
11 DESCRIPTION MENOPUR is a preparation of gonadotropins (FSH and LH activity), extracted from the urine of postmenopausal women, which has undergone additional steps for purification. MENOPUR is a sterile, lyophilized powder intended for subcutaneous (SC) injection after reconstitution with sterile 0.9% Sodium Chloride Injection, USP.
Mechanism of Action
12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action 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. 12.3 Pharmacokinetics Two open-label, randomized, controlled trials were conducted to assess the pharmacokinetics of MENOPUR. Study 2003-02 compared single doses of subcutaneous administration of the US and European (EU) formulations of MENOPUR in 57 healthy, pre-menopausal females who had undergone pituitary suppression. The study established that the two formulations are bioequivalent.
Indications
- 1 INDICATIONS AND USAGE 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 ( 1 ) 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...
Common Doses
- Refer to label
Dosage
2 DOSAGE AND ADMINISTRATION Initial starting dose of the first cycle - 225 International Units per day, administered subcutaneously ( 2.2 ) Dosage adjustments after 5 days and by no more than 150 International Units at each adjustment ( 2.2 ) Do not administer doses greater than 450 International Units per day ( 2.2 ) 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...
Contraindications
- 4 CONTRAINDICATIONS 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 [see Indications and Usage (1) ] Pregnancy MENOPUR may cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1) ]. 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.
Side Effects
- 6 ADVERSE REACTIONS The following serious adverse reactions are discussed elsewhere in the labeling: Abnormal Ovarian Enlargement [see Warnings and Precautions (5.1) ] Ovarian Hyperstimulation Syndrome [see Warnings and Precautions (5.2) ] Atelectasis, acute respiratory distress syndrome and exacerbation of asthma [see Warnings and Precautions (5.3) ] Thromboembolic events [see Warnings and Precautions (5.3) ] Ovarian Torsion [see Warnings and Precautions (5.4) ] Multi-fetal Gestation and Birth [see Warnings and Precautions (5.5) ] Congenital Malformations [see Warnings and Precautions (5.
Interactions
- 7 DRUG INTERACTIONS No drug/drug interaction studies in humans have been conducted for MENOPUR. No drug/drug interaction studies have been conducted for MENOPUR in humans. ( 7 )