Menopur (menotropins)

Follicle-Stimulating Hormone (FSH) Subcutaneous Vial (Ea)

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Last reviewed · Source: First Databank (FDB) drug data

Overview

Menotropins is a purified preparation of follicle-stimulating hormone (FSH) and luteinizing hormone (LH), which are human pituitary gonadotropins extracted from urine of postmenopausal women.

Menotropins is a preparation of gonadotropins (follicle-stimulating hormone (FSH) and luteinizing hormone (LH)) extracted from the urine of postmenopausal women) that has undergone additional steps for purification (e.g., hormone adsorption and elution, anion and cation exchange, hydrophobic cation exchange). Batch-to-batch consistency is guaranteed by FSH and LH bioactivity testing. FSH and LH are both acidic glycoproteins composed of alpha and beta subunits.

Human chorionic gonadotropin (hCG) is also detected in menotropins and contributes to the LH activity. Other urinary proteins are also present as impurities; however, the Menopur(R) preparation is approximately 25-fold more purified than traditional menotropin preparations, which are no longer commercially available in the US.

FSH and LH are synthesized and secreted in the lateral portion of the anterior pituitary gland, which is responsive to the pulsatile stimulation of the hypothalamic hormone gonadotropin-releasing hormone (GnRH). The development of human ovarian follicles is dependent upon the sequential effects of FSH and LH. FSH acts on early antral follicles to stimulate growth, steroidogenesis, and the expression of LH receptors.

LH in synergy with FSH subsequently acts on the FSH-stimulated follicle to maintain growth and is eventually responsible for the process of luteinization and ovulation. Administration of menotropins for 7-20 days produces ovarian follicular growth and maturation in women who do not have primary ovarian failure. Treatment with menotropins in most instances results only in follicular growth and maturation; to induce ovulation, a single dose of hCG, which has LH activity, must be given following administration of menotropins when clinical assessment of the patient indicates that sufficient follicular maturation has occurred (e.g., as determined by ultrasound monitoring and serum estradiol concentrations).

The subcutaneous route of administration of menotropins appears to result in greater bioavailability (as determined by area under the concentration-time curve (AUC) of FSH) than does IM administration. After subcutaneous or IM administration of a single 225-unit dose of menotropins, mean peak plasma FSH concentrations are reached at 17.9 or 27.5 hours, respectively. Data are lacking on the distribution and metabolism of FSH and LH in humans.

After multiple-dose subcutaneous or IM administration of menotropins (225 units once, followed by 150 units daily for 6 days), the elimination half-life of FSH averages 11-13 hours. Data are lacking on the pharmacokinetics of menotropins in women with renal or hepatic insufficiency.

USES: This medication is used to treat certain fertility problems in women. It provides follicle stimulating hormone (FSH) and luteinizing hormone (LH) that help healthy ovaries to make eggs. This medication is usually used in combination with another hormone (human chorionic gonadotropin-hCG) to help you become pregnant by bringing about the growth and release of a mature egg (ovulation).

This medication is not recommended for women whose ovaries no longer make eggs properly (primary ovarian failure).

Generic name: menotropins
Pronunciation: (men-oh-TROW-pins)
Drug class: Follicle-Stimulating Hormone (FSH)
Therapeutic class: Endocrine

Reference product & biosimilars

No reference, biosimilar or interchangeable associated with this drug.

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Indications

The following indications are listed for Menopur:

  • Follicle Stimulation For Assisted Fertilization Procedure

Also known as: Multifollicular Development For Assisted Reproductive Technologies.

Dosing

Dosage of menotropins is expressed in international units (IU, units) of FSH and LH activity; each unit of menotropins represents 1 unit of FSH and 1 unit of LH activity.

Drug interactions

Formal drug interaction studies with menotropins are lacking.

Contraindications

Known hypersensitivity to menotropins or any ingredient in the formulation.

Primary ovarian failure (as indicated by high concentrations of follicle-stimulating hormone (FSH)), uncontrolled non-gonadal endocrinopathies (e.g., thyroid, adrenal, pituitary disorders), or tumors of the pituitary gland or hypothalamus.

Abnormal intrauterine bleeding of undetermined origin, ovarian cysts or enlargement of undetermined origin (not due to polycystic ovary syndrome (PCOS)), or sex-hormone-dependent tumors of the reproductive tract and accessory organs.

Pregnancy.

Adverse reactions

Adverse effects reported in at least 2% of women (occurring on or after gonadotropin-releasing hormone (GnRH) administration) undergoing IVF and ICSI receiving menotropins subcutaneously include abdominal pain, headache, OHSS, injection site pain and reaction, abdominal cramps, abdominal enlargement, and injection site inflammation.

Precautions

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ICD codes

CodeTypeDescription
Follicle stimulation for assisted fertilization procedure
Z31.83ICD10CMEncounter for assisted reproductive fertility procedure cycle
Z31.89ICD10CMEncounter for other procreative management
Z52.81ICD10CMEgg (oocyte) donor
Z52.810ICD10CMEgg (oocyte) donor under age 35, anonymous recipient
Z52.811ICD10CMEgg (oocyte) donor under age 35, designated recipient
Z52.812ICD10CMEgg (oocyte) donor age 35 and over, anonymous recipient
Z52.813ICD10CMEgg (oocyte) donor age 35 and over, designated recipient
Z52.819ICD10CMEgg (oocyte) donor, unspecified

ICD code information from First Databank (FDB).

Formulary status

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Last reviewed · Source: First Databank (FDB) drug data