Prior Authorization Approval Criteria Menopur, Repronex (menotropin)

Generic name: Menotropins, Follicle Stimulating Hormone/Luteinizing Hormone

Brand name: Menopur, Repronex

Medication class: Endocrine-Metabolic Agent

FDA-approved uses:  Female infertility, For stimulation of the development of multiple follicles in ovulatory women - In vitro fertilization  Female infertility due to ovulatory disorder - Ovulation induction  Male hypogonadotropic hypogonadism, Primary or secondary - Spermatogenesis induction

Available dosage forms: 75 IU vials

Usual dose: female fertility: 75-150 IU IM per day for 7 -12 days

Male hypogonadotropic hypogonadism - Spermatogenesis induction: 75 – 150 IU IM 3 times weekly

Duration of therapy: varies

Criteria for use for female fertility (bullet points below are all inclusive unless otherwise noted):  The indicated diagnosis (including any applicable labs and /or tests) and medication usage must be supported by documentation from the patient’s medical records.  Must have an active medical authorization for fertility procedures and services.

 Patient is being seen by an infertility specialist.

 Duration of approval of medication will correspond to the duration of the medical approval for fertility procedures and services.

Criteria for use for Male hypogonadotropic hypogonadism (bullet points below are all inclusive unless otherwise noted):  Must have documented hypogonadotropic hypogonadism  Must have had pretreatment with 5000 Units hCG 3 times weekly and hCG pretreatment has been continued until serum testosterone levels are in the normal range and masculinization is reached (may require 4-6 months)  Being used with hCG

Criteria for quantities above 20 vials per month:

 Must have a clinically documented medical need for the increased quantity (including, but not limited to, increased dose, frequency, or duration).

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Contraindication:

Females:  A high FSH level indicating primary ovarian failure.  Uncontrolled thyroid and adrenal dysfunction.  An organic intracranial lesion such as a pituitary tumor.  Sex hormone dependent tumors of the reproductive tract and accessory organs.  Abnormal uterine bleeding of undetermined origin.  Ovarian cysts or enlargement not due to polycystic ovary syndrome.  Prior hypersensitivity to menotropins.  Not indicated in women who are pregnant. There are limited human data on the effects of menotropins when administered during pregnancy.

Males:  Uncontrolled thyroid and adrenal dysfunction.  An organic intracranial lesion such as a pituitary tumor.  Sex hormone dependent tumors of the reproductive tract and accessory organs.  Prior hypersensitivity to menotropins.

FCHP Pharmacy and Therapeutics Committee approval: ______

Date: ______

Adopted: 1/9/2013

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