menotropins (Rx)

Brand and Other Names:Menopur, Repronex
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

powder for injection: LH/FSH

  • 75 IU
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Ovulation Induction

Indicated for patients with oligoanovulation

Repronex: 150 IU IM/SC for the first 5 days of treatment; adjustments not to be made more frequently than every 2 days; not to exceed 75-150 IU per adjustment (not to exceed 450 IU/dose); not to exceed 12 days of therapy

If patient's response satisfactory, administer 5000-10,000 units of hCG one day following the last dose of menotropins

Do not administer hCG dose if serum estradiol >2000 pg/mL, if ovaries abnormally large, or abdominal pain occurs; patient should also refrain from intercourse

May repeat therapy if follicular development inadequate or pregnancy does not occur

ART (Assisted Reproductive Technology)

Menopur

  • Begin on cycle day 2 or 3
  • Initial dose for women who have received a GnRH agonist for pituitary suppression is 225 IU SC qDay
  • May be coadministered with urofollitropin (Bravelle), and the total initial dose when the products are combined should not exceed 225 IU (ie, menotropins 150 IU and urofollitropin 75 IU OR menotropins 75 IU and urofollitropin 150 IU)
  • Therapy should not exceed 20 days
  • Consider adjusting the dose after 5 days based on ovarian response, as determined by ultrasound evaluation of follicular growth and serum estradiol levels
  • Do not make additional dosage adjustments more frequently than q2days or by >150 IU at each adjustment
  • Continue treatment until adequate follicular development is evident, and then administer hCG Withhold hCG in cases where the ovarian monitoring suggests an increased risk of ovarian hyperstimulation syndrome on the last day of menotropin therapy
  • Do not administer daily doses of menotropins or menotropins in combination with urofollitropin that exceed 450 IU

Repronex

  • 225 units SC in patients that have received GnRH agonist for pituitary suppression; adjustments not to be made more frequently than every 2 days; not to exceed 75-150 IU per adjustment (not to exceed 450 IU/dose); not to exceed 12 days of therapy
  • If patient's response satisfactory, administer 5000-10,000 IU hCG one day following the last dose of menotropins
  • Do not administer hCG dose if serum estradiol >2000 pg/mL, if ovaries abnormally large, or abdominal pain occurs; patient should also refrain from intercourse
  • May repeat therapy if follicular development inadequate or pregnancy does not occur

Spermatogenesis

75 IU each of LH and FSH SC/IM 3 times/week for at least 4 months

Administration

Reconstitute with 1-2 mL NS

Use immediately following reconstitution, discard unused portion

Monitor

Females

  • Ovarian enlargement (ultrasonography)
  • Serum estradiol

Males

  • Serum testosterone
  • Secondary masculine characteristics

Safety and efficacy not established

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Adverse Effects

>10%

Heachache (34%)

Abdominal pain (18%)

Nausea (12%)

OHSS (13%-dose related)

Injection site pain (4-12%)

1-10%

Flushing (2.4%)

Dizziness (2.6%)

Malaise (2.8%)

Migraine (2.4%)

Breast tenderness (1.8%)

Hot flashes (0.6-2.6%)

Menstrual irregularities (3.2%)

Abdominal cramping/fullness (6%)

Constipation (1.6%)

Diarrhea (2.8%)

Ovarian disease (3.8%)

Vaginal hemorrhage (3.2%)

Back pain (3.2%)

Cough increased (1.6-2.6%)

Respiratory disorder (3.9-5.8%)

Flu-like syndrome (1.3-2.6%)

<1%

Ovarian enlargement & hyperstimulation

Frequency Not Defined

Arterial thromboembolism (rare but potentially fatal)

Gynecomastia in males

Hemoperitoneum

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Warnings

Contraindications

Pregnancy; may cause fetal harm

Hypersensitivity

High levels of FSH indicating primary ovarian failure

Presence of uncontrolled nongonadal endocrinopathies (eg, thyroid, adrenal, or pituitary disorders)

Sex hormone dependent tumors of the reproductive tract and accessory organ

Tumors of pituitary gland or hypothalamus

Abnormal uterine bleeding of undetermined origin

Ovarian cysts or enlargement of undetermined origin, not due to polycystic ovary syndrome

Cautions

Should be administered only by physicians thoroughly experienced in fertility disorders

Hypersensitivity/anaphylactic reactions reported

Ovarian hyperstimulation syndrome (OHSS) reported; OHSS is a medical event distinct from uncomplicated ovarian enlargement and may progress rapidly to become a serious medical event; characterized by dramatic increase in vascular permeability, which can result in a rapid accumulation of fluid in the peritoneal cavity, thorax, and potentially, the pericardium

Use lowest effect dose to minimize abnormal ovarian enlargement; if ovaries are enlarged on last day of therapy, do not administer hCG because of risk for OHSS

May cause pulmonary and vascular complications (eg, atelectasis, ARDS)

Ovarian torsion has been reported after treatment with gonadotropins

Multi-fetal gestation and births have been reported with all gonadotropin therapy

Incidence of congenital malformations after some ART (specifically IVF or ICSI) may be slightly higher than after spontaneous conception (likely due to parental characteristics)

Since infertile women undergoing ART often have tubal abnormalities, the incidence of ectopic pregnancy may be increased

Increased incidence of spontaneous abortion and ovarian neoplasms observed (without causality)

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Pregnancy & Lactation

Pregnancy Category: X

Lactation: Not known whether drug is excreted in breast milk; use caution

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

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Pharmacology

Mechanism of Action

LH & FSH are pituitary gonadotropins that stimulate gonadal function, including spermatogenesis & ovulation

Serum concentration:

Following 6 doses of 150 IU/day SC/IM, serum concentrations of FSH

  • SC: 1.7-15.9 mIU/mL
  • IM: 0.5-10.1 mIU/mL

LH serum concentrations were 0-3.2 mIU/mL for both routes of administration

Half-Life

Initial phase

  • FSH: 4 hr
  • LH: 20 min

Final phase

  • FSH: 70 hr
  • LH: 4 hr

Elimination

Excretion: Urine (8% unchanged)

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Formulary

FormularyPatient Discounts

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
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Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
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Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
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Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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