Dosing & Uses
Dosage Forms & Strengths
powder for injection: LH/FSH
- 75 IU
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
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
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)
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.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)
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Menopur subcutaneous - | 75 unit vial |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
menotropins subcutaneous
MENOTROPINS - SUBCUTANEOUS INJECTION
(men-oh-TROW-pins)
COMMON BRAND NAME(S): Menopur
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).
HOW TO USE: Read the Patient Information Leaflet provided by your pharmacist before starting this medication and each time you get a refill. You will be trained by a healthcare professional on how to properly use this medication. Learn and understand all preparation and usage instructions. If you have any questions, consult your doctor or pharmacist.Use this medication exactly as directed by your doctor in order to get the most benefit from it. To help you remember, use it at the same time each day.Inject this medication under the skin exactly as directed by your doctor. The dosage and length of treatment are based on your medical condition, response to therapy and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Be sure to keep all medical appointments so your doctor can closely monitor your response to determine the dosage that is right for you. The manufacturer recommends that your dose should not be more than 450 international units per day and that the medication should not be used for more than 20 days per treatment cycle. Do not change the dose or use this drug for a longer period than prescribed unless instructed by your doctor.Follow all instructions for proper mixing with the correct fluid provided with this medication. Before using, check the solution visually for particles or discoloration. If either is present, do not use the liquid. Use the solution immediately after the medication is mixed. Discard any unused solution. If you have questions regarding the use of this medication, consult your pharmacist.Wash hands with soap and water before using this medication. Before injecting each dose, clean the injection site with rubbing alcohol. It is important to change the location of the injection site daily to avoid discomfort and problem areas under the skin.Learn how to store and discard needles and medical supplies safely. Consult your pharmacist.
SIDE EFFECTS: Headache, mild stomach pain/bloating, redness/pain at the injection site, breast tenderness, or dizziness may occur. If any of these effects last or get worse, notify your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: flu-like symptoms (such as fever, chills, joint pain, muscle ache, tiredness).Get medical help right away if you have any very serious side effects, including: weakness on one side of the body, trouble speaking, sudden vision changes, sudden severe headache, pain/swelling of the calf muscles, chest pain, shortness of breath.This medication may cause a condition known as ovarian hyperstimulation syndrome (OHSS). This condition may occur during or after treatment. Rarely, serious OHSS causes fluid to suddenly build up in the stomach, chest, and heart area. Get medical help right away if you develop the following side effects: severe pain or swelling in the lower abdominal (pelvic) area, severe nausea/vomiting, sudden/rapid weight gain, or decreased urination.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before using this medication, tell your doctor or pharmacist if you are allergic to it; or to other products containing follicle stimulating hormone or luteinizing hormone; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: other fertility problems (such as primary ovarian failure), abnormal uterine/vaginal bleeding, thyroid problems, adrenal gland problems, cancer of the reproductive organs (breast, uterus, ovary), tumor in the brain (such as a pituitary tumor), ovarian cysts/enlarged ovaries (not due to polycystic ovary syndrome), twisting of the ovary (ovarian torsion), personal/family history of blood clots, blood clotting disorders (such as thrombophilia), obesity, stroke, certain heart diseases (such as heart attack), lung problems (such as asthma).This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).Multiple births may occur because of this treatment. Consult your doctor for more details.Stop using this medication when you become pregnant. This medication must not be used during pregnancy. If you think you may be pregnant, tell your doctor right away.It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.A product that may interact with this drug is: gonadorelin.
OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: Do not share this medication with others.Lab and/or medical tests (such as blood hormone tests such as estradiol level, vaginal ultrasound) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.Lifestyle changes that may help improve the effect of this medication include limiting alcohol and stopping smoking. Consult your doctor or pharmacist to discuss lifestyle changes that might benefit you.
MISSED DOSE: It is important to use this medication on a fixed schedule exactly as prescribed by your doctor. If you miss a dose, contact your doctor or pharmacist right away for instructions. Do not double the dose to catch up.
STORAGE: Store in the refrigerator or at room temperature. Protect from light. Do not freeze. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Information last revised December 2022. Copyright(c) 2023 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
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