General MedicinePrescription OnlyPregnancy Cat. XFDA Yes
Menopur
MENOTROPINS
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 diag...
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Brand names:Menopur
Quick Reference
Medicine ClassGeneral Medicine
FDA ApprovedYes
PregnancyCategory X
Quick Facts
- Active ingredient
- MENOTROPINS
- Medicine class
- General Medicine
- Brand names
- Menopur
- Availability
- Prescription only (Rx)
- Pregnancy category
- X
- FDA approved
- Yes
What Is Menopur?
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 diag...
Menopur (MENOTROPINS) belongs to the General Medicine class of medications. It was first approved by the FDA in Yes. This medication requires a prescription from a licensed healthcare provider.
Key Safety Information
- •Always follow the dose recommended by your healthcare professional. Taking more than prescribed increases the risk of side effects including serious complications.
- •Seek emergency care if you experience signs of an allergic reaction — hives, swelling, difficulty breathing, or rash. Stop the medication and call your doctor immediately.
- •Some medications can increase the risk of cardiovascular events. Tell your doctor if you have high blood pressure, a history of heart attack or stroke, or any pre-existing health condition.
- •Avoid or limit alcohol while taking Menopur. Do not drink alcohol without first discussing it with your healthcare provider as it may increase adverse effects.
- •Take Menopur with food or a full glass of water if stomach upset occurs. Stop use and talk to your doctor if you experience persistent stomach pain or GI symptoms.
- •Tell your doctor about all medications, supplements, and vitamins you take. Some combinations significantly increase the risk of harm.
This is a summary only. Always read the full prescribing information and consult your healthcare provider for personalized medical advice.
Uses & Indications
Menopur is prescribed for the following conditions. Some uses are FDA-approved indications; others may be evidence-based off-label uses. Consult your healthcare provider for personalized guidance.
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 the male partner Exclude a diagnosis of primary ovarian failure
Dosage Guide
The following are general dosing guidelines only. Your actual dose should be determined by your healthcare provider based on your condition, renal/hepatic function, and other medications.
AD
Adult 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 International Units of BRAVELLE) was studied in a clinical trial. ( 2.2 ) 2.1 General Dosing Information Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Administer MENOPUR subcutaneously in the abdomen as described in Instructions for Use. MENOPUR may be administered together with BRAVELLE ® (uro
Available Forms
Available Strengths
Side Effects
Common
- 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 (5.6) ] Ectopic Pregnancy [see Warnings and Precautions (5.7) ] Spontaneous Abortion [see Warnings and Precautions (5.8) ] Ovarian Neoplasms [see Warnings and Precautions (5.9) ] The most common adverse reactions (≥2%) in ART include: abdominal cramps;
- abdomen enlarged;
- abdominal pain;
- injection site pain and reaction;
- injection site inflammation;
- OHSS ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Ferring Pharmaceuticals Inc.
- at 1-888-FERRING (1-888-337-7464) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
Serious
- 5 WARNINGS AND PRECAUTIONS MENOPUR should only be used by physicians who are experienced in infertility treatment.
- MENOPUR contains gonadotropic substances capable of causing in women, Ovarian Hyperstimulation Syndrome (OHSS) with or without pulmonary or vascular complications [see Warnings and Precautions (5.2 , 5.3) ] and multiple births [see Warnings and Precautions (5.5) ] .
- Gonadotropin therapy requires the availability of appropriate monitoring facilities [see Warnings and Precautions (5.10) ] .
- Use the lowest effective dose.
- Abnormal Ovarian Enlargement ( 5.1 ) Ovarian Hyperstimulation Syndrome (OHSS) ( 5.2 ) Pulmonary and Vascular Complications ( 5.3 ) Ovarian Torsion ( 5.4 ) Multi-fetal Gestation and Birth ( 5.5 ) Congenital Malformation ( 5.6 ) Ectopic Pregnancy ( 5.7 ) Spontaneous Abortion ( 5.8 ) Ovarian Neoplasms ( 5.9 ) 5.1 Abnormal Ovarian Enlargement In order to minimize the hazards associated with abnormal ovarian enlargement that may occur with MENOPUR therapy, treatment should be individualized and the lowest effective dose should be used [see Dosage and Administration (2.2) ] .
Rare
Medicine Interactions
Always inform your healthcare provider and pharmacist about ALL medications you take, including prescriptions, OTC medicines, vitamins, and supplements.
MajorModerateMinor
Warnings & Contraindications
5 WARNINGS AND PRECAUTIONS MENOPUR should only be used by physicians who are experienced in infertility treatment. MENOPUR contains gonadotropic substances capable of causing in women, Ovarian Hyperstimulation Syndrome (OHSS) with or without pulmonary or vascular complications [see Warnings and Precautions (5.2 , 5.3) ] and multiple births [see Warnings and Precautions (5.5) ] . Gonadotropin thera
How Menopur Works
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.
Pharmacokinetics
Absorption
Absorption The subcutaneous route of administration trends toward greater bioavailability than the intramuscular route for single and multiple doses of MENOPUR
Metabolism
Metabolism Metabolism of FSH and LH has not been studied for MENOPUR in humans
Excretion
Excretion The elimination half-lives for FSH in the multiple-dose phase were similar (11-13 hours) for subcutaneously administered MENOPUR and intramuscularly administered MENOPUR
Pregnancy & Breastfeeding Safety
X
FDA Pregnancy Category X
Contraindicated in pregnancy. Studies show fetal risk that outweighs any potential benefit.
Full Pregnancy InformationBreastfeeding
Many medications pass into breast milk in varying amounts. Before using Menopurwhile breastfeeding, discuss the benefits and risks with your healthcare provider or pharmacist — they can weigh your dose, your infant's age, and available lactation safety data to find the safest option for you and your baby.
Storage & Handling
16.2 Storage and Handling Lyophilized powder may be stored refrigerated or at room temperature (3° to 25° C/37° to 77°F) until dispensed. Protect from light. Use immediately after reconstitution. Discard unused material.
Frequently Asked Questions
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Sources & References
- • FDA Prescribing Information — Official labeling and package insert for Menopur
- • U.S. National Library of Medicine — MedlinePlus drug information
- • American Hospital Formulary Service (AHFS) — Clinical pharmacology monograph
- • PubMed / MEDLINE — View clinical studies
Last reviewed by MedCentralHub Medical Review Board · MedCentralHub Editorial Policy
Medical Disclaimer
The information on this page is for educational purposes only and is not intended as medical advice, diagnosis, or treatment. Always consult your doctor, pharmacist, or qualified healthcare provider before starting, stopping, or changing any medication.