Menopur menotropins Kit
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Gonadotropin class.
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🏭 Manufacturer & labeler
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🩺 Clinical
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💊 What it looks like
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🧪 Inactive Ingredients / Excipients
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💲 Pricing
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| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $252.119 | — |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Menopurthis 55566-7501-02 | Ferring | 1 kit | $252.119 | — | Availability likely | — |
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⏳ Availability & biosimilar status
Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 55566-7501-02 You're viewing this | 1 CARTON in 1 CARTON (55566-7501-2) / 1 KIT in 1 CARTON (55566-7501-1) * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (55566-7502-0) * 1 INJECTION in 1 VIAL | 2004-10-29 | Active |
🧭 About this NDC listing & data coverage
Kit / multi-component package
This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.
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| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available. |
| NADAC pharmacy acquisition price (CMS) | ✓ Available |
| Orange Book / therapeutic-equivalence data | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
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 and Administration ▾
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 )
2.1General 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 ® (urofollitropin for injection, purified).
2.2Recommended Dosing for Assisted Reproductive Technology The recommended dosing scheme for patients undergoing IVF follows a stepwise approach and is individualized for each woman. The recommended initial dose of MENOPUR for women who have received a GnRH agonist for pituitary suppression is 225 International Units. MENOPUR may be administered together with BRAVELLE and the total initial dose when the products are combined should not exceed 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).
Beginning on cycle day 2 or 3, a starting dose of 225 International Units of MENOPUR is administered subcutaneously daily. Adjust the dose after 5 days based on the woman's ovarian response, as determined by ultrasound evaluation of follicular growth and serum estradiol levels. Do not make additional dosage adjustments more frequently than every 2 days or by more than 150 International Units at each adjustment.
Continue treatment until adequate follicular development is evident, and then administer hCG. Withhold the administration of hCG in cases where the ovarian monitoring suggests an increased risk of OHSS on the last day of MENOPUR therapy [ see Warnings and Precautions (5.1 , 5.2 , 5.10) ]. Do not administer daily doses of MENOPUR or MENOPUR in combination with BRAVELLE that exceed 450 International Units .
Therapy should not exceed 20 days.
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Lyophilized powder for Injection containing 75 International Units FSH and 75 International Units of LH activity, supplied as lyophilized powder or pellet in sterile vials with diluent vials and Q•Cap® vial adapters. Lyophilized powder for injection: containing 75 IU FSH and 75 IU of LH activity, supplied as lyophilized powder or pellet in sterile vials with diluent vials and Q•Cap® vial adapters. ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS MENOPUR is contraindicated in women who exhibit: Prior hypersensitivity to MENOPUR or menotropins products or one of their excipients High levels of FSH indicating primary ovarian failure [see Indications and Usage (1) ] Pregnancy MENOPUR may cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1) ]. MENOPUR is contraindicated in women who are pregnant. If this drug is used during pregnancy, or if the woman becomes pregnant while taking this drug, the woman should be apprised of the potential hazard to a fetus.
Presence of uncontrolled non-gonadal endocrinopathies (e.g., thyroid, adrenal, or pituitary disorders) [see Indications and Usage (1) ] Sex hormone dependent tumors of the reproductive tract and accessory organs Tumors of pituitary gland or hypothalamus Abnormal uterine bleeding of undetermined origin Ovarian cyst or enlargement of undetermined origin, not due to polycystic ovary syndrome MENOPUR is contraindicated in women who exhibit: Prior hypersensitivity to MENOPUR or menotropins products or one of their excipients ( 4 ) High levels of FSH indicating primary ovarian failure ( 4 ) Pregnancy ( 4 ) Presence of uncontrolled non-gonadal endocrinopathies ( 4 ) Sex hormone dependent tumors of the reproductive tract and accessory organ ( 4 ) Tumors of pituitary gland or hypothalamus ( 4 ) Abnormal uterine bleeding of undetermined origin ( 4 ) Ovarian cyst or enlargement of undetermined origin, not due to polycystic ovary syndrome ( 4 )
⚠️ Warnings and Cautions ▾
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 )
5.1Abnormal 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) ] . Use of ultrasound monitoring of ovarian response and/or measurement of serum estradiol levels is important to minimize the risk of ovarian stimulation [see Warnings and Precautions (5.10) ] . If the ovaries are abnormally enlarged on the last day of MENOPUR therapy, hCG should not be administered in order to reduce the chance of developing Ovarian Hyperstimulation Syndrome (OHSS) [see Warnings and Precautions (5.2) ] .
Prohibit intercourse in women with significant ovarian enlargement because of the danger of hemoperitoneum resulting from rupture of ovarian cysts [see Warnings and Precautions (5.2) ] .
5.2Ovarian Hyperstimulation Syndrome (OHSS) OHSS is a medical event distinct from uncomplicated ovarian enlargement and may progress rapidly to become a serious medical event. OHSS is characterized by a dramatic increase in vascular permeability, which can result in a rapid accumulation of fluid in the peritoneal cavity, thorax, and potentially, the pericardium. The early warning signs of development of OHSS are severe pelvic pain, nausea, vomiting, and weight gain.
Abdominal pain, abdominal distension, gastrointestinal symptoms including nausea, vomiting and diarrhea, severe ovarian enlargement, weight gain, dyspnea, and oliguria have been reported with OHSS. Clinical evaluation may reveal hypovolemia, hemoconcentration, electrolyte imbalances, ascites, hemoperitoneum, pleural effusion, hydrothorax, acute pulmonary distress, and thromboembolic reactions [see Warnings and Precautions (5.3) ]. Transient liver function test abnormalities suggestive of hepatic dysfunction, with or without morphologic changes on liver biopsy, have been reported in association with OHSS.
OHSS occurs after gonadotropin treatment has been discontinued and it can develop rapidly, reaching its maximum about seven to ten days following treatment. Usually, OHSS resolves spontaneously with the onset of menses. If there is evidence that OHSS may be developing prior to hCG administration [see Warnings and Precautions (5.1) ] , the hCG must be withheld.
Cases of OHSS are more common, more severe, and more protracted if pregnancy occurs; therefore, women should be assessed for the development of OHSS for at least two weeks after hCG administration. If serious OHSS occurs, gonadotropins, including hCG, should be stopped and consideration should be given as to whether the woman needs to be hospitalized. Treatment is primarily symptomatic and overall should consist of bed rest, fluid and electrolyte management, and analgesics (if needed).
Because the use of diuretics can accentuate the diminished intravascular volume, diuretics should be avoided except in the late phase of resolution as described below. The management of OHSS may be divided into three phases as follows: Acute Phase: Management should be directed at preventing hemoconcentration due to loss of intravascul…
🤒 Adverse Reactions ▾
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; headache; 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 .
6.1Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trial of another drug and may not reflect the rates observed in practice. In two single cycle, open label, multinational, multicenter, comparative trials, a total of 434 normal ovulatory infertile women were randomized and received subcutaneously administered MENOPUR as part of an in vitro fertilization (IVF) cycle (both trials) or intracytoplasmic sperm injection (ICSI) cycle (one of the two trials).
All women received pituitary down-regulation with gonadotropin releasing hormone (GnRH) agonist before stimulation. Adverse Reactions occurring at an incidence of ≥ 2% in women receiving MENOPUR are shown in Table 1. Table 1: MENOPUR Administered Subcutaneously in Women Undergoing IVF and ICSI.
Adverse Reactions with Incidence of 2% or Greater Occurring on or After GnRH Administration. Body System/Preferred Term IVF n=434 N % Body as a whole Abdominal cramps 13
3.0 Abdomen enlarged 10
2.3 Abdominal pain 29
6.7 Headache 27
6.2 Injection site pain + reaction 17
3.9 Injection site inflammation 10
2.3 Urogenital Ovarian Hyperstimulation Syndrome (OHSS) 27
6.2In addition, thrombophlebitis was reported in less than 1% of subjects. In an open label, US, multicenter, comparative IVF and ICSI trial, MENOPUR and BRAVELLE were administered in the same syringe to 60 normal ovulatory infertile women. OHSS, post retrieval cramping and nausea and spontaneous abortion were the most common adverse reactions occurring at an incidence of ≥ 5% in women receiving the combination of MENOPUR and BRAVELLE.
In another open label, US multicenter, comparative trial for ovulation induction in anovulatory or oligovulatory infertile women, 76 subjects received subcutaneous or intramuscular injections of MENOPUR. The most common adverse reactions occurring at an incidence of ≥ 5% in women receiving MENOPUR were: headache; OHSS; injection site reaction, abdominal cramps, fullness and pain; and nausea.
6.2Postmarketing Experience The following adverse reactions have been reported during postmarketing use of gonadotropins. Because these reactions were reported voluntarily from a population of uncertain size, the frequency or a causal relationship to MENOPUR cannot be reliably determined. Gastrointestinal disorders: abdominal pain, abdominal pain lower, abdominal distension, nausea, vomiting, abdominal discomfort General disorders and administration site conditions: injection site reactions (most frequently reported injection site reaction was injection site pain), fatigue Nervous system disorders: headache, dizziness Reproductive system disorders: OHSS [see Warnings and Precautions (5.2) ] , pelvic pain, ovarian cyst, breast complaints (incl…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS No drug/drug interaction studies in humans have been conducted for MENOPUR. No drug/drug interaction studies have been conducted for MENOPUR in humans. ( 7 )
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Pregnancy Category X. Do not use MENOPUR in pregnant women. ( 4 , 8.1 ) Nursing Mothers: It is not known whether this drug is excreted in human milk. ( 8.3 ) Pediatric Use: Safety and efficacy not established. ( 8.4 ) Renal and Hepatic Insufficiency: Safety, efficacy, and pharmacokinetics of MENOPUR in women with renal or hepatic insufficiency have not been established. ( 8.6 )
8.1Pregnancy Teratogenic effects Pregnancy Category X [see Contraindications (4) ] .
8.3Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in the nursing infant from MENOPUR, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established.
8.6Renal and Hepatic Insufficiency Safety, efficacy, and pharmacokinetics of MENOPUR in women with renal or hepatic insufficiency have not been established.
🤰 Pregnancy ▾
8.1Pregnancy Teratogenic effects Pregnancy Category X [see Contraindications (4) ] .
🧒 Pediatric Use ▾
8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established.
🆘 Overdosage ▾
10 OVERDOSAGE Aside from possible OHSS [see Warnings and Precautions (5.2) ] and multiple gestations [see Warnings and Precautions (5.5) ] , there is no additional information on the consequences of acute overdosage with MENOPUR.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism 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.
12.3Pharmacokinetics Two open-label, randomized, controlled trials were conducted to assess the pharmacokinetics of MENOPUR. Study 2003-02 compared single doses of subcutaneous administration of the US and European (EU) formulations of MENOPUR in 57 healthy, pre-menopausal females who had undergone pituitary suppression. The study established that the two formulations are bioequivalent.
Study 2000-03 assessed single and multiple doses of MENOPUR administered subcutaneously and intramuscularly in a 3 phase crossover design in 33 healthy, pre-menopausal females who had undergone pituitary suppression. The primary pharmacokinetic endpoints were FSH AUC and C max values. The results are summarized in Table 2.
Table 2: FSH Pharmacokinetic Parameters [Mean (SD)] Following MENOPUR Administration (Study 2000-03) PK Parameters Single Dose (225 IU) Multiple Dose (225 IU × 1 day then 150 IU × 6 days) Subcutaneous Intramuscular Subcutaneous Intramuscular C max Single dose C max , AUC 120 and multiple dose C maxss , AUC ss (mIU/mL) 8.5 (2.5) 7.8 (2.4) 15.0 (3.6) 12.5 (2.3) T max (hr) 17.9 (5.8) 27.5 (25.4) 8.0 (3.0) 9.0 (7.0) AUC† (hr-mlU/mL) 726.2 (243.0) 656.1 (233.7) 622.7 (153.0) 546.2 (91.2) Absorption The subcutaneous route of administration trends toward greater bioavailability than the intramuscular route for single and multiple doses of MENOPUR.
Distribution Human tissue or organ distribution of FSH and LH has not been studied for MENOPUR. Metabolism Metabolism of FSH and LH has not been studied for MENOPUR in humans. 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.
🧬 Mechanism of Action ▾
12.1Mechanism 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.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1How Supplied MENOPUR (menotropins for injection) is supplied in sterile vials as a lyophilized, white to off-white powder or pellet. Each vial of MENOPUR is accompanied by a vial of sterile diluent containing 2 mL of 0.9% Sodium Chloride for Injection, USP: 75 International Units FSH and 75 International Units of LH activity, supplied as NDC 55566-7501-2: Box of 5 vials + 5 vials diluent + 5 Q•Cap vial adapters
16.2Storage 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.
📦 Storage and Handling ▾
16.2Storage 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.
📋 Description ▾
11 DESCRIPTION MENOPUR is a preparation of gonadotropins (FSH and LH activity), extracted from the urine of postmenopausal women, which has undergone additional steps for purification. MENOPUR is a sterile, lyophilized powder intended for subcutaneous (SC) injection after reconstitution with sterile 0.9% Sodium Chloride Injection, USP. Each vial of MENOPUR contains 75 International Units of follicle-stimulating hormone (FSH) activity and 75 International Units of luteinizing hormone (LH) activity, plus 21 mg lactose monohydrate and 0.005 mg Polysorbate 20 and Sodium Phosphate Buffer (Sodium Phosphate Dibasic, Heptahydrate and Phosphoric Acid).
The biological activity of MENOPUR is determined using the bioassays for FSH (ovarian weight gain assay in female rats) and LH (seminal vesicle weight gain assay in male rats), modified to increase the accuracy and reproducibility of these assays. The FSH and LH activity assays are standardized using the Fourth International Standard for Urinary FSH and Urinary LH, November 2000, by the Expert Committee on Biological Standardization of the World Health Organization (WHO ECBS). Both FSH and LH are glycoproteins that are acidic and water-soluble.
Human Chorionic Gonadotropin (hCG) is detected in MENOPUR. MENOPUR has been mixed in vitro with BRAVELLE with no evidence of aggregation. Therapeutic class: Infertility
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION See FDA-approved patient labeling (Patient Information and Instructions for Use).
17.1Dosing and Use Instruct women on the correct usage and dosing of MENOPUR [see Dosage and Administration (2.2) ] . Caution women not to change the dosage or the schedule of administration unless she is told to do so by her healthcare provider.
17.2Duration and Monitoring Required Prior to beginning therapy with MENOPUR, inform women about the time commitment and monitoring procedures necessary for treatment [see Dosage and Administration (2.2) and Warnings and Precautions (5.10) ] .
17.3Instructions Regarding a Missed Dose Inform the woman that if she misses or forgets to take a dose of MENOPUR, the next dose should not be doubled and she should call her healthcare provider for further dosing instructions.
17.4Ovarian Hyperstimulation Syndrome Inform women regarding the risks of OHSS [see Warnings and Precautions (5.2) ] and OHSS-associated symptoms including lung and blood vessel problems [see Warnings and Precautions (5.3) ] and ovarian torsion [see Warnings and Precautions (5.4) ] with the use of MENOPUR.
17.5Multi-fetal Gestation and Birth Inform women regarding the risk of multi-fetal gestation and birth with the use of MENOPUR [see Warnings and Precautions (5.5) ] Vials of sterile diluent of 0.9% Sodium Chloride Injection, USP manufactured for Ferring Pharmaceuticals Inc.