Version May 2024
Assisted reproductive technologies (females): SUBQ: Initial: 225 units once daily beginning on cycle day 2 or 3; Menotropins may be administered together with urofollitropin and the total initial dose of both products combined should not exceed 225 units (menotropins 150 units and urofollitropin 75 units; or menotropins 75 units and urofollitropin 150 units). Adjust dose after 5 days based on ultrasound monitoring of ovarian response and/or measurement of serum estradiol levels. Do not make additional adjustments more frequently than once every 2 days or by >150 units. Maximum daily dose: 450 units (of menotropins, or menotropins plus urofollitropin); treatment >20 days is not recommended. Once follicular growth indicates an adequate ovarian response, administer hCG. Follow current clinical practice to reduce the risk of ovarian hyperstimulation syndrome.
Spermatogenesis (males) (off-label use): IM: Following pretreatment with hCG: 75 units 3 times per week with hCG twice weekly until sperm is detected in the ejaculate (4 to 6 months); if response is inadequate after 6 months, may increase menotropins dosage to 150 units 3 times per week for another 6 months (AACE [Petak 2002]).
There are no dosage adjustments provided in manufacturer's labeling (has not been studied).
There are no dosage adjustments provided in manufacturer's labeling (has not been studied).
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse effects and incidences may vary according to specific product, indication, dosage, or route of administration.
>10%: Genitourinary: Multiple gestation (35%)
1% to 10%:
Central nervous system: Headache (5% to 6%)
Endocrine & metabolic: Ovarian disease (3% to 8%), ovarian hyperstimulation syndrome (2% to 7%)
Gastrointestinal: Abdominal pain (5% to 7%), nausea (4% to 7%), abdominal cramps (3% to 7%), enlargement of abdomen (2% to 6%), gastrointestinal fullness (≥5%), vomiting (3%), diarrhea (2%)
Genitourinary: Vaginal hemorrhage (3% to 8%), pelvic pain (1% to 3%), breast tenderness (2%), ectopic pregnancy (1%)
Infection: Infection (1%)
Local: Injection site reaction (2% to 8%), swelling at injection site (1% to 8%), pain at injection site (≤4%), inflammation at injection site (2%)
Respiratory: Dyspnea (1% to 2%)
Frequency not defined:
Cardiovascular: Tachycardia
Central nervous system: Dizziness
Dermatologic: Rash at injection site, skin rash
Endocrine & metabolic: Ovarian cyst, ovary enlargement
Hematologic & oncologic: Hemoperitoneum, ovarian neoplasm
Hypersensitivity: Anaphylaxis
Local: Irritation at injection site
Respiratory: Flu-like symptoms, tachypnea
Miscellaneous: Fetal abnormality, ovarian torsion
<1%, postmarketing, and/or case reports: Abdominal distention, abdominal distress, acne vulgaris, acute respiratory distress syndrome, angioedema, atelectasis, cerebrovascular accident, embolism, facial edema, fatigue, hot flash, hypersensitivity reaction, laryngeal edema, local tissue necrosis, lower abdominal pain, malaise, occlusion of cerebral arteries, occlusive arterial disease (may result in loss of limb), pulmonary complications, pulmonary embolism, pulmonary infarct, thromboembolism, thrombophlebitis (includes venous), thrombosis
Hypersensitivity to menotropins or any component of the formulation; primary ovarian failure as indicated by a high follicle-stimulating hormone level; uncontrolled nongonadal endocrinopathies (eg, thyroid, adrenal, pituitary); pituitary or hypothalamic tumors; sex hormone-dependent tumors of the reproductive tract and accessory organs; abnormal uterine bleeding of undetermined origin; ovarian cyst or enlargement not due to polycystic ovary syndrome; pregnancy.
Concerns related to adverse effects:
• Hypersensitivity: Hypersensitivity and anaphylactic reactions have been reported; discontinue use for serious reactions and treat appropriately.
• Ovarian enlargement: The lowest effective dose should be used to decrease the risk of abnormal ovarian enlargement. If ovaries are abnormally enlarged on the last day of menotropin treatment, follow current clinical practice to reduce the risk of ovarian hyperstimulation syndrome (OHSS).
• Ovarian hyperstimulation syndrome: OHSS is a rare exaggerated response to ovulation induction therapy (Corbett 2014; Fiedler 2012). This syndrome may begin within 24 hours of hCG treatment but may become most severe 7 to 10 days after therapy (Corbett 2014). Mild/moderate OHSS signs/symptoms may include abdominal distention/discomfort, diarrhea, nausea, vomiting, and mild/moderate enlargement of ovaries/ovarian cysts. Severe OHSS signs/symptoms may include severe abdominal pain, anuria/oliguria, ascites, severe dyspnea, hypotension, hydrothorax, nausea/vomiting (intractable), pleural effusion, rapid weight gain, venous thrombosis, and large ovarian cysts. Decreased creatinine clearance, hemoconcentration, hypoproteinemia, elevated liver enzymes, elevated WBC, and electrolyte imbalances may also be present (ASRM 2016; Corbett 2014; Fiedler 2012). Treatment is primarily symptomatic and includes fluid and electrolyte management, analgesics, and prevention of thromboembolic complications (ASRM 2016; Shmorgun 2017).
• Ovarian torsion: Has been reported following gonadotropin treatment; may be related to OHSS, prior ovarian torsion, prior or current ovarian cyst, polycystic ovaries, pregnancy, or prior abdominal surgery. Early diagnosis and prompt detorsion may limit the extent of ovarian damage.
• Pulmonary effects: Serious pulmonary conditions (atelectasis, acute respiratory distress syndrome, and exacerbation of asthma) have been reported.
• Thromboembolism: In association with and separate from OHSS, thromboembolic events have been reported. Risk may be increased in patients with a personal or family history of thromboembolic events, severe obesity, or thrombophilia.
Other warnings/precautions:
• Appropriate use: To minimize risks, use only at the lowest effective dose. Monitor ovarian response with transvaginal ultrasound; concurrent measurement of estradiol levels may also be useful.
• Experienced physician: These medications should only be used by physicians who are thoroughly familiar with infertility problems and their management.
• Multiple births: May result from the use of these medications; advise patients of the potential risk of multi-fetal gestation and multiple births before starting the treatment.
75 units of menotropins represents 75 units each of FSH activity and LH activity
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Injection, powder for reconstitution:
Menopur: 75 units [supplied with diluent]
No
Solution (reconstituted) (Menopur Subcutaneous)
75 unit (per each): $280.09
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Injection, powder for reconstitution:
Menopur: 75 units
SubQ: Administer to alternating sites of the lower abdomen.
Hazardous agent (NIOSH 2016 [group 3]).
Use appropriate precautions for receiving, handling, administration, and disposal. Gloves (single) should be worn during receiving, unpacking, and placing in storage.
NIOSH recommends double gloving, a protective gown, ventilated engineering controls (a class II biological safety cabinet or a compounding aseptic containment isolator), and closed system transfer devices (CSTDs) for preparation. Double gloving and a gown are required during IM or subcutaneous administration (NIOSH 2016). Assess risk to determine appropriate containment strategy (USP-NF 2017).
For multiple follicle development and pregnancy in ovulatory women as part of an assisted reproductive technology cycle.
Limitations of use: Prior to therapy, preform a complete gynecologic exam and endocrinologic evaluation to 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.
Stimulation of spermatogenesis
The Institute for Safe Medication Practices (ISMP) includes this medication among its list of drugs that have a heightened risk of causing significant patient harm when used in error.
None known.
There are no known significant interactions.
Menotropins are used for the induction of ovulation and assisted reproductive technology (ART). Pregnancy should be excluded prior to treatment.
Evaluate pregnancy status as well as the fertility of the male partner prior to ovulation induction.
Evaluate fertility status of the female partner prior to induction of spermatogenesis when treating males with hypogonadotropic hypogonadism (AACE [Petak 2002]).
Menotropins are used for the induction of ovulation and with assisted reproductive technology (ART); use is contraindicated in women who are already pregnant.
Ectopic pregnancy, congenital abnormalities, spontaneous abortion, and multifetal gestations/ births have been reported. The incidence of congenital abnormality may be slightly higher after ART than with spontaneous conception; higher incidence may be related to parenteral characteristics (maternal age, genetics, sperm characteristics).
It is not known if menotropins is present in breast milk.
Due to the potential for serious adverse reactions in the breastfed infant, the manufacturer recommends a decision be made to discontinue breastfeeding or to discontinue the drug, considering the importance of treatment to the mother.
Monitor follicular growth by transvaginal ultrasound to determine adequate ovarian response and timing of hCG administration. Concurrent measurement of estradiol levels may also be useful.
Monitor for signs and symptoms of ovarian hyperstimulation syndrome (OHSS) for at least 2 weeks following hCG administration. Initial symptoms of moderate to severe OHSS may include a sensation of bloating, abdominal pain, rapid weight gain, and decreased urine output (Shmorgun 2017).
OHSS: Monitoring of hospitalized patients should include albumin, degree of ascites, cardiorespiratory status, electrolytes, fluid balance, hematocrit, hemoglobin, hydration, serum creatinine, urine output, urine specific gravity, signs of thromboembolism, vital signs, weight (daily or as necessary) and liver enzymes (weekly) (Shmorgun 2017).
Males: Monitor for sufficient spermatogenesis (AACE [Petak 2002]).
Menotropins is a purified combination of follicle stimulating hormone (FSH) and luteinizing hormone (LH) extracted from the urine of postmenopausal women. Treatment provides ovarian follicular growth and maturation in females who do not have primary ovarian failure. Also stimulates spermatogenesis in males (off-label use)
Half-life elimination: Follicle-stimulating hormone (FSH) 11 to 13 hours (following multiple doses).
Time to peak: FSH (following a single dose): 18 hours (SubQ).
Excretion: Urine.
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