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Menotropins

Medically reviewed by Drugs.com. Last updated on Aug 8, 2020.

Pronunciation

(men oh TROE pins)

Index Terms

  • hMG
  • Human Menopausal Gonadotropin

Dosage Forms

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]

Brand Names: U.S.

  • Menopur

Pharmacologic Category

  • Gonadotropin
  • Ovulation Stimulator

Pharmacology

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)

Excretion

Urine.

Time to Peak

FSH (following a single dose): 18 hours (SubQ).

Half-Life Elimination

Follicle-stimulating hormone (FSH) 11 to 13 hours (following multiple doses).

Use: Labeled Indications

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.

Off Label Uses

Stimulation of spermatogenesis

Based on the American Association of Clinical Endocrinologists medical guidelines for clinical practice for the evaluation and treatment of hypogonadism in adult male patients, menotropins given for stimulation of spermatogenesis in males with primary or secondary hypogonadotropic hypogonadism is effective and recommended in the management of this condition.

Contraindications

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.

Dosing: Adult

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]).

Reconstitution

Reconstitute with sodium chloride 0.9% for injection (provided); gently swirl to dissolve, do not shake to avoid formation of bubbles. Use immediately after reconstitution. May also be mixed with Bravelle (urofollitropin for injection).

If >1 vial of menotropins is required for a single dose, up to 6 vials can be reconstituted and administered as a single injection. This is done by first reconstituting 1 vial with sodium chloride 0.9% injection as previously described, withdrawing the entire contents of the reconstituted vial, and (using this as the diluent for the second vial) injecting into the second vial, etc. Use immediately after reconstitution.

After reconstitution inject immediately; discard any unused portion.

Administration

SubQ: Administer to alternating sites of the lower abdomen.

Storage

Store at 3°C to 25°C (37°F to 77°F). Protect from light.

Drug Interactions

There are no known significant interactions.

Adverse Reactions

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

Warnings/Precautions

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.

Monitoring Parameters

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]).

Reproductive Considerations

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]).

Pregnancy Risk Factor

X

Pregnancy Considerations

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).

Patient Education

What is this drug used for?

• It is used to help women get pregnant.

• It may be given to you for other reasons. Talk with the doctor.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Injection site irritation

• Nausea

• Abdominal pain

• Headache

• Abdominal cramps

• Bloating

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Breast pain

• Enlarged breasts

• Fast heartbeat

• Yellow skin

• Fast breathing

• Pale skin

• Blue/gray skin discoloration

• Flu-like symptoms

• Ovarian hyperstimulation syndrome like severe abdominal pain or bloating; severe nausea, vomiting, or diarrhea; excessive weight gain; shortness of breath; or change in amount of urine passed

• Blood clots like numbness or weakness on one side of the body; pain, redness, tenderness, warmth, or swelling in the arms or legs; change in color of an arm or leg; chest pain; shortness of breath; fast heartbeat; or coughing up blood

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Further information

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