Menotropins
Pronunciation
(men oh TROE pins)
U.S. Brand Names
Menopur®; Pergonal® [DSC]; Repronex®
Generic Available
No
Canadian Brand Names
Pergonal®; Repronex®
Use
Female:
In conjunction with hCG to induce ovulation and pregnancy in infertile females experiencing oligo-anovulation or anovulation when the cause of anovulation is functional and not caused by primary ovarian failure (Pergonal®, Repronex®)
Stimulation of multiple follicle development in ovulatory patients as part of an assisted reproductive technology (ART) (Menopur®, Pergonal®, Repronex®)
Male: Stimulation of spermatogenesis in primary or secondary hypogonadotropic hypogonadism (Pergonal®)
Pregnancy Risk Factor
X
Pregnancy Implications
Ectopic pregnancy and congenital abnormalities have been reported. The incidence of congenital abnormality is similar during natural conception.
Lactation
Excretion in breast milk unknown/use caution
Contraindications
Hypersensitivity to menotropins or any component of the formulation; primary ovarian failure as indicated by a high follicle-stimulating hormone (FSH) level; uncontrolled thyroid and adrenal dysfunction; abnormal bleeding of undetermined origin; intracranial lesion (ie, pituitary tumor); ovarian cyst or enlargement not due to polycystic ovary syndrome; infertility due to any cause other than anovulation (except candidates for
in vitro fertilization); men with normal urinary gonadotropin concentrations, elevated gonadotropin levels indicating primary testicular failure; sex hormone-dependent tumors of the reproductive tract and accessory organs; pregnancy
Warnings/Precautions
For use by infertility specialists. Advise patient of frequency and potential hazards of multiple pregnancy. May cause ovarian hyperstimulation syndrome (OHSS); if severe, treatment should be discontinued and patient should be hospitalized (may become more severe if pregnancy occurs). Monitor for ovarian enlargement; to minimize the hazard of abnormal ovarian enlargement, use the lowest possible dose. Serious pulmonary conditions (atelectasis, acute respiratory distress syndrome) and arterial thromboembolism have been reported. Safety and efficacy have not been established in renal or hepatic impairment, or in pediatric and geriatric patients.
Adverse Reactions
Adverse effects may vary according to specific product, route, and/or dosage.
Male:
>10%: Endocrine & metabolic: Gynecomastia
1% to 10%: Erythrocytosis (dyspnea, dizziness, anorexia, syncope, epistaxis)
Female:
>10%:
Central nervous system: Headache (up to 34%)
Gastrointestinal: Abdominal pain (up to 18%), nausea (up to 12%)
Genitourinary: OHSS (up to 13%, dose related)
Local: Injection site reaction (4% to 12%)
1% to 10%:
Cardiovascular: Flushing
Central nervous system: Dizziness, malaise, migraine
Endocrine & metabolic: Breast tenderness, hot flashes, menstrual irregularities
Gastrointestinal: Abdominal cramping, abdominal fullness, constipation, diarrhea, enlarged abdomen, vomiting
Genitourinary: Ectopic pregnancy, ovarian disease, vaginal hemorrhage
Local: Injection site edema/pain
Neuromuscular & skeletal: Back pain
Respiratory: Cough increased, respiratory disorder
Miscellaneous: Infection, flu-like syndrome
Frequency not defined:
Cardiovascular: Stroke, tachycardia, thrombosis (venous or arterial)
Central nervous system: Dizziness
Dermatologic: Angioedema, urticaria
Genitourinary: Adnexal torsion, hemoperitoneum, ovarian enlargement
Neuromuscular & skeletal: Limb necrosis
Respiratory: Acute respiratory distress syndrome, atelectasis, dyspnea, embolism, laryngeal edema pulmonary infarction tachypnea
Miscellaneous: Allergic reaction, anaphylaxis, rash
Overdosage/Toxicology
Symptoms of overdose include ovarian hyperstimulation.
Stability
Lyophilized powder may be refrigerated or stored at room temperature; after reconstitution inject immediately, discard any unused portion; protect from light
Mechanism of Action
Actions occur as a result of both follicle stimulating hormone (FSH) effects and luteinizing hormone (LH) effects; menotropins stimulate the development and maturation of the ovarian follicle (FSH), cause ovulation (LH), and stimulate the development of the corpus luteum (LH); in males it stimulates spermatogenesis (LH)
Pharmacodynamics/Kinetics
Excretion: Urine (~10% as unchanged drug)
Dosage
Adults:
Pergonal®: I.M.
Spermatogenesis (Male): Following pretreatment with hCG: 75 int. units 3 times/week and hCG 2000 units twice weekly until sperm is detected in the ejaculate (4-6 months); may then be increased to menotropins 150 int. units 3 times/week
Induction of ovulation (Female): 75 int. units for 7-12 days, followed by 10,000 units hCG one day after the last dose; repeated at least twice at same level before increasing dosage to 150 int. units
Repronex®: I.M., SubQ:
Induction of ovulation in patients with oligo-anovulation (Female): Initial: 150 int. units daily for the first 5 days of treatment. Adjustments should not be made more frequently than once every 2 days and should not exceed 75-150 int. units per adjustment. Maximum daily dose should not exceed 450 int. units and dosing beyond 12 days is not recommended. If patient's response is appropriate, hCG 5000-10,000 units should be given one day following the last dose of Repronex®. Hold dose if serum estradiol is >2000 pg/mL, if the ovaries are abnormally enlarged, or if abdominal pain occurs; the patient should also be advised to refrain from intercourse. May repeat process if follicular development is inadequate or if pregnancy does not occur.
Assisted reproductive technologies (Female): Initial (in patients who have received GnRH agonist or antagonist pituitary suppression): 225 int. units; adjustments in dose should not be made more frequently than once every 2 days and should not exceed more than 75-150 int. units per adjustment. The maximum daily doses of Repronex® given should not exceed 450 int. units and dosing beyond 12 days is not recommended. Once adequate follicular development is evident, hCG (5000-10,000 units) should be administered to induce final follicular maturation in preparation for oocyte retrieval. Withhold treatment when ovaries are abnormally enlarged on last day of therapy (to reduce chance of developing OHSS).
Menopur®: SubQ:
Assisted reproductive technologies (ART): Initial (in patients who have received GnRH agonist for pituitary suppression): 225 int. units; adjustments in dose should not be made more frequently than once every 2 days and should not exceed more than 150 int. units per adjustment. The maximum daily dose given should not exceed 450 int. units and dosing beyond 20 days is not recommended. Once adequate follicular development is evident, hCG should be administered to induce final follicular maturation in preparation for oocyte retrieval. Withhold treatment when ovaries are abnormally enlarged on last day of therapy (to reduce chance of developing OHSS).
Administration
Menopur®: SubQ: Administer to alternating sites of the abdomen; when administration to the lower abdomen is not possible, the injection may be given into the thigh.
Pergonal®: I.M.: Administer deep in a large muscle.
Repronex®:
I.M.: Administer deep in a large muscle.
SubQ: Administer to alternating sites of the lower abdomen.
Monitoring Parameters
hCG levels, serum estradiol; vaginal ultrasound; in cases of suspected OHSS, monitor fluid intake and output, weight, hematocrit, serum and urinary electrolytes, urine specific gravity, BUN and creatinine, and abdominal girth
Patient Education
Self injection: Follow prescriber's recommended schedule for injections. Multiple ovulations resulting in multiple pregnancies have been reported. Male infertility and/or breast enlargement may occur. You may experience headache, nausea, abdominal pain, flushing, dizziness, or menstrual irregularities. Report pain at injection site; enlarged breasts (male); respiratory difficulty; nosebleeds; acute abdominal discomfort; abdominal distention; fever; or warmth, swelling, weight gain, pain, or redness in calves.
Dental Health: Effects on Dental Treatment
No significant effects or complications reported
Dental Health: Vasoconstrictor/Local Anesthetic Precautions
No information available to require special precautions
Mental Health: Effects on Mental Status
None reported
Mental Health: Effects on Psychiatric Treatment
None reported
Dosage Forms
[DSC] = Discontinued product
Injection, powder for reconstitution:
Menopur®: Follicle stimulating hormone activity 75 int. units and luteinizing hormone activity 75 int. units [packaged with diluent; contains lactose 21 mg]
Pergonal®: Follicle stimulating hormone activity 75 int. units and luteinizing hormone activity 75 int. units [packaged with diluent; contains lactose 10 mg] [DSC]
Repronex®: Follicle stimulating hormone activity 75 int. units and luteinizing hormone activity 75 int. units [packaged with diluent]
International Brand Names
HMG Ferring® (NL); HMG Lepori® (ES); HMG Massone® [inj.] (AR, MX); Humegon® (AR, AU, BE, CL, CY, EG, HK, ID, IE, IT, JO, KW, LB, LU, MX, NL, PL, RO, RU, SI, SY, TR); Menogon® (BE, CH, CZ, DE, EG, FI, GB, HU, IE, IL, IT, JO, KW, LB, NL, PL, RO, RU, SG, SY, TR); Menopur® (AR, AT, BE, CH, DK, ES, FR, GB, IL); Menotropina® (CL); Merional® (CZ, GB, HU); Metrodin High Purity® (BE); Pergonal® (AR, BE, BR, CA, ES, HK, HR, ID, IL, IN, NL, PL, RO, RU, TR, YU); Repronex® (CA, NL)