Pronunciation:

(men oh TROE pins)

U.S. Brand Names:

Generic Available:

Canadian Brand Names:

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:

Pregnancy Implications:

Lactation:

Contraindications:

Warnings/Precautions:

Adverse Reactions:

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:

Stability:

Mechanism of Action:

Pharmacodynamics/Kinetics:

Dosage:

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:

Patient Education:

Dental Health: Effects on Dental Treatment:

Dental Health: Vasoconstrictor/Local Anesthetic Precautions:

Mental Health: Effects on Mental Status:

Mental Health: Effects on Psychiatric Treatment:

Dosage Forms:

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: