Human Menopausal Gonadotropin

Indications & Dose:

Women: Ovulatory disorders or anovulatory infertility. Wrong follicle maturation with consequences on the corpus luteum development. Ovulation induction in assisted reproductive treatments. Men: Abnormal spermatogenesis due to primary or secondary hypogonadotrophic hypogonadism.

DOSAGE

Women:

The administration of HMG Massone® 75 for 7 to 12 days causes follicle development and maturation n those patients with no early ovarian failure. To trigger ovulation, Human Chrionic Gonadotrophin (HCG) is administered after HMG administration.

Men:

The administration of HMG Massone® 75 for at least three months together with Human Chorionic Gonadotropin (HCG) induces spermatogenesis in men with primary or secondary pituitary hypofunction who were able to reach proper masculinization through previous HCG treatment.

Posology: Proper HMG Massone® 75 dose to stimulate the ovarian follicles is unique for each patient. Based on the clinical experience and data available, the lower dose with which good results can be obtained should be used.

The HMG Massone® 75 advisable initial dose is of 150 I.U. daily for the first five days of treatment. Based on the clinical monitoring (which include serum estradiol levels and vaginal ultrasound results) the subsequent dose should be determined according to the patient’s response. Dose adjustments should not be more frequent than one adjustment every two days, and not more than 75 to 150 I.U. should be used per adjustment.

HMG Massone® 75 maximum daily dose should not be higher than 450 I.U., and a dosage regimen beyond 12 days is not advisable. If patient’s reaction to HMG Massone® 75 is the proper one, HCG (5000 to 10000 I.U.) should be administered one day after the last HMG Massone® 75 administration. If serum estradiol is higher than 2000 pg/ml, HCG should not be administered. If ovaries are abnormally enlarged or abdominal pain is present, patient should be advised not to have sexual intercourse. The risk of Ovarian  Hyperstimulation Syndrome and multiple pregnancy shall be diminished with these precautions. After HCG administration, patients should be carefully monitored for at least 2 weeks. If an inadequate follicle growth or ovulation without pregnancy occur, the treatment cycle with HMG Massone® 75 can be repeated. The couple under treatment should be encouraged to have daily sexual intercourse starting the previous day of the HCG administration until ovulation becomes evident by means of the indices used to determine progesterone activity, and considering the indices and parameters mentioned above. It becomes clear that without a close guidance to these patients and being familiar with the laboratory studies, HMG Massone® 75 should not be used. 

Contraindications:

Women: 

Early ovarian failure. Gynecological hemorrhage of unknown tiology. Hypophysial tumors. Ovarian uterine, and mammary carcinoma. Thyroid and adrenal dysfunction. Ovarian cyst or enlargement not caused by polycystic ovarian syndrome. Hypersensitivity to Human Menopausal Gonadotropin. Pregnancy

Men:

Normal gonadotropins levels which indicate a normal pituitary function. Elevated gonadotropin levels which indicate a primary testicular failure. Infertility disorders other than hypogonadotrophic hypogonadism

Side Effects:

Cautions:

Precautions:

During treatments for ovulation induction, multiple pregnancies can take place. If an ovarian hyper stimulation is suspected, the HCG administration is not advisable. 

Interaction:

Interactions with other drugs or food are not known. Carcinogenesis and mutagenesis: No pertinent information is available. 

Warnings:

Adverse Effects:

Lactations:

It is not known if this drug is secreted through breast milk

Special Precautions:

Counselling:

Side Effects Or Adverse Reactions:

Women: 

Ovarian hyper stimulation syndrome.

Pulmonary and vascular complications.

Hemoperitoneum.

Adnexial torsion.

Mild to moderate ovarian enlargement.

Ovarian cyst.

Abdominal pain.

Hypersensitivity to Human Menopausal Gonadotropin.

Gastrointestinal symptoms (nausea, vomit, diarrhea, abdominal cramps).

Pain, tetter, swelling and/or irritation at the site of injection.

Dizziness, tachycardia, dyspnea, accelerated breathing.

Ectopic pregnancies.

Increase in adverse reactions at the site of injection when administered subcutaneously (edema, rubor).

Men:

Gynecomastia can occasionally occur during treatment.

Patient And Carer Advice: