Product Description
HMG Massone ®Human Menopausal Gonadotropin (75 I.U FSH & 75 I.U LH)
Contents:
a box contains 1 vial of lyophilized product and 1 ampoule of solvent.
Therapeutical action:
HMG Massone® 75 is a follicle and luteinic hormonal association, in which the follicle stimulating action prevails.
Composition:
each vial of lyophilized product HMG Massone® 75 IU contains:
Follicle - Stimulating Hormone (FSH) .......................... 75 I.U.
Luteinizing Hormone (LH) .......................................... 75 I.U.
Lactose ...................................................................... 20 mg.
Each ampoule of solvent contains:
Sodium chloride injection (USP) 0.85% ....................... 1 ml.
Therapeutical action: HMG Massone® 75 is a follicle and luteinic hormonal association, in which the follicle stimulating action prevails.
Indications:
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.
This product is contraindicated in people who are hypersensitive to the drug. Occasionally, women can suffer from an excessive ovarian enlargement, ascites, and pleural effusion requiring hospitalization. Risk can be reduced by a follow up of the patient.
Multiple births, of which twins are prevalent, have been reported.
Patient screening:
1) Before treatment implementation, a thorough gynecological and endocrine assessment have to be carried out. Except for those patients participating in in vitro fertilization programs, the assessment should include a hysterosalpingograma (to prove absence of uterine and tube pathology), anovulation documentation through basal body temperature, serial vaginal smear, cervical mucous examination, serum or urinary progesterone determinations, endometrial biopsy, and urinary pregnanediol determinations. Patients suffering from tubal pathology should receive Human Menopausal Gonadotropin only when they are part of an in vitro fertilization program.
2) A primary ovarian failure can be excluded by determination of the gonadotropin levels.
3) Careful examination to exclude early stages of pregnancy should be carried out.
4) Endometrial carcinoma and a higher incidence of anovulatory disorders are more frequent in patients who are living their last reproductive years.A cervical dilation and scaling should be always performed before starting a HMG therapy in patients with an abnormal uterine bleeding or other signs of endometrial abnormalities.
5) An assessment of the husband fertility potential should be included in this study.
Pharmacological action:
Women:
The administration of HMG Massone® 75 for 7 to 12 days causes follicle development and maturation in 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.
Assisted reproductive technologies:
The HMG Massone® 75 recommended initial dose for patients undergoing a GnRH agonist or antagonist pituitary suppression is 225 I.U. Based on clinical monitoring (including serum estradiol levels and vaginal ultrasound results), the subsequent dose will depend on 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. The maximum HMG Massone® 75 dose administered shall not exceed 450 I.U. and a dosage regimen beyond 12 days is not advisable.
When follicle development becomes evident, HCG (5000-10000 I.U. daily units) should be administered to induce follicle maturation with a view to oocytes recovery. When ovaries are abnormally enlarged on the last day of therapy, HCG administration should not take place. By this practice, the possibilities of an OHSS (Ovarian Hyperstimulation Syndrome) case should be reduced.
Administration:
Dissolve the content of the vial in 1 ml of 0.85% injectable sodium chloride solution and administer intramuscularly or subcutaneous immediately. Any reconstituted remaining material should be discarded.
If the subcutaneous administration is used, the injection should be given at the inferior hemiabdomen,
rotating the application site between the left and right side.
Contraindications:
Women:
It is not advisable to use this product with patients suffering from the following conditions:
1) Early ovarian failure.
2) Gynecological hemorrhage of unknown etiology.
3) Hypophysial tumors.
4) Ovarian, uterine, and mammary carcinoma.
5) Thyroid and adrenal dysfunction.
6) Ovarian cyst or enlargement not caused by polycystic ovarian syndrome.
7) Hypersensitivity to Human Menopausal Gonadotropin.
8) Pregnancy.
Men:
It is not advisable to use this product in patients with:
1) Normal gonadotropins levels which indicate a normal pituitary function.
2) Elevated gonadotropin levels which indicate a primary testicular failure.
3) Infertility disorders other than hypogonadotrophic hypogonadism.
Warnings:
1) Ovarian over stimulation:
Ovarian enlargement: a mild to moderate ovarian enlargement that can be accompanied by strain
and/or abdominal pain and that accounts for around 20% of treated patients, and goes down in two
to three weeks.
The lowest dose with which good results can be achieved should be administered to women to
avoid ovarian enlargement.
Ovarian hyper stimulation syndrome (OHSS):
it is a different medical event from the uncomplicated ovarian enlargement.
OHSS can rapidly progress to a severe complication.
It is characterized by an increase in vascular permeability which can cause a rapid fluid accumulation in the peritoneal cavity, chest, and pericardium.
The first signs of an OHSS development are a strong pelvic pain, nausea, vomit, weight gain, and hepatic disorders. In around 0.4% of patients receiving the recommended dose, said symptoms are present, and with doses higher than the recommended ones, 1.3% of patients experience the above
mentioned symptoms. In pregnant patients, the OHSS is more common, severe, and longer. If an OHSS occurs, the treatment should be discontinued and the patient hospitalized.
The treatment is based on the symptoms and lies in bed rest, fluid and electrolyte control, and analgesic administration when needed.
2) Pulmonary and vascular complications:
Cases of severe pulmonary complications and intravascular thrombosis have been reported. Sequelae of said cases include venous thrombophlebitis, pulmonary embolism, pulmonary infarct, and cerebral and arterial pulmonary occlusion in limbs. Complications have rarely been fatal.
3) Multiple births:
in around 20% of treated patients, multiple births can take place. The couple should be informed about the possible risk of multiple pregnancies before treatment initiation.
4) Hypersensitivity reactions:
with the use of Human Menopausal Gonadotropin, hypersensitivity reactions have been reported, the expression of which are, urticaria, facial edema, angioneurotic edema and/or dyspnea.
Precautions: During treatments for ovulation induction, multiple pregnancies can take place. If an ovarian hyper stimulation is suspected, the HCG administration is not advisable.
Laboratory control:
Women:
Serum and/or urinary estrogen levels and echographic visualization of the ovaries must be performed, since both controls allow to verify the follicle growth and development, to administer HCG at the right moment and to minimize the risk of an Ovarian Hyper stimulation Syndrome (OHSS) and multiple pregnancies.
Another clinical parameters to be taken in consideration are:
a) Vaginal cytology changes.
b) Aspect and volume of the cervical mucous.
c) Cervical mucous consistency.
d) Cervical mucous Ferning test.
Clinical confirmation of ovulation, except for pregnancy, is obtained by direct and indirect indicators of progesterone production.
The most common indicators are:
a) Basal body temperature increase.
b) Serum progesterone increase.
c) Menstruation after basal body temperature change.
Echographic ovulation evidence may include:
a) Fluid in the cul-de-sac.
b) Ovarian stigmas.
c) Collapsed follicle.
Interactions:
Interactions with other drugs or food are not known.
Carcinogenesis and mutagenesis:
No pertinent information is available.
Lactation:
It is not known if this drug is secreted through breast milk.
Adverse reactions:
Women:
The following adverse reactions have rarely been described:
1) Ovarian hyper stimulation syndrome.
2) Pulmonary and vascular complications.
3) Hemoperitoneum.
4) Adnexial torsion.
5) Mild to moderate ovarian enlargement.
6) Ovarian cyst.
7) Abdominal pain.
8) Hypersensitivity to Human Menopausal Gonadotropin.
9) Gastrointestinal symptoms (nausea, vomit, diarrhea, abdominal cramps).
10) Pain, tetter, swelling and/or irritation at the site of injection.
11) Dizziness, tachycardia, dyspnea, accelerated breathing.
12) Ectopic pregnancies.
13) Increase in adverse reactions at the site of injection when administered subcutaneously (edema,rubor).
Men:
Gynecomastia can occasionally occur during treatment.
Overdosage:
Human Menopausal Gonadotropin (HMG) over dosage can cause follicle cysts or multiple ovulations and, as a consequence, multiple pregnancies. Ovarian over stimulation can be observed in some patients several days after gonadotropin administration. In such cases, the ovarian enlargement causes pain at the inferior hemiabdomen.
If overdosage occurs, go to the nearest hospital or call the toxicology centers.
Drug abuse and drug dependency:
No drug abuse or drug dependency has been reported with the use of Human Menopausal Gonadotropin.
Keep below 25 ºC. Keep preferably refrigerated between 2 - 8 ºC.
Keep away from children.
HMG Massone® 75 has to be administered under medical control.
Antagonism and antidotes:
No cases have been informed yet.
Medicinal specialty authorized by the Ministry of Health.
Certificate Nº 35.415.
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