GYNOGEN HP Menotrophin 75IU Lyophilized Powder for IM/SC Injection 2mL 1's + 0.9% Sodium Chloride Injection 1's
RXDRUG-BR-986
Discreet Packaging
FDA-registered Products
FDA-licensed Pharmacies
Indications/Uses
Selection of Patients: A thorough gynecologic and endocrine evaluation, including an assessment of pelvic anatomy must be performed before treatment with Menotrophin (Gynogen HP) patients with tubal obstruction should receive Menotrophin (Gynogen HP) only if enrolled in an IVF program.
Primary ovarian failure should be excluded by the determination of gonadotropin levels.
Careful examination should be made to rule out the presence of an early pregnancy.
Patients in late reproductive life have a greater predilection to endometrial carcinoma as well as a higher incidence of anovulatory disorders. A thorough diagnostic evaluation should always be performed in patients who demonstrate abnormal uterine bleeding or other signs of endometrial abnormalities before starting Menotrophin therapy.
Evaluation of the partner's fertility potential should be included in the work up.
Primary ovarian failure should be excluded by the determination of gonadotropin levels.
Careful examination should be made to rule out the presence of an early pregnancy.
Patients in late reproductive life have a greater predilection to endometrial carcinoma as well as a higher incidence of anovulatory disorders. A thorough diagnostic evaluation should always be performed in patients who demonstrate abnormal uterine bleeding or other signs of endometrial abnormalities before starting Menotrophin therapy.
Evaluation of the partner's fertility potential should be included in the work up.
Dosage/Direction for Use
Assisted Reproductive Technologies: The recommended initial dose of Menotrophin (Gynogen HP) for patients who have received a GnRH agonist for pituitary suppression is 225 IU. Based on clinical monitoring (including serum estradiol levels and vaginal ultrasound results) subsequent dosing should be adjusted according to individual patient response. Adjustment in dose should not be made more frequently than once every two days and should not exceed 150 IU per adjustment. The maximum daily dose of Menotrophin (Gynogen HP) given should not exceed 450 IU and dosing beyond 20 days is not recommended.
Once adequate follicular development is evident, hCG (Pubergen) should be administered to induced final follicular maturation in preparation for oocyte retrieval. The administration of hCG must be withheld in cases where the ovaries are abnormally enlarged on the last day of therapy. This should reduce the chance of developing OHSS.
Administration: Dissolve the contents of the vial of Menotrophin (Gynogen HP) in one mL of sterile saline and administer either intramuscularly or subcutaneously immediately. Any unused reconstituted material should be discarded.
Once adequate follicular development is evident, hCG (Pubergen) should be administered to induced final follicular maturation in preparation for oocyte retrieval. The administration of hCG must be withheld in cases where the ovaries are abnormally enlarged on the last day of therapy. This should reduce the chance of developing OHSS.
Administration: Dissolve the contents of the vial of Menotrophin (Gynogen HP) in one mL of sterile saline and administer either intramuscularly or subcutaneously immediately. Any unused reconstituted material should be discarded.
Overdosage
Aside from possible ovarian hyperstimulation, little is known concerning the consequences of acute overdosage with Menotrophin (Gynogen HP).
Contraindications
Menotrophin (Gynogen HP) is contraindicated in women who have: A high FSH level indicating primary ovarian failure.
Uncontrolled thyroid and adrenal dysfunction.
An organic intracranial lesion such as pituitary tumor.
Sex hormone dependent tumors of the reproductive tract and accessory organs.
Abnormal uterine bleeding of undetermined origin.
Ovarian cysts or enlargement not due to polycystic ovary syndrome.
Prior to hypersensitive to Menotrophins.
Menotrophins is not indicated in women who are pregnant.
Uncontrolled thyroid and adrenal dysfunction.
An organic intracranial lesion such as pituitary tumor.
Sex hormone dependent tumors of the reproductive tract and accessory organs.
Abnormal uterine bleeding of undetermined origin.
Ovarian cysts or enlargement not due to polycystic ovary syndrome.
Prior to hypersensitive to Menotrophins.
Menotrophins is not indicated in women who are pregnant.
Warnings
Menotrophin (Gynogen HP) is a drug that should only be used by physicians who are thoroughly familiar with infertility problems.
Overstimulation of the Ovary During Menotrophin Therapy: Ovarian Enlargement: Mild to moderate uncomplicated ovarian enlargement which may be accompanied by abdominal distention or abdominal pain occurs in approximately 5 to 10 % of women treated with menotrophins and hCG, and generally regresses without treatment within two or three weeks. The lowest dose consistent with expectation of good results and careful monitoring of ovarian response can further minimized the risk of over stimulation. If the ovaries are abnormally enlarged on the last day of Menotrophin (Gynogen HP) therapy, hCG should not be administered in this course of treatment; this will reduce the chances of development of Ovarian Hyperstimulation Syndrome (OHSS).
Overstimulation of the Ovary During Menotrophin Therapy: Ovarian Enlargement: Mild to moderate uncomplicated ovarian enlargement which may be accompanied by abdominal distention or abdominal pain occurs in approximately 5 to 10 % of women treated with menotrophins and hCG, and generally regresses without treatment within two or three weeks. The lowest dose consistent with expectation of good results and careful monitoring of ovarian response can further minimized the risk of over stimulation. If the ovaries are abnormally enlarged on the last day of Menotrophin (Gynogen HP) therapy, hCG should not be administered in this course of treatment; this will reduce the chances of development of Ovarian Hyperstimulation Syndrome (OHSS).
Special Precautions
Laboratory Tests: The combination of both estradiol levels and ultrasonography are useful for monitoring the growth and development of follicles, timing hCG administration, as well as minimizing the risk of the OHSS and multiple gestations. The clinical confirmation of ovulation, is determined by: Arise in basal body temperature; Increase in serum progesterone; and Menstruation following the shift in basal body temperature.
When used in conjunction with indices of progesterone production, sonographic visualization of the ovaries will assist in determining if ovulation has occurred. Sonographic evidence of ovulation may include the following: Fluid in the cul-de-sac; Ovarian stigmata; and Collapsed follicle.
Carcinogenesis and Mutagenesis: Long-term toxicity studies in animals have not been performed to evaluate the carcinogenic potential of Menotrophins.
Use in Children: Safety and effectiveness in pediatric patients have not been established.
Use in Elderly: Safety and effectiveness in geriatric patients have not been established.
When used in conjunction with indices of progesterone production, sonographic visualization of the ovaries will assist in determining if ovulation has occurred. Sonographic evidence of ovulation may include the following: Fluid in the cul-de-sac; Ovarian stigmata; and Collapsed follicle.
Carcinogenesis and Mutagenesis: Long-term toxicity studies in animals have not been performed to evaluate the carcinogenic potential of Menotrophins.
Use in Children: Safety and effectiveness in pediatric patients have not been established.
Use in Elderly: Safety and effectiveness in geriatric patients have not been established.
Use In Pregnancy & Lactation
Menotrophins are not to be used in pregnancy. Clinical studies have not established as to whether menotrophins are secreted in breastmilk.
Adverse Reactions
Pain/rash at inj site, headache, malaise; nausea, vomiting, abdominal pain, bloating; breast tenderness, hot flushes, OHSS (insusceptible individuals).
Caution For Usage
Direction for reconstitution: To reconstitute, inject 1 mL of 0.9% w/v Sodium Chloride Solution to the vial of HMG and shake well.
Use immediately after reconstitution.
After reconstitution of Menotrophin (Gynogen HP), if the reconstituted solution is not used, do not store, discard the portion.
Use immediately after reconstitution.
After reconstitution of Menotrophin (Gynogen HP), if the reconstituted solution is not used, do not store, discard the portion.
Storage
Store between 2°C-8°C. Do not freeze. Protect from light.
Action
Pharmacology: Pharmacodynamics: Menotrophin (Gynogen HP), administered for 7 to 20 days, produces ovarian follicular growth and maturation in women who do not have primary ovarian failure. In order to produce final follicular maturation and ovulation in the absence of an endogenous LH surge, hCG must be administered following Menotrophin (Gynogen HP) treatment, at a time when patient monitoring indicates sufficient follicular development has occurred.
Pharmacokinetics: Absorption: The SC route of administration trends toward greater bioavailability than the IM route for single and multiple dose of Menotrophins (Gynogen HP).
Distribution: Human tissue or organ distribution of FSH and LH has not been studied for Menotrophin (Gynogen HP).
Metabolism: Metabolism of FSH and LH has not been studied for in humans.
Pediatric Populations: Menotrophin (Gynogen HP) has not been studied in the pediatric population.
Geriatric Population: Menotrophin (Gynogen HP) has not been studied in the geriatric population.
Special Populations: The safety and efficacy of Menotrophin (Gynogen HP) in renal and hepatic insufficiency has not been studied.
Pharmacokinetics: Absorption: The SC route of administration trends toward greater bioavailability than the IM route for single and multiple dose of Menotrophins (Gynogen HP).
Distribution: Human tissue or organ distribution of FSH and LH has not been studied for Menotrophin (Gynogen HP).
Metabolism: Metabolism of FSH and LH has not been studied for in humans.
Pediatric Populations: Menotrophin (Gynogen HP) has not been studied in the pediatric population.
Geriatric Population: Menotrophin (Gynogen HP) has not been studied in the geriatric population.
Special Populations: The safety and efficacy of Menotrophin (Gynogen HP) in renal and hepatic insufficiency has not been studied.
MedsGo Class
Trophic Hormones & Related Synthetic Drugs
Features
Brand
GYNOGEN HP
Full Details
Dosage Strength
75 IU
Drug Ingredients
- Menotrophin
Drug Packaging
Lyophilized Powder for Injection (IM/SC) 2mL 1's + 0.9% Sodium Chloride Injection 1's
Generic Name
MENOTROPHIN (HUMAN MENOPAUSAL GONADOTROPHIN)
Dosage Form
Lyophilized Powder for Injection
Registration Number
BR-986
Drug Classification
Prescription Drug (RX)
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