Inceptova HMG is a preparation of gonadotropins, extracted from the urine of postmenopausal women which has undergone additional steps for purification. Each vial of Inceptova HMG contains 75/150 IU of FSH activity and 75/150 IU of LH activity. The biological activity of Inceptova HMG is determined using the BP bio-assays for FSH (ovarian weight gain assay in female rats) and LH (seminal vesicle weight gain assay in male rats), modified to increase the accuracy and reproducibility of these assays.
- A thorough gynecologic and endocrine evaluation, including an assessment of pelvic anatomy must be performed before treatment with Inceptova HMG. Patients with tubal obstruction should receive Inceptova HMG 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 Inceptova - HMG therapy.
- Evaluation of the partner's fertility potential should be included in the work up
Assisted Reproductive Technologies: The recommended initial dose of Inceptova HMG 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. Adjustments 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 Inceptova HMG given should not exceed 450 IU 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. 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 Inceptova HMG in one mL of diluent supplied and administer either intramuscularly or subcutaneously immediately. Any unused reconstituted material should be discarded.
The following are the common side effects of inceptova HMG:
- Pain, swelling, and rash at injection site
- Abdominal pain
- Breast tenderness
- Hot flushes
- Inceptova HMG is a drug that should only be used by physicians who are thoroughly familiar with infertility problems.
- Overstimulation of the Ovary during Inceptova HMG
Ovarian Enlargement: Mild to moderate uncomplicated ovarian enlargement which may be accompanied by abdominal distension and/or abdominal pain occurs in approximately 5–10% of women treated with Menotrophin and HCG and generally regresses without treatment within 2 or 3 weeks. The lowest dose consistent with expectation of good results and careful monitoring of ovarian response can further minimize the risk of overstimulation.
If the ovaries are abnormally enlarged on the last day of Inceptova HMG therapy, HCG should not be administered in this course of treatment. This will reduce the chances of development of the OHSS.
- A high FSH level indicating primary ovarian failure.
- Uncontrolled thyroid and adrenal dysfunction.
- An organic intracranial lesion such as a 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 hypersensitivity to menotrophin or Inceptova HMG.
- Inceptova HMG is not indicated in pregnant women.