IVF-M HP Dosage/Direction for Use

RECOMMENDED DOSE: 1. Anovulation (including WHO Group Ⅱ) in women who have been unresponsive to treatment with clomiphene citrate: The treatment should be started within the initial 7 days of the menstrual cycle. IVF-M HP may be given daily by subcutaneous injection to provide a dose of 75 IU for 7 days to maximum 12 days until an adequate response is achieved based on estradiol level (Serum estradiol level 1.1~2.9 nMol/L = 300~800 pg/mL) and maturation of follicles (Diameter ≤ 18 mm). If serum estradiol levels rise too rapidly (more than twice in 2~3 days) or FSH is given concomitantly, the dose should be decreased. If the ovaries do not respond, discontinue the treatment or the dosage can be increased to 150 IU per day. Treatment with the previous dosage may be repeated at least twice, before increase the dosage to 150 IU per day. When an optimal response is obtained, administration of IVF-M HP is stopped. A single injection of 5,000 IU to 10,000 IU of human chorionic gonadotrophin (hCG) should be given 1 day after the last IVF-M HP injection. If the ovaries are abnormally enlarged on the last day of the treatment, hCG injection should be withheld. It will minimize the incidence of Ovarian Hyperstimulation Syndrome (OHSS).
2. Women undergoing controlled ovarian hyperstimulation for multiple follicular development for assisted reproductive technologies (ART): In a protocol using down-regulation with a Gonadotrophin-releasing hormone (GnRH) agonist or antagonist, the recommended initial dose of IVF-M HP is 225 IU daily. Based on clinical monitoring (including serum estradiol levels and ovarian ultrasound) subsequent dosing should be adjusted according to individual patient response.
Usually IVF-M HP therapy starts on day 2 or 3 of the menstrual cycle with 150~300 IU daily until an adequate maturation of follicles is obtained. Generally adequate development of follicle is achieved around 10th day of treatment (Treatment period is approximately 5~20 days). Dose adjustment should not be made more frequently than once every two days and should not exceed more than 150 IU per adjustment. The maximum daily dose given should not be higher than 450 IU and dosing beyond 20 days in a treatment cycle is not recommended. If FSH is given concomitantly, the dose should be decreased.
When adequate response is obtained, 24~48 hours after the last IVF-M HP injection, 5,000~10,000 IU hCG should be administered to induce final follicular maturation. Ovulation occurs after 32~48 hours. The patient is recommended to have coitus every day from the day of hCG administration until the day of expecting ovulation. If there is evidence of ovulation but not pregnant, repeat the previous treatment cycle for at least twice before increasing the dosage.
MODE OF ADMINISTRATION: The powder must be reconstituted with the solvent provided prior to use and injected subcutaneously. Use immediately after reconstitution and discard the unused material.
Preparation process: 1) Withdraw 1.0 mL of the solvent from the vial.
2) Inject into the vial containing the powder.
3) Roll the vial gently between the hands until the solution is clear. Do not shake.
4) Draw up the solution from the vial into syringe.
5) Administer the solution immediately.