Inceptova r-FSH

Inceptova r-FSH is a recombinant form of Urofollitropin (FSH) for Injection 75IU. r-FSH is used for stimulation of multifollicular development in ART procedures. Anovulation [including Polycystic Ovarian Disease (PCOD)] in women who have been unresponsive to treatment with Clomiphene citrate. Stimulation of multifollicular development in patients undergoing superovulation for ART such as IVF, Gamete Intra­Fallopian Transfer (GIFT) and Zygote Intra-Fallopian Transfer (ZIFT).

Posology and Method of Administration:

Treatment with lnceptova r-FSH should be initiated under the supervision of a physician experienced in the treatment of fertility problems. lnceptova r-FSH is intended for subcutaneous administration. The dosage recommendations given for lnceptova r-FSH are those in use for uFSH. Clinical assessment of lnceptova r-FSH indicates that its daily doses, regimens of administration and treatment monitoring procedures should not be different from those currently used for urinary FSH-containing preparations. However, the study reports conclude that lnceptova r-FSH is more effective than uFSH in terms of a lower total dose and a shorter treatment period needed to achieve preovulatory conditions.

Contraindications:

lnceptova r-FSH must not be used in:

• Hypersensitivity to lnceptova r-FSH, FSH or to any of the excipients.
• Case of tumors of the hypothalamus and pituitary gland.
• Ovarian enlargement or cyst not due to PCOD.
• Gynecological hemorrhages of unknown etiology.
• Ovarian, uterine or mammary carcinoma.

lnceptova r-FSH should not be used when an effective response cannot be obtained such as:

• Primary ovarian failure.
• Malformations of sexual organs incompatible with pregnancy.
• Fibroid tumors of the uterus incompatible with pregnancy.

Special Warnings and Special Precautions for Use:

lnceptova r-FSH™ is a potent gonadotrophic substance capable of causing mild to severe adverse reactions and should only be used by physicians who are thoroughly familiar with infertility problems and their management.

Gonadotrophin therapy requires a certain time commitment by physicians and supportive health professionals, as well as the availability of appropriate monitoring facilities. In women, safe and effective use of lnceptova r-FSH™ calls for monitoring of ovarian response with ultrasound, alone or preferably in combination with measurement of serum estradiol levels, on a regular basis. There may be a degree of interpatient variability in response to FSH administration, with a poor response to FSH in some patients. The lowest effective dose in relation to the treatment objective should be used. Self-administration of lnceptova r-FSH™ should only be performed by patients who are well-motivated, adequately trained and with access to expert advice. The first injection of lnceptova r-FSH™ should be performed under direct medical supervision. Before starting treatment, the couple’s infertility should be assessed as appropriate and putative contraindications for pregnancy evaluated. In particular, patients should be evaluated for hypothyroidism, adrenocortical deficiency, hyperprolactinemia and pituitary or hypothalamic tumors and appropriate specific treatment given. Patients undergoing stimulation of follicular growth, whether in the frame of a treatment for anovulatory infertility or ART procedures, may experience ovarian enlargement or develop hyperstimulation. Adherence to recommended lnceptova r-FSH™ dosage and regimen of administration and careful monitoring of therapy will minimize the incidence of such events. Acute interpretation of the indices of follicle development and maturation requires a physician who is experienced in the interpretation of the relevant tests. If an FSH dose increase is deemed appropriate, dose adaptation should preferably be at 7-14 days intervals and preferably with 37.5-75 IU increments.