Follitrope Warnings

Since infertile women undergoing assisted reproduction, and particularly IVF, often have tubal abnormalities, the incidence of ectopic pregnancies might be increased. Early ultrasound confirmation that a pregnancy is intrauterine is therefore important.
The diagnosis of ovarian hyperstimulation may be confirmed by ultrasound examination. Ultrasonographic assessment of follicular development, and determination of oestradiol levels should be performed prior to treatment and at regular intervals during treatment. If unwanted ovarian hyperstimulation occurs, the administration of FSH should be discontinued and hCG must be withheld, because it may induce the ovarian hyperstimulation syndrome (OHSS). Clinical symptoms and sign of mild ovarian hyperstimulation syndrome are abdominal pain, nausea, vomiting and weight gain. In rare cases, severe ovarian hyperstimulation syndrome can happen characterized by large ovarian cysts (prone to rupture), ascites, often hydrothorax, which may be life-threatening. In rare instances, venous or arterial thromboembolism may occur in association with OHSS. But if hCG administration is withheld and intercourse is avoided at least for 4 days, excessive estrogen response does not cause ovarian hyperstimulation.
The combination of both ultrasound and serum estradiol measurement are useful for monitoring the development of follicles, for timing of the ovulatory trigger, as well as for detecting ovarian enlargement and minimizing the risk of the Ovarian Hyperstimulation Syndrome and multiple gestation.
In anovulation, the risk of OHSS and multiple pregnancy is increased by high concentration of serum oestradiol and a number of matured follicles. Prior to therapy with Follitropin alfa (Follitrope), patients should be informed of the duration of treatment and monitoring of their condition that will be required. To minimize ovarian hyperstimulation and multiple pregnancy, monitoring is required.
There were no reports of hypersensitivity of human FSH, but the possibility of anaphylaxis response is present. The first injection of Follitropin alfa (Follitrope) should be performed under direct medical supervision.
Rates of pregnancy loss in women undergoing assisted reproduction techniques, patients treated with FSH are higher than in the normal population.