Foligest Injection

Foligest Injection is used for: Ovulation Induction, Multi-follicular Development, Polycystic Ovarian Syndrome, in Female, Male infertility

IM or SC injection In the Female: Ovulation Induction: Follicle Stimulating Hormone administered IM or SC with HCG in a sequential manner, which is indicated for ovulation induction in patients who have previously received pituitary suppression. Starting daily dose of 50 international units (IU) is administered subcutaneously or intramuscularly for at least the first 7 days. The dose is increased by 25 or 50 international units (IU) at weekly intervals until follicular growth and/or serum estradiol levels indicate an adequate response. When an acceptable pre-ovulatory state is achieved, final oocyte maturation is achieved with 5000 to 10,000 international units (IU) of human chorionic Gonadotrophin (HCG). The woman and her partner should have intercourse daily, beginning on the day prior to the administration of HCG and until ovulation becomes apparent. Multi-follicular Development: During ART Follicle Stimulating Hormone administered IM in conjunction with Human Chorionic Gonadotrop in is indicated for multiple follicular developments (controlled ovarian stimulation) during ART cycles in patients who have previously received pituitary suppression. Starting dose of 150 to 225 international units (IU) is administered intramuscularly for at least the first 4 days of treatment. Subsequent doses are adjusted based upon ovarian response as determined by ultrasound evaluation of follicular growth and serum estradiol levels. Final oocyte maturation is induced with a dose of 5000-10,000 international units of HCG Oocyte (egg) retrieval is performed 34 to 36 hours later. Polycystic Ovarian Syndrome (PCOS): Used to treat Polycystic Ovarian Syndrome (PCOS) related infertility Follicle Stimulating Hormone injections are therefore given each morning as an intramuscular injection. It is best to start with the lowest dose per day (using 50 IU per day). These doses are used for 4 to 6 days at a time. The ovarian response is determined by measuring estrogen levels in the blood. When the estrogen begins to rise, the Follicle Stimulating Hormone is successfully growing an egg or eggs. If there is no response to a dose of Follicle Stimulating Hormone in 5- 6 days of injections the dose will be increased. The normal dose increments are 75 units, 112 units, 150 units and 225 units per day. Most patients respond with 75 to 150 IU per day. However it is very important that increments are only made cautiously. In the Male: Male infertility treatment in combination with Human Chorionic Gonadotrophin Induction of Spermatogenesis in men deficient spermatogenesis due to Hypogonadotrophic hypogonadism. Pre-treatment with Human Chorionic Gonadotrophin alone (1500 international units (IU) twice weekly) is required. If serum testosterone levels have not normalized after 8 weeks of Human Chorionic Gonadotrophin treatment, the dose may be increased to 3000 international units (IU) twice a week. After normalization of serum testosterone levels, administer 450 international units (IU) per week (225 international units twice weekly or 150 international units (IU) three times weekly) of FSH subcutaneously with the same pre-treatment HCG dose used to normalize testosterone level.

Renal Insufficiency: Safety, efficacy, and pharmacokinetics of Follicle Stimulating Hormone in women with renal insufficiency have not been established

IM or SC injection only.

Hypersensitivity to the active substance or to any of the excipients Tumors of the ovary, breast, uterus, pituitary or hypothalamus Pregnancy or lactation Undiagnosed vaginal bleeding Primary ovarian failure Fibroid tumors of the uterus incompatible with pregnancy Primary testicular failure

The presence of uncontrolled non gonadalendocrinopathies (e.g. thyroid, adrenal or pituitary disorders) should be excluded. • In pregnancies occurring after induction of ovulation with Gonadotrophin preparations, there is an increased risk of multiple gestations (Multiple birth). • There has been no reports of hypersentivity to Follicle Stimulating hormone, but there remains the possibility of anaphylactic responses. • The first injection of Follicle Stimulating Hormone should be performed under direct medical supervision. • 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. • Rates of pregnancy loss in women undergoing assisted reproduction techniques are higher than normal population. • Unwanted ovarian hyperstimulation in the treatment of female patients, ultrasonographic assessment of follicular development, and determination of oestradiol levels should be performed prior to treatment and at regular intervals during treatment. Apart from the development of a high number of follicles, oestradiol levels may rise very rapidly, e.g. more than a daily doubling for two or three consecutive days, and possibly reaching excessively high values. The diagnosis of ovarian hyperstimulation may be confirmed by ultrasound examination. If this unwanted ovarian hyperstimulation occurs (i.e. not as part of controlled ovarian hyperstimulation in medically assisted reproduction programs), the administration of Follicle Stimulating Hormone should be discontinued. In that case pregnancy should be avoided and Human Chorionic Gonadotrophin must be withheld, because it may induce, in addition to multiple ovulation, the Ovarian Hyperstimulation Syndrome (OHSS).

Pregnancy Teratogenic effects Pregnancy Category X Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in the nursing infant from Follicle Stimulating Hormone, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Side effects of Follicle Stimulating Hormone : The most common adverse reactions (>5% incidence) in ovulation induction include: headache, hot flashes, OHSS, pain, and respiratory disorder. The most common adverse reactions (>2% incidence) in ART include: abdominal cramps, abdominal fullness/enlargement, headache, nausea, OHSS, pain, pelvic pain, and post retrieval pain. • Follicle Stimulating Hormone sometimes excites the ovaries too much. This may cause pelvic pain or breathing problems. It may also make you urinate less. In rare cases, patients with this problem have had serious lung problems, including fluid in the lungs, trouble-breathing, and worsening of asthma blood clots and strokes, severe pelvic pain, chest pain, or abdominal pain, Nausea, Vomiting, Sudden weight gain, Bloating, Trouble-breathing. • Follicle Stimulating Hormone may cause twins or multiple births. • The most common side effects with Follicle Stimulating Hormone are headache, vaginal bleeding, nausea, and hot flashes. Sometimes there is a reaction at the spot where you give yourself the injection. This can include bruising, pain, or redness.

Follicle Stimulating Hormone administered for 7 to 12 days produces ovarian follicular growth in women who do not have primary ovarian failure. Treatment with Follicle Stimulating Hormone in most instances results only in follicular growth and maturation. When sufficient follicular maturation has occurred, hCG must be given to induce ovulation.

Foligest 75 IU/vial Injection manufactured by Renata PLC.. Its generic name is Follicle Stimulating Hormone. Foligest is availble in Bangladesh. Farmaco BD drug index information on Foligest Injection is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.