Indications
In the Female:
Ovulation Induction
FSH™ administered IM or SC with HCG in a sequential manner, which is indicated for ovulation induction in patients who have previously received pituitary suppression.
Multi-follicular Development
During ART FSH™ administered IM in conjunction with HCG is indicated for multiple follicular developments (controlled ovarian stimulation) during ART cycles in patients who have previously received pituitary suppression.
Polycystic Ovarian Syndrome (PCOS)
Used to treat Polycystic Ovarian Syndrome (PCOS) related infertility In the Male:
Male infertility treatment in combination with HCG Induction of Spermatogenesis in men deficient spermatogenesis due to Hypogonadotrophic-hypogonadism.
Ovulation Induction
FSH™ administered IM or SC with HCG in a sequential manner, which is indicated for ovulation induction in patients who have previously received pituitary suppression.
Multi-follicular Development
During ART FSH™ administered IM in conjunction with HCG is indicated for multiple follicular developments (controlled ovarian stimulation) during ART cycles in patients who have previously received pituitary suppression.
Polycystic Ovarian Syndrome (PCOS)
Used to treat Polycystic Ovarian Syndrome (PCOS) related infertility In the Male:
Male infertility treatment in combination with HCG Induction of Spermatogenesis in men deficient spermatogenesis due to Hypogonadotrophic-hypogonadism.
Pharmacology
FSH™ administered for 7 to 12 days produces ovarian follicular growth in women who do not have primary ovarian failure. Treatment with FSH™ in most instances results only in follicular growth and maturation. When sufficient follicular maturation has occurred, HCG must be given to induce ovulation.
Dosage & Administration
To prevent painful injections and minimize leakage from the injection site FSH™ should be slowly administered intramuscularly or subcutaneously. The subcutaneous injection site should be alternated to prevent lipoathrophy. Any unused solution should be discarded. Subcutaneous injection of FSH™ may be carried out by patient or partner, provided that proper instructions are given by the physician. Self administration of FSH™ should only be performed by patients who are well-motivated, adequately trained and with access to expert advice.
Dosage in Female
There are great inter-and intra-individual variations in the response of the ovaries to exogenous gonadotrophins. This makes it impossible to set a uniform dosage scheme. The dosage should, therefore, be adjusted individually depending on the ovarian response. This requires ultrasonography and monitoring of oestradiol levels. There should be consideration to minimize the risk of unwanted ovarian hyperstimulation. FSH™ can be given either alone, or in combination with a GnRH analogue to prevent premature luteinisation. In the latter case, especially when using a GnRH agonist, a higher total treatment dose of FSH™ may be required to achieve an adequate follicular response. Clinical experience with FSH™ is based on up to three treatment cycles in both indications. Overall experience with IVF indicates that in general the treatment success rate remains stable during the first four attempts and gradually declines thereafter.
Ovulation Induction in Women
Starting daily dose of 50 international units (IU) of FSH™ 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 gonadotropin (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
Assisted Reproductive Technology (ART)
In Women; Starting dose of 150 to 225 international units (IU) of FSH™ 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 Hyperstimulation (PCOS)
FSH™ injections are therefore given each morning as an intramuscular injection. It is best to start with the lowest dose of FSH™ 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 oestrogen levels in the blood. When the oestrogen begins to rise, the FSH™ is successfully growing an egg or eggs. If there is no response to a dose of FSH™ 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.
Dosage in Male
Induction of Spermatogenesis in Men
Pre-treatment with HCG alone (1500 international units (IU) twice weekly) is required. If serum testosterone levels have not normalized after 8 weeks of HCG 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.
Dosage in Female
There are great inter-and intra-individual variations in the response of the ovaries to exogenous gonadotrophins. This makes it impossible to set a uniform dosage scheme. The dosage should, therefore, be adjusted individually depending on the ovarian response. This requires ultrasonography and monitoring of oestradiol levels. There should be consideration to minimize the risk of unwanted ovarian hyperstimulation. FSH™ can be given either alone, or in combination with a GnRH analogue to prevent premature luteinisation. In the latter case, especially when using a GnRH agonist, a higher total treatment dose of FSH™ may be required to achieve an adequate follicular response. Clinical experience with FSH™ is based on up to three treatment cycles in both indications. Overall experience with IVF indicates that in general the treatment success rate remains stable during the first four attempts and gradually declines thereafter.
Ovulation Induction in Women
Starting daily dose of 50 international units (IU) of FSH™ 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 gonadotropin (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
Assisted Reproductive Technology (ART)
In Women; Starting dose of 150 to 225 international units (IU) of FSH™ 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 Hyperstimulation (PCOS)
FSH™ injections are therefore given each morning as an intramuscular injection. It is best to start with the lowest dose of FSH™ 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 oestrogen levels in the blood. When the oestrogen begins to rise, the FSH™ is successfully growing an egg or eggs. If there is no response to a dose of FSH™ 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.
Dosage in Male
Induction of Spermatogenesis in Men
Pre-treatment with HCG alone (1500 international units (IU) twice weekly) is required. If serum testosterone levels have not normalized after 8 weeks of HCG 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.
Contraindications
Tumours of the ovary, breast, uterus, pituitary or hypothalamus
Pregnancy or lactation
Undiagnosed vaginal bleeding
Hypersensitivity to the active substance or to any of the excipients
Primary ovarian failure
Fibroid tumors of the uterus incompatible with pregnancy
Primary testicular failure
Pregnancy or lactation
Undiagnosed vaginal bleeding
Hypersensitivity to the active substance or to any of the excipients
Primary ovarian failure
Fibroid tumors of the uterus incompatible with pregnancy
Primary testicular failure
Side Effects
FSH™ 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, troublebreathing, and worsening of asthma blood clots and strokes, severe pelvic pain, chest pain, or abdominal pain, Nausea, Vomiting, Sudden weight gain, Bloating, Trouble, breathing FSH™ may cause twins or multiple births. The most common side effects with FSH™ 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.
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