FSH

FSH is a product containing a highly purified preparation of human follicle stimulating hormone (FSH-HP) extracted from the urine of postmenopausal women. Third generation of urinary gonadotrophins FSH-HP;Use of monoclonal antibodies specific to FSH resulted in further refinements in manufacture, and the production of highly purified (HP) urinary FSH. The presence of LH is less than 0.1% per 75 IU of FSH & Unidentified urinary proteins are less than 5% in Human FSH-HP. FSH consists of two non-covalently linked glycoproteins designated as the alfa and beta subunits. The alfa subunit has 92 amino acids of which two are modified by attachment of carbohydrates. The beta subunit has 111 amino acids of which two are modified by attachment of carbohydrates. FSH is a sterile, lyophilized powder intended for subcutaneous (SC) or intramuscular (IM) injection after reconstitution with sterile 0.9% Sodium Chloride Injection. Each vial of FSH contains 75 International Units (IU) of Follicle Stimulating Hormone (FSH) which is reconstituted with diluents. The in vivo biological activity of Urofollitropin (FSH) for injection, purified is determined by using reference standards calibrated against the First International Standard for follicle- stimulating hormone (FSH, Urofollitropin), Urinary, and Human for Bioassay, National Institute for Biological Standards and Control (NIBSC) at its 46th meeting in 1995. FSH is a glycoprotein that is acidic and water-soluble.

No drug/drug interaction studies have been conducted for Urofollitropin in humans

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.

Pregnancy Category X. FSH must not be used during pregnancy and lactation.

The presence of uncontrolled non gonodalendocrinopathies (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 hypersensitivity to FSH, but there remains the possibility of anaphylactic responses
• The first injection of FSH 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 in the 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 FSH should be discontinued. In that case pregnancy should be avoided and HCG must be withheld, because it may induce, in addition to multiple ovulation, the ovarian hyperstimulation syndrome (OHSS).
• In men, semen analysis is recommended 4 to 6 months after the beginning of treatment in assessing the response

Drugs for Infertility, Trophic Hormones & Related Synthetic Drugs

No data on acute toxicity of FSH in humans is available, but the acute toxicity of FSH and of urinary gonadotrophin preparations in animal studies has been shown to be very low. Too high a dosage of FSH may lead to hyperstimulation of the ovaries.

Store at 2°C to 8°C (in a refrigerator). Do not keep in deep freeze. Can be stored below 25°C for a maximum of 3 months. Protect from light & keep in dry place .