GONAL-f 300 IU/0.48 ml (22 micrograms/0.48 ml) Solution for Injection in Pre-filled Pen

A prescription-only fertility medicine containing follitropin alfa, a recombinant human follicle stimulating hormone produced by recombinant DNA technology. The pack holds one multidose pre-filled pen delivering 300 IU in 0.48 ml, together with eight injection needles, and is given by subcutaneous injection. Treatment must be started and supervised by a physician experienced in fertility disorders.

What is in it

• Follitropin alfa (recombinant human FSH), 300 IU equivalent to 22 micrograms, in 0.48 ml.
• Excipients: poloxamer 188, sucrose, methionine, sodium dihydrogen phosphate monohydrate, disodium phosphate dihydrate, m-cresol, phosphoric acid and sodium hydroxide for pH adjustment, and water for injections.
• The pen is designed for more than one dose; the product information controls this with the 28-day in-use limit below.
• One multidose pre-filled pen and eight injection needles in the carton.

What it is used for

• In adult women: anovulation, including polycystic ovarian syndrome, where clomifene citrate has not worked.
• In adult women: stimulation of multifollicular development for assisted reproductive technologies.
• In adult women with severe LH and FSH deficiency: stimulation of follicular development, alongside a luteinising hormone preparation.
• In adult men: stimulation of spermatogenesis in congenital or acquired hypogonadotrophic hypogonadism, with concomitant human chorionic gonadotropin (hCG) therapy.

Storage

• Store in a refrigerator at 2°C to 8°C. Do not freeze.
• Keep the cap on the pen to protect it from light.
• Before opening, it may be kept out of the refrigerator at up to 25°C for one single period of up to three months, and must be discarded if it has not been used within those three months.
• Once opened, keep between 2°C and 25°C and use within 28 days.

Good to know

This is a prescription-only medicine and is dispensed against a valid prescription. The SmPC lists ovarian hyperstimulation syndrome, multiple pregnancy, a higher rate of miscarriage than natural conception and thromboembolic events among the risks. It is contraindicated in hypersensitivity to the active substance or any excipient; tumours of the hypothalamus or pituitary gland; ovarian enlargement or an ovarian cyst of unknown origin unrelated to polycystic ovarian disease; gynaecological haemorrhages of unknown origin; and ovarian, uterine or mammary carcinoma. It must not be used where an effective response cannot be obtained, such as primary ovarian failure, malformations of the sexual organs or fibroid tumours of the uterus incompatible with pregnancy, or primary testicular insufficiency. Read the patient leaflet, follow the dose your specialist sets, and keep the pen out of the sight and reach of children. Do not use it if the solution is not clear or contains particles, or if the pen shows any sign of damage, and keep a record of the name and batch number of each pen you use. The EU carton names the marketing authorisation holder as Merck Europe B.V., Amsterdam; the UK licence is held by Merck Serono Ltd - check your own carton for the holder that applies to it.