Puregon solution for injection – follitropin beta (FSH) for infertility treatment

Puregon is a solution for injection in a cartridge containing follitropin beta – recombinant follicle-stimulating hormone (FSH). FSH belongs to the gonadotropins, hormones that play an important role in fertility: in women it is needed for the growth and development of follicles (sacs containing egg cells) in the ovaries, and in men for sperm production.

The medicine is available in cartridges of 300 IU/0.36 mL, 600 IU/0.72 mL and 900 IU/1.08 mL (833 IU/mL) and is intended for injection under the skin with the Puregon Pen injector. Treatment is managed by a specialist, with regular ultrasound scans and hormone tests.

What is Puregon used for and how is it used during infertility treatment?

Key information about the medicine

What is Puregon used for?

According to the package leaflet, Puregon is used to treat infertility:

• in women who do not ovulate and do not respond to treatment with clomifene citrate – to induce ovulation;
• in women undergoing assisted reproduction, including in vitro fertilisation (IVF) – to bring about the development of multiple follicles;
• in men whose infertility is caused by low levels of certain hormones (hypogonadotropic hypogonadism) – to stimulate sperm production.

How is Puregon used and dosed?

The dose is set by the doctor and adjusted during treatment, because ovarian response to FSH varies greatly between women. According to the leaflet:

• Women who do not ovulate: the starting dose is given for at least 7 days; if there is no response, the daily dose is gradually increased until ultrasound and/or oestradiol show an adequate response. Usually 7–14 days of treatment are sufficient, and ovulation is then triggered with human chorionic gonadotropin (hCG).
• Assisted reproduction (IVF): the starting dose is given for at least the first four days, then adjusted according to ovarian response. When enough follicles of adequate size are present, hCG triggers final maturation and the eggs are collected 34–35 hours later.
• Men: usually 450 IU per week, mostly divided into 3 doses of 150 IU, together with hCG, for at least 3–4 months; if sperm production is not achieved, treatment may continue for at least another 18 months.
• Administration: the cartridge is used only with the Puregon Pen; you (or your partner) inject it under the skin, e.g. into the lower abdomen, as instructed by the doctor and the pen instructions. Do not use the cartridge if the solution is not clear or contains particles.

Special patient groups

• Children and adolescents: there is no relevant indication.
• Men with raised FSH: raised FSH levels indicate testicular damage, in which case Puregon is usually not effective; the doctor assesses the effect with a semen analysis 4–6 months after starting treatment.
• Women with an increased risk of thrombosis (personal or family history of thrombosis, being overweight) – talk to the doctor before starting treatment.

Contraindications – when the medicine must not be used

• allergy to follitropin beta or any of the excipients;
• tumour of the ovary, breast, uterus, testis or brain (pituitary or hypothalamus);
• heavy or irregular vaginal bleeding of unknown cause;
• primary ovarian failure (ovaries not functioning);
• ovarian cysts or enlarged ovaries not caused by polycystic ovary syndrome (PCOS);
• malformations of the sexual organs or fibroid tumours of the uterus incompatible with normal pregnancy;
• in men – infertility due to primary testicular failure;
• pregnancy or suspected pregnancy.

Warnings and precautions

Talk to your doctor before use if you have had an allergic reaction to the antibiotics neomycin and/or streptomycin, if you have uncontrolled pituitary or hypothalamic problems, an underactive thyroid, adrenal insufficiency, raised prolactin or another chronic disease (e.g. diabetes, heart disease). In women:

• OHSS: regular ultrasound scans and hormone tests help prevent ovarian overstimulation; a severe form can be life-threatening.
• Multiple pregnancy and birth defects: after treatment with gonadotropins there is a higher chance of multiple pregnancy, even when one embryo is transferred.
• Pregnancy complications: slightly increased risk of ectopic pregnancy and miscarriage.
• Thrombosis: treatment, like pregnancy itself, increases the risk of blood clots (pulmonary embolism, stroke or heart attack).
• Ovarian torsion: tell the doctor if you have had OHSS, abdominal surgery, ovarian torsion or cysts.
• Tumours: ovarian and other reproductive tumours have been reported in women treated for infertility; it is not known whether fertility medicines increase this risk.
• The medicine contains 10 mg benzyl alcohol per mL, which may cause allergic reactions; in liver or kidney disease talk to your doctor. It contains less than 1 mmol (23 mg) sodium per injection.

Interactions with other medicines, food and drink

• The effect of Puregon may be increased when used together with clomifene citrate.
• If GnRH agonists (medicines to prevent premature ovulation) have been used, higher doses of Puregon may be needed.
• Tell your doctor about all medicines you are taking or have recently taken.

Pregnancy and breast-feeding

• Pregnancy: Puregon must not be used if you are pregnant or think you may be pregnant.
• Breast-feeding: Puregon may affect milk production; it is unlikely to pass into breast milk. If you are breast-feeding, talk to your doctor before use.

Driving and using machines

• Puregon is unlikely to affect the ability to drive and use machines.

Possible side effects

• Serious in women – contact a doctor immediately: abdominal pain, nausea or diarrhoea, abdominal swelling, sudden weight gain, difficulty breathing (signs of ovarian hyperstimulation – OHSS), even several days after the last injection; signs of a blood clot (rare).
• Common in women: headache, injection site reactions (bruising, pain, redness, swelling, itching), OHSS, pelvic pain, abdominal pain and/or bloating.
• Uncommon in women: breast complaints (including tenderness), diarrhoea, constipation or abdominal discomfort, enlarged uterus, nausea, hypersensitivity reactions (rash, redness, hives, itching), ovarian cyst or enlargement, ovarian torsion, vaginal bleeding.
• Common in men: acne, injection site reaction (hardening, pain), headache, rash, breast enlargement, testicular cyst.
• Ectopic pregnancy, miscarriage and multiple pregnancy have also been reported; these are considered to be related to the assisted reproduction procedure or the pregnancy, not the medicine itself.

Overdose, missed dose and stopping treatment

• Overdose: tell your doctor immediately. Too high a dose can cause ovarian hyperstimulation, felt as abdominal pain.
• Missed dose: do not take a double dose; inform your doctor.
• Stopping treatment: the duration of stimulation and the timing of hCG are decided by the doctor based on ultrasound and hormone tests.

Related information

For support while planning a pregnancy and during pregnancy, see also the category Maternity & Nursing – Essentials for Mom & Baby – products in this category do not replace the medicine you have been prescribed.

Composition, pack and manufacturer

• Active substance: follitropin beta (FSH) 833 IU/mL aqueous solution; cartridge of 300 IU/0.36 mL, 600 IU/0.72 mL or 900 IU/1.08 mL (the cartridges contain a small overfill – at least 400, 700 or 1025 IU respectively – sufficient for the stated dose).
• Excipients: sucrose, sodium citrate, L-methionine, polysorbate 20, benzyl alcohol, water for injections; sodium hydroxide and/or hydrochloric acid for pH adjustment.
• Appearance: clear, colourless solution.
• Pack: 1.5 mL glass cartridge; carton with 1 cartridge and 6 needles (300 and 600 IU) or 9 needles (900 IU) for the Puregon Pen.
• Marketing authorisation holder: Organon d.o.o., Milutina Milankovića 1i, Belgrade – Novi Beograd; manufacturer: N.V. Organon, Kloosterstraat 6, Oss, the Netherlands.
• Marketing authorisation numbers (renewals of 23.12.2022): 300 IU – 515-01-05136-21-001; 600 IU – 515-01-05138-21-001; 900 IU – 515-01-05143-21-001.

Storage

• In the pharmacy: store in a refrigerator (2 °C to 8 °C); do not freeze.
• At home: in a refrigerator (2 °C to 8 °C) or, once only, for up to 3 months below 25 °C (note the date on the carton). Keep the cartridge in the outer carton.
• Once the rubber stopper has been pierced by a needle, the cartridge may be used for at most 28 days. Empty cartridges must not be refilled and no other medicine may be mixed in the cartridge.
• Shelf life: 3 years. Keep out of the sight and reach of children.

Frequently asked questions

How is Puregon given?

By injection under the skin with the Puregon Pen, usually into the lower abdomen. You can inject yourself or your partner can do it, and the first injection must be given in the presence of a doctor or nurse.

How long does stimulation with Puregon last?

In women who do not ovulate usually 7–14 days; in IVF the dose is adjusted until enough follicles have developed. In men treatment lasts at least 3–4 months. The exact duration is decided by the doctor.

What are the signs of ovarian hyperstimulation?

Abdominal pain and bloating, nausea, vomiting or diarrhoea, and in more severe cases sudden weight gain, reduced urination and difficulty breathing. Contact your doctor immediately, even if several days have passed since the last injection.

How should Puregon be stored at home?

In the refrigerator at 2–8 °C or, once only, for up to 3 months below 25 °C. An opened cartridge (pierced stopper) is used for at most 28 days.

Sources

• ALIMS – Puregon package leaflet (PIL, 300 IU authorisation, in Serbian)
• ALIMS – Puregon summary of product characteristics (SmPC, 300 IU authorisation, in Serbian)
• ALIMS – Puregon package leaflet (PIL, 600 IU authorisation, in Serbian)
• ALIMS – Puregon package leaflet (PIL, 900 IU authorisation, in Serbian)

Sources checked on: 25.10.2026.