Pergoveris pen – follitropin alfa and lutropin alfa for follicle stimulation in infertility

Pergoveris® is a fertility medicine that contains two active substances: follitropin alfa (recombinant follicle-stimulating hormone, FSH) and lutropin alfa (recombinant luteinising hormone, LH). Both belong to a group of hormones called gonadotropins.

It is used to stimulate the development of follicles (egg cells) in the ovaries of adult women with severe FSH and LH deficiency. In Serbia it is authorised as a solution for injection in a pre-filled pen in three multidose presentations: 300 IU + 150 IU, 450 IU + 225 IU and 900 IU + 450 IU. It is injected under the skin once a day, under the supervision of a doctor experienced in treating infertility.

What is Pergoveris used for and how should it be used correctly?

Key information about the medicine

What is Pergoveris used for?

Pergoveris is indicated for stimulation of follicular development in adult women (18 years and older) with severe LH and FSH deficiency. These women are usually infertile.

FSH stimulates the production of eggs, and LH their release. By replacing the missing hormones a follicle can develop, and after an injection of human chorionic gonadotropin (hCG) the egg is released. Before treatment the doctor examines the fertility of both partners.

How is Pergoveris used and dosed?

• The injection is given under the skin (in the abdomen) at the same time every day; the injection site is changed daily to reduce skin irritation.
• A doctor or nurse trains the patient to use the pen; self-injection at home is only possible after training.
• A new needle is used for each injection and removed immediately after the injection. The pen and needles must not be shared with anyone else.
• The numbers in the pen window show the follitropin alfa dose; the dial turns in steps of 12.5 IU. The maximum dose that can be selected is 300 IU (300 + 150 IU pen) or 450 IU (450 + 225 IU and 900 + 450 IU pens).
• If the ovarian response is excessive, treatment is stopped, hCG is not given and in the next cycle the doctor prescribes a lower dose.

Special patient groups

• Children and adolescents under 18 years: not intended for this group.
• Elderly patients: no relevant indication; safety and efficacy have not been studied.
• Impaired kidney and liver function: safety, efficacy and pharmacokinetics have not been studied.

Contraindications – when the medicine must not be used

• allergy to FSH, LH or any of the excipients;
• brain tumour (hypothalamus or pituitary gland);
• enlarged ovaries or ovarian cysts of unknown origin;
• vaginal bleeding of unknown cause;
• cancer of the ovary, uterus or breast;
• conditions that make a normal pregnancy impossible (early menopause, malformation of the sexual organs, benign tumours of the uterus).

Precautions and warnings

• Ovarian hyperstimulation syndrome (OHSS): caused by excessive follicle growth; the severe form is rare unless hCG is given. If OHSS develops, the doctor will not give hCG in that cycle and will advise abstaining from intercourse or using barrier contraception for at least 4 days.
• Multiple pregnancy: more likely than with natural conception (most often twins); the risk is reduced by keeping to the prescribed dose and regular ultrasound scans.
• Miscarriage and ectopic pregnancy: the risk is higher, especially in women with previous tubal disease.
• Blood clots: tell your doctor if you or a family member have had thrombosis, a heart attack or stroke.
• Porphyria: inform your doctor before treatment; report if your skin becomes fragile and blisters easily or if you have pain in the stomach, arms or legs.
• Benign and malignant tumours of the reproductive organs have been reported in women who have undergone multiple infertility treatments.
• If you have previously had an allergic reaction to similar medicines, tell your doctor.
• The medicine contains less than 1 mmol sodium (23 mg) per dose – essentially "sodium-free".

Interactions with other medicines

• Pergoveris must not be mixed with other medicines in the same injection.
• It may be used with an authorised follitropin alfa medicine, but as a separate injection, if prescribed by the doctor.
• Tell your doctor about all medicines you are taking.

Pregnancy and breast-feeding

• Pergoveris is not used during pregnancy and breast-feeding – there is no indication for use in these periods.

Driving and using machines

• The medicine is not expected to affect the ability to drive or use machines.

Possible side effects

• Most serious – contact your doctor immediately: allergic reactions (rash, redness, hives, facial swelling with difficulty breathing – very rare); OHSS – lower abdominal pain with nausea and vomiting (common); severe OHSS with markedly enlarged ovaries, reduced urination, weight gain, difficulty breathing and fluid accumulation (uncommon); ovarian torsion or blood clot (rare); serious thromboembolic events with chest pain, shortness of breath, stroke or heart attack (very rare).
• Very common: ovarian cysts, headache, local reactions at the injection site (pain, itching, bruising, swelling, irritation).
• Common: diarrhoea, breast pain, nausea or vomiting, abdominal or pelvic pain, abdominal cramps or bloating.
• Very rare: worsening of asthma.

Overdose, missed dose and stopping treatment

• Overdose: the effects are not known, but OHSS may be expected – which only occurs if hCG is also given. Contact your doctor.
• Missed dose: do not inject a double dose – contact your doctor.
• Stopping treatment: the doctor decides on stopping or changing the dose based on ultrasound and tests.

Related information

For checking results after treatment, in agreement with your doctor, see also the category Pregnancy and ovulation tests – products from this category do not replace the medicine prescribed for you or medical check-ups.

Composition, pack and manufacturer

• Active substances: the 300 + 150 IU pen contains 300 IU (22 micrograms) follitropin alfa and 150 IU (6 micrograms) lutropin alfa in 0.48 mL; the 450 + 225 IU pen contains 450 IU (33 micrograms) and 225 IU (9 micrograms) in 0.72 mL; the 900 + 450 IU pen contains 900 IU (66 micrograms) and 450 IU (18 micrograms) in 1.44 mL.
• Excipients: sucrose; L-arginine monohydrochloride; poloxamer 188; L-methionine; phenol; disodium phosphate dihydrate; sodium dihydrogen phosphate monohydrate; sodium hydroxide and phosphoric acid (for pH adjustment); water for injections.
• Pack: 3 mL multidose cartridge (type I glass) in a pre-filled pen; each box contains 1 pen and 5 (300 + 150 IU), 7 (450 + 225 IU) or 14 needles (900 + 450 IU).
• Marketing authorisation holder: Merck d.o.o. Beograd, Omladinskih brigada 90v, Belgrade – Novi Beograd; manufacturer: Merck Serono S.p.A., Modugno, Italy.
• Authorisations: 000457269 2023 (300 + 150 IU), 000457270 2023 (450 + 225 IU) and 000457271 2023 (900 + 450 IU) of 05.09.2024. The powder and solvent form (150 + 75 IU) is not described on this page.

Storage

• Store in a refrigerator (2 °C – 8 °C). Do not freeze. Keep in the original package to protect from light.
• After opening, the pen may be stored for up to 28 days outside the refrigerator at up to 25 °C; after 28 days any remaining medicine must not be used.
• Do not use if the solution is not clear or contains particles.
• Keep out of the sight and reach of children. Dispose of used needles safely; return unused medicines to a pharmacy that collects them.

Frequently asked questions

Who is Pergoveris intended for?

Adult women with severe deficiency of the hormones FSH and LH who need stimulation of follicular development. Treatment is prescribed and monitored by a doctor experienced in treating infertility.

How is the Pergoveris injection given?

Under the skin, usually in the abdomen, once a day at the same time, changing the injection site. After training by a doctor or nurse the patient can give the injections herself at home.

How long does the treatment last?

Stimulation lasts until a suitable follicle has developed, which is checked by ultrasound and blood tests – up to 5 weeks. Then an hCG injection is given 24–48 hours after the last Pergoveris dose.

How long can an opened pen be used?

For up to 28 days after opening if stored at up to 25 °C. Unopened pens are kept in the refrigerator at 2–8 °C.

Sources

• ALIMS – Package leaflet Pergoveris pre-filled pen (PIL with instructions for use, Serbian)
• ALIMS – Summary of product characteristics Pergoveris pre-filled pen (SmPC, Serbian)

Sources checked on: 25.10.2026.