Luveris 75 IU powder and solvent for injection (lutropin alfa) – to stimulate follicle development

Luveris 75 IU contains lutropin alfa – a recombinant luteinising hormone (LH) produced by biotechnology that is essentially similar to natural LH. It belongs to the gonadotropins, hormones involved in the control of reproduction.

In Serbia it is authorised as Luveris® 75 IU, 75 IU/mL, powder and solvent for solution for injection (marketing authorisation holder Merck d.o.o. Belgrade; manufacturer according to the renewal list Merck Serono S.p.A., Italy). It is used together with follicle-stimulating hormone (FSH) in women with very low levels of these hormones to stimulate the development of follicles in the ovaries; ovulation is then triggered with a single dose of hCG.

What is Luveris 75 IU used for and how should it be given?

Key facts about the medicine

What is Luveris 75 IU used for?

According to the SmPC, Luveris 75 IU in combination with an FSH preparation is used to stimulate follicular development in adult women with severe deficiency of luteinising hormone (LH) and follicle-stimulating hormone (FSH). In clinical trials these patients had a serum LH level below 1.2 IU/L.

The aim of treatment is the development of a single mature follicle from which an egg is released (ovulation) after administration of human chorionic gonadotropin (hCG). Fertility of both partners should be assessed before treatment.

How is it given and dosed?

• The doctor decides the dose and schedule; treatment is adjusted to the ovarian response, monitored by ultrasound and oestrogen measurements.
• The medicine is usually given daily for up to 3 weeks, at the same time as FSH (follitropin alfa) injections; the doctor may extend stimulation to up to 5 weeks.
• The usual starting dose is 75 IU (one vial) of Luveris together with 75–150 IU of FSH; the doctor may increase the FSH dose by 37.5–75 IU at intervals of 7 to 14 days.
• When the desired response is reached, a single hCG injection is given 24–48 hours after the last Luveris and FSH injections; intercourse is recommended on the day of hCG and the following day, or intrauterine insemination is performed.
• It is given subcutaneously (under the skin, e.g. in the abdomen or front of the thigh); the first injection is given under medical supervision, and only trained patients may self-inject.
• Dissolve the powder in the solvent provided immediately before use; do not shake. The solution must be clear and free of particles. Luveris can be mixed with follitropin alfa in the same injection (up to 3 vials of powder can be dissolved in 1 mL of solvent); it is not mixed with other medicines in the same injection.
• Each vial is for single use; dispose of needles and vials in a sharps container.

Special patient groups

• Children and adolescents (under 18): not intended for this group.
• Elderly: no relevant use; safety and efficacy have not been established.
• Kidney or liver impairment: safety, efficacy and pharmacokinetics have not been established.

Contraindications – when the medicine must not be used

Do not use Luveris 75 IU if you:

• are allergic to gonadotropins (LH, FSH, hCG) or any of the other ingredients;
• have cancer of the ovary, uterus or breast;
• have been diagnosed with a brain tumour;
• have enlarged ovaries or an ovarian cyst of unknown origin;
• have vaginal bleeding of unknown cause.

Use is not recommended in conditions that make a normal pregnancy impossible, such as primary ovarian failure or malformations of the sexual organs.

Warnings and precautions

• Ovarian hyperstimulation syndrome (OHSS): caused by excessive follicle growth; the severe form is rare unless hCG is given. If OHSS develops, the doctor may withhold hCG in that cycle and advise avoiding intercourse or using barrier contraception for at least four days.
• Multiple pregnancy: more likely than with natural conception; the risk is reduced by following the recommended dose and schedule.
• Miscarriage and ectopic pregnancy: more common than in the general population, especially with previous tubal disease.
• Thromboembolic events: tell your doctor if you or a family member have had a clot in the leg or lung, a heart attack or a stroke.
• Porphyria: tell your doctor if you or a family member have porphyria.
• Reproductive tumours and birth defects: benign and malignant tumours have been reported in women who had multiple fertility treatments; birth defects after assisted reproduction may be slightly more common.

Interactions with other medicines, food and drink

Tell your doctor or pharmacist about all medicines you take, including those without a prescription. Luveris 75 IU must not be given in the same injection with other medicines, except follitropin alfa if prescribed by your doctor.

Pregnancy and breast-feeding

• Pregnancy and breast-feeding: do not use Luveris 75 IU if you are pregnant or breast-feeding.

Driving and using machines

The medicine has no or negligible influence on the ability to drive and use machines.

Possible side effects

Contact your doctor immediately if you notice serious side effects:

• Allergic reactions (rash, skin redness, hives, facial swelling with difficulty breathing) – very rare.
• Ovarian hyperstimulation syndrome (lower abdominal pain with nausea or vomiting) – common; your doctor should examine you as soon as possible.
• Serious blood clotting complications (chest pain, breathlessness, stroke or heart attack), usually associated with OHSS – very rare.

Other common side effects: headache; nausea, vomiting, diarrhoea, abdominal pain or discomfort; ovarian cysts, breast pain, pelvic pain; local reactions at the injection site (pain, itching, bruising, swelling, irritation). Ectopic pregnancy may occur, especially in women with tubal disease. Report suspected side effects to your doctor, pharmacist or ALIMS.

Overdose, missed dose and stopping treatment

• Overdose: the effects are unknown, but ovarian hyperstimulation syndrome is possible – only if hCG is given. Contact your doctor.
• Missed dose: do not use a double dose; contact your doctor.
• Excessive ovarian response: the doctor stops treatment and withholds hCG; the next cycle starts with a lower FSH dose.

Related information

For additional support when planning a pregnancy, see also the category Maternity & Nursing – products in this category do not replace the medicine prescribed for you.

Composition, pack and manufacturer

• Active substance: lutropin alfa (r-hLH) – 75 IU per vial.
• Powder excipients: polysorbate 20; sucrose; sodium dihydrogen phosphate monohydrate; disodium phosphate dihydrate; concentrated phosphoric acid; sodium hydroxide; L-methionine; nitrogen. Solvent: water for injections.
• The medicine contains less than 1 mmol (23 mg) sodium per dose, i.e. it is essentially "sodium-free".
• Pack: glass vial (3 mL) with powder and glass vial (2 mL or 3 mL) with solvent, in a carton with the leaflet.
• Marketing authorisation holder: Merck d.o.o. Belgrade, Omladinskih brigada 90v, Belgrade – Novi Beograd. Manufacturer (according to the ALIMS renewal list): Merck Serono S.p.A., Modugno, Italy.

Storage

• Store below 25 °C in the original package to protect from light.
• Use immediately after reconstitution; do not use a solution that contains particles or is not clear.
• Keep out of the sight and reach of children. Return unused medicine to a pharmacy that collects unused medicines.

Frequently asked questions

Why is Luveris given together with FSH?

Women with severe LH and FSH deficiency need both hormones for follicle development. Luveris replaces LH, and FSH (follitropin alfa) is given at the same time; ovulation is then triggered with an hCG injection.

Can Luveris and follitropin alfa be given in the same injection?

Yes – according to the leaflet, Luveris can be mixed with follitropin alfa instead of injecting each separately. It is not mixed with other medicines in the same injection.

How long does treatment last?

The medicine is usually given daily for up to 3 weeks, and the doctor may extend stimulation to up to 5 weeks, depending on the ovarian response.

What is ovarian hyperstimulation syndrome and how do I recognise it?

It is an excessive reaction of the ovaries with formation of large cysts. Signs include lower abdominal pain, nausea or vomiting, rapid weight gain and difficulty breathing – contact your doctor immediately if they occur.

Sources

• ALIMS – Summary of Product Characteristics, Luveris® 75 IU (SmPC, Serbian)
• ALIMS – Package leaflet, Luveris® 75 IU (PIL, Serbian)

Sources checked on: 25 October 2026.