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lutropin alfa

Luveris · ATC code G03GA07

Key facts
Active substance
lutropin alfa
Drug class
Gonadotropins
ATC code
G03GA07
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Luveris 75 IU powder and solvent for solution for injection
Marketing authorisation holder
Merck Europe B.V.
Information as of
2026-10-27

Key facts

Lutropin alfa is a recombinant luteinising hormone (LH). It is used with an FSH preparation to stimulate follicular development in adult women with severe LH and FSH deficiency.

What it is used for

  • Stimulation of follicular development in adult women with severe LH and FSH deficiency, in association with an FSH preparation

Dosing

  • Initiated under supervision of a physician experienced in treating fertility disorders
  • Recommended regimen: 75 IU lutropin alfa (one vial) daily together with 75 to 150 IU FSH (follitropin alfa), subcutaneously
  • Tailored to response (ultrasound follicle size, estrogen response); FSH increases preferably after 7- to 14-day intervals
  • At optimal response, a single injection of 250 micrograms r-hCG or 5,000 IU to 10,000 IU hCG 24 to 48 hours after the last injections
  • If the response is excessive, stop treatment and withhold hCG
  • First injection under direct medical supervision; safety in renal or hepatic impairment not established

Contraindications

  • Hypersensitivity to the active substance or any excipient
  • Tumours of the hypothalamus and pituitary gland
  • Ovarian enlargement or cyst of unknown origin not due to polycystic ovarian disease
  • Gynaecological haemorrhage of unknown origin; ovarian, uterine or mammary carcinoma
  • Conditions making a normal pregnancy impossible (e.g. primary ovarian failure)

Important warnings

  • Ovarian hyperstimulation syndrome (OHSS)
  • Multiple pregnancy is more frequent than with natural conception; careful monitoring of ovarian response
  • Thromboembolic events in women with risk factors
  • Porphyria: possible increased risk of an acute attack
  • Evaluate for hypothyroidism, adrenocortical deficiency and hyperprolactinemia before treatment

Side effects

  • Common: headache, abdominal pain, nausea, vomiting, diarrhoea, mild or moderate OHSS, ovarian cyst, breast and pelvic pain, injection site reactions
  • OHSS in less than 6% of patients; no severe OHSS reported
  • Very rare: hypersensitivity reactions including shock; thromboembolism, usually with severe OHSS
  • Ectopic pregnancy may occur, especially with prior tubal disease

Interactions

  • No interaction studies; not to be mixed with other medicines in the same injection, except follitropin alfa

Pregnancy and breastfeeding

  • No indication during pregnancy; a teratogenic effect after exposure cannot be excluded
  • Not indicated during breast-feeding

Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Package leaflet, verbatim

Package leaflet for patients →

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

  • LuverisMerck Europe B.V. · EMEA/H/C/000292

Source: European Medicines Agency (EMA), product information

Brand names in 3 more European countries
Iceland
Luveris
Liechtenstein
Luveris
Norway
Luveris

EMA – Article 57 product data (EU/EEA), 2026-10-28

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

Other substances in the same group

Another question about this substance?

Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.

Sources

  1. European Medicines Agency. Luveris – EPAR, Product Information (OF THE TEXT MM/YYYY Detailed information on this medicinal p). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/luveris-epar-product-information_en.pdf
  2. Wikidata (CC0): ATC G03GA.

Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.