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Romiplostim

Nplate · ATC code B02BX04

Key facts
Active substance
Romiplostim
ATC code
B02BX04
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Nplate 125 micrograms powder for solution for injection / Nplate 250 micrograms powder for solution for injection / Nplate 500 micrograms powder for solution for injection · Nplate 250 micrograms powder and solvent for solution for injection / Nplate 500 micrograms powder and solvent for solution for injection
Marketing authorisation holder
Amgen Europe B.V.
Information as of
2026-10-29

Key facts

Romiplostim is a thrombopoietin (TPO) receptor agonist that stimulates platelet production. It is used for primary immune thrombocytopenia (ITP) refractory to other treatments.

What it is used for

  • Nplate (powder for solution for injection): primary ITP in adults refractory to other treatments (e.g. corticosteroids, immunoglobulins), and chronic primary ITP in children one year of age and older under the same condition.
  • Nplate (powder and solvent): primary ITP in refractory adults.

Dosing

  • Once weekly as a subcutaneous injection; initial dose 1 mcg/kg based on actual body weight.
  • Increase the weekly dose in increments of 1 mcg/kg until platelets reach ≥ 50 x 10⁹/L; do not exceed a maximum of 10 mcg/kg once weekly.
  • Check platelets weekly until stable, then monthly; decrease the dose if > 150 x 10⁹/L for two consecutive weeks.
  • Discontinue if platelets do not rise sufficiently after four weeks at the highest weekly dose.
  • Children: dose adjusted by platelet count and body weight (reassess weight every 12 weeks). Moderate to severe hepatic impairment (Child-Pugh score ≥ 7): only if benefit outweighs the risk of portal venous thrombosis; renal impairment: caution.

Contraindications

  • Hypersensitivity to the active substance, to any of the excipients, or to E. coli derived proteins.

Important warnings

  • Thrombocytopenia is likely to reoccur after stopping, with bleeding risk, especially with anticoagulants or anti-platelet agents.
  • Increased bone marrow reticulin may occur.
  • Thrombotic/thromboembolic events (deep vein thrombosis, pulmonary embolism, myocardial infarction), including portal vein thrombosis in chronic liver disease.
  • Medication errors (overdose and underdose) have been reported; follow dose calculation guidelines, as some children need an additional dilution step.
  • For ITP only: progression of myelodysplastic syndrome to AML has been observed.

Side effects

  • Most common: hypersensitivity reactions (including rash, urticaria, angioedema) and headache.
  • Very common: upper respiratory tract infection.
  • Serious: recurrence of thrombocytopenia and bleeding after stopping, bone marrow reticulin, thromboembolic complications, progression of MDS to AML.

Interactions

  • No interaction studies. Monitor platelets when combining with, or reducing, other ITP medicines (corticosteroids, danazol, azathioprine, immunoglobulins, anti-D).

Pregnancy and breastfeeding

  • Not recommended during pregnancy or in women of childbearing potential not using contraception.
  • Breast-feeding: a risk to the infant cannot be excluded; weigh benefit and risk.

Summary of the official product information, written with AI on 2026-10-29. 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

This product has no separate US patient information.

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)

  • NplateAmgen Europe B.V. · EMEA/H/C/000942

Source: European Medicines Agency (EMA), product information

Turkey

  • NplateAMGEN İLAÇ TİC. LTD. ŞTİ. · 2 register entries

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

Brand names in 2 more European countries
Iceland
Nplate
Norway
Nplate

EMA – Article 57 product data (EU/EEA), 2026-10-29

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. Nplate – EPAR, Product Information. 2026-10-29. https://www.ema.europa.eu/en/documents/product-information/nplate-epar-product-information_en.pdf
  2. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85

Editorial: Medelix editorial team · last updated 2026-10-29 · 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.