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ofatumumab

Kesimpta · ATC code L04AA52

Key facts
Active substance
ofatumumab
Drug class
Immunosuppressive drug
ATC code
L04AA52
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Kesimpta 20 mg solution for injection in pre-filled syringe / Kesimpta 20 mg solution for injection in pre-filled pen
Marketing authorisation holder
Novartis Europharm Limited
Information as of
2026-10-27

Key facts

Ofatumumab is an anti-CD20 monoclonal antibody given subcutaneously to treat adults with relapsing forms of multiple sclerosis with active disease.

What it is used for

  • Relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features in adults

Dosing

  • 20 mg subcutaneously at weeks 0, 1 and 2, then monthly starting at week 4
  • A missed injection should be given as soon as possible; later doses at the recommended intervals
  • Self-injection into abdomen, thigh or upper outer arm; first injection under healthcare professional guidance
  • No dose modification expected for renal or hepatic impairment

Contraindications

  • Hypersensitivity to the active substance or any excipient
  • Severely immunocompromised state
  • Severe active infection until resolution
  • Known active malignancy

Important warnings

  • Systemic injection-related reactions, generally within 24 hours and mainly after the first injection, predominantly mild to moderate
  • Potential for increased infection risk; evaluate immune status before starting
  • Hepatitis B reactivation with anti-CD20 antibodies; screen for HBV before starting, do not treat active hepatitis B
  • Be vigilant for signs of progressive multifocal leukoencephalopathy (PML)
  • Complete immunisations before starting therapy

Side effects

  • Most frequent: upper respiratory tract infections (39.4%), systemic injection-related reactions (20.6%), urinary tract infections (11.9%), local injection-site reactions (10.9%)
  • Common: oral herpes, nausea, vomiting, hepatic enzymes increased; decreased immunoglobulin M

Interactions

  • No interactions expected via cytochrome P450 enzymes
  • Vaccine response could be impaired with B-cell depletion
  • Other immunosuppressive therapies: consider additive immune effects

Pregnancy and breastfeeding

  • Women of childbearing potential should use effective contraception during treatment and for 2 months after the last dose
  • Data from early pregnancy exposure do not suggest increased risk but are insufficient for firm conclusions

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)

  • KesimptaNovartis Europharm Limited · EMEA/H/C/005410

Source: European Medicines Agency (EMA), product information

Turkey

  • JemvyFARMANOVA SAĞLIK HİZMETLERİ LTD. ŞTİ. · 2 register entries

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

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

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?

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Sources

  1. European Medicines Agency. Kesimpta – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/kesimpta-epar-product-information_en.pdf
  2. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
  3. Wikidata (CC0): ATC L04AA.

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.