Bulgarian.pdf

Rybrevant 350 mg concentrate for solution for infusion is a medicinal product subject to additional monitoring, with healthcare professionals asked to report suspected adverse reactions. It contains 50 mg amivantamab per mL, a fully-human Immunoglobulin G1-based bispecific antibody directed against EGF and MET receptors. Rybrevant is indicated for first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with EGFR Exon 19 deletions or Exon 21 L858R substitution mutations, in combination with lazertinib or carboplatin and pemetrexed. It is also indicated for treatment of adult patients with advanced NSCLC with activating EGFR Exon 20 insertion mutations, as monotherapy or in combination with carboplatin and pemetrexed. The recommended dosages of Rybrevant vary depending on body weight and treatment regimen, with administration every 2 or 3 weeks. Treatment should be initiated and supervised by a physician experienced in the use of anticancer medicinal products, with patients treated until disease progression or unacceptable toxicity. Dose modifications are recommended for adverse reactions, including infusion-related reactions, venous thromboembolic events, and skin and nail reactions.