Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Loqtorzi

LOQTORZI 240 mg concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 9

HOS-151540 · Präparat HOS-100567

Toripalimab in combination with platinum containing chemotherapy (see section 4.2) The safety of toripalimab in combination with platinum containing chemotherapy has been evaluated in 403 patients with NPC or oesophageal squamous cell carcinoma (OSCC) receiving 240 mg toripalimab every 3 weeks in JUPITER-02 or JUPITER-06. The median duration of treatment in these patients was 6.5 months (range 1 day-2.1 years). The frequencies included below and in Table 2 are based on all reported adverse drug reactions, regardless of the investigator assessment of causality. In this patient population, the most frequent adverse reactions were anaemia (44.9%), leukopenia (41.7%), neutropenia (39.0%), thrombocytopenia (30.3%), nausea (29.8%), vomiting (27.3%), decreased appetite (23.8%), rash (23.8%), fatigue (23.6%), liver function test abnormal (22.3%), hypothyroidism (18.4%), constipation (16.6%), neuropathy (15.1%), colitis (14.1%), pyrexia (13.6%), cough (11.4%), pruritus (11.4%), creatinine renal clearance decreased (11.2%), and hyponatraemia (10.2%). Incidences of grades 3-5 adverse reactions in patients with NPC were 81.5% for toripalimab combination therapy and 83.9% for chemotherapy alone and in patients with OSCC were 24.9% for toripalimab combination therapy and 13.6% for chemotherapy alone.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.