CME in Biomarker Driven Oncology

▼ This drug is subject to additional monitoring. For detailed information, please refer to the published product information at www.swissmedicinfo.ch.

Active substance: Larotrectinib (Larotrectinib sulfate). Indication: Vitrakvi is indicated for the treatment of adult and pediatric patients with solid tumors who have a tumor with a NTRK (neurotrophic tyrosine receptor kinase) gene fusion without known NTRK resistance mutation, and a tumor that is metastatic or where surgical resection will likely result in severe morbidity, and who have no satisfactory treatment options available or have had progressed after previous treatment. Vitrakvi is not indicated for the treatment of lymphoma (see section “Properties/Effects”). Dosage/administration: Confirm presence of a NTRK gene fusion by a validated test prior to initiation of treatment. Treatment until disease progression or until unacceptable toxicity. Dosage: adult patients: 100 mg orally twice daily; pediatric patients: with body surface area < 1 m²: 100 mg/m2 body surface area orally twice daily; with body surface area of at least 1 m²: 100 mg orally twice daily. Safety and efficacy not established in newborns under the age of 28 days. Reduce starting dose by 50% in patients with Child-Pugh B and Child-Pugh C hepatic impairment. Reduce Vitrakvi dose by 50% in case of unavoidable concomitant use with strong CYP3A4-inhibitors. Double Vitrakvi dose in case of unavoidable concomitant use with strong or moderate CYP3A4- and strong P-gp-inductors. Contraindications: Hypersensitivity to the drug substance or to any of the excipients. Warnings/precautions: Efficacy may be quantitatively different depending on tumor type; molecular causes for primary resistance unknown; minimal activity in case of acquired resistance mutations; advise patients not to drive or operate hazardous machinery in the event of neurologic reactions; hepatotoxicity (monitoring of liver function including ALT, AST, ALP and bilirubin); reported fractures; embryotoxicity can not be excluded; dosage recommendation in children below 3 months of age (limited PK data, close monitoring). Ingredients of special interest: sodium, hydroxypropylbetadex, sodium benzoate, benzyl alcohol. Interactions: Larotrectinib is a weak inhibitor of CYP3A4, an inductor of CYP2B6, and a substrate of CYP3A, P-gp and BCRP (see Dosage/administration). Undesirable effects: Very common: musculoskeletal pain (41%), transaminase increase (36%), decreased general strength and energy (30%), anemia (29%), vomiting (28%), cough (27%), constipation (27%), leukopenia (26%), diarrhea (25%), nausea (25%), fever (25%), dizziness (22%), gastrointestinal and abdominal pains (21%), dyspnea (18%), rash (18%), edema (16%), headache (16%), weight increased (16%), neutropenia (15%), mood disorders (14%), decreased appetite and food intake (14%), urinary tract infect (14%), lymphopenia (12%), hypoalbuminemia (12%), nasopharyngitis (12%), blood creatinine increased (12%), cognitive impairment (11%), hyperlipidemia (11%), nasal congestion (10%). Dispensing category: category A. Marketing authorization holder: Bayer (Schweiz) AG, Uetlibergstrasse 132, 8045 Zurich. 
For detailed information, please refer to the published product information at www.swissmedicinfo.ch. MA-LAR-CH-0048-7 03/2024