▼ 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, Grubenstrasse 8, 8045 Zurich.
For detailed information, please refer to the published product information at www.swissmedicinfo.ch. MA-LAR-CH-0048-7 03/2024.
