Vitrakvi (Larotrectinib) 100mg×60 Capsules | Bayer US NTRK Fusion | GLT

Generic Information: Vitrakvi (Larotrectinib) — Bayer Originator, US Pack

This is the United States presentation of Vitrakvi, the originator larotrectinib developed by Loxo Oncology and brought to market with Bayer after Bayer's acquisition of Loxo. The US Food and Drug Administration approved it on November 26, 2018, making it one of the first tissue-agnostic oral oncology therapies — a drug selected by biomarker rather than by tumor location. The pack shown and supplied is the 100 mg capsule in a 60-capsule bottle, NDC 71777-391-01, manufactured for Loxo Oncology, Inc. of Stamford, CT, with Bayer AG — the Leverkusen, Germany-based group — as the global marketing authorization holder.

What Is Vitrakvi (Larotrectinib) Used For?

Vitrakvi treats adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation, where the disease is metastatic or surgery would likely cause severe morbidity, and where there is no satisfactory alternative or the cancer has progressed after treatment. The indication is defined by the fusion, not the organ, so it spans salivary gland tumors, soft-tissue sarcoma, infantile fibrosarcoma, thyroid cancer, lung cancer and other NTRK fusion-positive solid tumors confirmed by testing.

How Does Vitrakvi (Larotrectinib) Work?

Larotrectinib selectively inhibits the tropomyosin receptor kinase (TRK) family — TRKA, TRKB and TRKC, encoded by the NTRK1, NTRK2 and NTRK3 genes. An NTRK gene fusion produces an abnormal, always-on TRK fusion protein that drives tumor growth regardless of where the cancer began. By binding the ATP pocket of all three TRK kinases, larotrectinib blocks that driver signal and shrinks tumors across tissue types. Its selectivity for TRK over other kinases is a deliberate design choice that keeps the side-effect profile manageable.

Indications of Vitrakvi (US Label)

The US label carries the original FDA indication: adult and pediatric patients with solid tumors harboring a confirmed NTRK gene fusion without a known acquired resistance mutation, that are either metastatic or where surgical resection would likely result in severe morbidity, and that have no satisfactory alternative therapy or have progressed following treatment. Dispensing follows the US prescription-only model — a validated molecular pathology test confirms the fusion before therapy starts, because the drug has no meaningful activity against fusion-negative tumors.

The US Pack: Bottle, Capsule and Label Details

The US commercial pack of Vitrakvi is a white 60-capsule child-resistant bottle of 100 mg capsules, labeled NDC 71777-391-01 with the instruction to store at 20°C to 25°C. A 25 mg capsule bottle exists in the same presentation for pediatric and dose-reduction use, so the 60-capsule count is consistent across strengths. Buyers comparing regional presentations will notice the mainland China pack holds 56 capsules (维泰凯, approved by NMPA in April 2022), while the US and Hong Kong markets follow the 60-capsule configuration — a packaging difference only, with identical capsule strength and daily dose.

Dosage and Administration

The recommended dose is 100 mg orally twice daily for adults and for children with body surface area of at least 1.0 m², with or without food, continued until disease progression or unacceptable toxicity. Children below 1.0 m² receive 100 mg/m² twice daily, up to 100 mg per dose. Capsules are swallowed whole and must not be chewed or crushed. Toxicity-driven reductions step through 75 mg twice daily, 50 mg twice daily, then 100 mg once daily before discontinuation; coadministration of strong CYP3A4 inhibitors or inducers requires dose adjustment, and moderate-to-severe hepatic impairment calls for a halved starting dose.

Side Effects of Vitrakvi

The common reactions in at least 20% of patients are fatigue, nausea, dizziness, vomiting, cough, constipation, diarrhea and raised AST and ALT. Neurotoxicity — dizziness, cognitive impairment, mood disorders and sleep disturbance — warrants avoiding driving or hazardous machinery while affected, and hepatotoxicity is managed with liver-function tests every two weeks for the first two months, then monthly. Skeletal fractures should be evaluated promptly, and the drug can harm a fetus, so contraception is required during treatment and for one week afterward.

Storage Instructions

Keep the 60-capsule bottle at room temperature between 20°C and 25°C, with brief excursions of 15°C to 30°C permitted, in a closed container protected from moisture and away from children. US-labeled stock carries the Bayer/Loxo batch number printed on the bottle and carton, so a buyer can verify provenance against the manufacturer's distribution records for a medicine that travels across borders.

Why Choose Vitrakvi (US Pack) from GLT?

This pack suits buyers who want the originator molecule in the original US bottle configuration at the full 60-capsule count. GLT positions it next to the mainland 维泰凯 presentation and the Bangladesh and Laos generics so the complete NTRK landscape — originator versus generic, 56 versus 60 count — is visible before a purchase. Every order ships sealed with export documentation, and a real person answers on WhatsApp +86 15234153837 or at [email protected] from quotation through delivery.

How to Order Vitrakvi (Larotrectinib)

Message GLT on WhatsApp +86 15234153837 or write to [email protected] with the bottle quantity and destination. A formal quotation with courier and payment options returns, usually within a working day, and on confirmation the sealed bottles ship with complete paperwork. Recurring supply can be arranged in advance for patients on continuous twice-daily therapy.

FAQ

Is the US Vitrakvi the same as the mainland Chinese version? Same Bayer originator molecule and same 100 mg capsule, but the US bottle holds 60 capsules while the mainland 维泰凯 bottle holds 56 — a packaging difference, not a dosing difference.

Who makes Vitrakvi? Loxo Oncology developed it; Bayer AG, the German healthcare group headquartered in Leverkusen, acquired Loxo in 2019 and markets Vitrakvi worldwide. The US pack is labeled for Loxo Oncology, Inc., Stamford, CT.

Is a gene test required? Yes — a validated test must confirm an NTRK fusion, because larotrectinib only acts on fusion-driven tumors.

Is this chemotherapy? No, it is an oral targeted TRK inhibitor, taken twice daily, not a cytotoxic infusion.

Can children use it? Yes, it has a pediatric indication with body-surface-area-based dosing.