Vitrakvi (Larotrectinib) 100mg×56 Capsules | Bayer China 维泰凯 NTRK Fusion | GLT

Generic Information: Vitrakvi (Larotrectinib) — China Mainland Presentation by Bayer

This listing is the mainland China presentation of Vitrakvi, the originator larotrectinib that Chinese prescribers know as 维泰凯. The molecule was co-developed by Loxo Oncology and Bayer, and mainland regulators approved it in April 2022 as the first tumor-agnostic targeted therapy cleared for China — a drug prescribed by genetic signature rather than by where the tumor started. The Chinese label carries a single registered presentation, 100 mg capsules in a 56-capsule bottle (国药准字 HJ20220033), with Bayer AG as the marketing authorization holder and Penn Pharmaceutical Services in the United Kingdom as the manufacturing site. That 56-capsule bottle is the mainland standard, distinct from the 60-capsule count used in the United States and Hong Kong.

What Is Vitrakvi (Larotrectinib) Used For?

Vitrakvi is indicated for adult and pediatric patients with solid tumors that carry a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation, that are metastatic or where surgery would likely cause severe morbidity, and who have no satisfactory alternative treatment or whose disease has progressed after prior therapy. Because the approval is based on the fusion rather than the organ, the same prescription covers infantile fibrosarcoma, salivary gland cancer, soft-tissue sarcoma, thyroid cancer, lung cancer, and a long list of other solid tumors — as long as NTRK fusion is confirmed by a validated test.

How Does Vitrakvi (Larotrectinib) Work?

Larotrectinib is an adenosine triphosphate-competitive, highly selective inhibitor of the tropomyosin receptor kinase (TRK) family — TRKA, TRKB and TRKC, the proteins encoded by the NTRK1, NTRK2 and NTRK3 genes. When an NTRK gene fuses with an unrelated partner, it produces a constitutively active TRK fusion protein that keeps driving cell growth. By blocking all three TRK kinases, larotrectinib shuts down that abnormal signal, causing tumor shrinkage across many tissue types. It was deliberately designed to spare off-target kinases, which is why its side-effect profile is relatively clean for a cancer drug.

NMPA-Approved Indications (China Label)

The Chinese approval mirrors the global label: adult and pediatric solid tumors with a confirmed NTRK gene fusion, no known acquired resistance mutation, locally advanced or metastatic disease or disease where resection would be morbid, and no satisfactory alternative or progression after prior therapy. The label was granted under conditional approval based on overall response rate and duration of response, with continued approval contingent on confirmatory trials. It sits in China's national reimbursement drug list with a defined reimbursement scope for NTRK fusion-positive solid tumors meeting those same criteria.

Dosage and Administration

The recommended dose is 100 mg orally twice daily for adults and for children with a body surface area of 1.0 m² or greater, with or without food, until disease progression or unacceptable toxicity. For children with a body surface area below 1.0 m², the dose is 100 mg/m² twice daily, capped at 100 mg per dose. Capsules are swallowed whole with water and must not be chewed or crushed. Dose reductions for grade 3–4 adverse reactions step down through 75 mg, 50 mg, then 100 mg once daily before permanent discontinuation; strong CYP3A4 inhibitors and inducers require dose adjustment, and moderate-to-severe hepatic impairment warrants a halved starting dose.

Side Effects of Vitrakvi

The most common reactions, seen in at least 20% of patients, are fatigue, nausea, dizziness, vomiting, cough, constipation, diarrhea and elevated AST and ALT. Two cautions deserve special attention. The first is neurotoxicity — dizziness, cognitive impairment, mood changes and sleep disturbance, which is why patients are told not to drive or operate machinery while affected. The second is hepatotoxicity, managed with liver-function monitoring every two weeks for the first two months and monthly thereafter. Skeletal fractures should be evaluated promptly, and the drug can cause fetal harm, so effective contraception is required during and for one week after treatment.

Storage Instructions

Store the 56-capsule bottle at room temperature, 20°C to 25°C, with excursions of 15°C to 30°C permitted, in a closed container protected from moisture and out of children's reach. The mainland bottle is sealed with Chinese labeling and a batch number that maps to the NMPA registry, which is exactly what hospitals and pharmacies across China verify when confirming a prescription's provenance.

Why Choose Vitrakvi (维泰凯) from GLT?

Buyers who want the originator molecule with mainland labeling and batch traceability choose this pack. It pairs Bayer's provenance with the 56-capsule China configuration that mainland clinicians are trained on, so a prescription written in China maps directly to what GLT ships. GLT quotes the China original alongside the Hong Kong presentation and the Bangladesh and Laos generics (Laronib, Tractoni, LuciLaro, Larotreni, Larodx) so the landed cost of every NTRK option is visible before a decision is made. A real person answers on WhatsApp +86 15234153837 or at [email protected] for every step between quotation and delivery.

How to Order Vitrakvi (Larotrectinib)

Message GLT on WhatsApp +86 15234153837 or write to [email protected] with the bottle quantity and destination country. A formal quotation with courier options and payment routes returns, usually within one working day; on confirmation, sealed stock with complete export documentation ships. Because NTRK fusion-positive patients are often on continuous daily therapy, recurring supply can be scheduled in advance so treatment never breaks.

FAQ

Is 维泰凯 the same molecule as US Vitrakvi? Identical active ingredient — larotrectinib — sold under the same Vitrakvi trade name; 维泰凯 is the Chinese registered brand, supplied as a 100 mg × 56-capsule bottle.

Why is the China bottle 56 capsules and the US 60? The mainland presentation follows the Bayer global 56-count pack; the US and Hong Kong bottles use a 60-count format. The capsule strength is the same 100 mg in both.

Does Vitrakvi need a gene test first? Yes. It only works when the tumor has an NTRK gene fusion, so a validated test must confirm the fusion before treatment, regardless of the cancer's location.

Is larotrectinib chemotherapy? No. It is an oral, once-daily-multiple targeted kinase inhibitor that attacks a specific genetic driver, not a cytotoxic agent.

Can children take it? Yes — it carries a pediatric indication, with dosing based on body surface area, which is one reason it is regarded as a breakthrough in pediatric precision oncology.