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fumeina vorolanib tablets 100mg per tablet

Description

 Indication & Scope

Vorolanib is an oral multi-target anti-angiogenic tyrosine kinase inhibitor for adult patients with advanced RCC who failed prior TKI therapy, applied in second-line targeted treatment of renal cell carcinoma and must be used in combination with everolimus.

  • Mechanism
    As a novel multi-target tyrosine kinase inhibitor, it selectively suppresses VEGFR, PDGFR, c-Kit and FLT3 to block tumor angiogenesis and inhibit proliferation of renal cancer cells.
  • Drug class
    Class 1 innovative small-molecule chemical drug, multi-target anti-angiogenic TKI, renal cell carcinoma targeted therapeutic agent.
  • Clinical use
    Phase III CONCEPT clinical trials verified its superior progression-free survival and controllable safety combined with everolimus; clinically administered orally at a daily dose of 200mg with food, the first domestic category 1 targeted drug exclusively approved for advanced renal cell carcinoma.
Specification
Generic Name Vorolanib Tablets
Brand Name FuMeiNa®
Ingredient Vorolanib
Dosage Form Film-coated Tablets
Package 100mg*20 tablets /box
Conditions Treated Treatment combined with everolimus for adult patients with advanced RCC who have failed prior tyrosine kinase inhibitor therapy, to be used in combination with everolimus
Taboos Contraindicated for patients with hypersensitivity to the active ingredient or any excipients of this product, or those with severe allergic history
Place of origin Zhejiang, China
Priscription Type Prescription drug (Rx)
Storage Conditions Seal tightly, store below 30℃, avoid light
Manufacturer Betta Pharmaceuticals Co., Ltd.
Registration Authority National Medical Products Administration (NMPA)
Approval number H20230013
Date of Revision June 07, 2023
Shelf Life 36 months

How to use ?

Recommended Dose:200mg taken orally once daily with food, combined with everolimus 5mg once daily at the same meal; reduce to 100mg daily when co-administered with strong CYP3A4 inhibitors. Take the tablet whole without splitting or crushing.
Time: Take at a fixed daily mealtime; skip the missed dose if less than 12 hours remain before the next scheduled administration, do not double the dose next time. Continue treatment until disease progression or intolerable toxicity.
Interaction:  Oral tablet administration only, intravenous injection forbidden. Avoid strong CYP3A4 inhibitors and strong CYP3A4 inducers throughout treatment. Must be used in combination with everolimus for the approved indication of advanced RCC.
Side effects:Mild, persistent reactions common: proteinuria, thrombocytopenia, diarrhea, fatigue, stomatitis, hypertension, hair discoloration. Rare interstitial lung disease, severe liver function injury; severe anaphylaxis very rare.

Important Notice

This product shall only be used for post-exposure rabies prophylaxis by professional medical staff. It must be applied combined with rabies vaccine and injected via wound infiltration plus intramuscular routes as specified. Do not administer intravenously or alter the dosage at will. Hypersensitivity monitoring is required throughout the whole injection process.

Packaging & Shipping

Packaging

Original manufacturer’s packaging with secure export carton. Customized export packaging is available upon request.

Shipping Methods

Express Courier (EMS, DHL, FedEx, UPS), Air Freight, and Sea Freight. Cold-chain transportation is available for products requiring temperature-controlled logistics.

Export Support

Certificate of Analysis

GMP Certificate

Commercial Invoice

Packing List & CPP

Cold Chain Logistics

Customs Documentation

Scientific and regulatory sources

1.WHO References
2.NMPA
3.FDA
4.EMA

FAQ

What is vorolanib?

A new-generation targeted kinase inhibitor possessing strong preclinical activity against tumor angiogenesis and tumor proliferation

Can Vorolanib be taken alone for advanced RCC?

No, it must be used in combination with everolimus for the approved indication.

What type of drug is Vorolanib?

A Class 1 innovative small-molecule multi-target anti-angiogenic tyrosine kinase inhibitor.

How to adjust Vorolanib dose when combined with strong CYP3A4 inhibitors?

Reduce the daily dose of Vorolanib to 100mg.

FuMeiNa®Vorolanib Tablets | RCC | DengYueRX

INN: Vorolanib
Indications: RCC (Renal Cell Carcinoma)
Dosage Form: Film-coated Tablets
Strength: 100mg/tablet

Low MOQ

WHO-GMP

Worldwide Delivery

Compliance and Regulatory Documents

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