Description
Indication & Scope
Vebreltinib Enteric selectively inhibits the activity of mutated ALK tyrosine kinase. It suppresses downstream signal transduction pathways that drive lung cancer cell growth, blocks tumor cell proliferation and triggers cancer cell apoptosis.
- Mechanism: It is a CD19-targeted CAR-T therapy, guiding autologous T cells to eliminate CD19-positive tumor cells.
- Drug class: Anaplastic Lymphoma Kinase (ALK) tyrosine kinase inhibitor, targeted oral anti-tumor agent.
- Clinical use:First-line treatment for untreated ALK-positive advanced NSCLC; Second-line treatment for patients whose disease progressed after prior crizotinib therapy.
| Generic Name | Vebreltinib Enteric Capsules (also known as bozitinib) |
| Brand Name | WanBiRui |
| Ingredient | Vebreltinib Enteric Capsules (also known as bozitinib) |
| Dosage Form | capsules |
| Package | 100mg*60 capsules/package |
| Conditions Treated | It is indicated for adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC). |
| Taboos | 1. Patients with severe hypersensitivity to brigatinib or any excipients contained in this product are prohibited from taking this medicine.
2.Patients with severe hepatic insufficiency and uncontrolled severe hypertension are not recommended to receive this drug. 3.Pregnant women are forbidden to use it, as the medicine may cause developmental toxicity to the fetus. 4.Patients with a medical history of interstitial lung disease or pneumonitis must avoid administration to prevent further lung damage. |
| Place of origin | China |
| Prescription type | Prescription-only |
| Storage Conditions | Store at room temperature below 25°C, in a dry place, protected from light and moisture. Keep the container tightly closed to prevent ingress of humidity. |
| Manufacturer | PuRuAo Biotechnology, Ltd |
| Registration Authority | National Medical Products Administration (NMPA), China |
| Approval number | H20230027 |
| Date of Revision | 2023 |
| Shelf Life | 6 months |
How to use ?
Recommended Dose: The recommended initial dose is 200 mg taken orally twice daily (morning and evening respectively). Treatment shall be continued until disease progression or intolerable toxicity appears. Dose adjustment should be conducted by physicians according to individual patient tolerance.
Time: Take the medicine at roughly the same time every day. It must be administered on an empty stomach: no food is allowed for at least 2 hours before dosing and 0.5 hours after dosing, while water intake is permitted during this period.
Instructions for use: Swallow the capsules whole; do not chew or crush them. Do not make up for a missed dose. If vomiting occurs after taking the drug, skip the supplementary dose and take the next scheduled dose as usual. This medicine should only be used under the guidance of doctors with oncology treatment experience, and confirmed MET exon 14 skipping mutation positivity is required before treatment initiation.
Interaction:
1. Strong CYP3A inhibitors will increase the systemic exposure of vebreltinib, so co-administration is not recommended; if unavoidable, dose reduction is needed.
2. Strong CYP3A inducers can reduce the drug’s plasma concentration, so concomitant use is forbidden.
3. Drugs that elevate gastric pH may impair the absorption of enteric-coated capsules, so they should not be taken together within the fasting period for this product.
4. Inform your doctor of all concurrent medications, supplements and herbal products to avoid potential drug-drug interactions.
Side effects:
1. Common Adverse Reactions: Peripheral edema, fatigue, liver enzyme elevation, nausea, lipase/amylase increase, rash, thrombocytopenia, QT interval prolongation.
2. Severe Rare Reactions: Severe liver injury, serious pulmonary inflammation, remarkable platelet drop, clinically significant QT prolongation.
Important Notice
This product should be administered only by qualified healthcare professionals in accordance with the approved prescribing information and local clinical guidelines. Dosage and administration may vary depending on patient condition, indicatiaon, and regional regulatory requirements.
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
FAQ
What is Vebreltinib Enteric used to treat?
It is an oral targeted anticancer drug for adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer.
What is Vebreltinib Enteric's mechanism of action?
Brigatinib works as a selective ALK inhibitor. It blocks abnormal ALK protein activity, inhibits cancer cell proliferation and induces tumor cell apoptosis.
How should patients take Vebreltinib enteric capsule?
Take orally once daily at a fixed time, with or without food. The capsules must be swallowed whole and cannot be crushed or chewed.
How long does the whole treatment last?
Treatment continues long-term until disease progression, unbearable toxic side effects, or patient discontinuation. There is no fixed limited treatment cycle.
WanBiRui® | Vebreltinib Enteric Capsule | Local Advanced or Metastatic Non-small Cell Lung Cancer with MET Exon 14 Skipping | DengYueRX
INN: Vebreltinib Enteric Capsules (also known as bozitinib)
Indications: Anaplastic lymphoma kinase (ALK) or non-small cell lung cancer (NSCLC)
Dosage Form: Capsules
Strength: 100mg/capsule
