Description
Indication & Scope
Rezivertinib Mesylate Capsule helps with treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC).
- Mechanism: Selective epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor. It inhibits mutant EGFR kinase activity, blocks RAS/RAF downstream signaling pathway, suppresses proliferation of EGFR-mutant NSCLC cells and triggers tumor cell death.
- Drug class: EGFR Tyrosine Kinase Inhibitor (TKI), oral targeted anti-lung cancer antineoplastic drug.
- Clinical use: Targeted therapy for EGFR-mutant locally advanced or metastatic NSCLC for first-line and post-progression treatment.
| Generic Name | Rezivertinib Mesylate Capsules |
| Brand Name | RuiBiDa |
| Ingredient | Rezivertinib Mesylate Capsules |
| Dosage Form | Capsules |
| Package | 30mg*30 capsules/box |
| Conditions Treated | Locally advanced or metastatic non-small cell lung cancer |
| Taboos | 1. Hypersensitivity to rezivertinib mesylate or capsule excipients
2. Severe interstitial lung disease at baseline 3. Uncontrolled severe ocular keratitis 4. Pregnant and breastfeeding women |
| Place of origin | China |
| Prescription type | Prescription-only |
| Storage Conditions | Light-proof, sealed and dry storage at temperature below 25°C. |
| Manufacturer | BeiErDa Pharmaceutical, Ltd |
| Registration Authority | National Medical Products Administration (NMPA), China |
| Approval number | H20240017 |
| Date of Revision | 2024 |
| Shelf Life | 24 months |
How to use ?
Recommended Dose: Standard dose: 200 mg orally once daily; dose reduction is implemented for grade 3 and above adverse reactions.
Time: Take at a fixed time every day after meals to reduce gastrointestinal irritation.
Instructions for use:
1. Confirm EGFR gene mutation status via companion diagnostic test before medication.
2. Swallow capsules whole with water; do not break or chew.
3. Monitor for interstitial lung disease symptoms, diarrhea and skin toxicity regularly.
4. Discontinue permanently for confirmed severe interstitial lung disease.
Interaction:
1. Strong CYP3A4 inhibitors increase systemic drug exposure and adverse reaction risks.
2. Strong CYP3A4 inducers reduce therapeutic efficacy.
3. Concomitant anti-diarrheal agents can manage EGFR-TKI related diarrhea.
Side effects:
1. Common: Diarrhea, rash, paronychia, dry skin, elevated liver enzymes, stomatitis
2. Severe: Interstitial lung disease, severe hepatotoxicity, grade 4 cutaneous toxicity, ocular keratitis
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 the molecular target of Rezivertinib Mesylate, and what is its primary indication?
It is an irreversible epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) indicated for locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR mutations (exon 19 deletion, L858R, or T790M).
What patient populations can benefit from Rezivertinib, based on its indication?
It is approved as first-line treatment for patients with common EGFR mutations and for those with T790M-positive disease who have progressed on prior EGFR TKI therapy.
What is the typical route of administration and daily dosing of Rezivertinib Mesylate?
It is taken orally once daily, with doses adjusted based on patient response and adverse reactions.
What key safety monitoring is required during treatment with Rezivertinib?
Patients require monitoring for common EGFR TKI toxicities, including interstitial lung disease, hepatotoxicity, and diarrhea, as well as dose-limiting adverse events.
RuiBiDa® | Rezivertinib Mesylate Capsules | Locally Advanced or Metastatic Non-small Cell Lung Cancer | DengYueRX
INN: Rezivertinib Mesylate Capsules
Indications: Treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC).
Dosage Form: Capsules
Strength: 30mg/capsule
