Description
Indication & Scope
Envonalkib Citrate Capsules proceeds the treatment of locally advanced or metastatic non-small cell lung cancer.
- Mechanism: Selective ALK tyrosine kinase inhibitor, blocks ATP binding site of ALK fusion oncoproteins, inhibits downstream RAS/MEK/ERK signaling to suppress tumor proliferation and induce apoptosis. Effective against multiple ALK resistance mutations.
- Drug class: ALK Tyrosine Kinase Inhibitor (TKI), oral targeted anti-cancer agent.
- Clinical use: First-line and second-line targeted therapy for ALK fusion-positive locally advanced/metastatic NSCLC.
| Generic Name | Envonalkib Citrate Capsules |
| Brand Name | AnLuoQing |
| Ingredient | Envonalkib Citrate Capsules |
| Dosage Form | Capsules |
| Package | 100mg*28 capsules/box |
| Conditions Treated | Locally advanced or metastatic non-small cell lung cancer with confirmed ALK gene fusion |
| Taboos | 1. Hypersensitivity to envonalkib citrate or capsule excipients
2. Uncontrolled severe QT interval prolongation 3. Severe hepatic or renal dysfunction 4. Pregnant women |
| Place of origin | China |
| Prescription type | Prescription-only |
| Storage Conditions | Sealed, light-proof and dry storage at 15°C to 30°C. |
| Manufacturer | ZhengDaTianQing Pharmaceutical Co., Ltd. |
| Registration Authority | National Medical Products Administration (NMPA), China |
| Approval number | H20240021; H20240022; H20240023 |
| Approval Date | Jun 11, 2024 |
| Shelf Life | 36 months |
How to use ?
Recommended Dose: 100 mg orally once daily. Dose reduction to 100 mg daily for grade 3 or higher adverse reactions.
Time: Taken at a fixed daily time, with or without food.
Instructions for use:
1. Confirm ALK fusion positivity via companion diagnostic testing before treatment initiation.
2. Swallow capsules whole, do not open or chew.
3. Regular ECG and liver function monitoring during treatment.
4. Skip missed doses if less than 12 hours remain until next scheduled dose.
Interaction:
1. Strong CYP3A4 inhibitors increase plasma concentration and toxicity risk.
2. Strong CYP3A4 inducers reduce therapeutic efficacy.
3. QT-prolonging concomitant medications increase arrhythmia risk.
Side effects:
1. Common: Fatigue, elevated liver enzymes, diarrhea, nausea, peripheral edema, myalgia.
2. Severe: Severe hepatotoxicity, interstitial lung disease, grade 3 QT prolongation, bradycardia.
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 type of cancer does Envonalkib Citrate Capsules target?
Locally advanced or metastatic non-small cell lung cancer with confirmed ALK gene fusion.
When should a missed dose be skipped when using Envonalkib Citrate Capsules?
Skip the missed dose if less than 12 hours remain until the next scheduled dose.
What serious risks require monitoring with Envonalkib Citrate Capsules?
Severe hepatotoxicity, interstitial lung disease, QT prolongation, and bradycardia.
What drugs interact with Envonalkib Citrate Capsules?
Strong CYP3A4 inhibitors, CYP3A4 inducers, and QT-prolonging medications.
AnLuoQing® | Envonalkib Citrate Capsules | NSCLC | DengYueRX
INN: Envonalkib Citrate Capsules
Indications: NSCLC
Dosage Form: Capsules
Strength: 100mg/capsule; 125mg/capsule; 150mg/capsule
