Avutometinib / Defactinib 0.8mg / 200mg
Product Overview
| Generic Name | Avutometinib / Defactinib 0.8mg / 200mg |
| Brand Name(s) | Avmapki™ Fakzynja™ Co-Pack |
| Category | Antineoplastic / Cancer |
| Form | Co-packaged oral therapy: capsules + tablets |
| Strength | 0.8 mg capsule (avutometinib) + 200 mg tablet (defactinib) |
| Therapeutic Class | Antineoplastic combination; RAF/MEK inhibitor + FAK inhibitor |
| ATC Code | No ATC |
Manufacturing & Regulatory
| Manufacturer | Verastem, Inc. |
| GMP Compliance | WHO-GMP, EU-GMP |
| COFEPRIS | No confirmed COFEPRIS clave found |
| Free Sale Certificate | request CPP/FSC referencing the exact co-pack, NDC, strength, pack configuration |
Logistics & Export
| MOQ | 1 Bottle |
| Shelf Life | 36 Months |
| Storage | Refrigerated 2°C to 8°C in original bottles |
| Incoterms | EXW |
| Lead Time | 7 - 10 Business Days |
Documentation Available Upon Request
| Certificate of Analysis (PDF) | requested from Verastem or authorised specialty distributor |
| CTD Summary (PDF) | Full CTD/eCTD Modules 2–5 are proprietary and are not provided freely |
Special Notes
The Co-Pack is a co-packaged oral kinase-inhibitor regimen containing avutometinib and defactinib. Indicated for adult patients with KRAS-mutated recurrent low-grade serous ovarian cancer who have received prior systemic therapy