exkivity mobocertinib succinate capsule 40mg per bottle

Description

Indication & Scope

Mobocertinib Succinate Capsules (EXKIVITY, Anweili) is an oral targeted therapeutic agent for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations whose disease has progressed during or after platinum-based chemotherapy.

Mechanism
As an irreversible epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor specially designed for EGFR exon 20 insertion mutations, it features an innovative isopropyl ester structure to achieve high selectivity and affinity for mutant EGFR protein, irreversibly binding to and inhibiting EGFR kinase activity, thereby blocking downstream oncogenic signaling pathways to suppress tumor cell proliferation and induce tumor cell apoptosis.
Drug class
Class 1 small-molecule targeted anti-tumor drug, irreversible EGFR tyrosine kinase inhibitor, oral therapeutic agent for EGFR exon 20 insertion-mutant NSCLC.
Clinical use
Clinical studies have confirmed its reliable efficacy and controllable safety in platinum-pretreated NSCLC patients with EGFR exon 20 insertion mutations. It is orally administered at a daily dose of 160 mg, serving as the first approved oral targeted drug for this specific NSCLC patient population in China.

Specification

Generic Name	Mobocertinib Succinate Capsule
Brand Name	Exkivity®
Ingredient	Mobocertinib Succinate
Dosage Form	Capsule
Package	40mg × 112 capsules/ blister / carton
Conditions Treated	For adult patients with locally advanced or metastatic non-small cell lung cancer harboring EGFR exon 20 insertion mutations with disease progression after platinum-based chemotherapy
Taboos	Contraindicated for patients with hypersensitivity to mobocertinib succinate or any excipients contained in the preparation
Place of origin	Janpan
Priscription Type	Prescription drug (Rx)
Storage Conditions	Store below 25℃, keep away from moisture and direct sunlight
Manufacturer	Takeda Pharmaceutical Company Limited
Registration Authority	National Medical Products Administration (NMPA)
Approval number	J20230004
Date of Revision	January 10, 2023
Shelf Life	24 months

How to use ?

Recommended Dose: 160 mg orally once daily (4 capsules of 40 mg each), taken with or without food. Continue treatment until disease progression or unacceptable toxicity occurs.
Time: Take at approximately the same time every day; if a dose is missed by more than 6 hours, skip the missed dose and resume regular dosing the next day. Do not take double doses.
Interaction:CYP3A strong inhibitors or inducers shall be avoided during treatment, as they may alter mobocertinib exposure. Co-administration with P-gp substrates needs monitoring. Avoid grapefruit and grapefruit juice. Dose adjustment is required for concurrent QT-prolonging agents.
Side effects: Common: diarrhea, rash, stomatitis, fatigue, nausea. Rare severe risks: interstitial lung disease, QT prolongation, severe hypersensitivity.

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