China's Anlotinib(盐酸安罗替尼胶囊):Pictures,Uses,Dosage,Side Effects,Warnings-SEAGULL HEALTH

Introduction of Anlotinib

Anlotinib is a domestically innovative Class 1.1 drug independently developed by Chia Tai-Tianqing Pharmaceutical Group. It was approved for marketing via the priority review and approval pathway of the National Medical Products Administration (NMPA) in May 2018, with its first indication being the third-line treatment of advanced or metastatic non-small cell lung cancer(NSCLC).

Indications

1.It is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer who have progressed or relapsed after receiving at least two prior lines of systemic chemotherapy. For patients with epidermal growth factor receptor (EGFR) gene mutation or anaplastic lymphoma kinase (ALK) positivity, treatment with this product should be initiated only after disease progression following corresponding standard targeted therapy and progression or relapse after at least two prior lines of systemic chemotherapy.

2.It is indicated for the treatment of patients with alveolar soft part sarcoma, clear cell sarcoma, and other advanced soft tissue sarcomas who have progressed or relapsed after receiving at least one prior anthracycline-containing chemotherapy regimen.

3.It is indicated for the treatment of patients with small cell lung cancer who have progressed or relapsed after receiving at least two prior lines of chemotherapy.

4.It is indicated for the treatment of patients with unresectable locally advanced or metastatic medullary thyroid carcinoma presenting with clinical symptoms or definite disease progression.

This indication was granted conditional approval based on the results of a phase IIB clinical trial involving 91 patients with advanced medullary thyroid carcinoma. Full approval of this indication is contingent upon confirmation of clinical benefit in this patient population by ongoing confirmatory trials.

5.It is indicated for patients with progressive, locally advanced or metastatic radioactive iodine-refractory differentiated thyroid carcinoma.

6.This product, in combination with bemosudab injection, carboplatin and etoposide, is indicated for the first-line treatment of patients with extensive-stage small cell lung cancer (ES-SCLC).

7.This product, in combination with bemosudab injection, is indicated for the treatment of patients with recurrent or metastatic endometrial carcinoma who are not microsatellite instability-high (non-MSI-H) or not deficient in mismatch repair (non-dMMR), have failed prior systemic anti-tumor therapy, and are ineligible for curative surgery or radical radiotherapy.

This indication was granted conditional approval based on surrogate endpoints, with clinical endpoint data not yet available. Its efficacy and safety are pending further confirmation post-marketing. Full approval of this indication is subject to verification of clinical benefit of bemosudab injection combined with anlotinib capsules through ongoing confirmatory randomized controlled clinical trials.

Overview

Generic Name

Anlotinib Hydrochloride Capsules,盐酸安罗替尼胶囊

Brand Name

福可维

Drug Type

Rx Drug,targeted drug

Approval No.

8mg:国药准字H20180002;10mg:国药准字H20180003;12mg:国药准字H20180004

Active Ingredient

Anlotinib Hydrochloride

Dosage Form

8mg*7capsules;10mg*7capsules;12mg*7capsules

Specification

Capsule preparation

Description

The contents are white or off-white powder or granules.

Expiry Date

36 months

Manufacturer

Jiangsu Chia Tai-Tianqing Pharmaceutical Group Co., Ltd.

Storage

Store in a light-resistant, tightly sealed container below 25℃.

Dosage and Administration

The recommended dose of anlotinib hydrochloride is 12 mg once daily, to be taken orally before breakfast. Treatment should be administered on a 2-week on/1-week off schedule, i.e., a 3-week (21-day) cycle. Continue treatment until disease progression or unacceptable adverse reactions occur. If a dose is missed during treatment and less than 12 hours remain before the next scheduled dose, the missed dose should not be supplemented.

Contraindications

This product is contraindicated in patients with hypersensitivity to any component of anlotinib, patients with central squamous cell lung carcinoma or at high risk of massive hemoptysis, patients with severe hepatic or renal insufficiency, as well as pregnant and lactating women.