Apatinib Application Scope

Apatinib is indicated for the treatment of advanced or metastatic solid tumors, with specific regulatory approvals and clinical use focused on:

Advanced gastric adenocarcinoma or gastroesophageal junction adenocarcinoma in patients who have progressed after at least two prior systemic chemotherapy regimens (primary approved indication in China).
Additional approved or guideline-recommended uses in China (varying by label updates and national reimbursement/clinical guideline decisions) include selected indications in hepatocellular carcinoma (HCC) and combinations with checkpoint inhibitors or other agents for HCC and selected breast cancer settings—see national product information for country-specific approvals.

aitan apatinib

Apatinib Characteristics

Ingredients: Apatinib
Properties: Small-molecule oral tyrosine kinase inhibitor
Packaging Specification: Available in strengths of 0.25g, 0.375g, and 0.425g
Storage: Store protected from light, in a sealed container; store below 25°C
Expiry Date: Typical shelf life: 24 months
Executive Standard: National Medical Products Administration (NMPA) standard YBH03692014
Approval Number: Chinese approval numbers (examples from the product monograph): National Drug Approval Nos. H20140105, H20140104, H20140103
Date of Revision: See the latest version of the product leaflet filing for the date of revision
Manufacturer: Jiangsu Hengrui Medicine Co., Ltd.

Guidelines for the Use of Apatinib

Dosage and Administration:
- Recommended Dose:
  - Advanced gastric/gastroesophageal junction adenocarcinoma (monotherapy): 500 mg orally once daily.
  - Selected hepatocellular carcinoma regimens: different dosing regimens have been used (e.g., 750 mg daily for certain HCC monotherapy registrations; 250 mg daily when combined with a PD-1 inhibitor in specific first-line HCC combination regimens)—follow the approved local indication and label for exact dosing.
- Administration: The tablet should be taken orally, half an hour after a meal, with warm water. It is advised to take the medication at approximately the same time every day.
- Missed Dose: If a dose is missed, do not make it up. Simply take the next scheduled dose at the regular time.
Adverse Reactions:
- Common Adverse Reactions: Common reactions (occurring in ≥5% of patients) include.
- Serious Adverse Reactions:
  - Severe bleeding (e.g., gastrointestinal bleeding, hemoptysis).
  - Gastrointestinal perforation.
  - Hypertensive crisis.
  - Nephrotic syndrome.
Contraindications: Contraindications listed in the local product label should be followed. Typical contraindications include known hypersensitivity to apatinib or any excipient in the formulation. Use in pregnancy is contraindicated unless the potential benefit outweighs risk; effective contraception is advised for patients of reproductive potential. Check the most recent local label for full contraindication list.
Precautions:
- Monitor blood pressure regularly, treat hypertension per local guidelines, and consider dose modification for severe or uncontrolled hypertension.
- Monitor urine protein (urinalysis) prior to and during therapy; consider discontinuation or dose reduction for significant proteinuria.
- Monitor blood counts and liver function tests regularly; manage cytopenias and hepatic dysfunction per label.
- Use caution in patients with history of bleeding, recent major surgery, or non-healing wounds.
- Avoid pregnancy; advise contraception. Breastfeeding should be discontinued during treatment.

Apatinib Interactions

Apatinib is metabolized in part by CYP enzymes (CYP3A4 involvement reported); co-administration with strong CYP3A4 inhibitors or inducers may alter apatinib exposure—adjust therapy or monitor closely.
Concomitant use of agents that increase bleeding risk or uncontrolled hypertension requires careful assessment.
Refer to local label for a full interaction list and dose-adjustment recommendations.

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
This content is for reference only. Prescription drugs must be used under a doctor’s guidance and purchased from authorized sources.