What important information is included in the instructions for Platinib/Pujihua?

Pralsetinib (Pralsetinib) is a targeted drug targeting RET gene mutations. It is specially used to treat cancers caused by RET fusion positivity, especially in patients with metastatic non-small cell lung cancer (NSCLC) and metastatic thyroid cancer (TC). Its targeting effect makes it an important option in cancer treatment targeting specific genetic mutations.

1. Indications

1. MetastaticRET fusion-positive non-small cell lung cancer (NSCLC): Platinib is suitable for the treatment of adult patients with metastaticRET fusion-positive non-small cell lung cancer. RET gene fusion is a common driver gene mutation that is closely related to the growth and spread of cancer cells. Platinib helps inhibit the growth and spread of tumors by targeting and inhibiting the RET protein. Therefore, platinib provides an effective targeted treatment option for NSCLC patients with RET mutations.

2. RET fusion-positive thyroid cancer (TC): Platinib is also suitable for the treatment of adult and pediatric patients withRET fusion-positive thyroid cancer, especially those with advanced or metastatic disease that are refractory to radioactive iodine therapy. It is also indicated for patients 12 years and older with advanced or metastatic RET-mutated medullary thyroid cancer (MTC). These patients require systemic therapy, and platinib provides them with a new treatment option.

2. Usage and dosage

The recommended dose of Platinib is400 mg once daily, which must be taken on an empty stomach. Patients should not eat at least 2 hours before or 1 hour after taking this medication. This dosing arrangement ensures optimal absorption and effectiveness of the medication, thereby improving treatment effectiveness.

For those patients selected for platinib treatment due toRET gene fusion, treatment should be continued until disease progression or unacceptable toxicity occurs. Platinib is a highly effective targeted drug that can precisely act on tumor cells, but it needs to be monitored based on patient tolerance and toxicity.

3. Adverse reactions

Although Platinib is a targeted therapy, it may also cause some side effects. Common adverse reactions include, but are not limited to, fatigue, nausea, decreased appetite, headache, and abnormal liver function. Most side effects are mild and can be alleviated by adjusting drug dosage or adjunctive treatment.

Some patients may experience more serious side effects, such as lung problems (such as pneumonia) and hematological abnormalities (such as anemia or a decrease in white blood cells). Therefore, during the treatment process, patients need to regularly check liver function, blood routine and other indicators to detect potential problems in a timely manner.

4. Storage conditions

Platinib should be stored at room temperature, away from direct sunlight and moisture. Medications should be stored out of the reach of children to ensure their safety and effectiveness.

5. Contraindications

Platinib is contraindicated in combination with certain drugs, especially drugs related toCYP3A4. Before using platinib, patients should inform their doctor about all medications they are taking to avoid drug interactions. At the same time, platinib may interact with certain antiviral and antifungal drugs, so it must be used with caution.

6. Mechanism of action

Platinib is a RET inhibitor that inhibits the growth and spread of cancer cells mainly by inhibiting the abnormal protein produced by RET gene fusion. RET gene mutations play an important role in certain types of cancer. Platinib targets this mutation to reduce the proliferation of tumor cells and achieve therapeutic effects. Unlike traditional chemotherapy, Platinib is a targeted drug that can act on cancer cells more accurately and reduce damage to normal cells.

Keyword tags: pralsetinib,Pralsetinib, RET gene fusion, targeted therapy, non-small cell lung cancer, thyroid cancer, treatment regimen, drug dosage, side effects

Reference materials:https://www.bccancer.bc.ca/drug-database-site/Drug%20Index/Pralsetinib_monograph.pdf