What important information does the Chinese version of Platinib contain?

Pralsetinib is a highly selective RET inhibitor that is widely used to treat patients with RET gene fusion-related non-small cell lung cancer (NSCLC) and thyroid cancer. As a new generation of targeted anti-cancer drugs, its Chinese version of the instructions provides detailed guidance on clinical use. The following are the most critical points in the instructions to help patients and doctors understand how to use the drug, safety warnings and precautions.

1. Description of indications

The instructions clearly state that Platinib is suitable for patients with non-small cell lung cancer (NSCLC) who have been confirmed to have RET gene fusion by testing, especially those who have locally advanced or metastasized and failed standard treatment.

It is also applicable to patients withRET mutation-positive medullary thyroid carcinoma (MTC) and partial RET fusion-related anaplastic thyroid carcinoma.

Molecular pathology testing must be used to confirm the diagnosis before useRET fusion or mutation status.

2. Recommended dosage and administration method

The recommended dose is 400mg per day, which is taken orally once a day and cannot be divided or increased. It must be taken on an empty stomach: no food for at least 2 hours before taking the medicine, and no food for at least 1 hour after taking the medicine to avoid food affecting the absorption of the medicine. Tablets should be swallowed whole and should not be broken, crushed or chewed. It is recommended to take it at a fixed time every day to maintain stable blood concentration in the body.

3. Treatment of missed doses and vomiting

If you miss a dose, you should take it as soon as possible on the same day; if it is close to the time of the next dose, do not take it twice, just skip it. If you accidentally vomit after taking the medicine, you should not take another dose, but continue taking the next dose according to the plan.

4. Treatment cycle and efficacy monitoring

Platinib therapy should be continued until disease progression or unacceptable toxicity occurs. It is recommended that patients re-examine their tumor status every 4-8 weeks to evaluate the efficacy of the drug. They also monitor liver function, blood and lung imaging to detect adverse reactions in a timely manner.

5. Tips on common adverse reactions

The instructions indicate that common side effects include high blood pressure, elevated liver enzymes, constipation, fatigue, and muscle pain.

Individual patients may develop symptoms of interstitial lung disease or pneumonia, and need to be alert to signs such as persistent cough and shortness of breath.

Liver function, blood pressure, thyroid function and white blood cell count should be checked regularly during treatment, and risks should be dynamically managed.

6. Contraindications and caution for use

It is contraindicated in those allergic to platinib or any of its components.

Pregnant and lactating women should avoid using it; women of childbearing age need to take highly effective contraceptive measures while taking the drug, and should continue to use it for several weeks after treatment.

Patients with abnormal liver and kidney function should adjust the dosage as appropriate or strengthen monitoring under the guidance of a doctor.

7. Drug Interaction Warning

Platinib is metabolized byCYP3A4 enzyme. The instructions emphasize to avoid co-use with strong CYP3A inhibitors or inducers, such as certain antibiotics, anti-epileptic drugs or foods containing grapefruit, to prevent affecting drug metabolism.

At the same time, it is necessary to evaluate whether the patient is taking anticoagulants, immunosuppressants and other drugs that may interact to avoid drug conflicts.

8. Storage conditions and validity period

It is recommended to store medicinesin a dry environment below 25°C and away from light.

Do not store medicines in hot and humid environments such as bathrooms or kitchens.

Keep medicines sealed and out of reach of children. Expired medicines must be properly disposed of in accordance with medical waste disposal regulations.

Reference: https://gavreto.com/