PHOSIMER 80 Drug name: PHOSIMER 80 Generic name: Osimertinib Mesylate Tablets/Osimertinib/AZD-9291/

The following is the general instructions for Osimertinib, which is for reference only. Please refer to the instructions in the drug packaging for specific use and follow the doctor's instructions.

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Drug Name

Generic Name: Osimertinib
Product Name: OSIMAKS80

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Indications

Osimertinib is a targeted drug that is indicated for the following conditions:

1. EGFR mutation-positive non-small cell lung cancer (NSCLC) :
   • For the treatment of patients with locally advanced or metastatic non-small cell lung cancer carrying the epidermal growth factor receptor (EGFR) T790M mutation, especially those who have become resistant to EGFR tyrosine kinase inhibitor (TKI) treatment.
2. First-line treatment of EGFR mutation-positive non-small cell lung cancer :
   • For use in patients with locally advanced or metastatic non-small cell lung cancer with EGFR exon 19 deletion or exon 21 L858R mutation.

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Mechanism of action

Osimertinib is an irreversible EGFR tyrosine kinase inhibitor that selectively inhibits the activation of EGFR, especially the T790M mutant EGFR, inhibits the growth and proliferation of tumor cells, thereby delaying the progression of non-small cell lung cancer.

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Dosage

• Recommended dose :
  • Take orally once a day, 80 mg each time.
• Directions :
  • May be taken with or without food. Tablets should be swallowed whole and should not be crushed, chewed or split.

Dosage adjustments :

• If serious adverse reactions occur (such as rash, diarrhea, or lung reactions), your doctor may stop treatment or reduce the dose.

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Precautions

1. Side Effect Monitoring :
   • Common side effects : rash, diarrhea, dry cough, fatigue, decreased appetite, nausea, shortness of breath, etc.
   • Serious side effects : pneumonia, interstitial lung disease, QT interval prolongation, heart problems, severe skin reactions, etc.
2. Use in special populations :
   • Pregnant and lactating women : Do not use, may cause serious harm to the fetus or infant.
   • Children : Safety and effectiveness have not been established.
   • Elderly : Need to be closely monitored based on the patient's overall health.
3. Other notes :
   • Chest imaging studies are performed periodically during treatment to monitor lung health.
   • Monitor ECG periodically to detect QT prolongation.
   • If you experience severe breathing difficulties or coughing during treatment, you should seek medical attention immediately.

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Drug interactions

• CYP3A4 inhibitors : Drugs such as ketoconazole and erythromycin may increase the blood concentration of osimertinib. When used together, the dose of osimertinib may need to be adjusted.
• CYP3A4 inducers : such as rifampicin and St. John's wort, may reduce the blood concentration of osimertinib and should be avoided or the dose should be adjusted.

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Contraindications

• Patients who are allergic to osimertinib or its excipients are contraindicated.
• It is contraindicated for pregnant or lactating women.

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Storage conditions

• Store in a dry environment at 20°C to 25°C, away from heat, humidity and direct sunlight.
• Keep this medicine out of the reach of children.

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Important Tips

• The use of osimertinib should be carried out under the guidance of a physician with experience in treating non-small cell lung cancer.
• Imaging assessments, particularly chest CT scans, should be performed regularly during treatment to monitor lung health.
• If symptoms such as shortness of breath, dry cough or fever occur, seek medical attention immediately and stop treatment.

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Note : For more detailed information or special case medication regimens, please consult your doctor or pharmacist. If you have any other questions, please let me know!