Full text of Erlotinib/Tarceva drug instructions

1. Common name: Erlotinib,Erlotinib

Product name: Tarceva, Tarceva

Other names: Erlotinib

2. Who can take erlotinib? Indications?

1. Non-small cell lung cancer (NSCLC):

Erlotinib (Erlotinib) is suitable for the treatment of patients with metastatic non-small cell lung cancer (NSCLC). Tumor harboring epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 (L858R) substitution mutation, as detected by an FDA-approved test, receiving first-line, maintenance, or second-line or more second-line therapy after progression on at least one prior chemotherapy regimen.

Restrictions on Use: The safety and efficacy of erlotinib in patients with NSCLC whose tumors have otherEGFR mutations has not been established. The combination of erlotinib and platinum-based chemotherapy is not recommended.

2. Pancreatic cancer

Erlotinib combined with gemcitabine is indicated for first-line treatment of patients with locally advanced, unresectable or metastatic cancer.

3. What are the side effects of erlotinib?

The most common side effects of erlotinib as monotherapy for lung cancer are rash, diarrhea, loss of appetite, and fatigue. In studies of erlotinib in combination with gemcitabine to treat pancreatic cancer, the most common side effects were fatigue, rash, and diarrhea.

4. How should you take erlotinib?

1. Selection of patients with metastatic non-small cell lung cancer: based on whether it is present in tumors or plasma samplesPatients with EGFR exon 19 deletions or exon 21 (L858R) substitution mutations are candidates for TARCEVA for the treatment of metastatic NSCLC [see Clinical Studies (14.1, 14.2)]. If these mutations are not detected in the plasma sample, test the tumor tissue (if available).

2. Recommended dosage

1) Non-small cell lung cancer: The recommended daily dose of erlotinib is 150 mg, taken on an empty stomach, that is, at least one hour before or two hours after eating. Treatment should be continued until disease progression or unacceptable toxicity occurs.

2) Pancreatic cancer: The recommended daily dose of erlotinib is 100 mg once daily, taken in combination with gemcitabine. Take erlotinib on an empty stomach, that is, at least one hour before or two hours after eating. Treatment should be continued until disease progression or unacceptable toxicity occurs.

5. How to store erlotinib?

Erlotinib tablets may be stored at 25°C (77°F); excursions are permitted within the temperature range of 15°C to 30°C (59°F to 86°F).

6. How does erlotinib work?

Epidermal growth factor receptor (EGFR) is expressed on the cell surface of normal and cancer cells. In some tumor cells, signaling through this receptor plays an important role in tumor cell survival and proliferation regardless of EGFR mutation status. Erlotinib reversibly inhibits the kinase activity of EGFR and prevents autophosphorylation of receptor-associated tyrosine residues, thereby inhibiting further downstream signaling. The binding affinity of erlotinib to EGFR exon 19 deletions or exon 21 (L858R) mutations is higher than its affinity to the wild-type receptor. The inhibitory effect of erlotinib on other tyrosine kinase receptors has not been fully established.

7. What will happen if you overdose?

Discontinue erlotinib and initiate symptomatic treatment in patients who have overdosed or are suspected of overdose.

Reference materials:https://en.wikipedia.org/wiki/Erlotinib