Formulari Ubat KKM (FUKKM)

# Generic Name MDC Category Indications Pres. Restrictions Dosage
1 Osimertinib 40mg Tablet L01XE35-000-T32-01-XXX A* 1. The treatment of adult patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC whose disease has progressed on or after EGFR TKI therapy

2. As monotherapy for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations.		 Indication 1:
Second-line therapy, in patients who progressed from first-line EGFR TKI therapy.
To be prescribed by oncologists and oncology-trained respiratory physicians

Indication 2:
To be prescribed by Oncologist and Consultant Respiratory Physician only.		 80 mg once a day until disease progression or unacceptable toxicity, taken with or without food at the same time each day.
If dose reduction is necessary, then the dose should be reduced to 40 mg taken once daily.
2 Osimertinib 80mg Tablet L01XE35-000-T32-02-XXX A* 1. The treatment of adult patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC whose disease has progressed on or after EGFR TKI therapy

2. As monotherapy for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations.		 Indication 1:
Second-line therapy, in patients who progressed from first-line EGFR TKI therapy.
To be prescribed by oncologists and oncology-trained respiratory physicians

Indication 2:
To be prescribed by Oncologist and Consultant Respiratory Physician only.		 80 mg once a day until disease progression or unacceptable toxicity, taken with or without food at the same time each day.
If dose reduction is necessary, then the dose should be reduced to 40 mg taken once daily.