- Approval Id
- 26f2fe5230728a8d
- Drug Name
- TABRECTA FILM-COATED TABLET 200MG
- Product Name
- TABRECTA FILM-COATED TABLET 200MG
- Approval Number
- SIN16351P
- Approval Date
- 2021-10-22
- Registrant
- NOVARTIS (SINGAPORE) PTE LTD
- Licence Holder
- NOVARTIS (SINGAPORE) PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- TABLET, FILM COATED
- Dosage
- <p><strong>4 Dosage regimen and administration</strong></p>
<p><strong>Patient selection</strong></p>
<p>Patients should be selected for treatment with Tabrecta based on the presence of a MET exon 14 skipping mutation in tumor or plasma specimens using a validated test. If a MET exon 14 skipping mutation is not detected in a plasma specimen, tumor tissue should be tested if feasible.</p>
<p><strong>Dosage regimen</strong></p>
<p><strong>General target population</strong></p>
<p>The recommended dose of Tabrecta is 400 mg orally twice daily with or without food (see section 11 Clinical pharmacology – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><strong>Treatment duration</strong></p>
<p>Treatment should be continued based on individual safety and tolerability and as long as the patient is deriving clinical benefit from therapy.</p>
<p><strong>Dose modifications for adverse drug reactions</strong></p>
<p>The recommended dose reduction schedule for the management of adverse drug reactions (ADRs) based on individual safety and tolerability is listed in Table 4-1.</p>
<img src="/TGIF/Tabrecta-Table4-1.png" alt="Tabrecta Dosage Table 4-1" /><br><br>
<p>Tabrecta should be permanently discontinued in patients unable to tolerate 200 mg orally twice daily.</p>
<p>Recommendations for dose modifications of Tabrecta for ADRs are provided in Table 4-2.</p>
<img src="/TGIF/Tabrecta-Table4-2.png" alt="Tabrecta Dosage Table 4-2" /><br><br>
<p><strong>Special populations</strong></p>
<p><strong>Renal impairment</strong></p>
<p>No dose adjustment is necessary in patients with mild or moderate renal impairment based on population pharmacokinetic evaluations; Tabrecta has not been studied in patients with severe renal impairment (see section 11 Clinical pharmacology – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><strong>Hepatic impairment</strong></p>
<p>No dose adjustment is necessary in patients with mild, moderate, or severe hepatic impairment (see section 11 Clinical pharmacology – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><strong>Pediatric patients (below 18 years of age)</strong></p>
<p>The safety and efficacy of Tabrecta in pediatric patients have not been established.</p>
<p><strong>Geriatric patients (65 years of age or older)</strong></p>
<p>No dose adjustment is necessary in patients 65 years of age or older.</p>
<p><strong>Method of administration</strong></p>
<p>Tabrecta should be taken orally twice daily with or without food. The tablets should be swallowed whole and should not be broken, chewed, or crushed.</p>
<p>If a dose of Tabrecta is missed or vomiting occurs, the patient should not make up the dose, but take the next dose at the scheduled time.</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>3 Indications</strong></p>
<p>Tabrecta is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with a MET exon 14 skipping mutation.</p>
- Contraindications
- <p><strong>5 Contraindications</strong></p>
<p>None.</p>
- Atc Code
- pending
- Atc Item Name
- xpending
- Pharma Manufacturer Name
- NOVARTIS (SINGAPORE) PTE LTD
