- Approval Id
- 89526b6eb894ecc4
- Drug Name
- TANSTRIVE HARD CAPSULES 80MG
- Product Name
- TANSTRIVE HARD CAPSULES 80MG
- Approval Number
- SIN16991P
- Approval Date
- 2024-04-24
- Registrant
- DKSH SINGAPORE PTE. LTD.
- Licence Holder
- DKSH SINGAPORE PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- CAPSULE
- Dosage
- <p><strong>2 DOSAGE AND ADMINISTRATION</strong></p>
<p><strong>2.1 Patient Selection</strong></p>
<p>Select patients for treatment with TANSTRIVE based on the presence of a <em>RET</em> gene fusion (NSCLC or thyroid cancer) or specific <em>RET</em> gene mutation (MTC) in tumor specimens <em>[see Clinical Studies (14)</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em><em>]</em>.</p>
<p><strong>2.2 Important Administration Instructions</strong></p>
<p>TANSTRIVE may be taken with or without food unless coadministered with a proton pump inhibitor (PPI) <em>[see Dosage and Administration (2.4), Clinical Pharmacology (12.3)</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em><em>]</em>.</p>
<p><strong>2.3 Recommended Dosage</strong></p>
<p>The recommended dosage of TANSTRIVE based on body weight is:</p>
<ul>
<li><p>Less than 50 kg: 120 mg</p></li>
<li><p>50 kg or greater: 160 mg</p></li>
</ul>
<p>Take TANSTRIVE orally twice daily (approximately every 12 hours) until disease progression or unacceptable toxicity. Swallow the capsules whole. Do not crush or chew the capsules.</p>
<p>Do not take a missed dose if it is less than 6 hours until next scheduled dose.</p>
<p>If vomiting occurs after TANSTRIVE administration, do not take an additional dose and continue to the next scheduled time for the next dose.</p>
<p><strong>2.4 Dosage Modifications for Concomitant Use of Acid-Reducing Agents</strong></p>
<p>Avoid concomitant use of a PPI, a histamine-2 (H2) receptor antagonist, or a locally-acting antacid with TANSTRIVE <em>[see Drug Interactions (7.1)</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em><em>]</em>. If concomitant use cannot be avoided:</p>
<ul>
<li><p>Take TANSTRIVE with food when coadministered with a PPI.</p></li>
<li><p>Take TANSTRIVE 2 hours before or 10 hours after administration of an H2 receptor antagonist.</p></li>
<li><p>Take TANSTRIVE 2 hours before or 2 hours after administration of a locally-acting antacid.</p></li>
</ul>
<p><strong>2.5 Dosage Modifications for Adverse Reactions</strong></p>
<p>The recommended dose reductions for adverse reactions are provided in Table 1.</p>
<img src="/TGIF/Tanstrive-Table1.png" alt="Tanstrive Dosage Table 1" /><br><br>
<p>Permanently discontinue TANSTRIVE in patients unable to tolerate three dose reductions. The recommended dosage modifications for adverse reactions are provided in Table 2.</p>
<img src="/TGIF/Tanstrive-Table2.png" alt="Tanstrive Dosage Table 2" /><br><br>
<p><strong>2.6 Dosage Modifications for Concomitant Use of Strong and Moderate CYP3A Inhibitors</strong></p>
<p>Avoid concomitant use of strong and moderate CYP3A inhibitors with TANSTRIVE. If concomitant use of a strong or moderate CYP3A inhibitor cannot be avoided, reduce the TANSTRIVE dose as recommended in Table 3. After the inhibitor has been discontinued for 3 to 5 elimination half-lives, resume TANSTRIVE at the dose taken prior to initiating the CYP3A inhibitor <em>[see Drug Interactions (7.1)</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em><em>]</em>.</p>
<img src="/TGIF/Tanstrive-Table3.png" alt="Tanstrive Dosage Table 3" /><br><br>
<p><strong>2.7 Dosage Modification for Severe Hepatic Impairment</strong></p>
<p>Reduce the recommended dosage of TANSTRIVE for patients with severe hepatic impairment as recommended in Table 4 <em>[see Use in Specific Populations (8.7)</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em><em>]</em>.</p>
<img src="/TGIF/Tanstrive-Table4.png" alt="Tanstrive Dosage Table 4" /><br><br>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>1 INDICATIONS AND USAGE</strong></p>
<p><strong>1.1 <em>RET</em> Fusion-Positive Non-Small Cell Lung Cancer</strong></p>
<p>TANSTRIVE is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a <em>rearranged during transfection (RET)</em> gene fusion.</p>
<p><strong>1.2 <em>RET</em>-Mutant Medullary Thyroid Cancer</strong></p>
<p>TANSTRIVE is indicated for the treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic medullary thyroid cancer (MTC) with a <em>RET</em> mutation who require systemic therapy.</p>
<p><strong>1.3 <em>RET</em> Fusion-Positive Thyroid Cancer</strong></p>
<p>TANSTRIVE is indicated for the treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic thyroid cancer with a <em>RET</em> gene fusion who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).</p>
- Contraindications
- <p><strong>4 CONTRAINDICATIONS</strong></p>
<p>None.</p>
- Atc Code
- L01EX22
- Atc Item Name
- selpercatinib
- Pharma Manufacturer Name
- DKSH SINGAPORE PTE. LTD.
