- Approval Id
- 70b99ccb4687fd25
- Drug Name
- LONSURF FILM-COATED TABLET 20MG/8.19MG
- Product Name
- LONSURF FILM-COATED TABLET 20MG/8.19MG
- Approval Number
- SIN15494P
- Approval Date
- 2018-05-24
- Registrant
- TAIHO PHARMA ASIA PACIFIC PTE. LTD.
- Licence Holder
- TAIHO PHARMA ASIA PACIFIC PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- TABLET, FILM COATED
- Dosage
- <p><strong>2 DOSAGE AND ADMINISTRATION</strong></p>
<p><strong>2.1 Recommended Dosage</strong></p>
<p>The recommended dosage of Lonsurf® as a single agent or in combination with bevacizumab is 35 mg/m<sup>2</sup> up to a maximum of 80 mg per dose (based on the trifluridine component) orally twice daily within one hour of completion of morning and evening meals on Days 1 through 5 and Days 8 through 12 of each 28-day cycle until disease progression or unacceptable toxicity. Round dose to the nearest 5 mg increment.</p>
<p>Refer to the Prescribing Information for bevacizumab dosing information.</p>
<p>Instruct patients to swallow Lonsurf® tablets whole.</p>
<p>Instruct patients not to retake doses of Lonsurf® that are vomited or missed and to continue with the next scheduled dose.</p>
<p>Table 1 shows the calculated initial daily dose based on body surface area (BSA).</p>
<img src="/TGIF/Lonsurf-Table1.png" alt="Lonsurf Dosage Table 1" /><br><br>
<p><strong>2.2 Dosage Modifications for Adverse Reactions</strong></p>
<p>Obtain complete blood cell counts prior to and on Day 15 of each cycle. <em>[see Warnings and Precautions (5.1)</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em><em>]</em></p>
<p>Do not initiate the cycle of Lonsurf® until:</p>
<ul>
<li>Absolute neutrophil count (ANC) is greater than or equal to 1,500/mm<sup>3</sup> or febrile neutropenia is resolved</li>
<li>Platelets are greater than or equal to 75,000/mm<sup>3</sup></li>
<li>Grade 3 or 4 non-hematological adverse reactions are resolved to Grade 0 or 1</li>
</ul>
<p>Within a treatment cycle, withhold Lonsurf® for any of the following:</p>
<ul>
<li>Absolute neutrophil count (ANC) less than 500/mm<sup>3</sup> or febrile neutropenia</li>
<li>Platelets less than 50,000/mm<sup>3</sup></li>
<li>Grade 3 or 4 non-hematological adverse reaction</li>
</ul>
<p>After recovery, resume Lonsurf® after reducing the dose by 5 mg/m<sup>2</sup>/dose from the previous dose, if the following occur:</p>
<ul>
<li>Febrile neutropenia</li>
<li>Uncomplicated Grade 4 neutropenia (which has recovered to greater than or equal to 1,500/mm<sup>3</sup>) or thrombocytopenia (which has recovered to greater than or equal to 75,000/mm<sup>3</sup>) that results in more than 1 week delay in start of next cycle</li>
<li>Non-hematologic Grade 3 or Grade 4 adverse reaction except for Grade 3 nausea and/or vomiting controlled by antiemetic therapy or Grade 3 diarrhea responsive to antidiarrheal medication</li>
</ul>
<p>A maximum of 3 dose reductions are permitted. Permanently discontinue Lonsurf® in patients who are unable to tolerate a dose of 20 mg/m<sup>2</sup> orally twice daily. Do not escalate Lonsurf® dosage after it has been reduced.</p>
<p>Refer to the bevacizumab prescribing information for dose modifications for adverse reactions associated with bevacizumab.</p>
<p><strong>2.3 Recommended Dosage for Renal Impairment</strong></p>
<p><u>Severe Renal Impairment</u></p>
<p>In patients with severe renal impairment [creatinine clearance (CLcr) of 15 to 29 mL/min as determined by the Cockcroft-Gault formula], the recommended dosage is 20 mg/m<sup>2</sup> (based on the trifluridine component) orally twice daily within one hour of completion of morning and evening meals on Days 1 through 5 and Days 8 through 12 of each 28-day cycle (Table 2). <em>[see Use in Specific Populations (7.7), Clinical Pharmacology (10.3)</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em><em>]</em> Reduce dose to 15 mg/m<sup>2</sup> twice daily in patients with severe renal impairment who are unable to tolerate a dose of 20 mg/m<sup>2</sup> twice daily (Table 2). Permanently discontinue Lonsurf® in patients who are unable to tolerate a dose of 15 mg/m<sup>2</sup> twice daily.</p>
<img src="/TGIF/Lonsurf-Table2.png" alt="Lonsurf Dosage Table 2" /><br><br>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>1 INDICATIONS AND USAGE</strong></p>
<p><strong>1.1 Metastatic Colorectal Cancer</strong></p>
<p>Lonsurf®, as a single agent or in combination with bevacizumab, is indicated for the treatment of adult patients with metastatic colorectal cancer who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy.</p>
<p><strong>1.2 Metastatic Gastric Cancer</strong></p>
<p>Lonsurf® is indicated for the treatment of adult patients with metastatic gastric or gastroesophageal junction adenocarcinoma who have been previously treated with at least two prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neutargeted therapy.</p>
- Contraindications
- <p><strong>4 CONTRAINDICATIONS</strong></p>
<p>None.</p>
- Atc Code
- L01BC59
- Atc Item Name
- trifluridine, combinations
- Pharma Manufacturer Name
- TAIHO PHARMA ASIA PACIFIC PTE. LTD.
