- Approval Id
- 09814cb40a91d320
- Drug Name
- LONSURF FILM-COATED TABLET 15MG/6.14MG
- Product Name
- LONSURF FILM-COATED TABLET 15MG/6.14MG
- Approval Number
- SIN15491P
- 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
- Dosage Form
- TABLET, FILM COATED
- Dosage
- **2 DOSAGE AND ADMINISTRATION**
**2.1 Recommended Dosage**
The recommended dosage of Lonsurf® is 35 mg/m2 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.
Instruct patients to swallow Lonsurf® tablets whole.
Instruct patients not to retake doses of Lonsurf® that are vomited or missed and to continue with the next scheduled dose.
Table 1 shows the calculated initial daily dose based on body surface area (BSA).
**2.2 Dosage Modifications for Adverse Reactions**
Obtain complete blood cell counts prior to and on Day 15 of each cycle. _\[see Warnings and Precautions (5.1)_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ _\]_
Do not initiate the cycle of Lonsurf® until:
- Absolute neutrophil count (ANC) is greater than or equal to 1,500/mm3 or febrile neutropenia is resolved
- Platelets are greater than or equal to 75,000/mm3
- Grade 3 or 4 non-hematological adverse reactions are resolved to Grade 0 or 1
Within a treatment cycle, withhold Lonsurf® for any of the following:
- Absolute neutrophil count (ANC) less than 500/mm3 or febrile neutropenia
- Platelets less than 50,000/mm3
- Grade 3 or 4 non-hematological adverse reaction
After recovery, resume Lonsurf® after reducing the dose by 5 mg/m2/dose from the previous dose, if the following occur:
- Febrile neutropenia
- Uncomplicated Grade 4 neutropenia (which has recovered to greater than or equal to 1,500/mm3) or thrombocytopenia (which has recovered to greater than or equal to 75,000/mm3) that results in more than 1 week delay in start of next cycle
- 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
A maximum of 3 dose reductions are permitted. Permanently discontinue Lonsurf® in patients who are unable to tolerate a dose of 20 mg/m2 orally twice daily. Do not escalate Lonsurf® dosage after it has been reduced.
**2.3 Recommended Dosage for Renal Impairment**
Severe Renal Impairment
In patients with severe renal impairment \[creatinine clearance (CLcr) of 15 to 29 mL/min as determined by the Cockcroft-Gault formula\], the recommended initial dosage is 20 mg/m2 (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). _\[see Use in Specific Populations (7.7), Clinical Pharmacology (10.3)_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ _\]_ Reduce dose to 15 mg/m2 twice daily in patients with severe renal impairment who are unable to tolerate a dose of 20 mg/m2 twice daily (Table 2). Permanently discontinue Lonsurf® in patients who are unable to tolerate a dose of 15 mg/m2 twice daily.
- Route Of Administration
- ORAL
- Indication Info
- **1 INDICATIONS AND USAGE**
**1.1 Metastatic Colorectal Cancer**
Lonsurf® 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.
**1.2 Metastatic Gastric Cancer**
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.
- Contraindications
- **4 CONTRAINDICATIONS**
None.
- Atc Code
- L01BC59
- Atc Item Name
- trifluridine, combinations
- Pharma Manufacturer Name
- TAIHO PHARMA ASIA PACIFIC PTE. LTD.
- Company Detail Path
- /organization/taiho-pharma-asia-pacific-pte-ltd
