Advertisement
Advertisement
Lonsurf

Lonsurf

Manufacturer:

Taiho Pharma

Distributor:

DKLL
Concise Prescribing Info
Contents
Per 15 mg/6.14 mg FC tab Trifluridine 15 mg, tipiracil 6.14 mg. Per 20 mg/8.19 mg FC tab Trifluridine 20 mg, tipiracil 8.19 mg
Indications/Uses
Monotherapy in adults w/ metastatic CRC who have been previously treated w/, or not considered candidates for, therapies including fluoropyrimidine-, oxaliplatin- & irinotecan-based chemotherapies, anti-vascular endothelial growth factor (VEGF) agents, & anti-epidermal growth factor receptor (EGFR) agents. In combination w/ bevacizumab in adults w/ metastatic CRC who have received 2 prior anticancer treatment regimens including fluoropyrimidine-, oxaliplatin- & irinotecan-based chemotherapies, anti-VEGF agents, &/or anti-EGFR agents. Metastatic gastric or gastroesophageal junction adenocarcinoma previously treated w/ at least 2 prior lines of chemotherapy including fluoropyrimidine, platinum, either taxane or irinotecan, & if appropriate, human epidermal growth factor receptor 2 (HER-2)/neu-targeted therapy.
Dosage/Direction for Use
Adult Initially 35 mg/m2 bid on Days 1-5 & 8-12 of each 28-day cycle until disease progression or unacceptable toxicity. Max: Not to exceed 80 mg/dose. Patient w/ severe renal impairment (CrCl 15-29 mL/min) Initially 20 mg/m2 bid. 1 dose reduction to min dose of 15 mg/m2 bid.
Administration
Should be taken with food: Take w/in 1 hr after morning & evening meals.
Contraindications
Special Precautions
Not to start treatment if ANC is <1.5 x 109/L, platelet counts are <75 x 109/L, or w/ unresolved Grade 3 or 4 non-haematological clinically relevant toxicity from prior therapies. Increased incidence of myelopsuppression eg, anaemia, neutropenia, leukopenia & thrombocytopenia, GI toxicities. Closely monitor patient if serious infections occur; patient w/ nausea, vomiting, diarrhoea & other GI toxicities. Obtain complete blood cell counts prior to initiation of therapy. Monitor proteinuria prior to & during therapy. Black/African American patients. Not to be taken by patients w/ rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Has minor influence on the ability to drive & use machines. Not recommended in patients w/ ESRD (CrCl <15 mL/min or requiring dialysis); baseline moderate or severe hepatic impairment (total bilirubin >1.5x ULN). Not recommended in patients w/ moderate or severe renal impairment. Women of childbearing potential & men must use highly effective contraceptives during & for 6 mth after treatment. Not to be used during pregnancy. Discontinue during breast-feeding. Ped. Elderly >75 yr.
Adverse Reactions
Bone marrow suppression & GI toxicity. Neutropenia, fatigue, nausea, thrombocytopenia, anaemia; decreased appetite; diarrhoea; vomiting; stomatitis; leukopenia, lymphopenia; dysgeusia; dyspnoea; abdominal pain, constipation; hyperbilirubinaemia; alopecia, dry skin; decreased wt, increased hepatic enzyme. Monotherapy: Lower resp tract infection; febrile neutropenia; hypoalbuminaemia; pruritus, rash; proteinuria; pyrexia, mucosal inflammation, malaise, oedema; increased blood alkaline phosphatase. In combination: Infection; dizziness, headache; HTN; mouth ulceration, oral disorder; arthralgia, myalgia.
Drug Interactions
Increased conc w/ OCT2 or MATE1 inhibitors. Decreased efficacy of antivirals eg, zidovudine. Reduced effectiveness of hormonal contraceptives.
MIMS Class
Cytotoxic Chemotherapy
ATC Classification
L01BC59 - trifluridine, combinations ; Belongs to the class of antimetabolites, pyrimidine analogues. Used in the treatment of cancer.
Presentation/Packing
Form
Lonsurf 15 mg/6.14 mg FC tab
Packing/Price
2 × 10's
Form
Lonsurf 20 mg/8.19 mg FC tab
Packing/Price
2 × 10's
Advertisement
Advertisement
Advertisement
Advertisement
Advertisement
Advertisement
Advertisement