Caxeta

Caxeta

capecitabine

Manufacturer:

Sun Pharma

Distributor:

DKLL

Marketer:

Ranbaxy
Concise Prescribing Info
Contents
Capecitabine
Indications/Uses
Metastatic CRC. 1st-line treatment for patients w/ advanced oesophagogastric cancer. Monotherapy or in combination w/ docetaxel for patients w/ locally advanced or metastatic breast cancer after failure of taxane & anthracycline-containing chemotherapy regimen or for whom further anthracycline therapy is not indicated. Adjuvant treatment for colon cancer. In combination w/ oxaliplatin as adjuvant treatment for patients following complete resection of stage II & III adenocarcinoma.
Dosage/Direction for Use
Monotherapy: Colon & breast cancer, CRC Initially 1,250 mg/m2 bid (morning & evening, equiv to 2,500 mg/m2 total daily dose) for 2 wk followed by 7-day rest period. Combination therapy: Breast cancer In combination w/ docetaxel: Start premed prior to docetaxel administration. Initially 1,250 mg/m2 bid for 2 wk followed by 7-day rest period + docetaxel 75 mg/m2 as 1-hr IV infusion every 3 wk. Colon, gastric & oesophagogastric cancer, CRC In combination treatment (except w/ irinotecan): Initially 800-1,000 mg/m2 bid for 2 wk followed by 7-day rest period, or 625 mg/m2 bid when administered continuously. In combination w/ irinotecan: Initially 800 mg/m2 bid for 2 wk followed by 7-day rest period + irinotecan 200 mg/m2 on day 1 of each 3 wk cycle. Adjuvant treatment: Patients w/ stage III colon cancer Recommended: 6 mth. Start premed prior to cisplatin or oxaliplatin combination.
Administration
Should be taken with food: Swallow whole w/ water w/in 30 min after a meal, do not crush/cut. For patients w/ difficulty swallowing, crushing/cutting of tab should be done by a trained professional.
Contraindications
Hypersensitivity to capecitabine & fluorouracil; history of severe & unexpected reactions to fluoropyrimidine therapy. Patients w/ known complete absence of dihydropyrimidine dehydrogenase (DPD) activity. Concomitant administration w/ sorivudine or its chemically related analogues eg, brivudine. Severe renal impairment (CrCl <30 mL/min).
Special Precautions
Discontinue treatment immediately in the event of grade 2-4 acute toxicity in patients w/ unrecognised DPD deficiency & patients who test -ve for specific DPYD variations; if ≥grade 2 dehydration occurs. Interrupt administration if grade 2 or 3 hand-foot syndrome; treatment-related bilirubin elevations of >3x ULN or hepatic aminotransferases (ALT, AST) elevations of >2.5x ULN occur. Not to be used in patients w/ certain homozygous or compound heterozygous mutations in DPYD gene locus causing complete or near complete absence of DPD activity. Patients w/ severe diarrhea; anorexia, asthenia, nausea, vomiting or diarrhea; complete absence of DPD activity; partial DPD deficiency; prior history of CAD. Carefully monitor patients w/ severe diarrhea; for toxicity. Closely monitor INR or prothrombin time in patients receiving oral coumarin-derivative anticoagulant therapy. Regularly monitor for increased phenytoin plasma conc in patients taking phenytoin. Cardiotoxicity eg, MI, angina, dysrhythmias, cardiac arrest/failure & electrocardiographic changes. Concomitant administration w/ known nephrotoxic agents. Co-administration w/ drugs metabolized by cytochrome P450 2C9 eg, warfarin or phenytoin. May affect ability to drive & use machines. Moderate renal impairment. Mild to moderate hepatic impairment. Not to be used during pregnancy. Discontinue lactation during treatment & for 2 wk after final dose. Childn & adolescent (<18 yr). Elderly.
Adverse Reactions
Paraesthesia, dysgeusia, headache; increased lacrimation; constipation, dyspepsia; alopecia; pyrexia, weakness, asthenia. Monotherapy: Anorexia; diarrhea, vomiting, nausea, stomatitis (mucosal inflammation/ulceration, mouth ulceration), abdominal pain; palmar-plantar erythrodysaesthesia syndrome, dermatitis; fatigue, lethargy. Dehydration, appetite disorder; dizziness (excluding vertigo); conjunctivitis; upper abdominal pain; hyperbilirubinemia; rash, erythema, dry skin. Combination therapy: Neutropenia, leukopenia, febrile neutropenia, thrombocytopenia, anaemia; decreased appetite; peripheral neuropathy/sensory neuropathy, neuropathy, paraesthesia, dysaesthesia; thrombosis/embolism, HTN, lower limb oedema; pharynx dysaesthesia, sore throat; nail disorder; arthralgia, myalgia, pain in extremity; temp intolerance. Infection, oral candidiasis; hypokalaemia, decreased wt; insomnia; hypoaesthesia; epistaxis, dysphonia, rhinorrhoea, dyspnoea; dry mouth; jaw & back pain; fever, pain.
Drug Interactions
Altered coagulation parameters &/or bleeding w/ coumarin-derivative anticoagulants eg, warfarin & phenprocoumon. Increased phenytoin plasma conc. Slight increased plasma conc & metabolite (5'-DFCR) w/ Al- & Mg- hydroxide. Enhanced toxicity by leucovorin. Increased fluoropyrimidine toxicity w/ sorivudine or its chemically related analogues eg, brivudine.
MIMS Class
Cytotoxic Chemotherapy
ATC Classification
L01BC06 - capecitabine ; Belongs to the class of antimetabolites, pyrimidine analogues. Used in the treatment of cancer.
Presentation/Packing
Form
Caxeta FC tab 500 mg
Packing/Price
12 × 10's
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