Capiibine

Capiibine

capecitabine

Manufacturer:

Dr. Reddy's

Distributor:

Zuellig Pharma

Marketer:

Dr. Reddy's
Concise Prescribing Info
Contents
Capecitabine
Indications/Uses
In combination w/ docetaxel for locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Monotherapy for locally advanced or metastatic breast cancer after failure of taxanes & an anthracycline-containing chemotherapy regimen or for whom further anthracycline therapy is not indicated. Adjuvant treatment of colon cancer. Metastatic colorectal cancer. 1st-line treatment of advanced oesophagogastric cancer.
Dosage/Direction for Use
Adult Colon, colorectal & breast cancer Monotherapy: Initially 1,250 mg/m2 administered bid (morning & evening) for 2 wk followed by 1 wk rest period. Total daily dose: 2,500 mg/m2. Breast cancer In combination w/ docetaxel: Initially capecitabine 1,250 mg/m2 bid for 2 wk followed by 1 wk rest period, combined w/ docetaxel 75 mg/m2 as 1 hr IV infusion every 3 wk. Colon, colorectal & oesophagogastric cancer Combination therapy: Initially capecitabine should be reduced to 800-1,000 mg/m2 when administered bid for 2 wk followed by 1 wk rest period or 625 mg/m2 bid when administered continuously. Duration for adjuvant treatment in stage III colon cancer: 6 mth. Elderly ≥60 yr In combination w/ docetaxel: Initially dose reduction of capecitabine to 75% (950 mg/m2 bid). Moderate renal impairment Dose reduction to 75% for an initial dose of 1,250 mg/m2.
Administration
Should be taken with food: Take w/in 30 min after meals.
Contraindications
Hypersensitivity to capecitabine or fluorouracil. Known dihydropyrimidine dehydrogenase (DPD) deficiency. Severe neutropenia. Concomitant use w/ folic acid. Severe hepatic & renal (CrCl <30 mL/min) impairment.
Special Precautions
Concomitant use w/ warfarin. Monitor prothrombin time & INR; CBC w/ differential, hepatic & renal function; stomatitis. Withhold treatment for grade 2-4 diarrhea subsequent doses should be reduced after grade 3 or 4 diarrhea on occurrence of grade 2 diarrhea. Adequately hydrate prior to treatment initiation especially for patients w/ diarrhea, nausea, vomiting, anorexia &/or weakness. Cardiotoxicity; history of CAD. Dihydropyrimidine dehydrogenase deficiency. Permanently discontinue if severe dermatologic or mucocutaneous reaction occurs. Hand-foot syndrome eg, palmar-plantar erythrodysesthesia or chemotherapy-induced acral erythema. Interrupt therapy if grade 3 or 4 hyperbilirubinemia occurs; until bilirubin is ≤3 x ULN. Bone marrow suppression. Patients w/ baseline platelets <100,000/mm3 &/or neutrophils <1,500/mm3 should not receive therapy, & withhold therapy for grade 3 or 4 hematologic toxicity during treatment. Concomitant use w/ fluorouracil/leucovorin & nephrotoxic agents. Patients w/ baseline renal dysfunction. Mild to moderate renal & hepatic impairment. Women of childbearing potential should use effective contraception. Pregnancy & lactation. Childn Elderly ≥60 yr. May diminish diagnostic effect of Coccidiodes immitis skin test.
Adverse Reactions
Edema; fatigue, pain, paresthesia; dermatitis, palmar-plantar erythrodysesthesia; abdominal pain, anorexia, constipation, decreased appetite, diarrhea, nausea, stomatitis, vomiting; anemia, lymphocytopenia, neutropenia, thrombocytopenia; hyperbilirubinemia (metastatic colorectal cancer); fever; weakness; eye irritation.
Drug Interactions
May diminish therapeutic effect of BCG, lenograstim, nivolumab, sipuleucel-T, live & inactivated vaccines. May increase serum conc of bosentan, cannabis, carvedilol, diclofenac, dronabinol, fosphenytoin, lacosamide, ospemifene, parecoxib, phenytoin, ramelteon, tetrahydrocannabinol, vit K antagonists (eg, warfarin). Increased serum conc w/ cimetidine, gimeracil, systemic metronidazole. May enhance adverse/toxic effect of clozapine, leflunomide, natalizumab; live vaccines. May decrease metabolism of CYP2C9 substrates. May enhance neutropenic effect of deferiprone. Enhanced adverse/toxic effect w/ denosumab, dipyrone, pimecrolimus, tacrolimus. May have diminished therapeutic effect w/ echinacea. May enhance immunosuppressive effect of fingolimod, tofacitinib. Enhanced immunosuppressive effect w/ roflumilast. Enhanced neutropenic effect w/ trastuzumab. Reduced rate & extent of absorption w/ food.
ATC Classification
L01BC06 - capecitabine ; Belongs to the class of antimetabolites, pyrimidine analogues. Used in the treatment of cancer.
Presentation/Packing
Form
Capiibine FC tab 500 mg
Packing/Price
12 × 10's
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