Capecitabine Alvogen

Capecitabine Alvogen

capecitabine

Manufacturer:

Alvogen

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Capecitabine
Indications/Uses
Adjuvant treatment of patients following surgery of stage III (Dukes' stage C) colon cancer. Metastatic colorectal cancer. 1st-line treatment of advanced gastric cancer in combination w/ a platinum-based regimen. In combination w/ docetaxel for the treatment of 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.
Dosage/Direction for Use
Breast cancer Combination therapy: Initially capecitabine 1,250 mg/m2 bid (morning & evening), equiv to a total daily dose of 2,500 mg/m2, for 2 wk followed by a 1-wk rest period; given in 3-wk cycles. Docetaxel 75 mg/m2 as a 1-hr IV infusion administered on the 1st day of each 3-wk cycle. Patients should be premedicated prior to docetaxel administration. Monotherapy (disease-resistant to both paclitaxel & anthracycline-containing chemotherapy regimen or w/ disease resistant to paclitaxel who are not candidates for further anthracycline therapy): Initially capecitabine 1,250 mg/m2 bid (morning & evening), equiv to 2,500 mg/m2 total daily dose, for 2 wk followed by a 1-wk rest period; given in 3-wk cycles. Colorectal cancer Adjuvant therapy for colon cancer: 1,250 mg/m2 bid (morning & evening) for 2 wk followed by a 1-wk rest period; given in 3-wk cycles for a total of 8 cycles & a treatment period of 6 mth. 1st-line therapy for metastatic colorectal cancer: 1,250 mg/m2 bid (morning & evening), equiv to 2,500 mg/m2 total daily dose, for 2 wk followed by a 1-wk rest period; given in 3-wk cycles. Elderly >80 yr Reduce dose by up to 20%, ≥60 yr Reduce 25% of the initial dose (to 950 mg/m2). Moderate renal impairment Reduce dose 75% of the initial dose when used as monotherapy or in combination w/ docetaxel (eg, from 1,250 to 950 mg/m2 bid).
Administration
Should be taken with food: Take w/in 30 min after meals w/ water.
Contraindications
Hypersensitivity to capecitabine or fluorouracil. History of severe & unexpected reactions to fluoropyrimidine therapy. Patients w/ known dihydropyrimidine dehydrogenase (DPD) deficiency. Severe leucopenia, neutropenia, or thrombocytopenia; severe hepatic & renal impairment (CrCl <30 mL/min). Pregnancy & lactation.
Special Precautions
Monitor patients w/ severe diarrhoea; give fluid & electrolyte replacement if dehydrated. Interrupt treatment in case of dehydration, grade 2 or 3 hand-foot syndrome. History of CAD. Mild & moderate renal impairment. Mild to moderate hepatic dysfunction due to liver metastases. May affect ability to drive & use machines. Childn <18 yr. Elderly ≥80 yr.
Adverse Reactions
Nausea, vomiting. Hypotension, postural hypotension, supraventricular tachycardia syncope, venous phlebitis & thrombophlebitis; ataxia, polyneuropathy, migraine; ileus, necrotizing enterocolitis, esophageal ulcer, hemorrhagic diarrhea, taste loss; agranulocytosis, decreased prothrombin; abnormal liver function tests; hepatic coma, hepatic failure, hepatotoxic, jaundice; bronchopneumonia, hypersensitvity, neutropenic sepsis, renal failure, sepsis. Atrial fibrillation, bradycardis, CVA, extrasystoles, HTN, myocarditis, tachycardia, ventricular extrasystoles, pulmonary embolism, pericardial effusion; insomnia, confusion, depression, difficult walking, dysphasia, encephalopathy, irritability, tremor, abnormal coordination, dysarthria, loss of conciousness, impaired balance, sedation, vertigo; nail disorder, photosensitivity reaction, increased sweating, pruritus, radiation recall syndrome, skin ulceration; adominal distension, ascites, dysphagia, gastric ulcer, gastroenteritis, proctalgia, toxic dilation of dilation of intestine, ileus; leukopenia, bone marrow depression, coagulation disorder, lymphedema, pancytopenia, idiopathic thrombocytopenia purpura; cholestatic hepatitis, hepatic fibrosis, hepatitis; cachexia, increased wt, hypertriglyceridemia, edema, hypokalemia, hypomagnesemia; arthritis, bone pain, myalgia, muscle weakness; cough, epistaxis, hemoptysis, resp distress, asthma, bronchitis, pneumonia, dyspnea.
Drug Interactions
Increased rate & extent of absorption w/ Al & Mg hydroxide. Altered coagulation parameters &/or bleeding episodes w/ anticoagulants. Toxicity from increased serum phenytoin conc may occur w/ phenytoin. Potentiated antineoplastic activity of fluorouracil w/ leucovorin. Enhanced toxicity w/ folinic acid.
ATC Classification
L01BC06 - capecitabine ; Belongs to the class of antimetabolites, pyrimidine analogues. Used in the treatment of cancer.
Presentation/Packing
Form
Capecitabine Alvogen FC tab 500 mg
Packing/Price
120's
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