Capecitabine Teva

Capecitabine Teva

capecitabine

Manufacturer:

Remedica

Distributor:

DKLL

Marketer:

Teva 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. Patients w/ locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy in combination w/ docetaxel; previous therapy should have included an anthracycline. As monotherapy in patients w/ 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
Monotherapy: Adjuvant treatment of colon cancer, treatment of metastatic colorectal cancer or of locally advanced or metastatic cancer Initially 1,250 mg/m2 bid (morning & evening) for 14 days followed by a 7-day rest period. Adjuvant treatment in patients w/ stage III colon cancer Duration of treatment: 6 mth. Combination therapy: Colon, colorectal & gastric cancer Recommended starting dose: Reduced to 800-1,000 mg/m2 bid for 14 days followed by a 7-day rest period, or to 625 mg/m2 bid when administered continuously. In combination w/ irinotecan: 800 mg/m2 capecitabine bid for 14 days followed by a 7-day rest period combined w/ irinotecan 200 mg/m2 on Day 1. Adjuvant treatment w/ stage III colon cancer Duration: 6 mth. Breast cancer Initially 1,250 mg/m2 bid for 14 days followed by a 7-day rest period combined w/ 75 mg/m2 docetaxel as a 1-hr IV infusion every 3 wk. Pre-medication w/ an oral corticosteroids eg, dexamethasone should be started prior to docetaxel. Elderly ≥60 yr In combination w/ docetaxel: Starting dose reduction of 75% (950 mg/m2 bid).
Administration
Should be taken with food: Take w/in 30 min after meals.
Contraindications
Hypersensitivity to capecitabine or fluorouracil. History of severe & unexpected reactions to fluoropyrimidine therapy. Patients w/ known complete absence of dihydropyrimidine dehydrogenase activity. Severe leukopenia, neutropenia or thrombocytopenia. Severe hepatic & renal impairment (CrCl <30 mL/min). Treatment w/ sorivudine or its chemically related analogues eg, brivudine. Contraindications in combination regimen. Pregnancy & lactation.
Special Precautions
Carefully monitor patients w/ severe diarrhoea & administer fluid & electrolyte replacement upon dehydration. Interrupt treatment if grade ≥2 dehydration, grade 2 or 3 hand-foot syndrome, treatment-related elevations in bilirubin of >3 x ULN or in hepatic aminotransferases (ALT, AST) of >2.5 x ULN  occur. Hand & foot syndrome. Patients w/ a prior history of CAD, significant cardiac disease, arrhythmias & angina pectoris. Preexisting hypo- or hypercalcaemia. Patients w/ central or peripheral nervous system disease eg, brain metastasis or neuropathy; DM or electrolyte disturbances; low or absent dihyropyrimidine dehydrogenase activity. Closely monitor INR or prothrombin time in patients receiving oral coumarin-derivative anticoagulant therapy during therapy. Discontinue treatment if grade 2-4 acute toxicity & severe skin reaction occur. Carefully monitor in patients w/ mild to moderate liver dysfunction; for ophthalmological complications eg, keratitis & corneal disorders. Moderate renal impairment. May cause minor or moderate influence on ability to drive & use machines. Women of childbearing potential should use effective contraception method during treatment.
Adverse Reactions
Monotherapy: Anorexia; diarrhoea, vomiting, nausea, stomatitis, abdominal pain; palmar-plantar erythrodysaesthesia syndrome; fatigue, asthenia. Herpes viral infection, nasopharyngitis, lower resp tract infection; neutropenia, anaemia; dehydration, decreased wt; insomnia, depression; headache, lethargy, dizziness, paraesthesia, dysgeusia; increased lacrimation, conjunctivitis, eye irritation; thrombophlebitis; dyspnoea, epistaxis, cough, rhinorrhoea; GI haemorrhage, constipation, upper abdominal pain, dyspepsia, flatulence, dry mouth; hyperbilirubinemia, liver function test abnormalities; rash, alopecia, erythema, dry skin, pruritis, skin hyperpigmentation, macular rash, skin desquamation, dermatitis, pigmentation disorder, nail disorder; pain in extremity, back pain, arthralgia; pyrexia, peripheral oedema, malaise, chest pain. Combination therapy: Neutropenia, leucopenia, anaemia, neutropenic fever, thrombocytopenia; decreased appetite; paraesthesia, dysaesthesia, peripheral neuropathy, peripheral sensory neuropathy, dysgeusia, headache; increased lacrimation; lower limb oedema, HTN, embolism & thrombosis; sore throat, dysaesthesia pharynx; constipation, dyspepsia; alopecia, nail disorder; myalgia, arthralgia, pain in extremity; pyrexia, weakness, lethargy, temp intolerance. Herpes zoster, UTI, oral candidiasis, upper resp tract infection, rhinitis, influenza, infection, oral herpes; bone marrow depression, febrile neutropenia; hypersensitivity; hypokalaemia, hyponatraemia, hypomagnesaemia, hypocalcaemia, hyperglycaemia; sleep disorder, anxiety; neurotoxicity, tremor, neuralgia; hypersensitivity reaction, hypoaesthesia; visual disorders, dry eye, eye pain, visual impairment, blurred vision; tinnitus, hypoacusis; atrial fibrillation, cardiac ischaemia/infarction; flushing, hypotension, hypertensive crisis, hot flush phlebitis; hiccups, pharyngolaryngeal pain, dysphonia; upper GI haemorrhage, mouth ulceration, gastritis, abdominal distension, GERD, oral pain, dysphagia, rectal haemorrhage, lower abdominal pain, oral dysaesthesia, oral paraesthesia, oral hypoaesthesia, abdominal discomfort, abnormal hepatic function; hyperhidrosis, erythematous rash, urticaria, night sweats; pain in jaw, muscle spasms, trismus, muscular weakness; haematuria, proteinuria, decreased creatinine renal clearance, dysuria; mucosal inflammation, pain in limb, pain, chills, chest pain, influenza-like illness, fever, infusion-related reaction & pain, inj site reaction & pain; contusion.
Drug Interactions
Increase plasma conc of phenytoin; CYP2C9 substrates. May alter coagulation parameters &/or bleeding w/ coumarin-derivative anticoagulants eg, warfarin & phenprocoumon. Inhibition of dihydropyrimidine dehydrogenase may occur w/ sorivudine & analogues eg, brivudine. Allopurinol. May enhance toxicity w/ folinic acid. Increased plasma conc w/ Al- & Mg hydroxide antacid.
ATC Classification
L01BC06 - capecitabine ; Belongs to the class of antimetabolites, pyrimidine analogues. Used in the treatment of cancer.
Presentation/Packing
Form
Capecitabine Teva FC tab 500 mg
Packing/Price
12 × 10's
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