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Sancitabin

Sancitabin

capecitabine

Manufacturer:

Sanbe

Marketer:

Sanbe
Full Prescribing Info
Contents
Capecitabine.
Description
Peach film coated tablet of biconvex, oblong shape with marking "500" on one side and "RDY" on other side.
Each film-coated tablet contains: Capecitabine 500 mg.
Excipients/Inactive Ingredients: Croscarmellose Sodium, Microcrystalline Cellulose, Hydroxypropyl Methyl Cellulose, Lactose Anhydrous, Magnesium Stearate, Coating Material (Colouring agents contains of Hypromellose, Titanium Dioxide, Talc, Red Iron Oxide Non-IRR, and Yellow Iron Oxide Non-IRR), Purified Water.
Action
Pharmacology: Capecitabine is a non-cytotoxic Fluoropyrimidine Carbamate, which functions as an orally administered precursor of the cytotoxic moiety 5-Fluorouracil (5-FU). Capecitabine is activated via several enzymatic steps. The enzyme involved in the final conversion to 5-FU, Thymidine Phosphorylase (ThyPase), is found in tumour tissues, but also in normal tissues albeit usually at lower levels. Capecitabine demonstrated a synergistic effect in combination with Docetaxel, which may be related to the up-regulation of Thymidine Phosphorylase by Docetaxel.
The metabolism of 5-FU in the anabolic pathway blocks the methylation reaction of deoxyuridylic acid to thymidylic acid, thereby interfering with the synthesis of deoxyribonucleic acid (DNA). The incorporation of 5-FU also leads to inhibition of RNA and protein synthesis. Since DNA and RNA are essential for cell division and growth, the effect of 5-FU may be to create a Thymidine deficiency that provokes unbalanced growth and death of a cell. The effects of DNA and RNA deprivation are most marked on those cells which proliferate more rapidly and which metabolism 5-FU at a more rapid rate.
Indications/Uses
SANCITABIN is indicated for: Adjuvant treatment of patients following surgery of stage III (Dukes' stage C) colon cancer.
Metastatic colorectal cancer.
First-line treatment of advanced gastric cancer in combination with a platinum based regimen.
In combination with Docetaxel for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an Anthracycline.
As monotherapy for the treatment of patients with locally advanced or metastatic breast cancer after failure of Taxane and an Anthracycline-containing chemotherapy regimen or for whom further Anthracycline therapy is not indicated.
Dosage/Direction for Use
SANCITABIN should only be prescribed by qualified physician experienced in the utilization of antineoplastic agents. SANCITABIN tablets should be swallowed with water within 30 minutes after a meal. Treatment should be discontinued if progressive disease or intolerable toxicity is observed. Standard and reduced dose calculations according to body surface area for starting doses of SANCITABIN of 1250 mg/m2 and 1000 mg/m2 are provided in Tables 1 and 2, respectively.
Monotherapy: Colon and Colorectal Cancer: The recommended dose of SANCITABIN in the adjuvant treatment of colon cancer or in the treatment of metastatic colorectal cancer is 1250 mg/m2 administered twice daily (morning and evening; equivalent to 2500 mg/m2 total daily dose) for 14 days followed by a 7-day rest period.
Adjuvant treatment in patients with stage III colon cancer is recommended for a total of 6 months, SANCITABIN 1250 mg/m2 administered twice daily for 14 days followed by a 7-day rest period, given as 3-week cycles for a total of 8 cycles (24 weeks).
Breast Cancer: Given as a monotherapy, the recommended dose of SANCITABIN in the treatment of locally advanced or metastatic breast cancer is 1250 mg/m2 twice daily for 14 days followed by a 7-day rest period.
Combination Therapy: Breast Cancer: In combination with Docetaxel, the recommended dose of SANCITABIN in the treatment of metastatic breast cancer is 1250 mg/m2 twice daily for 14 days followed by a 7-day rest period, combined with Docetaxel at 75 mg/m2 as a 1 hour intravenous infusion every 3 weeks. Premedication with an oral corticosteroid such as Dexamethasone according to the Docetaxel summary of product characteristics should be started prior to Docetaxel administration for patients receiving the SANCITABIN plus Docetaxel combination.
Advanced Gastric Cancer: In combination with a platinum-based compound the recommended dose of SANCITABIN for the treatment of advanced gastric cancer is 1000 mg/m2 administered twice daily for 14 days followed by a 7-day rest period. The first dose of SANCITABIN should be given on the evening of day 1 and the last dose should be given on the morning of day 15.
Premedication to maintain adequate hydration and anti-emesis according to the Cisplatin summary of product characteristics should be started prior to Cisplatin administration for patients receiving the SANCITABIN plus Cisplatin combination. (See Tables 1 and 2.)


Click on icon to see table/diagram/image




Click on icon to see table/diagram/image


Patients with Renal Impairment: SANCITABIN is contraindicated in patients with severe renal impairment (creatinine clearance below 30 mL/min). In patients with moderate renal impairment (creatinine clearance 30-50 mL/min) at baseline, a dose reduction to 75% for a starting dose of 1250 mg/m2 is recommended and no required dose reduction for a starting dose of 1000 mg/m2. In patents with mild renal impairment (creatinine clearance 51-80 mL/min) no recommended adjustment of the starting dose. These dose adjustment recommendations for renal impairment apply both to monotherapy and combination use.
Children: There is no experience in children (under 18 years).
Elderly Patients: For SANCITABIN monotherapy, no needed adjustment of the starting doses. Careful monitoring of patients ≥60 years of age is advisable.
For patients 60 years of age or more treated with the combination of SANCITABIN plus Docetaxel, a starting dose reduction of SANCITABIN to 75% (950 mg/m2 twice daily) is recommended. If no toxicity is observed in patients ≥60 years of age treated with a reduced SANCITABIN starting dose in combination with Docetaxel, the dose of SANCITABIN may be cautiously escalated to 1250 mg/m2 twice daily.
Toxicity: Toxicity due to SANCITABIN administration may be managed by symptomatic treatment and/or modification of the SANCITABIN dose (treatment interruption or dose reduction). Once the dose has been reduced it should not be increased at a later time. Patients taking SANCITABIN should be informed of the need to interrupt treatment immediately if moderate or worse toxicity occurs. Doses of SANCITABIN omitted for toxicity are not replaced or restored, instead the patient should resume the planned treatment cycle. The following are recommended dose modifications: (See Table 3.)


Click on icon to see table/diagram/image


Dose modifications for toxicity when SANCITABIN is used as a 3 weekly cycle in combination with other agents: SANCITABIN should be used according to Table 3 as previously mentioned and according to the appropriate of product characteristics for the other agent.
At the beginning of a treatment cycle, if a treatment delay is indicated for either SANCITABIN or the other agent, then administration of both agents should be delayed until requirement for restarting both drugs are met.
During treatment cycle for those toxicities considered by the treating physician not to be related SANCITABIN (for example, neurotoxicity or ototoxicity), then SANCITABIN should be continued and the other agent should be discontinued according to the appropriate Prescribing Information.
If the other agent(s) have to be discontinued permanently, SANCITABIN treatment can be resumed when the requirements for restarting SANCITABIN are met. This advice is applicable to all indications and to all special populations.
For those toxicities considered by the treating physician to be unlikely to become serious or life-threatening, e.g. alopecia, altered taste, nail changes, treatment can be continued at the same dose without reduction or interruption.
Dose modification for toxicity when SANCITABIN is used continuously in combination with other agents: SANCITABIN should be used according to Table 3 as previously mentioned and according to the appropriate of product characteristics for the other agent.
Haematology: SANCITABIN treatment may continue throughout a grade 3 neutropenic episode. However, the patient should be closely monitored and administration of SANCITABIN should be interrupted if any grade 2 clinical event (e.g. diarrhoea, stomatitis, fever) coincides with the grade 3 neutropenic episode. If grade 4 neutropenia occurs treatment with SANCITABIN should be interrupted until recovery to grade 0-1. Treatment should only be readministered when the neutrophil count is ≥1.5x109/L (grade 0-1).
Patients with baseline neutrophil counts of ≤1.5x109/L and/or thrombocyte counts of <100x109/L should not be treated with SANCITABIN.
If the neutrophil count drops below 1.0x109/L or if the platelet count drops below 75x109/L, stop SANCITABIN. At recovery, restart SANCITABIN at full dose.
Dehydration: Dehydration should be prevented or corrected at the onset. Patients with anorexia, asthenia, nausea, vomiting or diarrhoea may rapidly become dehydrated. If Grade 2 (or higher) dehydration occurs, SANCITABIN treatment should be immediately interrupted and the dehydration corrected. Treatment should not be restarted until the patient is rehydrated and any precipitating causes have been corrected or controlled. Dose modifications applied should be those for the precipitating adverse event in accordance with the previously mentioned guidelines.
Overdosage
The manifestations of acute overdose include nausea, vomiting, diarrhea, mucositis, gastrointestinal irritation and bleeding, and bone marrow depression. Medical management of overdose should include customary therapeutic and supportive medical interventions aimed at correcting the presenting clinical manifestations and preventing their possible complications.
Contraindications
Capecitabine is contraindicated in the following patients: Patients with known hypersensitivity to Capecitabine or any of its components.
Patients who have severe renal impairment (Creatinine clearance below 30 ml/min).
Patients with known complete absence of dihydropyrimidine dehydrogenase (DPD) activity.
Patients who concomitantly taking medicine containing Sorivudine or its chemically related analogues such as Brivudine.
Patients who have a history of severe and unexpected reactions to Fluoropyrimidine therapy or with known hypersensitivity to Fluorouracil.
Patient with severe leucopenia, neutropenia, or thrombocytopenia.
During pregnancy and lactation.
Patient with severe hepatic impairment.
If contraindications exist to any of the agents in a combination regimen, that agent should not be used.
Warnings
Dose limiting toxicities include diarrhea, abdominal pain, nausea, stomatitis and hand-foot syndrome (hand-foot skin reaction, palmar-plantar erythrodysesthesia). Most adverse reactions are reversible and do not require permanent discontinuation of therapy, although doses may need to be with held or reduced.
Diarrhea: Capecitabine can induce diarrhea. Patient with severe diarrhea should be carefully monitored and if they become dehydrated, should be given fluid and electrolyte replacement.
Dehydration: dehydration should be prevented or corrected at the onset. Patients with anorexia, asthenia, nausea, vomiting or diarrhea may rapidly become dehydrated.
Dehydration may cause acute renal failure, especially in patients with pre-existing compromised renal function or when Capecitabine is given concomitantly with known nephrotoxic agents.
If grade 2 (or higher) dehydration occur, Capecitabine treatment should be immediately interrupted and the dehydration corrected. Treatment should not be restarted until the patient is rehydrated and any precipitating causes have been corrected or controlled. Dose modification should be applied for the precipitating adverse event as necessary.
Dihydropyrimidine dehydrogenase (DPD) deficiency: rarely, unexpected, severe toxicity (e.g. stomatitis, diarrhea, mucosal inflammation, neutropenia and neurotoxicity) associated with 5-FU has been attributed to a deficiency of DPD activity. Patients with low or absent DPD activity, an enzyme involved in fluorouracil degradation, are at increased risk for severe, life-threatening, or fatal adverse reactions caused by fluorouracil. Patients with certain homozygous or certain compound heterozygous mutations in the DPYD gene locus that cause complete or near complete absence of DPD activity, have the highest risk of life-threatening or fatal toxicity and should not be treated with Capecitabine. No doses has been proven safe for patients with complete absence of DPD activity.
For patients with partial DPD deficiency where the benefits of Capecitabine are considered to outweigh the risks (taking into account the suitability of an alternative non-fluoropyrimidine chemotherapeutic regimen), these patients must be treated with extreme caution, initially with a substantial dose reduction and frequent subsequent monitoring and dose adjustment according to toxicity.
In patients with unrecognised DPD deficiency treated with Capecitabine, life-threatening toxicities manifesting as acute overdose may occur. In the event of grade 2-4 acute toxicity, treatment must be discontinued immediately. Permanent discontinuation should be considered based on clinical assessment of the onset, duration and severity of the observed toxicities.
Special Precautions
Cardiotoxicity: cardiotoxicity has been associated with fluoropyrimidine therapy, including myocardial infarction, angina, dysrhythmias, cardiogenic shock, sudden death and electrocardiographic changes. These adverse reactions may be more common in patients with a prior history of coronary artery disease. Cardiac arrhythmias, angina pectoris, myocardial infarction, heart failure and cardiomyopathy have been reported in patients receiving Capecitabine. Caution must be exercised in patients with history of significant cardiac disease, arrhythmias and angina pectoris.
Capecitabine can induce severe skin reactions such as Stevens-Johnson syndrome and Toxic Epidermal Necrolysis (TEN). Capecitabine should be permanently discontinued in patients who experience a severe skin reaction possibly attributable to Capecitabine treatment.
Capecitabine can induce hand-foot syndrome (also known as hand-foot skin reaction palmar-plantar erythrodysesthesia or chemotherapy-induced acral erythema), which is a cutaneous toxicity. Persistent or severe hand-foot syndrome (grade 2 and above) can eventually lead to loss of fingerprints, which could impact patient identification. If grade 2 or 3 hand-foot syndrome occurs, administration of Capecitabine should be interrupted until the event resolves or decreases in intensity to grade 1. Following grade 3 hand-foot syndrome, subsequent doses of Capecitabine should be decreased. When Capecitabine and Cisplatin are used in combination, use of vitamin B6 (pyridoxine) is not advised for the symptomatic or secondary prophylactic treatment of hand-foot syndrome, because of published reports that it may decreases the efficacy of Cisplatin. There is some evidence that dexpanthenol is effective for hand-foot syndrome prophylaxis in patients treated with Capecitabine.
Hepatic impairment: Capecitabine can induce hyperbilirubinemia. In the absence of safety and efficacy data in patients with hepatic impairment, Capecitabine use should be carefully monitored in patients with mild to moderate liver dysfunction, regardless of the presence or absence of liver metastasis. Administration of Capecitabine should be interrupted if treatment-related elevations in bilirubin of >3.0 x ULN or treatment-related elevations in hepatic aminotransferases (ALT, AST) of 2.5 x ULN occur. Treatment with Capecitabine monotherapy may be resumed when bilirubin decreases to ≤3.0 x ULN or hepatic aminotransferases decreases to ≤2.5 x ULN. For combination treatment with Capecitabine and Docetaxel, see also Dosage & Administration.
Patients with hepatic impairment should be carefully monitored when Capecitabine is administered. The effect of hepatic impairment not due to liver metastases or severe hepatic impairment on the disposition of Capecitabine is not known.
Patient with hypo- or hypercalcemia.
Patient with central or peripheral nervous system disease.
Patient with diabetes mellitus or electrolyte disturbances.
Coumarin-derivative anticoagulant: Patient receiving concomitant Capecitabine and oral coumarin-derivative anticoagulant therapy should have their anticoagulant response (INR or prothrombin time) monitored closely and the anticoagulant dose adjusted accordingly.
Patient with renal impairment (creatinine clearance 30-50 mL/min).
As this medicinal product contains anhydrous lactose as an excipient, patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Ability to drive and use machine: Capecitabine has minor or moderate influence on the ability to drive and use machines. Capecitabine may cause dizziness, fatigue and nausea.
Use In Pregnancy & Lactation
Pregnancy: Pregnancy category D: Capecitabine should be considered a potential human teratogen. Capecitabine should not be used during pregnancy. If Capecitabine is used during pregnancy, or if the patient becomes pregnant while receiving this drug, the patient must be apprised of the potential hazard to the fetus. Women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment with Capecitabine.
Nursing mothers: Nursing should be discontinued during Capecitabine treatment.
Adverse Reactions
Capecitabine monotherapy: Infections and infestations: Herpes simplex, nasopharyngitis, lower respiratory tract infection, sepsis, urinary tract infection, cellulitis, tonsilitis, pharyngitis, oral candidiasis, influenza, gastroenteritis, fungal infection, herpes infection, tooth abscess.
Neoplasm benign, malignant and unspecified: Lipoma.
Blood and lymphatic system disorders: neutropenia, anaemia, febrile neutropenia, pancytopenia, granulocytopenia, thrombocytopenia, leucopenia, haemolytic anaemia.
Immune system disorders: Hypersensitivity.
Metabolism and nutrition disorders: Anorexia, dehydration, decreased appetite, diabetes, hypokalaemia, appetite disorder, malnutrition, hypertriglyceridaemia.
Psychiatric disorders: insomnia, depression, confusional state, panic attack, depressed mood, libido decreased.
Nervous system disorders: Headache, lethargy, dizziness, paresthesia, dysgeusia, aphasia, memory impairment, ataxia, syncope, balance disorder, sensory disorder, neuropathy peripheral.
Eye disorders: Lacrimation increased, conjunctivitis, eye irritation, visual acuity reduced, diplopia.
Ear and labyrinth disorders: Vertigo, ear pain.
Cardiac disorders: Angina unstable, angina pectoris, myocardial ischaemia, atrial fibrillation, arrhythmia, tachycardia, sinus tachycardia, palpitations.
Vascular disorders: thrombophlebitis, deep vein thrombosis, hypertension, petechiae, hypotension, hot flush, peripheral coldness.
Respiratory, thoracic and mediastinal disorders: Dyspnea, epistaxis, cough, rhinorrhea, pulmonary embolism, pneumothorax, haemoptysis, asthma, dyspnea exertional.
Gastrointestinal disorders: Diarrhea, vomiting, nausea, stomatitis, abdominal pain, gastrointestinal haemorrhage, constipation, upper abdominal pain, dyspepsia, flatulence, dry mouth, loose stools, intestinal obstruction, ascites, enteritis, gastritis, dysphagia, abdominal pain lower, esophagitis, abdominal discomfort, gastroesophageal reflux disease, colitis.
Hepatobiliary disorders: Hyperbilirubinemia/blood bilirubin/ blood bilirubin increased, jaundice.
Skin and subcutaneous tissue disorders: Palmar-plantar, erythrodysaesthesia syndrome, rash, alopecia, erythema, dry skin, pruritus, skin hyperpigmentation, rash macular, skin desquamation, dermatitis, pigmentation disorders, nail disorder, skin ulcer, urticaria, photosensitivity reaction, palmar erythema, swelling face, purpura.
Musculoskeletal and connective tissue disorders: Pain in extremity, back pain, arthralgia, joint swelling, bone pain, facial pain, musculoskeletal, stiffness, muscular weakness.
Renal and urinary disorders: Hydronephrosis, urinary incontinence, hematuria, nocturia.
Reproductive system and breast disorders: Vaginal hemorrhage.
General disorders and administration site conditions: Fatigue, asthenia, pyrexia, lethargy, edema peripheral, malaise, non-cardiac chest pain, edema, chills, influenza-like illness, rigors.
Investigations: Weight decreased, liver function tests abnormalities, blood in stool, international normalised ratio increased, blood creatinine increased, body temperature increased.
Injury, poisoning and procedural complications: Blister, overdose.
Laboratory abnormalities observed with Capecitabine monotherapy: Decreased hemoglobin, neutrophils/granulocytes, platelets, lymphocytes, sodium, and potassium.
Increased bilirubin, alkaline phosphatase, SGPT and SGOT.
Increased or decreased calcium.
Capecitabine in combination with Cisplatin: Infections and infestations: Herpes zoster, urinary tract infection.
Neoplasm benign, malignant and unspecified: Aleukaemic leukaemia.
Blood and lymphatic system disorders: Neutropenia, leucopenia, anaemia, thrombocytopenia, bone marrow depression.
Metabolism and nutrition disorders: Hypokalemia, hyponatremia, dehydration, hyperglycemia, decreased appetite.
Psychiatric disorders: Sleep disorder.
Nervous system disorders: Neuropathy, peripheral sensory neuropathy, hypoaesthesia, dizziness.
Ear and labyrinth disorders: Tinnitus, hypoacusis.
Gastrointestinal disorders: Upper gastrointestinal hemorrhage, mouth ulceration, gastritis, constipation, mouth ulceration, abdominal pain.
Hepatobiliary disorders: Hepatic function abnormal.
Skin and subcutaneous tissue disorders: Hyperhidrosis.
Musculoskeletal and connective tissue disorders: Myalgia.
Renal and urinary disorders: renal failure, renal failure acute.
General disorders and administration site conditions: Mucosal inflammation, fatigue, malaise.
Investigations: Creatinine renal clearance decreased.
Capecitabine in combination with Docetaxel: Infections and infestations: Oral candidiasis.
Neoplasm benign, malignant and unspecified: Neutropenic fever.
Metabolism and nutrition disorders: Appetite decreased.
Nervous system disorders: Taste disturbance, paresthesia, peripheral neuropathy, headache.
Eye disorders: Lacrimation increased.
Vascular disorders: Lower limb edema.
Respiratory, thoracic and mediastinal system disorders: Sore throat, epistaxis, cough.
Gastrointestinal disorders: Constipation, dyspepsia.
Skin and subcutaneous tissue disorders: Alopecia, nail disorder, rash erythematous, nail discolouration, onycholysis.
Musculoskeletal and connective tissue disorders: Myalgia, arthralgia.
General disorders and administration site conditions: Pyrexia, weakness, pain in limb, pain.
Capecitabine in combination with Oxaliplatin: Anemia, leukopenia, neutropenia, thrombocytopenia, neuropathy, bleeding.
Capecitabine in combination with Epirubicin and Oxaliplatin: Leukopenia, neutropenia, lethargy, anemia, thrombocytopenia, febrile neutropenia, peripheral neuropathy, infection, fever, thromboembolism.
Capecitabine in combination with Epirubicin and Cisplatin: Leukopenia, neutropenia, anemia, lethargy, thromboembolism, thrombocytopenia, febrile neutropenia, peripheral neuropathy, infection, fever.
Post-marketing: Renal and urinary disorders: Acute renal failure secondary to dehydration.
Nervous system disorders: Toxic leukoencephalopathy.
Hepatobiliary disorders: Hepatic failure, cholestatic hepatitis.
Metabolism and nutrition disorders: Hypertriglyceridemia.
Skin and subcutaneous tissue disorders: Cutaneous lupus erythematosus, severe skin reactions such as Steven-Johnson syndrome and toxic epidermal necrolysis (TEN).
Eye disorders: Lacrimal duct stenosis NOS, corneal disorders including keratitis.
Drug Interactions
Some medicine may interfere with Capecitabine. These medicine include: Coumarin anticoagulants: Patients taking Coumarin-derivative anticoagulants concomitantly with Capecitabine should be monitored regularly for alterations in their coagulation parameters (PT or INR) and the anticoagulant dose adjusted accordingly.
Cytochrome P-450 2C9 substrates: Care should be exercised when Capecitabine is co-administered with these drugs.
Phenytoin: Patients taking Phenytoin concomitantly with Capecitabine should be regularly monitored for increased Phenytoin plasma concentrations.
Drug-food interaction: It is recommended that Capecitabine be administered with food. Administration with food decreases the rate of Capecitabine absorption.
Antacid: There was a small increase in plasma concentrations of Capecitabine and one metabolite (5'-DCFR); there was no effect on the 3 major metabolites (5'DFUR, 5-FU, FBAL).
Leucovorin (Folinic Acid): A combination study with Capecitabine and Folinic Acid indicated that Folinic Acid has no major effect on the pharmacokinetics of Capecitabine and its metabolites. However, Folinic Acid has an effect on the pharmacodynamics of Capecitabine and its toxicity may be enhanced by Leucovorin; the maximum tolerated dose (MTD) of Capecitabine alone using the intermittent regimen is 3000 mg/m2 per day whereas it is only 2000 mg/m2 per day when Capecitabine with Folinic Acid (30 mg orally bid).
Sorivudine and analogues: There must be at least a 4-week waiting period between the end of treatment with sorivudine or its chemically related analogues such as Brivudine and start of Capecitabine therapy.
Oxaliplatin: No clinically significant differences in exposure to Capecitabine or its metabolites, free platinum or total platinum occur when Capecitabine and Oxaliplatin were administered in combination, with or without Bevacizumab.
Bevacizumab: There was no clinically significant effect of Bevacizumab on the pharmacokinetic parameters of Capecitabine or its metabolites.
Allopurinol: Interactions with Allopurinol have been observed for 5-FU; with possible decreased efficacy of 5-FU. Concomitant use of Allopurinol with Capecitabine should be avoided.
Interaction with cytochrome P-450: See interaction with Coumarin-derivative anti-coagulation.
Interferon alpha: The MTD of Capecitabine was 2000 mg/m2 per day when combined with interferon alpha-2a (3 MIU/m2 per day) compared to 3000 mg/m2 per day when Capecitabine was used alone.
Radiotherapy: The MTD of Capecitabine alone using the intermittent regimen is 30000 mg/m2 per day, whereas when combined with radiotherapy for rectal cancer, the MTD of Capecitabine is 2000 mg/m2 per day using either a continuous schedule or given daily Monday through Friday during 6-week course of radiotherapy.
Storage
Store below 30°C.
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
Sancitabin FC tab 500 mg
Packing/Price
12 × 10's
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