Citabol

Citabol

gemcitabine

Manufacturer:

Venus Remedies

Distributor:

Unimed
Concise Prescribing Info
Contents
Gemcitabine HCl
Indications/Uses
Locally advanced or metastatic non-small cell lung cancer (NSCLC) & pancreatic adenocarcinoma, 5-FU refractory pancreatic cancer; invasive bladder cancer. In combination w/ paclitaxel for unresectable, locally recurrent or metastatic breast cancer relapse following adjuvant/neoadjuvant chemotherapy. In combination w/ carboplatin for recurrent epithelial ovarian carcinoma relapse >6 mth following platinum-based therapy.
Dosage/Direction for Use
Adult NSCLC Monotherapy: 1,000 mg/m2 IV infusion, repeated once wkly for 3 wk, followed by 1-wk rest period. This 4-wk cycle is then repeated. Combination w/ cisplatin: Regimen 1: 1,250 mg/m2 given as 30-min IV infusion on days 1 & 8 followed by 1-wk rest period. This 3-wk cycle is then repeated. Regimen 2: 1,000 mg/m2 given as 30-min IV infusion on days 1, 8 & 15 followed by 1-wk rest period. This 4-wk cycle is then repeated. Pancreatic adenocarcinoma 1,000 mg/m2 given as 30-min IV infusion, repeated once wkly for 7 wk followed by 1-wk rest period. Subsequent cycles: Inj once wkly for 3 consecutive wk out of every 4 wk. Invasive bladder cancer Combination w/ cisplatin: 1,000 mg/m2 given as 30-min IV infusion on days 1, 8 & 15 followed by 1-wk rest period for 28-day cycle. Cisplatin 70 mg/m2 to be given on day 2. This 4-week cycle is then repeated. Breast cancer Paclitaxel 175 mg/m2 as 3-hr IV infusion on day 1, followed by gemcitabine 1,250 mg/m2 as 30-min IV infusion on days 1 & 8 of each 21-day cycle. Ovarian cancer Combination w/ carboplatin: 1,000 mg/m2 as 30-min IV infusion on days 1 & 8 of each 21-day cycle followed by carboplatin on day 1 to attain target AUC of 4 mg/mL/min.
Contraindications
Hypersensitivity. Concomitant use w/ radiotherapy. Combination of cisplatin/gemcitabine in patients w/ severe renal failure.
Special Precautions
Discontinue use if posterior reversible encephalopathy or capillary leak syndrome, severe pulmonary effects eg, pulmonary oedema, interstitial pneumonitis or adult resp distress syndrome develops; at 1st sign evidence of microangiopahtic haemolytic anaemia. Impaired bone marrow function; history of CV events. Concurrent liver metastases or preexisting medical history of hepatitis, alcoholism or liver cirrhosis. Monitor platelet, leucocyte & granulocyte counts prior to each dose. Not recommended w/ yellow fever & other live attenuated vaccines. Concomitant use w/ radiotherapy. Patients on controlled Na diet. Prolonged & high-dose use. May affect ability to drive & use machines. Hepatic or renal impairment. Men should not father a child during & up to 6 mth after treatment. Avoid use during pregnancy. Lactation. Childn.
Adverse Reactions
Leucopaenia, thrombocytopaenia, anaemia; dyspnoea; vomiting, nausea; elevated liver transaminases & alkaline phosphatase; allergic skin rash, alopecia; haematuria, mild proteinuria; influenza-like symptoms, oedema, peripheral oedema. Febrile neutropaenia; anorexia; headache; cough, rhinitis; diarrhoea, stomatitis, mouth ulceration, constipation; increased bilirubin; itching, sweating; burning; back pain, myalgia; fever, asthenia, chills.
Drug Interactions
Risk of radiosensitization w/ radiotherapy. Risk of systemic fatal disease in immunosuppressed patients w/ yellow fever & other live attenuated vaccines.
ATC Classification
L01BC05 - gemcitabine ; Belongs to the class of antimetabolites, pyrimidine analogues. Used in the treatment of cancer.
Presentation/Packing
Form
Citabol powd for infusion 200 mg
Packing/Price
1's
Form
Citabol powd for infusion 1,000 mg
Packing/Price
1's
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