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Gecita 200/Gecita

Gecita 200/Gecita

gemcitabine

Manufacturer:

Admac Lifesciences

Distributor:

Orange Biotec
Concise Prescribing Info
Contents
Gemcitabine
Indications/Uses
Locally advanced or metastatic bladder cancer in combination w/ cisplatin. Locally advanced or metastatic adenocarcinoma of the pancreas. 1st-line treatment of locally advanced or metastatic NSCLC in combination w/ cisplatin. Locally advanced or metastatic epithelial ovarian carcinoma in combination w/ carboplatin in patients w/ relapsed disease following a recurrence-free interval of at least 6 mth after platinum-based, 1st-line therapy. Unresectable, locally recurrent or metastatic breast cancer in combination w/ paclitaxel in patients who have relapsed following adjuvant/neoadjuvant chemotherapy.
Dosage/Direction for Use
Bladder cancer 1,000 mg/m2 by 30-min infusion on days 1, 8 & 15 of each 28-day cycle + cisplatin 70 mg/m2 on day 1 following gemcitabine or day 2 of each 28-day cycle. The 4-wk cycle is then repeated. Pancreatic cancer 1,000 mg/m2 by 30-min IV infusion, repeated once wkly for up to 7 wk followed by a wk of rest. Subsequent cycles: Once wkly inj for 3 consecutive wk out of every 4 wk. NSCLC Monotherapy: 1,000 mg/m2 by 30-min IV infusion, repeated once wkly for 3 wk followed by 1-wk rest period. The 4-wk cycle is then repeated. Combination: 1,250 mg/m2 by 30-min IV infusion on days 1 & 8 of the treatment cycle (21 days) + cisplatin 75-100 mg/m2 once every 3 wk. Breast cancer Paclitaxel 175 mg/m2 on day 1 over approx 3-hr by IV infusion followed by gemcitabine 1,250 mg/m2 by 30-min IV infusion on days 1 & 8 of each 21-day cycle. Ovarian cancer 1,000 mg/m2 on days 1 & 8 of each 21-day cycle by 30-min IV infusion followed by carboplatin on day 1 w/ a target AUC of 4 mg/mL·min.
Contraindications
Special Precautions
Discontinue use & implement supportive measures if capillary leak syndrome or posterior reversible encephalopathy syndrome develops during therapy. Consider discontinuing use if pulmonary effects develop. Increased toxicity in prolonged infusion time & increased dosing frequency. Rare reports of haemolytic uraemic syndrome. Patients w/ impaired bone marrow function; history of CV events. Patients on a controlled Na diet; suffering from alcoholism & high-risk groups eg, patients w/ liver disease or epilepsy. Monitor patients prior to each dose for platelet, leucocyte & granulocyte counts. Perform lab evaluation of renal & hepatic function (including virological tests) periodically. Not recommended in concomitant use w/ live vaccinations eg, yellow fever vaccine & other live attenuated vaccines. Concomitant RT. Patients w/ hepatic insufficiency or impaired renal function. Not to be used during pregnancy unless clearly necessary. Advise women not to become pregnant during treatment. Discontinue breastfeeding during therapy.
Adverse Reactions
Leucopaenia, bone marrow suppression, thrombocytopaenia, anaemia; dyspnoea; vomiting, nausea; elevation of liver transaminases (AST & ALT) & alkaline phosphatase; allergic skin rash, alopecia; back pain, myalgia; haematuria, mild proteinuria; flu-like symptoms, malaise, perspiration, sleeping difficulties, oedema/peripheral oedema including facial oedema. Infections; febrile neutropaenia; anorexia; headache, insomnia, somnolence; cough, rhinitis; diarrhoea, stomatitis & ulceration of the mouth, constipation; increased bilirubin; itching, sweating; fever, asthenia, chills.
Drug Interactions
Toxicity w/ RT. Risk of systemic, possibly fatal, disease w/ yellow fever & other live attenuated vaccines, particularly in immunosuppressed patients. May alter effects of other medicines due to alcohol content.
MIMS Class
Cytotoxic Chemotherapy
ATC Classification
L01BC05 - gemcitabine ; Belongs to the class of antimetabolites, pyrimidine analogues. Used in the treatment of cancer.
Presentation/Packing
Form
Gecita 200 lyo powd for IV infusion 200 mg
Packing/Price
1's
Form
Gecita lyo powd for IV infusion 1 g
Packing/Price
1's
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