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GEMCITABINE is a brand name for Gemcitabine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Gemcitabine is indicated for the treatment of locally advanced or metastatic bladder cancer in combination with cisplatin. Gemcitabine is indicated for the treatment of patients with locally advanced or metastatic adenocarcinoma of the pancreas. Gemcitabine, in combination with cisplatin, is indicated as first-line…
Verbatim from this product's MHRA label. Tap a section to expand.
Gemcitabine should only be prescribed by a physician qualified in the use of anti- cancer chemotherapy. Posology Bladder cancer Combination use The recommended dose for gemcitabine is 1,000 mg/m2, given by 30-minute infusion. The dose should be given on Days 1, 8 and 15 of each 28-day cycle in combination with cisplatin.
Cisplatin is given at a recommended dose of 70 mg/m2 on Day 1 following gemcitabine or Day 2 of each 28-day cycle. This 4-week cycle is then repeated. Dosage reduction with each cycle or within a cycle may be applied based upon the grade of toxicity experienced by the patient.
Pancreatic cancer The recommended dose of gemcitabine is 1,000 mg/m2, given by 30-minute intravenous infusion. This should be repeated once weekly for up to 7 weeks followed by a week of rest. Subsequent cycles should consist of injections once weekly for 3 consecutive weeks out of every 4 weeks.
Dosage reduction with each cycle or within a cycle may be applied based upon the grade of toxicity experienced by the patient. Non-small cell lung cancer Monotherapy The recommended dose of gemcitabine is 1,000 mg/m2, given by 30-minute intravenous infusion.
This administration should be repeated once weekly for 3 weeks, followed by a 1-week rest period. This 4-week cycle is then repeated. Dosage reduction with each cycle or within a cycle may be applied based upon the grade of toxicity experienced by the patient.
Combination use The recommended dose for gemcitabine is 1,250 mg/m2 body surface area given as a 30-minute intravenous infusion on Days 1 and 8 of the treatment cycle (21 days). Dosage reduction with each cycle or within a cycle may be applied based upon the grade of toxicity experienced by the patient.
Cisplatin has been used at doses between 75-100 mg/m2 once every 3 weeks. Breast cancer Combination use Gemcitabine, in combination with paclitaxel, is recommended using paclitaxel (175 mg/m2) administered on Day 1 over approximately 3 hours as an intravenous infusion, followed by gemcitabine (1,250 mg/m2) as a 30 minute intravenous infusion on Days 1 and 8 of each 21 day cycle.
Dose reduction with each cycle or within a cycle may be applied based upon the grade of toxicity experienced by the patient. Patients should have an absolute granulocyte count of at least 1,500 (x 106/l) prior to initiation of gemcitabine + paclitaxel combination.
The most commonly reported adverse drug reactions associated with gemcitabine treatment include: nausea with or without vomiting, raised liver transaminases (AST/ALT) and alkaline phosphatase, reported in approximately 60% of patients; proteinuria and haematuria reported in approximately 50% of patients; dyspnoea reported in 10 to 40% of patients (highest incidence in lung cancer patients); allergic skin rashes occur in approximately 25% of patients and are associated with itching in 10% of patients.
4). 2).
Clinical trial data Frequencies are defined as:
Very common ( 1/10), Common ( 1/100 to <1/10), Uncommon ( 1/1,000 to <1/100), Rare ( 1/10,000 to <1/1,000), Very Rare ( <1/10,000). The following table of undesirable effects and frequencies is based on data from clinical trials. 4).
thrombocyto penia, anaemia febrile neutro penia. 4) Cardiac disorders arrhythmia s, predomina ntly supraventr icular in nature, myocardi al infarct heart failure Vascular disorders hypotens ion, clinical signs of periphera l vasculitis and gangrene .
4) Respiratory, thoracic, and mediastinal disorders dyspnoea usually mild and passes rapidly without treatment. 4), bronchosp asm usually mild and transient but may require parenteral treatment. 4) Gastro- intestinal disorders nausea, vomiting.
stomatitis and ulceration of mouth, diarrhoea, consti pation. ischaemic colitis Hepatobiliar y disorders elevation of liver transaminases (AST and ALT) and alkaline phosphate. increased bilirubin. serious hepatotoxi city, including liver failure and death increased gamma- glutamyl transfera se (GGT).
4) General disorders and administrati on site conditions Influenza-like symptoms - the most common symptoms are fever, headache, chills, myalgia, asthenia and anorexia. cough, rhinitis, malaise, perspiration and sleeping difficulties have also been reported.
Severe cutaneous adverse reactions (SCARs) including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP), which can be life-threatening or fatal, have been reported in association with gemcitabine treatment.
Patients should be advised of the signs and symptoms and monitored closely for skin reactions. If signs and symptoms suggestive of these reactions appear, gemcitabine should be withdrawn immediately. Prolongation of the infusion time and increased dosing frequency have been shown to increase toxicity.
Haematological toxicity Gemcitabine can suppress bone marrow function as manifested by leukopenia, thrombocytopenia and anaemia. Patients receiving gemcitabine should be monitored prior to each dose for platelet, leukocyte and granulocyte counts.
2). However, myelosuppression is short-lived and usually does not result in dose reduction and rarely in discontinuation. Blood counts may continue to decrease after cessation of treatment with gemcitabine. The treatment must be initiated with caution in patients with impaired bone marrow function.
As with other cytolytic treatments, the risk of cumulative bone-marrow suppression taken into consideration in cases of combined or sequential chemotherapy. 2). The administration of gemcitabine in patients with concurrent liver metastases or a pre- existing medical history of hepatitis, alcoholism or liver cirrhosis may lead to exacerbation of the underlying hepatic impairment.
Renal and hepatic function must be checked periodically (including virology testing). 5 for details and recommendations for use). 5). Cardiovascular Due to the risk of cardiac and/or vascular disorders with gemcitabine, particular caution must be exercised with patients presenting a history of cardiovascular events.
8). The condition is usually treatable if recognised early and managed appropriately, but fatal cases have been reported. This condition involves systemic capillary hyperpermeability during which fluid and proteins from the intravascular space leak into the interstitium.
1. 6).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Ovarian cancer Combination use Gemcitabine, in combination with carboplatin, is recommended using gemcitabine 1,000 mg/m2 administered on Days 1 and 8 of each 21-day cycle as a 30 minute intravenous infusion. 0 mg/ml-min to be reached.
Dosage reduction with each cycle or within a cycle may be applied based upon the grade of toxicity experienced by the patient. Monitoring for toxicity and dose modification due to toxicity Dose modification due to non-haematological toxicity Periodic physical examination and checks of renal and hepatic function should be made to detect non-haematological toxicity.
Dosage reduction with each cycle or within a cycle may be applied based upon the grade of toxicity experienced by the patient. In general, for severe (Grade 3 or 4) non-haematological toxicity, except nausea/vomiting, therapy with gemcitabine should be withheld or decreased depending on the judgement of the treating physician.
Doses should be withheld until the toxicity has resolved, in the opinion of the physician. For cisplatin, carboplatin, and paclitaxel dosage adjustment in combination therapy, please refer to the corresponding Summary of Product Characteristics.
Dose modification due to haematological toxicity Initiation of a cycle For all indications, the patient must be monitored before each dose for platelet and granulocyte counts. Patients should have an absolute granulocyte count of at least 1,500 (x 106/l) and platelet count of 100,000 (x 106/l) prior to the initiation of a cycle.
Within a cycle Dose modifications of gemcitabine within a cycle should be performed according to the following tables: *Treatment omitted will not be reinstated within a cycle before the absolute granulocyte count reaches at least 500 (x106/l) and the platelet count reaches 50,000 (x106/l).
Dose modification of gemcitabine within a cycle for breast cancer, given in combination with paclitaxel Absolute granulocyte count (x 106 /l) Platelet count (x 106 /l) Percentage of standard dose of gemcitabine (%) ≥1,200 and >75,000 100 1,000-< 1,200 or 50,000-75,000 75 700-< 1,000 and ≥ 50,000 50 <700 or <50,000 Omit dose* *Treatment omitted will not be reinstated within a cycle.
Treatment will start on Day 1 of the next cycle once the absolute granulocyte count reaches at least 1,500 (x106/l) and the platelet count reaches 100,000 (x106/l). Dose modification of gemcitabine within a cycle ovarian cancer, given in combination with carboplatin Absolute granulocyte count (x 106 /l) Platelet count (x 106 /l) Percentage of standard dose of gemcitabine (%) >1,500 and ≥100,000 100 1,000 - < 1,500 or 75,000-100,000 50 <1000 or <75,000 Omit dose* *Treatment omitted will not be reinstated within a cycle.
Treatment will start on Day 1 of the next cycle once the absolute granulocyte count reaches at least 1,500 (x106/l) and the platelet count reaches 100,000 (x106/l). Dose modifications due to haematological toxicity in subsequent cycles, for all indications The gemcitabine dose should be reduced to 75% of the original cycle initiation dose, in the case of the following haematological toxicities: - Absolute granulocyte count < 500 x 106/l for more than 5 days - Absolute granulocyte count < 100 x 106/l for more than 3 days - Febrile neutropenia - Platelets < 25,000 x 106/l - Cycle delay of more than 1 week due to toxicity Dose modification of gemcitabine within a cycle for bladder cancer, NSCLC and pancreatic cancer, given in monotherapy or in combination with cisplatin Absolute granulocyte count (x […]
oedema/peripher al oedema - including facial oedema. oedema is usually reversible after stopping treatment. fever, asthenia, chills Inject ion site reactions - mainly mild in nature. 4) Injury, poisoning and procedural complications Radiation recall Combination use in breast cancer The frequency of Grade 3 and 4 haematological toxicities, particularly neutropenia, increases when gemcitabine is used in combination with paclitaxel.
However, the increase in these adverse reactions is not associated with an increased incidence of infections or haemorrhagic events. Fatigue and febrile neutropenia occur more frequently when gemcitabine is used in combination with paclitaxel.
Fatigue, which is not associated with anaemia, usually resolves after the first cycle. 0% of patients in the paclitaxel arm. Combination use in bladder cancer Grade 3 and 4 Adverse Events MVAC versus […]
The clinical characteristics include generalised oedema, weight gain, hypoalbuminaemia, severe hypotension, acute renal failure and pulmonary oedema. Gemcitabine must be stopped and symptomatic treatments must be initiated if capillary leak syndrome develops during treatment.
Capillary leak syndrome may occur during subsequent cycles and has been associated with adult respiratory distress syndrome in the literature. Posterior reversible encephalopathy syndrome Cases of posterior reversible encephalopathy syndrome (PRES) with potentially severe consequences have been reported in patients receiving gemcitabine alone or in combination with other chemotherapeutic anti-cancer agents.
Severe hypertension and seizures have been reported in the majority of patients receiving gemcitabine who experienced PRES, but other symptoms such as headaches, lethargy, confusion and blindness may also be present. The diagnosis is ideally confirmed through magnetic resonance imaging (MRI).
PRES was generally reversible with appropriate symptomatic treatment. If PRES develops during treatment, gemcitabine must be permanently discontinued and symptomatic treatments must be initiated such as blood pressure control and anti-seizure medication.
Pulmonary Pulmonary effects, which are sometimes severe (such as pulmonary oedema, interstitial lung disease and adult respiratory distress syndrome (ARDS) have been reported in association with gemcitabine treatment. If such effects occur, discontinuation of treatment with gemcitabine should be considered.
Early initiation of supportive measures may help to improve the patient’s condition. 8). HUS is a potentially life-threatening condition. Gemcitabine must be stopped at the first signs of microangiopathic haemolytic anaemia, such as rapidly falling haemoglobin with concurrent thrombocytopenia, and elevated serum bilirubin, serum creatinine, blood urea nitrogen, or LDH levels.
Renal failure may not be reversible with discontinuation of therapy and dialysis may be required. 985 mg (<1 mmol) sodium per vial, i. , essentially sodium free.