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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 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 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 Day 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 % patients; dyspnoea reported in 10 - 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 list of undesirable effects and frequencies is based on data from clinical trials.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Infections and infestations Common:
Infections.
Uncommon:
Sepsis. 2), Thrombocytopenia, Anaemia.
Common:
Febrile neutropenia.
Uncommon:
Thrombotic microangiopathy Very rare: Thrombocytosis.
Immune system disorders Very rare:
Anaphylactoid reaction.
Metabolism and nutrition disorders Common:
Anorexia.
Nervous system disorders Common:
Prolongation of the infusion time and increased dosing frequency has been shown to increase toxicity. Haematological toxicity Gemcitabine can suppress bone marrow function as manifested by leucopenia, thrombocytopenia and anaemia. Patients receiving gemcitabine should be monitored prior to each dose for platelet, leucocyte and granulocyte counts.
2). However, myelosuppression is short lived and usually does not result in dose reduction and rarely in discontinuation. Peripheral blood counts may continue to deteriorate after gemcitabine administration has been stopped. In patients with impaired bone marrow function, the treatment should be started with caution.
As with other cytotoxic treatments, the risk of cumulative bone-marrow suppression must be considered when gemcitabine treatment is given together with other chemotherapy. 2). 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 insufficiency.
Laboratory evaluation of renal and hepatic function (including virological tests) should be performed periodically. 5 for details and recommendations for use). 5). Posterior reversible encephalopathy syndrome Reports of posterior reversible encephalopathy syndrome (PRES) with potentially severe consequences have been reported in patients receiving gemcitabine as single agent or in combination with other chemotherapeutic agents.
Acute hypertension and seizure activity were reported in most gemcitabine patients experiencing PRES, but other symptoms such as headache, lethargy, confusion and blindness could also be present. Diagnosis is optimally confirmed by magnetic resonance imaging (MRI).
PRES was typically reversible with appropriate supportive measures. Gemcitabine should be permanently discontinued and supportive measures implemented, including blood pressure control and anti-seizure therapy, if PRES develops during therapy.
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 and min. 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 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 account 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: 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 106/l) Platelet count (x 106/l) Percentage of standard dose of Gemcitabine (%) > 1,000 and > 100,000 100 500 – 1,000 or 50,000 – 100,000 75 < 500 or < 50,000 Omit dose* *Treatment omitted will not be re-instated within a cycle before the absolute granulocyte count reaches at least 500 (x 106/l) and the platelet count reaches 50,000 (x 106/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 re-instated 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 for 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 < 1,000 or < 75,000 Omit dose* *Treatment omitted will not be re-instated 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 • […]
Headache, Insomnia, Somnolence.
Uncommon:
Cerebrovascular accident. 4).
Cardiac disorders Uncommon:
Arrhythmias, predominantly supraventricular in nature, Heart failure.
Rare:
Myocardial infarct.
Vascular disorders Rare:
Clinical signs of peripheral vasculitis and gangrene, Hypotension. ). Respiratory, thoracic and mediastinal disorders.
Very common:
Dyspnoea –usually mild and passes rapidly without treatment.
Common:
Cough, Rhinitis. 4), Bronchospasm –usually mild and transient but may require parenteral treatment. 4).
Gastrointestinal disorders Very common:
Vomiting, Nausea.
Common:
Diarrhoea, Stomatitis and ulceration of the mouth, Constipation.
Very rare:
Ischaemic colitis.
Hepatobiliary disorders Very common:
Elevation of liver transaminases (AST and ALT) and alkaline phosphatase.
Common:
Increased bilirubin.
Uncommon:
Serious hepatotoxicity, including liver failure and death.
Rare:
Increased gamma-glutamyl transferase (GGT).
Skin and subcutaneous tissue disorders Very common:
Allergic skin rash frequently associated with pruritus, Alopecia.
Common:
Itching, Sweating.
Rare:
Severe skin reactions, including desquamation and bullous skin eruptions, Ulceration, Vesicle and sore formation, Scaling.
Very rare:
Toxic epidermal necrolysis, Stevens-Johnson Syndrome.
Musculoskeletal and connective tissue disorders Common:
Back pain, Myalgia.
Renal and urinary disorders Very common:
Haematuria, Mild proteinuria. 4).
General disorders and administration site conditions Very common:
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. Oedema/peripheral oedema-including facial oedema.
Oedema is usually reversible after stopping treatment.
Common:
Fever, Asthenia, Chills.
Rare:
Injection site reactions – mainly mild in nature. 5), 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 gemcitabine plus cisplatin Number (%) of Patients MVAC (methotrexate, vinblastine, doxorubicin and cisplatin) arm (N = 196) Gemcitabine plus cisplatin arm (N = 200) Grade 3 Grade 4 Grade 3 Grade 4 Laboratory Anaemia 30 (16) 4 (2) 47 (24) 7 (4) Thrombocytopenia 15 (8) 25 (13) 57 (29) 57 (29) Non-laboratory Nausea and vomiting 37 (19) 3 (2) 44 (22) 0 (0) Diarrhoea 15 (8) 1 (1) 6 (3) 0 (0) Infection 19 (10) 10 (5) 4 (2) 1 (1) Stomatitis 34 (18) 8 (4) 2 (1) 0 (0) Combination use in ovarian cancer Grade 3 and 4 Adverse Events Carboplatin versus gemcitabine plus carboplatin Number (%) of Patients Carboplatin arm (N = 174) Gemcitabine plus carboplatin arm (N […]
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.
The condition involves systemic capillary hyperpermeability during which fluid and proteins from the intravascular space leak into the interstitium. The clinical features include generalised oedema, weight gain, hypoalbuminaemia, severe hypotension, acute renal impairment and pulmonary oedema.
Gemcitabine should be discontinued and supportive measures implemented if capillary leak syndrome develops during therapy. Capillary leak syndrome can occur in later cycles and has been associated in the literature with adult respiratory distress syndrome.
Pulmonary Pulmonary effects, sometimes severe (such as pulmonary oedema, interstitial pneumonitis or adult respiratory distress syndrome (ARDS)) have been reported in association with gemcitabine therapy. The aetiology of these effects is unknown.
If such effects develop, consideration should be made to discontinuing gemcitabine therapy. Early use of supportive care measure may help ameliorate the condition. 8). HUS is a potentially life- threatening disorder. Gemcitabine should be discontinued at the first signs of any evidence of microangiopathic haemolytic anaemia, such as rapidly falling haemoglobin with concomitant thrombocytopenia, elevation of serum bilirubin, serum creatinine, blood urea nitrogen, or LDH.
Renal failure may not be reversible with discontinuation of therapy and dialysis may be required. 3). 6). Sodium Each 200 mg vial gemcitabine contains 460 mg (20 mmol) sodium. Each 1,000 mg vial gemcitabine contains 2300 mg (100 mmol) sodium.
Each 2,000 mg vial gemcitabine contains 4600 mg (200 mmol) sodium. This should be taken into consideration by patients on a controlled sodium diet.