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CARBOPLATIN is a brand name for Carboplatin. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Treatment of advanced ovarian carcinoma of epithelial origin in: - first line therapy - second line therapy, after other treatments have failed High risk seminoma (stage I) testicular germ cells tumors as adjuvant treatment Treatment of small cell carcinoma of the lung.
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Adults The recommended dose of carboplatin in previously untreated adults with normal renal function is 400 mg/m2, as a single dose during 15 to 60 minutes. min carboplatin + cyclophosphamide Previously untreated Note: With the Calvert formula, the total dose of Carboplatin is calculated in mg, not mg/m2.
Therapy should not be repeated until 4 weeks after the previous administration and/or until the neutrophil count is at least 2,000 cells/mm³ and the platelet count is at least 100,000 cells/mm³. Initial dosage should be reduced by 20-25% in patients with risk factors such as prior myelosuppressive treatment and/or low performance status (ECOG-Zubrod 2-4 or Karnofsky below 80).
Determination of haematologic nadir by weekly blood counts during initial courses is recommended for future dosage adjustment and scheduling of carboplatin. Impaired renal function In patients with impaired renal function, dosage of carboplatin should be reduced (refer to Calvert formula) and haematological nadirs and renal function monitored.
Patients with creatinine clearance values below 60 ml/min are at increased risk of severe myelosuppression. V. V. Insufficient data exist on the use of carboplatin injection in patients with creatinine clearance of 15 ml/min or less to permit a recommendation for treatment.
All of the above dosing recommendations apply to the initial course of treatment. Subsequent dosages should be adjusted according to the patient's tolerance and to an acceptable level of myelosuppression. Combination Therapy The optimal use of Carboplatin in combination with other myelosuppressive agents requires dosage adjustments according to the regimen and schedule to be adopted.
Paediatric population Use in children and infants is not recommended due to lack of sufficient data in this area. Elderly In patients of more than 65 years of age, adjustment of the carboplatin dose to the general condition is necessary during the first and the subsequent therapeutic courses.
Method of administration Carboplatin injection should be used by the intravenous route only. Injection or intravenous infusion. Carboplatin may interact with aluminum, forming a black precipitate. Needles, syringes, catheters or IV administration sets containing aluminum should not be used for preparation and administration of Carboplatin in order to avoid interactions.
The frequency of adverse reactions reported is based on a cumulative database of 1893 patients receiving single Carboplatin injection and post-marketing experience. The list is presented by system organ class, MedDRA preferred term, and frequency using the following frequency categories: very common (≥1/10), common (≥1/100 to < 1/10), uncommon, (≥1/1000 to <1/100), rare (≥1/10000 to <1/1000), very rare (< 1/10000), and not known (cannot be estimated from the available data).
g. myocardial infarction, cardiac arrest, angina pectoris, myocardial ischemia) Vascular disorders Not known Embolism*, hypertension, hypotension, venoocclusive disease (including fatal events) Respiratory, thoracic and mediastinal disorders Common Respiratory disorder, interstitial lung disease, bronchospasm Very rare Pulmonary fibrosis Gastrointestinal disorders Very common Common Not known Vomiting, nausea, abdominal pain Diarrhoea, constipation, mucous membrane disorder Stomatitis, pancreatitis Skin and subcutaneous tissue disorders Common Not known Alopecia, skin disorder Urticaria, rash, erythema, pruritus Rare Exfoliative dermatitis Musculoskeletal and connective tissue disorders Common Musculoskeletal disorder Uncommon Myalgia, arthralgia Renal and urinary disorders Common Urogenital disorder Very common Renal impairment General disorders and administration site conditions Common Not known Asthenia Injection site necrosis, injection site reaction, injection site extravasation, injection site erythema, malaise Uncommon Flu-like symptoms, chills, headache Investigations Very Common Common Creatinine renal clearance decreased Blood urea increased, blood alkaline phosphatase increased, aspartate aminotransferase increased, liver function test abnormal Blood sodium decreased, blood potassium decreased, blood calcium decreased, blood magnesium decreased Blood bilirubin increased, blood creatinine increased, blood uric acid increased * Fatal in <1%, fatal cardiovascular events in <1% included cardiac failure, embolism, and cerebrovascular accident combined.
Myelosuppression The severity of myelosuppression is superior in previously treated patients (particularly with cisplatin) and/or impaired renal function. Myelosuppression as a result of carboplatin treatment is closely related to the renal clearance of the drug.
Therefore, in patients with abnormal renal function, with prolonged prior treatment, general malaise or more than 65 years of age, or who are receiving concomitant therapy with nephrotoxic drugs, myelosuppression, especially thrombocytopenia, may be more severe and prolonged.
Parameters of renal function should be assessed before, during and after treatment with carboplatin. 2). Myelosuppressive effects may be additive to those of concomitant chemotherapy. Peripheral blood counts (including platelets, white blood cells and haemoglobin) should be followed during and after therapy.
Combination therapy with other myelosuppressive drugs may require modification of dosage/timing of schedules in order to minimise additive effects. Carboplatin courses should not, in general, be repeated more frequently than every 4 weeks in order to ensure that the nadir in blood counts has occurred and there has been recovery to a satisfactory level.
8). If any of these events occur, administration of carboplatin should be discontinued and treatment modification or discontinuation should be considered. Haematologic Toxicity Hemolytic anemia with the presence of serologic drug-induced antibodies has been reported in patients treated with carboplatin.
This event can be fatal. Leukopenia, neutropenia, and thrombocytopenia are dose-dependent and dose-limiting. Peripheral blood counts should be monitored before start of treatment with carboplatin and then at weekly intervals and, in case of toxicity, until recovery is achieved.
This will monitor toxicity and help determine the nadir and recovery of haematological parameters and assist in subsequent dosage adjustments. Median day of nadir is day 21 in patients receiving single agent carboplatin and day 15 in patients receiving carboplatin in combination with other chemotherapeutic agents.
1. - patients with severe myelosuppression. - patients with pre-existing severe renal impairment (with creatinine clearance of less than 30 ml/min) unless in the judgment of the physician and patient, the possible benefits of treatment outweigh the risks.
2). 6).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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The safety measures used for preparation and administration of dangerous substances should be applied. Preparation must be carried out byprofessionals who have been trained in the safe use while wearing protective gloves, face mask and protective clothing.
Duration of treatment The duration of treatment depends on the condition and the clinical protocol used.
Blood and lymphatic system disorders:
Myelosuppression is the dose-limiting toxicity of carboplatin injection. In patients with normal baseline values, thrombocytopenia with platelet counts below 50,000/mm3 occurs in 25% of patients, neutropenia with granulocyte counts below 1,000/mm3 in 18% of patients, and leukopenia with WBC counts below 2,000/mm3 in 14% of patients.
The nadir usually occurs on day 21. Myelosuppression can be worsened by combination of carboplatin injection with other myelosuppressive compounds or forms of treatment. Myelotoxicity is more severe in previously treated patients, in particular in patients previously treated with cisplatin and in patients with impaired kidney function.
Patients with poor performance status have also experienced increased leukopenia and thrombocytopenia. These effects, although usually reversible, have resulted in infectious and hemorrhagic complications in 4% and 5% of patients given carboplatin injection, respectively.
These complications have led to death in less than 1% of patients. Anaemia with haemoglobin values below 8 g/dL has been observed in 15% of patients with normal baseline values. The incidence of anaemia is increased with increasing exposure to carboplatin injection.
Respiratory, thoracic and mediastinal disorders:
Pulmonary fibrosis has been reported very rarely, manifested by tightness of the chest and dyspnoea. This should be considered if a pulmonary hypersensitivity state is excluded (see immune diseases).
Gastrointestinal disorders:
Vomiting occurs in 65% of patients, in one-third of whom it is severe. Nausea occurs in an additional 15%. Nausea and vomiting are generally delayed until 6 to 12 hours after administration of carboplatin, are readily controlled or prevented with antiemetics and disappear within 24 hours.
Previously treated patients (in particular patients previously treated with cisplatin) appear to be more prone to vomiting. Vomiting is more likely when carboplatin injection is given in combination with other emetogenic compounds. The other gastrointestinal complaints corresponded to pain in 8% of patients, diarrhoea, and constipation in 6 % of patients.
Renal and urinary disorders:
When given in usual doses, development of abnormal renal function has been uncommon, despite the fact that carboplatin injection has been administered without high-volume fluid hydration and/or forced diuresis. […]
Lowest levels of platelets are generally seen between days 14 and 21 of initial therapy. A greater reduction is seen in patients who previously received extensive myelosuppressive chemotherapy. Lowest levels of white cells occur generally between days 14 and 28 of initial therapy.
In general, single intermittent courses of carboplatin should not be repeated until leukocyte, neutrophil, and platelet counts have returned to normal. If levels fall below 2000 cells/mm3 or platelets are less than 100,000 cells/mm3 then postponement of carboplatin therapy until bone barrow recovery is evident, should be considered.
This recovery usually takes 5 to 6 weeks. Transfusions may be necessary and dosage reductions recommended for subsequent treatment. Anaemia is frequent and cumulative, however rarely requires a transfusion. Acute promyelocytic leukaemia and myelodysplastic syndrome (MDS)/ acute myeloid leukemia (AML) have been reported years after therapy with carboplatin and other antineoplastic treatments.
Haemolytic-uraemic syndrome (HUS) Haemolytic-uraemic syndrome (HUS) is a life-threatening side effect. Carboplatin 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. Renal toxicity In patients with impaired renal function, the effect of carboplatin in the hematopoietic system is more pronounced and more prolonged action than in patients with normal renal function.
2). The incidence and severity of nephrotoxicity may increase in patients who have impaired kidney function before carboplatin treatment. It is not clear whether an appropriate hydration programme might overcome such an effect but dosage reduction or discontinuation of therapy is required in the presence of severe alteration in renal function test.
Impairment of renal function is more likely in patients who have previously experienced nephrotoxicity as a result of cisplatin therapy. 5) The carcinogenic potential of carboplatin has not been studied, but compounds with similar mechanisms of action and mutagenicity have been reported to be carcinogenic.
Venoocclusive liver disease Cases of hepatic venoocclusive disease (sinusoidal obstruction syndrome) have been reported, some of which were fatal. Patients should be monitored for signs and symptoms of abnormal liver function or portal hypertension which do not obviously result from liver metastases.
Tumour lysis syndrome (TLS) In post marketing experience tumour lysis syndrome (TLS) has been reported in patients following the use of carboplatin alone or in combination with other chemotherapeutic agents. Patient at high risk of TLS, such as patients with high proliferative rate, high tumor burden, and high sensitivity to cytotoxic agents, should be monitored closely and appropriate precaution taken.
Allergic Reactions As with other platinum-based drugs, allergic reactions appearing most often during administration may occur and necessitate discontinuation of infusion. In such cases, an appropriate symptomatic treatment must be initiated.
Cross reactions, sometimes fatal, have been reported with all […]