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CARBOPLATIN CONCENTRATE FOR is a brand name for Carboplatin. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Carboplatin is indicated for the treatment of 1. Advanced ovarian carcinoma of epithelial origin in: - first line therapy - second line therapy, after other treatments have failed. 2. Small cell carcinoma of the lung, in association with other chemotherapeutic agents.
Verbatim from this product's MHRA label. Tap a section to expand.
v. dose administered by a short term (15 to 60 minutes) infusion. Therapy should not be repeated until four weeks after the previous carboplatin course and/or until the neutrophil count is at least 2,000 cells/mm3 and the platelet count is at least 100,000 cells/mm3.
, cyclophosphamide) therapy may be increased by 25%. Reduction of the initial dosage by 20 - 25% is recommended for those patients who present with risk factors such as prior myelosuppressive treatment and low performance status (ECOG-Zubrod 2 - 4 or Karnofsky below 80).
Determination of the haematologic nadir by weekly blood count during the initial courses of treatment with carboplatin is recommended for dosage adjustment for subsequent courses of therapy. Dose recommendations according to AUC Alternatively, the initial dose can be calculated using the Calvert formula.
This is based on renal function (glomerular filtration rate [GFR]). Thereby, the risk of underdosing or overdosing due to individual differences in renal function is reduced.
Calvert formula: total dose (mg) = (target AUC*) × (GFR + 25) Note:
With the Calvert formula, the total dose of carboplatin is calculated in mg, not mg/m2. *target AUC planned chemotherapy pre-treatment status 5-7 mg/ml min single agent carboplatin no prior therapy 4-6 mg/ml min single agent carboplatin prior therapy 4-6 mg/ml min carboplatin plus cyclophosphamide no prior therapy The Calvert formula should not be used in heavily pre-treated patients who have already received one of the following regimens: - mitomycin C - nitrosourea - doxorubicin/cyclophosphamide/cisplatin combination chemotherapy - combination therapy including 5 or more cytostatic agents - radiation therapy ≥ 5000 rad focused on a field of 20 × 20 cm or more than one field.
Renal Impairment 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 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 the acceptable level of myelosuppression. The optimal use of carboplatin in patients presenting with renal impairment requires frequent monitoring of haematological nadirs, electrolytes and renal function.
The frequency of adverse reactions reported is based on a cumulative database of 1,893 patients receiving single agent carboplatin 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 (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (< 1/10,000), and not known (cannot be estimated from the available data).
System Organ Class Frequency MedDRA Term Common Infections*Infections and infestations Not known Pneumonia Neoplasms, benign, malignant and unspecified (incl. cysts and polyps) Not known Treatment related secondary malignancy Very common Thrombocytopenia, neutropenia, leukopenia, anaemia Common Haemorrhage* Blood and lymphatic system disorders Not known Bone marrow failure, febrile neutropenia, hemolytic-uraemic syndrome Immune system disorders Common Hypersensitivity, anaphylactoid type reaction Metabolism and nutrition disorders Not known Dehydration, anorexia, hyponatraemia, tumor lysis syndrome Common Neuropathy peripheral, paraesthesia, decrease of osteotendinous reflexes, sensory disturbance, dysgeusia Nervous system disorders Not known Cerebrovascular accident*, Reversible Posterior Leukoencephalopathy Syndrome (RPLS)# Eye disorders Common Visual disturbance, rare cases of loss of vision Ear and labyrinth disorders Common Ototoxicity Common Cardiovascular disorder*Cardiac disorders Not known Cardiac failure*, Kounis syndrome Vascular disorders Not known Embolism*, hypertension, hypotension Respiratory, thoracic and mediastinal disorders Common Respiratory disorder, interstitial lung disease, bronchospasm Very common Vomiting, nausea, abdominal pain Common Diarrhoea, constipation, mucous membrane disorder Gastrointestinal disorders Not known Stomatitis, pancreatitis# Common Alopecia, skin disorderSkin and subcutaneous tissue disorders Not known Urticaria, rash, erythema, pruritus Musculoskeletal and connective tissue disorders Common Musculoskeletal disorder Renal and urinary disorders Common Urogenital disorder General disorders and Common Asthenia System Organ Class Frequency MedDRA Term administration site conditions Not known Injection site necrosis, injection site reaction, injection site extravasation, injection site erythema, malaise Very 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.
Carboplatin should be used only by physicians experienced with cancer chemotherapeutic drugs. Blood counts as well as renal and hepatic function tests must be done regularly and the drug should be discontinued if abnormal depression of the bone marrow or abnormal renal or hepatic function is seen.
Hematologic toxicity Leukopenia, neutropenia, and thrombocytopenia are dose-dependent and dose-limiting. Peripheral blood counts should be monitored during carboplatin treatment frequently and, in case of toxicity, until recovery is achieved.
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. In general, single intermittent courses of carboplatin should not be repeated until leukocyte, neutrophil, and platelet counts have returned to normal.
Therapy should not be repeated until 4 weeks after the previous carboplatin course and/or until the neutrophil count is at least 2,000 cells/mm3 and the platelet count is at least 100,000 cells/mm3. Anemia is frequent and cumulative requiring very rarely a transfusion.
Hemolytic anemia with the presence of serologic drug-induced antibodies has been reported in patients treated with carboplatin. This event can be fatal. Severity of myelosuppression is increased in patients with prior treatment (in particular with cisplatin) and/or impaired kidney function.
2) and the effects carefully monitored through frequent blood counts between courses. Carboplatin combination therapy with other myelosuppressive forms of treatment must be planned very carefully with respect to dosages and timing in order to minimise additive effects.
Myelosuppressive effects may be additive to those of concomitant chemotherapy. 8). If any of these events occurs, carboplatin dosing should be interrupted and dose modification or discontinuation should be considered. Acute promyelocytic leukaemia and myelodysplastic syndrome (MDS)/ acute myeloid leukemia (AML) have been reported years after therapy with carboplatin and other antineoplastic treatments.
1. • Pre-existing severe renal impairment (creatinine clearance < 30 mL/min), unless in the judgement of the physician and patient, the possible benefits of treatment outweigh the risks. • Severe myelosuppression. • Bleeding tumours. 5).
• During breast-feeding.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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 There is insufficient information available to recommend a dosage in the paediatric population.
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 should be used by the intravenous route only.
The solution for infusion is administered by a short term (15 to 60 minutes) infusion. 5 mg/ml (500 micrograms/ml). Preparation and administration Needles or intravenous sets containing aluminium parts that may come in contact with carboplatin should not be used for preparation or administration.
Aluminium reacts with carboplatin causing precipitate formation and/or loss of potency. The safety measures for dangerous substances are to be complied with preparation and administration. 6).
Investigation Common 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. # based on the post-marketing experience Description of selected adverse reactions Blood and lymphatic system disorders Myelosuppression is the dose-limiting toxicity of carboplatin.
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 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, 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.
Gastrointestinal disorders Vomiting occurs in 65% of patients, in one-third of whom it is severe. Nausea occurs in an additional 15%. Previously treated patients (in particular patients previously treated with cisplatin) appear to be more prone to vomiting.
These effects usually disappear within 24 hours after treatment and are generally responsive to or prevented by antiemetic medication. Vomiting is more likely when carboplatin is given in combination with other emetogenic compounds.
The other gastro-intestinal complaints corresponded to pain in 8% of patients, diarrhoea, and constipation in 6 % of patients. Nervous system disorders Peripheral neuropathy (mainly paresthesias and decrease of osteotendinous reflexes) has occurred in 4% of patients administered carboplatin.
Patients older than 65 years and patients previously treated with cisplatin, as well as those receiving prolonged treatment with carboplatin, appear to be at increased risk. , visual disturbances and taste modifications) have occurred in 1% of patients.
The overall frequency of neurologic side effects seems to be increased in patients receiving carboplatin in combination. This may also be related to longer cumulative exposure. Ear and labyrinth disorders Auditory defects out of the speech range with impairments in the high-frequency range (4,000-8,000 Hz) were found in serial audiometric investigations with a frequency of 15%.
Very rare cases of hypoacusia have been reported. In patients with a hearing organ predamaged due to cisplatin, a further exacerbation in the hearing function sometimes occurs during treatment with carboplatin. Renal and urinary disorders When given in usual doses, development of abnormal renal function has been uncommon, despite the fact that carboplatin has been […]
Nausea and vomiting Carboplatin can cause nausea and vomiting. Pre-medication with anti-emetics and slower drug administration have been reported to be useful in reducing the incidence and intensity of these effects. 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 thrombocytopaenia, 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. Hypersensitivity reactions As with other platinum-based drugs, allergic reactions appearing most often during perfusion may occur and necessitate discontinuation of the perfusion and an appropriate symptomatic treatment.
8). 8). Renal toxicity In patients with impaired renal function, the effect of carboplatin on the haematopoietic system is more pronounced and longer-acting than in patients with normal renal function. 2). Neurologic toxicity Although peripheral neurologic toxicity is generally common and mild, limited to paresthesia and decrease of osteotendinous reflexes, its frequency is increased in patients older than 65 years and/or in patients previously treated with cisplatin.
Monitoring and neurological examinations should be carried out at regular intervals. Visual disturbances, including loss of vision, have been reported after the use of carboplatin in doses higher than those recommended in patients with renal impairment.
Vision appears to recover totally or to a significant extent within weeks of stopping these high doses. Geriatric use In studies involving combination therapy with carboplatin and cyclophosphamide, elderly patients treated with carboplatin were more likely to develop severe thrombocytopenia than younger patients.
2). Reversible Posterior Leukoencephalopathy Syndrome (RPLS) Cases of Reversible Posterior Leukoencephalopathy Syndrome (RPLS) have been reported in patients receiving carboplatin in combination chemotherapy. 8). Diagnosis of RPLS is based upon confirmation by brain imaging, preferably MRI (Magnetic Resonance Imaging).
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 […]