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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: Carboplatin is indicated for the treatment of: 1) advanced ovarian carcinoma of epithelial origin in: a. first line therapy b. second line therapy, after other treatments have failed. 2) small cell carcinoma of the lung.
Verbatim from this product's MHRA label. Tap a section to expand.
Dosage and Administration:
Carboplatin should be used by the intravenous route only. e. creatinine clearance > 60 ml/min is 400 mg/m² as a single short-term IV dose administered by a 15 to 60 minutes infusion. min carboplatin plus cyclophosphamide Previously untreated Note: With the Calvert formula, the total dose of carboplatin is calculated in mg, not mg/m².
Calvert's formula should not be used in patients who have received extensive pretreatment**. **Patients are considered heavily pretreated if they have received any of the following: - Mitomycin C - Nitrosourea - Combination therapy with doxorubicin/ cyclophosphamide/cisplatin, - Combination therapy with 5 or more agents - Radiotherapy ≥ 4500 rad, focused on a 20 x 20 cm field or on more than one field of therapy.
Therapy with Carboplatin should be discontinued in the case of an unresponsive tumour, progressive disease and/or occurrence of not tolerable side effects. 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.
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 haematological nadir by weekly blood counts during the initial courses of treatment with Carboplatin is recommended for future dosage adjustment.
Needles or intravenous sets containing aluminium parts that may come in contact with carboplatin injection should not be used for preparation or administration. Aluminium reacts with carboplatin injection causing precipitate formation and/or loss of potency.
The safety measures for dangerous substances are to be complied with for preparation and administration. Preparation must be carried out by personnel who have been trained in the safe use while wearing protective gloves, face mask and protective clothes.
Renal Impairment:
Patients with creatinine clearance values of less than 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.
The frequency of adverse reactions reported is based on a cumulative database of 1,893 patients receiving single agent 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 (≥1/1,000 to ≤1/100) Rare (≥1/10,000 to ≤1/1,000) Very rare (<1/10,000), not known (cannot be estimated from the available data).
MedDRA Organ system classes Very common Common Uncommon Rare Very rare Not Known Infections and infestations Infections* Pneumonia Neoplasms, benign and malignant (including cysts and polyps) Treatment related secondary malignancy Blood and lymphatic Thromboc ytopenia, Haemorrhag e* Bone marrow system disorders neutropen ia, leukopeni a, anaemia failure, febrile neutropenia, haemolytic- uraemic syndrome (HUS), haemolytic anaemia (sometimes fatal) Immune system disorders Hypersensiti vity, anaphylactoi d type reaction, Anaphylaxis, anaphylactic shock, Metabolism and nutrition disorders Hyperuric aemia Hyponatrae mia, anorexia Dehydration , anorexia, hyponatrae mia, Tumor lysis syndrome Nervous system disorders Neuropathy peripheral, paraesthesia, decrease of osteotendin ous reflexes, sensory disturbance, dysgeusia Cerebrovasc ular accident*, encephalopa thy, Reversible Posterior Leukoencep halopathy Syndrome (RPLS) Eye disorders Visual disturbance (incl.
rare cases of loss of vision). Ear and labyrinth disorders Subclinica l decrease in hearing acuity, Ototoxicity, Tinnitus, hearing loss Cardiac disorders Cardiovascul ar disorder* Cardiac failure* Cardiac failure* Kounis syndrome Vascular disorders Embolism*, hypertension , hypotension, venoocclusi ve disease (fatal) Respiratory, thoracic and mediastinal disorders Respiratory disorder, interstitial lung disease, bronchospas m Gastrointesti nal disorders Vomiting, nausea, abdominal pain Diarrhoea, constipation, mucous membrane disorder Stomatitis, pancreatitis Hepatobiliary disorders Severe hepatic dysfunction Skin and subcutaneous tissue disorders Alopecia, skin disorder, urticaria, rash, erythemato us,pruritus Musculoskele tal and connective tissue disorders Musculoskel etal disorder Renal and urinary disorders Urogenital disorder General disorders and administratio n site conditions Asthenia Injection site necrosis, injection site reaction, injection site extravasatio n, injection site erythema, malaise Investigations Creatinine renal clearance decreased, blood urea increased, blood alkaline phosphata se increased, aspartate aminotran sferase increased, Blood bilirubin increased, blood creatinine increased, blood uric acid increased liver function test abnormal, blood sodium decreased, blood potassium decreased, blood calcium decreased, blood magnesiu m decreased.
Warnings:
Myelosuppression Myelosuppression as a result of carboplatin treatment is closely related to the renal clearance of the drug. Therefore, in patients with abnormal renal function, or who are receiving concomitant therapy with nephrotoxic drugs, myelosuppression, especially thrombocytopenia, may be more severe and prolonged.
The occurrence, severity and protraction of toxicity is likely to be greater in patients who have received extensive prior treatment with the drug for their disease or with cisplatin, have poor performance status and are advanced in years.
Renal function parameters should be assessed prior to, during and after carboplatin therapy. 2) and the effects carefully monitored through frequent blood counts between courses. 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.
Myelosuppressive effects may be additive to those of concomitant chemotherapy. 8). If any of these events occurs, carboplatin should be discontinued. Precautions Carboplatin should be administered under the supervision of a qualified physician who is experienced in the use of chemotherapeutic agents.
Peripheral blood counts, renal and hepatic function tests should be monitored closely. Blood counts should be performed prior to commencement of carboplatin therapy and at weekly intervals thereafter. The drug should be discontinued if abnormal depression of the bone marrow or abnormal renal or hepatic function is seen.
1 • severe myelosuppression • bleeding tumours • 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. ) • a history of severe allergic reaction to carboplatin or other platinum containing compounds.
2).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Carboplatin in United Kingdom.
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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.
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.
Elderly patients:
In patients of more than 65 years of age, adjustment of the carboplatin dose to the general condition and renal function is necessary during the first and the subsequent therapeutic courses.
Paediatric Patients:
There is insufficient information available to recommend a dosage in the paediatric population. Method of administration Carboplatin should be used by the intravenous route only. The medicinal product must be diluted prior to infusion.
6. The safety measures for dangerous substances are to be complied with preparation and administration. Preparation must be carried out by personnel who have been trained in the safe use while wearing protective gloves, face mask and protective clothes.
* Fatal in <1%, fatal cardiovascular events in <1% included cardiac failure, embolism, and cerebrovascular accident combined.
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.
Neoplasms benign, malignant and unspecified (including cysts and polyps) Secondary acute malignancies (including promyelocytic leukaemia which occurred 6 years after monotherapy with carboplatin and preceding irradiation) have been reported following administration of carboplatin as a single agent or in combination therapy (causal relationship not established).
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 General disorders below).
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. 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.
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.
Cramps have also been reported.
Nervous system disorders:
Peripheral neuropathy (mainly paresthesias and decrease of osteotendinous reflexes) has occurred in 4% of patients administered carboplatin injection. Patients older than 65 years and patients previously treated with cisplatin, as well as those receiving prolonged treatment with carboplatin injection, appear to be at increased risk.
Clinically significant-sensory disturbances (ie, visual disturbances and taste modifications) […]
Diagnostic and treatment facilities should be readily available for management of therapy and possible complications. Haematological toxicity Carboplatin Infusion courses should not be repeated more frequently than monthly under normal circumstances.
Leukopenia, neutropenia, and thrombocytopenia are dose-dependent and dose limiting. Peripheral blood counts should be monitored during carboplatin treatment. 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 injection and day 15 in patients receiving carboplatin injection in combination with other chemotherapeutic agents. In general, single intermittent courses of carboplatin injection should not be repeated until leukocyte, neutrophil, and platelet counts have returned to normal.
Lowest levels of platelets are 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.
If neutrophil 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 requiring very rarely a transfusion. Haemolytic-uremic syndrome (HUS) Haemolytic-uremic 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. Supportive transfusional therapy may be required in patients who suffer severe myelosuppression. Haemolytic anaemia with the presence of serologic drug-induced antibodies has been reported in patients treated with carboplatin.
This event can be fatal. Acute promyelocytic leukaemia and myelodysplastic syndrome (MDS)/ acute myeloid leukemia (AML) have been reported years after therapy with carboplatin and other antineoplastic treatments. Hepatic and/or renal insufficiency Renal and hepatic function impairment may be encountered with carboplatin.
Very high doses of carboplatin (≥ 5 times single agent recommended dose) have resulted in severe abnormalities in hepatic and/or renal function. It is not clear whether an appropriate hydration programme might overcome effects on renal function.
Dose reduction or discontinuation of therapy is required in the presence of moderate to severe alteration in renal or hepatic function test. 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). The incidence and severity of nephrotoxicity may increase in patients who have impaired kidney function before carboplatin treatment. 5). Impairment of renal function is more likely in patients who have previously experienced nephrotoxicity as a result of cisplatin therapy.
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