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CARBOPLATIN VENUS PHARMA 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.
Verbatim from this product's MHRA label. Tap a section to expand.
e. creatinine clearance > 60 ml/min is 400 mg/m2 as a single IV dose administered as 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.
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. Initial dosage should be reduced by 20-25% in patients with risk factors such as previous myelosuppressive therapy and or poor 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 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 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.
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:
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. Paediatric population There is insufficient information to support a dosage recommendation in the paediatric population.
6 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 frequency of adverse reactions reported is based on a cumulative database of 1,893 patients receiving single agent carboplatin injection and post-marketing experience. Tabulated list of adverse reactions 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, <1/10) Uncommon (≥1/1,000, ≤1/100) Rare (≥1/10,000, ≤1/1,000) Very rare (<1/10,000), Not known (cannot be estimated from the available data) System Organ Class Frequency MedDRA Term Neoplasms, benign and malignant and unspecified (incl cysts and polyps) Not known Treatment related secondary malignancy Common Infections*Infections and infestations Not known Pneumonia Very common Thrombocytopenia, neutropenia, leukopenia, anaemia Common Haemorrhage* Rare febrile neutropenia, Not known Bone marrow failure, haemolytic-uraemic syndrome, haemolytic anaemia Blood and lymphatic system disorders Common Hypersensitivity, anaphylactoid type reaction Immune system disorders Rare Angioedema Rare hyponatraemia Not known Dehydration, anorexia, Tumor lysis syndrome Metabolism and nutrition disorders Nervous system disorders Common Peripheral neuropathy , paraesthesia, decrease of osteotendinous reflexes, sensory disturbance, dysgeusia Not known Cerebrovascular accident* encephalopathy, Reversible Posterior Leukoencephalopathy Syndrome (RPLS).
Eye disorders Common Visual disturbance (incl. 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 venoocclusive disease (fatal) 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.
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 duration of toxicity is likely to be greater in patients who have received extensive prior treatment carboplatin or cisplatin, have poor performance status and are advanced in years. 2) and the effects carefully monitored through frequent blood counts between courses.
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 minimize 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 occurs, carboplatin should be interrupted and dose modification or discontinuation should be considered.
Allergic reactions As with other platinum-based drugs, allergic reactions appearing most often during administration may occur and necessitate discontinuation of infusion. Patients should be observed carefully and an appropriate symptomatic treatment (including antihistamines, adrenaline and/or glucocorticoids) must be initiated in such cases.
8). The vial stopper contains dry natural rubber (a derivative of latex), which may cause allergic reactions. 8). Renal Toxicity In patients with impaired renal function, the effect of carboplatin on the haemotopoietic system is more pronounced and longer-lasting than in patients with normal renal function.
1 - patients with severe myelosuppression - patients with pre-existing severe renal impairment (with creatinine clearance of ≤ 30 ml per minute) unless in the judgment of the physician and patient, the possible benefits of treatment outweigh the risks.
5) - patients with a history of severe allergic reaction to other platinum containing compounds.
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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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.
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 Common AstheniaGeneral disorders and 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.
Investigations 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. Description of selected adverse reactions 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 8g/dl has been observed in 15% of patients with normal baseline values. The incidence of anaemia is increased with increasing exposure to carboplatin injection.
Myelosuppression may be more severe and prolonged in patients with impaired renal function, extensive prior treatment, poor performance status and age above 65. At maximum tolerated dosages of carboplatin administered as a single agent, thrombocytopenia, with nadir platelet counts of less than 50 x 109/l, occurs in about a third of the patients.
The nadir usually occurs between days 14 and 21, with recovery within 35 days from the start of therapy. Leukopenia has also occurred in approximately 20% of patients but its recovery from the day of nadir (day 14-28) may be slower and usually occurs within 42 days from the start of therapy.
Neutropenia with granulocyte counts below 1 x 109/l occurs in approximately one fifth of patients. 5 mg/100ml have been observed in 48% of patients with normal base-line values. Neoplasms benign, malignant and unspecified (including cysts and polyps) Secondary acute malignancies after cytostatic combination therapies containing carboplatin have been reported.
Respiratory, thoracic and mediastinal disorders Pulmonary fibrosis manifested by tightness of the chest and dyspnoeahas been reported very rarely. This should be considered if a pulmonary hypersensitivity state is excluded. 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 24hours.
Vomiting is more likely when carboplatin injection is […]
2).
Precautions:
Carboplatin should only be administered under the supervision of a qualified physician who is experienced in the use of chemotherapeutic agents. Diagnostic and treatment facilities should be readily available for management of therapy and possible complications.
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.
Haematologic Toxicity 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 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.
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.
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, however rarely requires a transfusion. 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. 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. 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 […]