Carboplatin Pfizer

Carboplatin Pfizer Adverse Reactions





Zuellig Pharma


Full Prescribing Info
Adverse Reactions
Myelosuppression: Haematological toxicity is the most common dose-limiting toxicity, with leucopenia in 55% of patients, thrombocytopenia in 62% of patients, anaemia in up to 59% of patients and neutropenia. When used as single agent therapy, toxicity is not usually cumulative and is reversible, although transfusional therapy may be necessary in severe cases.
Neoplasms: Benign, malignant and unspecified: There have been rare reports of acute myelogenous leukaemias and myelodysplastic syndromes arising in patients who have been treated with carboplatin, mostly when given in combination with other potentially leukemogenic agents.
Nephrotoxicity: Manifests as reduced creatinine clearance, elevated serum creatinine, blood urea nitrogen and uric acid levels. Acute renal failure has been reported rarely. Haemolytic uraemic syndrome. Risk of carboplatin-induced nephrotoxicity (e.g., impaired creatinine clearance) becomes more prominent at relatively high dosages or in patients previously treated with cisplatin.
Gastrointestinal Effects: Nausea and Vomiting: Onset may be delayed for 6-12 hours after administration of carboplatin and usually disappears within 24 hours. Antiemetic medication can be used to adequately control these effects. Diarrhoea and constipation have been reported with carboplatin therapy.
Hepatotoxicity: Mild and usually transient elevations of serum alkaline phosphatase, aspartate aminotransferase or bilirubin concentrations may occur. Substantial abnormalities in liver function test have been reported in patients treated with carboplatin at high doses and autologous bone marrow transplantation. Abnormalities of liver function tests have been reported in up to 30% of patients. These changes are normally only transient in nature and disappear spontaneously.
Ototoxicity: Manifests as tinnitus and hearing loss in the higher frequency range. Hearing impairment may persist or worsen with carboplatin therapy.
Eye Disorders: Visual abnormalities, such as transient sight loss (which can be complete for light and colours) or other disturbances may occur in patients treated with carboplatin. Improvement and/or total recovery of vision usually occurs within weeks after the drug is discontinued. Cortical blindness has been reported in patients with impaired renal function receiving high-dose carboplatin.
Cardiac Disorders: Cardiac failure, ischaemic coronary artery disorders (e.g. myocardial infarction, cardiac arrest, angina, myocardial ischaemia).
Vascular Disorders: Cerebrovascular events.
Allergic Reactions: Erythematous rash, fever and pruritus may occur (less than 2% of patients). These include anaphylaxis/anaphylactoid reactions, hypotension, bronchospasm and pyrexia. Hypersensitivity reactions may occur within a few minutes after IV administration of carboplatin.
Skin and Subcutaneous Tissue Disorders: Exfoliative dermatitis may rarely occur. Erythematous rash, pruritus, urticaria and alopecia have also been reported in association with carboplatin.
Musculoskeletal and Connective Tissue Disorders: Myalgia/arthralgia.
Neurotoxicity: In the majority of patients, neurotoxicity manifests mainly as paraesthesias and decreased deep tendon reflexes. The effect, more common in patients over 65 years of age, appears to be cumulative, occurring mainly in patients receiving prolonged therapy and/or in those who have received prior cisplatin therapy. Central nervous system effects may also occur. Pre-existing paraesthesias (especially those related to previous cisplatin treatment) may worsen during carboplatin therapy.
Metabolism and Nutrition Disorders: Electrolyte abnormalities (hypokalaemia, hypocalcaemia, hyponatraemia and/or hypomagnesaemia).
Others: Asthenia, flu-like symptoms (1%) and reactions at injection site (<1%).
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