Sanbeplatin

Sanbeplatin Adverse Reactions

carboplatin

Manufacturer:

Sanbe
Full Prescribing Info
Adverse Reactions
Myelosuppression is the dose-limiting toxicity of Carboplatin. It is generally reversible and is not cumulative when Carboplatin is used as single agent and at the recommended frequencies of administration. Adverse reactions which have been observed in studies to date can be grouped under the following organ systems: Haematopoietic system: Leucopenia, thrombocytopenia, anaemia. Transfusional support has been required in about one-fifth of patients.
Gastrointestinal system: Nausea and vomiting, nausea only, diarrhea, constipation. Nausea and vomiting are generally delay 6-12 hours after administration of Carboplatin and disappear within 24 hours. It is readily controlled (or may be prevented) with antiemetic medication.
Renal system: Decrease in creatinine clearance: increase in uric acid, blood urea nitrogen and serum creatinine.
Biochemistry: Decreases in serum magnesium, potassium and rarely, calcium. These changes have not been severe enough to cause clinical symptoms.
Neurotoxicity: Peripheral neuropathy which was mild and dysgeusia. Paraesthesias present prior to treatment, especially if caused by Cisplatin, may persist or worsen during Carboplatin therapy (see Precautions).
Ototoxicity: Subclinical decrease in hearing acuity as determined by audiogram, in the high frequency (4,000-8,000 Hz) range; clinical ototoxicity, usually manifested as tinnitus. In patients who developed hearing loss as a result of Cisplatin therapy, the impairment may persist or worsen.
Hepatic System: Increases in liver enzymes have been transient in the majority of cases. Alkaline phosphatase (ALP), aspartate, aminotransferase (AST), bilirubin.
Allergic reactions: In less than 2 % of patients similar to those seen after Cisplatin have been observed i.e. erythematous rash, fever and pruritus. In a few cases no cross-reactivity was present.
Others: Alopecia, flu-like syndrome, reaction at injection site (<1%).
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