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Carboplat

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Indications:

Antineoplastic agent indicated in the treatment of: • ovarian carcinoma of epithelial origin • small cell lung carcinoma.

Contraindications:

Carboplatin is contraindicated in patients with severe myelosuppression, pre-existing severe renal impairment (with creatinine clearance of less than 20 ml per minute) and a history of severe allergic reaction to carboplatin or other platinum containing compounds. Dosage adjustment may allow use in the presence of mild renal impairment

Adverse reactions:

Myelosuppression is the dose limiting toxic reaction of carboplatin. It is generally reversible and not cumulative when carboplatin is used as a single agent at recommended frequencies of administration. Adverse reactions which have occurred in studies to date can be grouped under the following systems: Blood and the lymphatic system disorders: Leucopenia (55%), thrombocytopenia (32%) and anaemia (59%) of patients. Transfusion support has been required in about 20% of patients. Haemolytic uraemic syndrome has been reported. Infectious complications and haemorrhagic complications have also been reported. 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: Nausea and vomiting (53%), nausea only in 25%. 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. Diarrhoea occurred in 6% and constipation in 3% of patients. Abdominal pain and cramps have also been reported. Nervous system disorders: Mild peripheral neuropathy occurred in 6% of patients and dysgeusia in less than 1% of patients. Parasthesias present prior to treatment, especially if caused by cisplatin, may persist or worsen during carboplatin therapy. (See Precautions). Eye disorders: Transient visual disturbances, sometimes including transient sight loss, have been reported rarely with platinum therapy. This is usually associated with high dose therapy in renally impaired patients. Ear and labyrinth disorders: A subclinical decrease in hearing acuity in the high frequency range (4000-8000 Hz), determined by audiogram, occurred in 15% of patients. Clinical ototoxicity also manifested itself as tinnitus (1% of patients). Hearing loss as a result of cisplatin therapy may give rise to persistent or worsening symptoms. At higher than recommended doses, in common with other ototoxic agents, clinically significant hearing loss has been reported to occur in paediatric patients when carboplatin is administered. Hepato-biliary disorders: Transient increases in liver enzymes have been reported in some patients. Alkaline phosphatase was increased in 30% of patients, with aspartate aminotransferase (15% patients) and elevated serum bilirubin (4% patients) occurring less frequently. Renal and urinary disorders: Renal toxicity is not usually dose limiting. However, a decrease in creatinine clearance is observed in approximately 25% of patients. A rise in uric acid (25%) and, less frequently, a rise in serum creatinine (7%) and blood urea nitrogen (16%) have also been observed. Impairment of renal function is more likely in patients who have previously experienced nephrotoxicity as a result of cisplatin therapy. General disorders: Rarely anaphylaxis and anaphylactic-like reactions have been reported including tachycardia, bronchospasm, dyspnoea, hypotension, wheezing, urticaria, facial oedema and facial flushing. Erythematous rash, fever and pruritis have been observed in less than 2% of patients treated. These were reactions similar to those seen after cisplatin therapy but in a few cases no cross-reactivity was present. Decreased serum levels of magnesium (37% patients), potassium (16% patients) and calcium (5% patients) have occurred although not severe enough to cause clinical symptoms. Decreased serum sodium has also been reported although it is normally insufficient to require treatment. There have also been rare reports of hyponatraemia. Asthenia is very commonly reported. Rare events have included alopecia (2%), a flu-like syndrome (1%) and reaction at the injection site (<1%). Cases of anorexia have been reported.

Interactions:

Carboplatin may interact with aluminium to form a black precipitate. Needles, syringes, catheters or IV administration sets that contain aluminium parts which may come into contact with carboplatin, should not be used for the preparation or administration of the drug. Concurrent therapy with nephrotoxic or ototoxic drugs such as aminoglycosides, vancomycin, capreomycin and diuretics, may increase or exacerbate toxicity due to carboplatin induced changes in renal clearance. Combination therapy with other myelosuppressive agents may require dose changes or rescheduling of doses in order to minimise the additive myelosuppressive effects.

Warnings:

* 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 for their disease, have poor performance status and are advanced in years. Renal function parameters should be assessed prior to, during and after carboplatin therapy. 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. Infrequent allergic reactions to carboplatin have been reported, e.g. erythematous rash, fever with no apparent cause or pruritus. Rarely, anaphylaxis, angio oedema and anaphylactoid reactions including bronchospasm, urticaria and facial oedema have occurred. These reactions are similar to those observed after administration of other platinum containing compounds and may occur within minutes. The incidence of allergic reactions may increase with previous exposure to platinum therapy; however, allergic reactions have been observed upon initial exposure to carboplatin. Patients should be observed carefully for possible allergic reactions and managed with appropriate therapy, including antihistamines, adrenaline and/or glucocorticoids. * 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 and renal function tests should be monitored closely. Blood counts should be performed prior to commencement of carboplatin therapy and at weekly intervals thereafter. This will monitor toxicity and help determine the nadir and recovery of haematological parameters and assist in subsequent dosage adjustments. 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 levels fall below 2000 cells/mm3 or platelets 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. The incidence and severity of nephrotoxicity may increase in patients who have impaired kidney function before carboplatin treatment. It is not clear whether an appropriate hydration programme might overcome such an effect but dosage reduction or discontinuation of therapy is required in the presence of severe alteration in renal function test. Impairment of renal function is more likely in patients who have previously experienced nephrotoxicity as a result of cisplatin therapy. Neurological evaluation and an assessment of hearing should be performed on a regular basis. Neurotoxicity, such as paraesthesia, decreased deep tendon reflexes and ototoxicity are more likely seen in patients previously treated with cisplatin.

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Consultants Corner

Dr. Samer Al-Jneidy

Dr. Samer Al-Jneidy Pediatrician

Dr. Hani Najjar

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Samir Moussa M.D.

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Dr . Dirar Abboud

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