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CARBOPLATIN

 For Healthcare Professional Only

CARBOPLATIN

Carboplatin - Vial 50mg, 150mg, 450mg

Indications:
Carboplatin is used alone or in combination with other antineoplastic agents in the treatment of following malignant tumours:
    • Advanced ovarian carcinoma of epithel origin in: First therapy, second line therapy after other treatments have failed
    • Small cell acrcinoma of the lung

Dosage:
Previously untreated adult patients with normal renal function receive 400mg carboplatin/m2 body surface as iv short term infusion (15-60 min), therapy cycles can be repeated after 4 weeks therapy free interval. Patients with risk (previously treated with myelosuppressive active drugs and/or radiation therapy or general bad condition) should be treated with an initial dose of 300-320mg/m2. Initial dosage should be reduced 20-25% in patients with risk factor such as previous myelosuppressive therapy and/or poor performance status. Determination of haemotologic nadir by weekly blood counts during initial courses is recommended for future dosage adjustment and scheduling of carboplatin.

Impaired renal function:
Dosage should be reduced with haemotological nadirs and renal function should have been monitored.
Combination therapy:
The optimal use of Carboplatin in combination with other myelopsuppressive agents required dosage adjustments according to the regiment and schedule to be adopted.
Use in elderly:
Dosage adjustments may be necessary in eldery patients and also in patients who receiving combination chemotherapy.
Use in children/infants:
A specific dosage recommendation for children and infants cannot made due to insufficient use in paedatrics at this time.

Contraindications:
    • hypersensitivity to drug components or other platin complexes.
    • pregnancy and lactation period.
    • severe myelopsuppression.
    • renal impairment (glomerular filtration rate <30ml/min).
    • bleeding tumours.

Special precautions:

Carboplatin should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. Before starting a therapy and before each new therapy cycle blood counts and renal function must be monitored. A strict blood picture control (particulary thrombocytes) during therapy free interval is required particulary in combination therapy schemata with myelopsuppressive agents. Dosage adjustment are in these cases also required. Neurologic examinations including ausiometric ones must be regulary done.

Therapy with carboplatin must be carried out only in patients with normal bone marrow,renal and nerve function, respectively after normalisation of these functions the therapy with carboplatin must be accurately be considered and carried out with precautions. Like all other cytostatic drugs care is to be taken in handling carboplatin. Pregnancy must be avoided before and after therapy. Pregnant patients must not be treated with carboplatin. Carboplatin may impair concentration capacity and ability in driving and handling with machines. A specific antidote for overdosage is not available. Bone marrow transplantation and transfusions can help to moderate hematologic side effects.

Anaphylactic-like reactions to carboplatin have been reported and may occur within minutes of carboplatin administration. Epinephrine, corticoides and antihistamines have been employed to alleviative symptoms. Bone marrow suppresion is dose related any may be severe,resulting in infection and/or bleeding Anemia may be cumulative and may require tranfusion support. Vomiting is another frequent drug-related side effect. Carboplatin can include emesis,which can be more severe in patients receiving emetogenic therapy. The incidence and intesity of emesis haev been reduced by using premedication with antiemetics. Although no conclusive efficacy data exist with the following schedules of Carboplatin lengthening the duration of single intravenous administration to 24 hours or dividing the total dose over five consecutive daily pulse had resulted in reduced emesis. Loss of vision,which can be complete for light colors,has been reported after the use of Carboplatin with doses higher than those recommended in the package insert. Vision appears to recover totally or to a significant extent within a few weeks of stopping these high doses.

Use only fresh prepared and clear solutions!

Only for single use!

Adverse Drug Reactions :
Hematopoietic system:
The normal reversible myelopsuppression represents a dose limitation. Thrombopenia can appear rarely with low doses (,200mg/m2). Hemoglobin can decrease under 9.5/100ml. Myelopsuppression can be of severe intensity in patients previously treted chemotherapeutically or with an age over 65 or with impaired renal function. Infections and/or bleedings were observed. Also with low dose therapy (,200mg/m2) rare cases of thrombopenia were observed.
Renal system : Disturbances of therenal function are usually not a dose limiting side effect. A carboplatin treatment without forced diuresis and liquid administraiton leads to renal function disturbances with a reversible increase of BUN or serum in about 15% of patients. A reversible creatinin-clearance decrease under 60ml/min was also observed. In severe cases of renal impairment the carboplatin dose must be reduced or therapy must be stopped. Hematuria and oedema formation were observed.
Hyperuricaemia:
a hyperuricaemia was observed in about 25% of patients. The administration of allopurinol can reduce the increased serum-uric acid value.
Plasma electrolyte:
A decrease of magnesium, calcium and potassium concentration is possible. This decrease of electrolytes is minimal and no clinical signs were observed.
Auditory System:
Disturbances of the audition with limitation in the high frequency range (4000-8000 Hz) were observed in about 15% of patients treated with carboplatin; in 1% of patients tinnitus was noted. In patients with disturbed audition caused by previously cisplatin treatment the auditory system disturbances are more frequent.
Neurology:
Peripheral neuropathies such as symptoms of paresthesia, formication and/or decrease of tendon relfex are described in a rate of 6%. In patients previously treated with cisplatin these side effects appear more often. Hallucination and anxiety appear also.
Hepatic:
An increase of liver enzymes was observed in 15-36% of patients treated with carboplatin. Usually they were reversible and no therapy interruption was necessary.
Gastrointestinal:
Anoressia and nausea without vomiting were reported in 25% of patients,with vomiting in 53% (severe vomiting in 17%)
Symptoms can be controlled and reduced using antiemetics and dissapear mainly 24 hours after carboplatin administration. Diarrhea and/or obstipation were observed in 6% resp. 4% of patients.
Allergic reactions:
Allergic reactions like fever,pruritus,erythema were observed in less than 2% of patients. treatment with antihistamines, glucocorticoids and andrenalin may be necessary if bronchospasm and hypotension appear.
Other rare side effect:
Alopecia,fever,chill,headache,taste disturbances were observed in less than 2% of patients.

For details information, please contact us at info@ferron-pharma.com