Carboplatin-Tranet

Carboplatin.

Carboplatin Infusion is a clear, colourless solution.
Each 1 ml of concentrate for solution for infusion contains 10 mg of carboplatin.
Each 15 ml vial contains 150 mg of carboplatin. Each 45 ml vial contains 450 mg of carboplatin.
Excipients/Inactive Ingredients: The other ingredient is water for injections.

Carboplatin Infusion contains carboplatin, which belongs to a group of medicines known as platinum coordination compounds, which are used to treat cancer.

Carboplatin Infusion is used against advanced cancer of the ovary and small cell cancer of the lung.

This medicine will be administered by infusion (drip) into a vein over 15-60 minutes.
Dose: The correct dose of carboplatin and how often it must be given should be determined.
The dose will depend on the medical condition, size and how well the kidneys are working. Patients should be informed how well their kidneys are working using blood or urine samples. Regular blood tests should be performed after the dose of carboplatin. Patients may also have checks for nerve damage and hearing loss.
There is likely to be about 4 weeks between each dose of carboplatin.
Instructions for use - Cytotoxic: Carboplatin should be used by the intravenous route only. The recommended dosage of carboplatin in previously untreated adult patients with normal kidney function, i.e. creatinine clearance >60 ml/min, is 400 mg/m² as a single short-term IV dose administered by a 15- to 60-minute infusion. Alternatively, the Calvert formula shown in the following table may be used to determine dosage: See table.

Click on icon to see table/diagram/image

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.
Reduction of the initial dosage by 20-25% is recommended for those patients who present with risk factors such as prior myelosuppressive treatment and low performance status (ECOG-Zubrod 2-4 or Karnofsky below 80).
Determination of the haematological nadir by weekly blood counts during the initial courses of treatment with Carboplatin Infusion is recommended for future dosage adjustment.
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 values of less than 60 ml/min are at greater risk to develop myelosuppression. The frequency of severe leukopenia, neutropenia, or thrombocytopenia has been maintained at about 25% with the following dosage recommendations: Combination Therapy: The optimal use of Carboplatin Infusion in combination with other myelosuppressive agents requires dosage adjustments according to the regimen and schedule to be adopted.
Paediatric patients: The safety and efficacy of carboplatin in children has not yet been established. No data are available. As no sufficient experience of carboplatin use in children is available, no specific dosage recommendations can be given.
Elderly: In the case of patients aged over 65, the carboplatin dosage needs to be adjusted to their general state of health during the first and subsequent courses of treatment.
Dilution and Reconstitution: The product must be diluted prior to infusion, with 5% glucose solution or 0.9% sodium chloride solution, to concentrates as low as 0.5 mg/ml.
Discontinuation of Carboplatin Infusion: Patients should be advised if they have any further questions on the use of this product.

This medicine will be administered in a hospital or clinic, under the supervision of a physician. It is unlikely that too much or too little will be administered, however, caution should be exercised.

Carboplatin Infusion should not be used in: patients with allergy to carboplatin or any of the other ingredients of this medicine (listed in Description) or similar platinum-containing medicines; patients with severe kidney disease; patients with fewer blood cells than normal (this should be checked with a blood test); patients with bleeding tumour; patients who plan to receive a yellow fever vaccination or have just received one.

Caution should be exercised before using Carboplatin Infusion in: patients who are pregnant or with a chance of being pregnant; patients who are breast-feeding; patients with mild renal disease (patients should be monitored more regularly); patients who are elderly (over 65 years old); patients who have been treated with cisplatin or similar anti-cancer medicines in the past (carboplatin may cause abnormalities in the nervous system, such as pins and needles or hearing and vision problems) (patients may be regularly assessed); patients with headache, altered mental functioning, seizures and abnormal vision from blurriness to vision loss; patients who develop extreme tiredness and shortness of breath with decreased number of red blood cells (haemolytic anaemia), alone or combined with low platelet count, abnormal bruising (thrombocytopenia) and kidney disease where little or no urine is passed (symptoms of haemolytic uraemic syndrome); patients with fever (temperature greater than or equal to 38°C), or chills, which could be signs of infection (patients may be at risk of getting an infection of the blood).
In some cases during treatment with carboplatin, patients will be given medicines which help reduce a potentially life-threatening complication known as tumour lysis syndrome, which is caused by chemical disturbances in the blood due to the breakdown of dying cancer cells that release their content to the bloodstream.
The Carboplatin Infusion vial stopper contains dry natural rubber (a derivative of latex), which may cause allergic reactions.
Driving and using machines: Patients should not drive or use machines if they experience any side effect which may lessen the ability to do so such as nausea, vomiting, worsening of eyesight, or changes to vision and hearing.

Patients should be advised before taking this medicine if they are pregnant or breast-feeding, may be pregnant or are planning to have a baby.
Pregnancy: Due to the possible risk of birth defects, female patients of childbearing potential should take contraceptive measures before and during treatment with carboplatin.
Breast-feeding: It is not known whether carboplatin is excreted into the breast milk. Therefore, during treatment with Carboplatin Infusion, breast-feeding should be discontinued.
Fertility: Men treated with this medicine are advised not to father a child during, and up to 6 months after treatment. Advice on conservation of sperm should be sought prior to treatment because of the possibility of irreversible infertility. Treatment with carboplatin may temporarily or permanently reduce fertility in men and women.

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Immediate medical attention is necessary in case of the following: Abnormal bruising, bleeding, or signs of infection such as a sore throat and high temperature; Severe allergic reaction (anaphylaxis/anaphylactic reactions) (patients may experience a sudden itchy rash (hives), swelling of the hands, feet, ankles, face, lips, mouth or throat which may cause difficulty in swallowing or breathing, and patients may feel they are going to faint); Muscle cramping, muscle weakness, confusion, visual loss or disturbances, irregular heartbeat, kidney failure or abnormal blood test results (symptoms of tumor lysis syndrome which can be caused by the rapid breakdown of tumour cells) (see Precautions).
These are serious side effects. Patients may need urgent medical attention.
Very common (may affect more than 1 in 10 people): Myelosuppression; Tiredness, shortness of breath and paleness caused by anaemia; Increase in the level of urea in the blood; Abnormal liver enzyme levels; Nausea or vomiting; Stomach pain and cramp; Decrease in the level of sodium, potassium, calcium and magnesium in the blood; Decrease in renal creatinine clearance.
Common (may affect up to 1 in 10 people): Diarrhoea or constipation; Rash and/or itchy skin; Ringing in the ears or changes in hearing; Hair loss; Flu-like symptoms; Signs of infection such as fever or sore throat; Symptoms of severe allergic reaction including sudden wheeziness or tightness of chest, swelling of the eyelids, face or lips, facial flushing, low blood pressure, rapid heartbeat, hives, shortness of breath, dizziness and anaphylactic shock; Tingling or numbness in the hands, feet, arms or legs; Burning or prickling sensation; Decreased tendon reflex; Taste disturbance or loss of taste; Temporary worsening of eyesight or changes to the vision; Heart disorders; Tightness of the chest or wheezing; Interstitial lung disease; Sore lips or mouth ulcers (mucous membrane disorders); Pain or discomfort in the bones, joints, muscles, or surrounding structures (musculoskeletal disorder); Problems with the kidneys or urine; Asthenia; Increased level of bilirubin and creatinine in the blood; Increased level of uric acid in the blood which may lead to gout.
Rare (may affect up to 1 in 1,000 people): Temporary sight loss; Febrile neutropenia.
Very rare (may affect up to 1 in 10,000 people): Pulmonary fibrosis.
Not known (frequency cannot be estimated from the available data): Secondary malignancies; Haemolytic uraemic syndrome; Dry mouth, tiredness, and headache due to dehydration; Loss of appetite, anorexia; Stroke; Severely impaired liver function, damage or death of liver cells; Heart failure; Embolism; Hypertension or hypotension; Skin disorders such as hives, rash, erythema, and itching; Swelling or soreness where the injection was given; Group of symptoms such as headache, altered mental functioning, seizures and abnormal vision from blurriness to vision loss (symptoms of reversible posterior leukoencephalopathy syndrome); Pancreatitis; Stomatitis; Lung infection.
Carboplatin may lead to problems with the blood, liver and kidneys. Blood samples should be taken to check for these problems.
Reporting of side effects: Side effects should be reported. This includes any possible side effects not previously listed.

Other medicines and Carboplatin Infusion: Special care is needed if patients are taking/using other medicines as some could interact with carboplatin, for example: medicines which can reduce the number of cells in the blood (at the same time as carboplatin, may require changes to the dosage and frequency of carboplatin treatment); aminoglycosides, vancomycin or capreomycin (at the same time as carboplatin, may increase the risk of kidney or hearing problems); some diuretics (at the same time as carboplatin, may increase the risk of kidney or hearing problems); live or live-attenuated vaccines (for yellow fever vaccine, see Contraindications); blood thinning medicines e.g. warfarin (at the same time as carboplatin, may require an increase in frequency of blood coagulation monitoring); phenytoin and fosphenytoin (at the same time as carboplatin, may increase the risk of a seizure); immunosuppressants (e.g. ciclosporin, tacrolimus, sirolimus).
Patients should inform their physician if they are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Carboplatin Infusion with food and drink: There is no known interaction between carboplatin and alcohol. However, patients should check with their physician as carboplatin may affect the liver's ability to cope with alcohol.

Handling of carboplatin: As with other antineoplastic agents, carboplatin must be prepared and handled with caution. The following protective measures should be taken when handling carboplatin. Personnel should be trained in appropriate techniques for reconstitution and handling.
1. Carboplatin should be prepared for administration only by professionals who have been trained in the safe use of chemotherapeutic agents. Personnel handling Carboplatin Infusion should wear protective clothing: goggles, gowns and disposable gloves and masks.
2. A designated area should be defined for syringe preparation (preferably under a laminar flow system), with the work surface protected by disposable, plastic-backed, absorbent paper.
3. All items used for reconstitution, administration or cleaning (including gloves) should be placed in high-risk, waste-disposal bags for high temperature incineration.
4. Spillage or leakage should be treated with dilute sodium hypochlorite (1% available chlorine) solution, preferably by soaking, and then water. All contaminated and cleaning materials should be placed in high-risk, waste-disposal bags for incineration. Accidental contact with the skin or eyes should be treated immediately by copious lavage with water, or soap and water, or sodium bicarbonate solution. However, do not abrade the skin by using a scrub brush. Medical attention should be sought. Always wash hands after removing gloves.
Preparation of infusion solution: The product must be diluted before use. It may be diluted with 5% Glucose or 0.9% Sodium Chloride, to concentrations as low as 0.5 mg/ml (500 micrograms/ml).
Disposal: Medicines should not be disposed of via wastewater or household waste. All material used for preparation, administration or otherwise coming into contact with carboplatin should undergo disposal according to local guidelines for the handling of cytotoxic compounds.
Incompatibilities: Carboplatin may interact with aluminium to form a black precipitate. Needles, syringes, catheters or intravenous sets containing aluminium parts that may come into contact with carboplatin should not be used for preparation or administration of drug. Precipitation can lead to a reduction of the antineoplastic activity.

Carboplatin Infusion is intended for single use only.
Before opening: Store below 25°C. Keep vial in the outer carton in order to protect from light.
After dilution: When diluted as directed with Glucose 5%, carboplatin solutions are stable for 8 hours at temperature ≤25°C or for 24 hours at 2° - 8°C.
When diluted as directed with Sodium Chloride 0.9%, carboplatin solutions are stable for 1 hour at temperature ≤25℃ or for 12 hours at 2° - 8°C.
From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user, and would normally not be longer than 24 hours at 2-8°C when diluted as directed with Glucose 5% or not be longer than 12 hours at 2-8°C when diluted as directed with Sodium Chloride 0.9%, unless dilution has taken place in controlled and validated aseptic conditions.

Cytotoxic Chemotherapy

L01XA02 - carboplatin ; Belongs to the class of platinum-containing antineoplastic agents. Used in the treatment of cancer.

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