Carboxa

Carboplatin

Chemical

Injectable

Dosage form :

Vials

Doses :

50/150/450 mg

Short Description:

Carboxa contains the active substance carboplatin. Carboxa is a medicine that is used to treat cancer of the ovaries. It acts by interfering with the division of rapidly multiplying cells, particularly cancer cells.

Product Introduction

What Carboxa is and what it is used for?

Carboxa is an anti-cancer medicine. Treatment with an anti-cancer medicine is sometimes called cancer chemotherapy.

Carboplatin is used in the treatment of some types of lung cancer and ovarian cancer.

Before you take Carboxa

Do not take Carboxa

If you are allergic to carboplatin.
If you have had hypersensitivity to similar platinum containing medicines in the past.
If you have severe kidney disease.
If you have fewer blood cells than normal (your doctor will check this with a blood test).
If you have a tumour that bleeds.
If you plan to receive a yellow fever vaccination or have just received one.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using Carboxa.

If you are pregnant or if there is a chance you may be pregnant.
If you are breast-feeding.
If you have mild renal disease. Your doctor will want to monitor you more regularly.
If you are elderly (over 65 years old).
If you have been treated with cisplatin or similar anti-cancer medicines in the past, carboplatin may cause abnormalities in your nervous system, such as pins and needles or hearing and vision problems. Your doctor may regularly assess you.
If you have headache, altered mental functioning, seizures and abnormal vision (from blurriness to vision loss).
If you develop extreme tiredness and shortness of breath with decreased number of red blood cells, (hemolytic anemia), alone or combined with low platelet count, abnormal bruising (thrombocytopenia) and kidney disease where you pass little or no urine (symptoms of hemolytic-uremic syndrome).
If you have fever (temperature greater than or equal to 38 °c), or chills, which could be signs of infection. You may be at risk of getting an infection of the blood.

Other medicines and Carboxa

Tell your doctor, pharmacist or nurse if you taking, have recently taken or might take any other medicines, for example:

Medicines which can reduce the number of cells in your blood, at the same time as carboplatin, may require changes to the dosage and frequency of your carboplatin treatment
Some antibiotics called aminoglycosides, vancomycin or capreomycin, at the same time as carboplatin, may increase the risk of kidney or hearing problems
Some water tablets (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)
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 (used to treat various types of convulsions and seizures), at the same time as carboplatin, may increase the risk of a seizure
Other medicines which decrease the activity of the immune system (e.g. ciclosporin, tacrolimus, sirolimus)

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Due to the possible risk of birth defects, female patients of childbearing potential should take contraceptive measures before and during treatment with carboplatin.

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. Tell your doctor if you have concerns.

Driving and using machines

Do not drive or use machines if you experience any side effect which may lessen your ability to do so such as nausea, vomiting, worsening of eyesight, or changes to your vision and hearing.

How to take Carboxa?

This medicine will be given by infusion (drip) into a vein over 15-60 minutes.

Your doctor will work out the correct dose of carboplatin for you and how often it must be given.

The recommended dose will depend on your medical condition, your size and how well your kidneys are working. Your doctor will tell how well your kidneys are working using blood or urine samples.

You will have regular blood tests after your dose of carboplatin. You may also have checks for nerve damage and hearing loss.

There is likely to be about 4 weeks between each dose of carboplatin.

Carboplatin should be prepared for administration only by professionals who have been trained in the safe use of chemotherapeutic agents.

Carboplatin solution for infusion may be further diluted in Dextrose 5% and administered as an intravenous infusion. Chemical and physical in-use stability has been demonstrated for 24 hours to final concentration of 0.5 mg/ml and 2 mg/ml when stored at 25°C in non-PVC infusion bags when protected from light.

Carboplatin solution for infusion may also be further diluted in Sodium Chloride 0.9% and administered as an intravenous infusion.

Chemical in-use stability has been demonstrated for 24 hours to final concentration of 1 mg/ml when stored at 25°C.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If any of the following happen, tell your doctor immediately:

Abnormal bruising, bleeding, or signs of infection such as a sore throat and high temperature
Severe allergic reaction ( anaphylaxis / anaphylactic reactions) – you 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 you may feel you are going to faint

Hemolytic-uremic syndrome (a disease characterized by acute kidney failure), decreased urination or blood in the urine

These are serious side effects. You may need urgent medical attention.

Very common side effects (may affect more than 1 in 10 people):

Tiredness, shortness of breath and paleness caused by anemia (a condition in which there is a decreased number of red blood cells)
Feeling sick (nausea) or being sick (vomiting)
Stomach pain and cramp
Changes in your red and white blood cells and platelets (myelosuppresion)
Increase in the level of urea in your blood
Decrease in the level of sodium, potassium, calcium and magnesium in your blood
Decrease in renal creatinine clearance
Abnormal liver enzyme levels

Common side effects (may affect up to 1 in 10 people):

Signs of infection such as fever or sore throat
Flu-like symptoms
Symptoms of severe allergic reaction include sudden wheeziness or tightness of chest, swelling of the eyelids, face or lips, facial flushing, low blood pressure, rapid heart beat, hives, shortness of breath, dizziness and anaphylactic shock
Tingling or numbness in your 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 your vision, ringing in the ears or changes in your hearing
Heart disorders
Tightness of the chest or wheezing
Interstitial lung disease (a group of lung disorders in which the deep lung tissues become inflamed)
Diarrhea or constipation
Sore lips or mouth ulcers (mucous membrane disorders)
Hair loss
Rash and/or itchy skin
Pain or discomfort in your bones, joints, muscles, or surrounding structures (musculoskeletal disorder)
Problems with your kidneys or urine
Extreme tiredness/ weakness (asthenia)
Increased level of bilirubin and creatinine in your blood
Increased level of uric acid in your blood which may lead to gout.

Rare side effects (may affect up to 1 in 1,000 people):

Temporary sight loss

Very rare side effects (may affect up to 1 in 10,000 people):

Scarring of the lungs which causes shortness of breath and/or cough (pulmonary fibrosis)

Not known side effects (frequency cannot be estimated from the available data):

Cancers caused by treatment with carboplatin (secondary malignancies)
Feeling unwell with high temperature due to low levels of white blood cells (febrile neutropenia)
A group of symptoms such as headache, altered mental functioning, seizures and abnormal vision (from blurriness to vision loss). These are symptoms of reversible posterior leukoencephalopathy syndrome, a rare neurological disorder
Dry mouth, tiredness, and headache due to excessive loss of body water (dehydration)
Loss of appetite, anorexia
Pancreatitis
Stroke (sudden numbness or weakness in the face, arm, or leg, especially on one side of the body)
Severely impaired liver function, damage or death of liver cells
Heart failure
Obstruction in blood vessel (embolism), swelling or tenderness of leg/ arm
Changes in blood pressure (hypertension or hypotension)
Skin disorders such as hives, rash, skin redness (erythema), and itching
Swelling or soreness where the injection was given
Lung infection

Carboplatin may lead to problems with your blood, liver and kidneys. Your doctor will take blood samples to check for these problems.

How to store Carboxa?

Keep out of the reach of children.

Store below 25°C. Keep vial in outer carton in order to protect from light.

Protect from freezing.

The diluted solution should be used immediately. If not used immediately it should not normally be stored for longer than 24 hours at 2 to 8°C.

Do not use this medicine after the expiry date which is stated on the label and carton.

For single-used only. Discard unused portion.

The medicine should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further information

What Carboxa contains?

The active substance is carboplatin. Each ml of solution contains 10 mg of carboplatin.

Carboxa

Carboplatin

Category:

Chemical

Injectable

Dosage form :

Vials

Doses :

50/150/450 mg

Short Description:

Carboxa contains the active substance carboplatin. Carboxa is a medicine that is used to treat cancer of the ovaries. It acts by interfering with the division of rapidly multiplying cells, particularly cancer cells.

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