Carboplatin 10 mg/ml Concentrate for Solution for Infusion – patient leaflet, side effects, dosage

1. What Carboplatin is and what it is used for

Carboplatin is an anti-cancer medicine. Treatment with an anti-cancer medicine is sometimes called cancer chemotherapy. It is used in the treatment of some types of lung cancer and ovarian cancer.

2. What you need to know before you use Carboplatin

Do not use Carboplatin

• if you are allergic to carboplatin or any of the other ingredients of this medicine (listed in section 6)
• 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.

Tell your doctor if any of the above applies to you before this medicine is used.

This medicine should be administered only by or under the direct supervision of a qualified physician who is experienced in the use of cancer chemotherapeutic agents.

Carboplatin is very toxic and treatment is likely to cause some side effects.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using Carboplatin

• if you are pregnant or if there is a chance you may be pregnant
• if you are breast-feeding
• if you have 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, this medicine may cause abnormalities in your nervous system, such as pins and needles or hearing and vision problems. Your doctor should 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 (haemolytic anaemia), alone or combined with low platelet count, abnormal bruising (thrombocytopenia) and kidney disease where you pass little or no urine (symptoms of Haemolytic-uraemic 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.

Kidney function and blood counts should be assessed before, during and after treatment. These measures are to monitor toxicity and assist in dose adjustment.

Your doctor may give you medicines immediately before treatment with Carboplatin to prevent vomiting. During treatment with Carboplatin, you 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.

Other medicines and Carboplatin

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

• medicines or treatments such as radiation therapy which reduce the number of cells in your blood, as this may require changes to the dosage and frequency of your Carboplatin treatment
• some antibiotics called aminoglycosides, as this may increase the risk of kidney or hearing problems
• medicines which are damaging to the kidney, will have an enhanced effect on the kidneys
• some water tablets (diuretics), as this may increase the risk of kidney or hearing problems
• live or live-attenuated vaccines (or yellow fever vaccine - see section 2 'Do not use Carboplatin')
• blood thinning medicines e.g. warfarin, as this may require an increase in frequency of blood coagulation monitoring
• phenytoin and fosphenytoin (used to treat various types of convulsions and seizures), as this may increase the risk of a seizure
• other medicines which decrease the activity of the immune system (e.g. ciclosporin, tacrolimus, sirolimus)
• medicines which cause vomiting, as these will have an enhanced effect.

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.

To avoid possible harmful effects in the infant, breast-feeding must be stopped during carboplatin therapy and for at least one month following the last dose.

Due to the possible risk of birth defects, female patients of childbearing potential should always use effective birth-control (contraception) during treatment with carboplatin, and for at least seven months after the last dose.

Men treated with this medicine are advised to use effective birth-control (contraception) during treatment, and up to four 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.

Talk to your doctor about birth control methods that are right for you and your partner.

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.

The Carboplatin vial stopper contains dry natural rubber (a derivative of latex), which may cause allergic reactions.

3. How to use Carboplatin

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

Dose

Your doctor will work out the correct dose of this medicine 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.

If you are given more Carboplatin than you should

This medicine will be given to you in a hospital, under the supervision of a doctor. It is unlikely that you will be given too much or too little, however, tell your doctor or nurse if you have any concerns.

4. 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), wheeziness or tightness of chest, swelling of the hands, feet, ankles, face, eyelids, lips, mouth or throat (which may cause difficulty in swallowing or breathing), facial flushing, low blood pressure, rapid heartbeat, shortness of breath, dizziness, you may feel you are going to faint and you may experience chest pain which can be a sign of a potentially serious allergic reaction called Kounis syndrome
• haemolytic-uraemic syndrome (a disease characterised by acute kidney failure), decreased urination or blood in the urine
• a side effect called tumour lysis syndrome, which can be caused by the rapid breakdown of tumour cells and may cause muscle cramping, muscle weakness, confusion, visual loss or disturbances, irregular heartbeat, kidney failure or abnormal blood test results (see section 2).

These are serious side effects. Tell your doctor straight away if you notice any of the following symptoms. You may need urgent medical attention.

Some side effects could be serious.

Very common: may affect more than 1 in 10 people

• tiredness, shortness of breath and paleness caused by anaemia (a condition in which there is a decreased number of red blood cells)
• feeling sick (nausea) or being sick (vomiting)
• stomach pain and cramp

Tests may also show:

• changes in your red and white blood cells and platelets (myelosuppression)
• 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: may affect up to 1 in 10 people

• signs of infection such as fever or sore throat
• flu-like symptoms
• tingling or numbness in your hands, feet, arms or legs
• burning or prickling sensation
• decreased tendon reflex
• taste disturbance or loss of taste
• 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)
• diarrhoea 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)

Tests may also show:

• increased level of bilirubin and creatinine in your blood
• increased level of uric acid in your blood which may lead to gout

Very rare: 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: frequency cannot be estimated from the available data

• cancers caused by treatment with carboplatin (secondary malignancies)
• cancers of the blood and bone
• 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
• toxicity of nervous system (peripheral neuropathy)
• 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
• abnormal breakdown of red blood cells, leading to a deficiency in the number or quality of red blood cells
• obstruction in a blood vessel (embolism and veno-occlusive disease), 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
• fewer red blood cells due to their excessive breakdown (haemolytic anaemia)
• mental changes (encephalopathy)
• muscle pain*, joint pain*
• kidney failure
• lung infection e.g. pneumonia

*with combined use

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

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Carboplatin

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label after EXP. The expiry date refers to the last day of that month.

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

If Carboplatin 10 mg/ml Concentrate for Solution for Infusion is diluted before use, 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 8ºC.

6. Contents of the pack and other information

What Carboplatin contains

The active substance is carboplatin. Each 1 ml of concentrate for solution for infusion contains 10 mg of carboplatin.

Each 10 ml vial contains 50 mg of carboplatin.

Each 20 ml vial contains 150 mg of carboplatin.

Each 50 ml vial contains 450 mg of carboplatin.

The other ingredient is water for injections.

What Carboplatin looks like and contents of the pack

Carboplatin 10 mg/ml Concentrate for Solution for Infusion is a clear, colourless to slightly pale yellow solution, free from particles.

Carboplatin 10 mg/ml concentrate for Solution for Infusion is supplied in 5 ml, 10 ml, 15 ml, 20 ml, 45 ml or 50 ml Type I amber glass vials respectively. The vials are closed with a grey chlorobutyl rubber stopper with an aluminium flip off seal.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Dawa Limited,

5 Sandridge Close, HA1 1XD – UK.

Manufacturer

Ascenders Consulting Services Limited,

Great Marlings, Luton, LU2 8DL,

United Kingdom.

This leaflet was last revised in August 2026.

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Carboplatin 10 mg/ml Concentrate for Solution for Infusion

carboplatin

The following information is intended for medical or healthcare professionals only

Further to the information included in section 3, practical information on the preparation/handling of the medicinal product is provided here.

Parenteral drugs should be inspected visually for particulate matter prior to administration, whenever solution and container permit. If particulate matter is observed, shake and re-inspect. Vials with visible particulate matter should not be used.

Incompatibilities

Carboplatin interacts with aluminium to form a black precipitate of platinum causing loss of potency. 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.

Handling

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

Carboplatin 10 mg/ml Concentrate for Solution for Infusion may be further diluted in glucose 5% and administered as an intravenous infusion. Chemical and physical in-use stability has been demonstrated for 56 days to final concentrations of 0.2 mg/ml and 3.5 mg/ml when stored at 2 to 8ºC in non-PVC (polyolefin) infusion bags when protected from light.

Carboplatin 10 mg/ml Concentrate for Solution for Infusion may also be further diluted in sodium chloride 0.9% and administered as an intravenous infusion. The infusion solution is chemically stable for up to 24 hours when stored at 2 to 8ºC and up to 8 hours when stored at 22ºC.

From a microbiological point of view however, 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 to 8ºC, unless dilution has taken place in controlled and validated aseptic conditions.

Contamination

In the event of contact of carboplatin with eyes or skin, wash affected area with copious amounts of water or normal saline. A bland cream may be used to treat transient stinging of skin. Medical advice should be sought if the eyes are affected.

In the event of a spillage, two operators should put on gloves and mop up the spilled material with a sponge kept for that purpose. In the event of a powder spillage, cover with a cloth and moisten with water before mopping up. Rinse the area twice with water. Put all solutions and sponges in a plastic bag, seal and label with the words 'CYTOTOXIC WASTE' and incinerate.

Disposal

Syringes, containers, absorbent materials, solutions and other material which have come into contact with carboplatin should be placed in a thick plastic bag or other impervious container and incinerated at 1000°C.

0464/L-2