CARBOPLATIN 10 MG / ML CONCENTRATE FOR SOLUTION FOR INFUSION - patient leaflet, side effects, dosage

Patient leaflet - CARBOPLATIN 10 MG / ML CONCENTRATE FOR SOLUTION FOR INFUSION

Carboplatin 10 mg/ml Concentrate for Solution for Infusion

Carboplatin

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1. What Carboplatin is and what it is used for.

2. What you need to know before you use Carboplatin.

3. How to use Carboplatin.

4. Possible side effects.

5. How to store Carboplatin.

6. Contents of the pack and further information.

1. what carboplatin is and what it is used for

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

Carboplatin is used against advanced cancer of the ovary

and small cell cancer of the lung.

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 are a patient with pre-existing severe renal impairment ( creatinine clearance <30ml/min ), unless in the judgement of the physician and patient, the possible benefits of treatment outweigh the risks.
– concomitant use with yellow fever vaccine
– if you are allergic to another drug that belongs to the group of platinum containing compound
– if you have severe problems with your kidneys
– if you have an imbalance of your blood cells (severe myelosuppression)
– if you have a tumour that bleeds
– if you are pregnant , trying to get pregnant or breast feeding

If any of these apply to you and you have not already discussed this with your doctor or nurse, you should do so as soon as possible and before receiving an infusion.

Warnings and precautions

Talk to your doctor or pharmacist before using Carboplatin.

If you have headache, altered mental functioning, seizures and abnormal vision from blurriness to vision loss, tell your doctor.
If you develop extreme tiredness and shortness of breath with decreased number of red blood cells (symptoms of haemolytic anaemia), alone or combined with a low platelet count, abnormal bruising (thrombocytopenia) and kidney disease where you pass little or no urine (symptoms of Haemolytic-uremic syndrome), tell your doctor.
If you have fever (temperature greater than or equal to 38°C), or chills, which could be signs of infection, tell your doctor immediately. You may be at risk of getting an infection of the blood.

Carboplatin is usually given to patients in hospital. Normally you should not handle this medicine. Your doctor or nurse will administer the medicine and will carefully and frequently monitor you during and after treatment.

Take special care with Carboplatin

Carboplatin can cause visual disturbances in doses higher than those recommended
Carboplatin may cause toxicity in the blood and blood counts will be monitored by your doctor frequently in case of such toxicity
If your kidneys are not working properly the effects of carboplatin on the blood (haematopoietic system) are increased and prolonged compared to patients with normal kidney function. Your doctor will want to monitor you more regularly if your kidneys are not working properly.
Carboplatin can cause serious allergic reactions (difficulty in breathing and dizziness), especially if you had previously received a platinum medicine.
Carboplatin may cause severe depression of your bone marrow and a decrease of blood cells. This is more pronounced if you are also receiving other myelosuppressive medicines or your kidneys are not working properly.
Carboplatin may cause severe sickness and you may receive premedication with anti-emetics to reduce this side effect.
Carboplatin may cause abnormalities in your nervous system, such as pins and needles or hearing problems, especially if you have received platinum treatments in the past. Your doctor may regularly assess you.

If any of these apply to you and you have not already discussed this with your doctor or nurse, you should do as soon as possible and before receiving Carboplatin.

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 or pharmacist if you are using, have recently used or might use any other medicines, including medicines obtained without a prescription.

You should tell your doctor if you are taking any of the following medicines as they may interact with Carboplatin.

– yellow fever vaccine (used to treat yellow fever, a serious viral infection)
– other live attenuated vaccines
– phenytoin, fosphenytoin (used to treat epilepsy)-other medicines that are used as immunosuppressant drugs to prevent rejection in organ transplantation (e.g. cyclosporin, tacrolimus, sirolimus)- other medicines that are known to be toxic to your kidneys (e.g.

aminoglycosides antibiotics, vancomycin or capreomycin)

– loop diuretics (e.g. furosemide, bumetanide, ethacrynic acid, torsemide) used to treat impaired kidney function
– other medicines that are known to damage the hearing or balance functions of the ear (e.g. vancomycin, capreomycin, or aminoglycosides antibiotics; furosemide [used to treat heart failure and oedema])
– blood thinning medicines e.g. warfarin, at the same time as carboplatin, may require an increase in frequency of blood coagulation monitoring

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 or pharmacist for advice before taking this medicine. If any of these apply to you and you have not already discussed this with your doctor or nurse, you should do as soon as possible and before receiving Carboplatin.

Pregnancy

You must not be treated with Carboplatin during pregnancy unless clearly indicated by your doctor. Animal studies have shown a possible risk of abnormalities in the developing foetus. If you are being treated with carboplatin whilst pregnant, you should discuss with your doctor the possible risk of effects on your unborn child. Women of child bearing potential must use an effective method of contraception both before and during treatment with carboplatin. Since carboplatin can cause genetic damage, if pregnancy occurs during treatment with carboplatin, genetic counselling is recommended. Genetic counselling is also recommended for patients wishing to have children after treatment with Carboplatin.

Breast-feeding

It is not known whether carboplatin is excreted into the breast milk. Therefore, during treatment with Carboplatin you should discontinue breast-feeding.

Fertility

Carboplatin can cause genetic damage. Women of childbearing potential should be advised to avoid becoming pregnant by using effective contraception before and during treatment. For women who are pregnant or become pregnant during therapy, genetic counselling should be provided.

Men treated with carboplatin 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. Ask your doctor or nurse for advice before using any medicine.

Driving and using machines

Carboplatin does not affect your ability to drive and use machines. However you should take extra care when you are first given carboplatin, especially if you feel dizzy or unwell.

3. how to use carboplatin

Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not sure. Carboplatin will always be administered by a nurse or doctor experienced in the use of cancer treatment. It is usually given in a drip by slow injection into a vein and will usually take between 15 and 60 minutes to be administered. If you require any further information, ask your doctor or nurse. Your dose will be dependent on your height and weight, function of your blood system and your kidney function. Your doctor will choose the best dose for you. Carboplatin will be diluted before use.

Adult

The recommended dose is 400 mg/m2 of your body surface area (calculated from your height and weight).

Elderly

The adult doses may be used although the doctor may choose to use a different dose.

Kidney problems

The amount given may vary, according to how well your kidneys are working. If you suffer from kidney problems your doctor may reduce the dose and may perform frequent blood tests as well as monitoring your kidney function.

Use in children

There has not been enough usage of carboplatin in children to allow the recommendation of specific dose. You may feel sick while you are being treated with Carboplatin. Your doctor may give you another medicine to reduce these effects before you are treated with Carboplatin. There will be usual gap of 4 weeks between each dose of Carboplatin. Your doctor will want to perform some blood tests each week after giving you Carboplatin. So he/she can decide on the correct next dosage for you. You may receive Carboplatin in combination with other medicines and your dose may be adjusted.

If you use more Carboplatin than you should It is unlikely that you will be given too much carboplatin. However in the event that this occurs you may have some problems with your kidneys. If you are worried that too much has been administered or you have any questions about the dose being given you should talk to the doctor.

If you forget to use Carboplatin

It is very unlikely that you will miss a dose of your medicine, as your doctor will have instructions on when to give it to you. If you think you have missed a dose please talk to your doctor. Do not take a double dose to make up for the forgotten dose.

If you stop using Carboplatin

Do not stop treatment before talking to your doctor. If you have any further question on the use of this product ask your doctor or nurse. If you have any further questions on the use of this medicine, ask your doctor or nurse.

4. possible side effects

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

Tell your doctor immediately if you notice any of the following:

– abnormal bruising, bleeding, or signs of infection such as a sore throat and high temperature
– severe allergic reaction (anaphylaxis/ anaphylactic reactions) – you may experience severe itching of the skin (with raised lumps) or swelling of the face, lips, tongue and/or throat, which may cause difficulty in swallowing or breathing (angio-oedema)
– stomatitis/mucositis (e.g. sore lips or mouth ulcers).

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

If any of the following side effects gets serious, please tell your doctor or nurse.

Very common side effects (affects more than 1 user in 10)

– Changes in platelets, red or white blood cells (myelosuppression, thrombocytopenia, neutropenia, leukopenia)
– anaemia (a condition in which there is a decreased number of red blood cells which leads to tiredness, shortness of breath and paleness) – increase in the level of the creatinine and urea in your blood. Your doctor may want to monitor you.
– Increase in blood alkaline phosphate, aspartate aminotransferase or decrease in blood sodium, blood potassium, blood calcium and blood magnesium
– Vomiting or nausea
– abdominal pain and cramp
– abnormal liver enzyme levels

Common side effects (affects 1 to 10 users in 100)

– signs of infection such as fever or sore throat
– flu-like symptoms
– nerve damage (neuropathy peripheral), tingling or burning sensation e.g. pins and needles (paraesthesia), decrease of deep tendon reflexes, sensory disturbances, distorted sense of taste (dysgeusia)
– damage to the ear (otoxicity), ringing in the ears or changes in your hearing
– cardiovascular disorder
– interstital lung disease, bronchospasm (wheezing)
– diarrhoea, constipation, mucous membrane disorder
– alopecia (hair loss), skin disorder
– musculoskeletal disorder (disorders of muscles, joints and tendons)
– loss or lack of body strength (asthenia)
– unusual bruising or bleeding (haemorrhagic complications)
– reduced function of your kidneys
– hypersensitivity and allergic-type reactions including wheeziness or tightness of chest, swelling of the eyelids, face or lips, facial flushing, low blood pressure, rapid heartbeat, hives, shortness of breath, dizziness, rash, urticaria, skin reddening, itching, high temperature
– visual disturbances
– infection
– blood bilirubin increased, blood creatinine increased, blood uric acid increased
– heart disorders

– sore lips or mouth ulcers (mucous membrane disorder

Rare side effects (affects 1 to 10 users in 10,000)

– Temporary sight loss

Very rare side effects (affects less than 1 user in 10,000)

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

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

– dehydration, severe appetite loss (anorexia) or low sodium levels in the blood (hyponatraemia) – bone marrow failure, feeling unwell with high temperature due to abnormally low white blood cell count and fever (febrile neutropenia), anemia caused by destruction of red blood cells, kidney failure and low platelet count (hemolytic-uraemic syndrome)
– stroke
– heart failure
– secondary cancer related to treatment
– hypertension, hypotension (high or low blood pressure)
– inflammation of the mouth (stomatitis)
– hives (urticaria), rash, redness of the skin (erythema), itching (pruritus)
– injection site reactions such as redness, swelling and pain or dead skin at the injection site.
– malaise (a general feeling of discomfort).
– dry mouth, tiredness and headache due to excessive loss of body water
– severely impaired liver function, damage or death of liver cells
– obstruction in blood vessel (embolism)
– a group of symptoms such as headache, altered mental functioning, seizures and abnormal vision from blurriness to vision loss (symptoms of reversible posterior leukoencephalopathy syndrome, a rare neurological disorder)

– pancreatitis
– lung infection
– 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 section 2).

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

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the yellow card scheme aty reporting side effects you can help provide more information on the safety of this medicine.

5. how to store carboplatin

Keep out of the reach and sight of children.

Do not store above 25 °C. Do not store in a refrigerator.

Keep the vial in the outer carton in order to protect from light. Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

The product should be diluted and used immediately after opening.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6.contents of the pack and further information

What Carboplatin 10 mg/ml Concentrate for Solution for Infusion contains

The vials contain:

The active substance Carboplatin.
Each ml of concentrate for solution for infusion contains 10mg of carboplatin. Each 5ml vial contains 50mg of carboplatin, each 15ml vial

contains 150mg of carboplatin and each 45ml vial contains 450mg of carboplatin.

The other ingredient is water for injections

What Carboplatin 10 mg/ml Concentrate for Solution for Infusion looks like and contents of the pack

Carboplatin 10 mg/ml Concentrate for Solution for Infusion is a clear, colourless or almost colourless solution. It is presented in clear vials of hydrolytic Type I glass, packed in a carton. Vials are closed with a fluororesin coated bromobutyl rubber stopper with an aluminium crimp cap with a polypropylene flip-off lid.

Packs of 1 vial containing 50 mg/5mlof carboplatin.

Packs of 1 vial containing 150 mg/15ml of carboplatin.

Packs of 1 vial containing 450 mg/45ml of carboplatin.

Marketing Authorisation Holder:

Kent Pharma UK Limited, The Bower, 4 Roundwood Avenue, Stockley Park, Heathrow, United Kingdom, UB11 1AF.

Manufacturer responsible for batch release:

Fannin (UK) Limited, 42–46 Booth Drive, Park Farm South, Wellingborough, Northamptonshire, NN8 6GT, UK.

This leaflet was last approved in December 2019