Carboplatin Venus Pharma 10 mg/ml concentrate for solution for infusion – patient leaflet, side effects, dosage

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

This medicine contains carboplatin, which belongs to a group of medicines known as platinum containing compounds, which are used to treat cancer.

This medicine is used in the treatment of small cell lung cancer and advanced ovarian cancer.

2. What you need to know before you are given Carboplatin Venus Pharma

Do not have this medicine

• If you are allergic to Carboplatin or any of the other ingredients of this medicine (listed in section 6) or similar platinum containing medicines.
• 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 are pregnant

• if you have tumor that bleeds
• if you plan to or have just received a yellow fever vaccination

Tell your doctor if any of the above apply to you before you are given this medicine. Warnings and precautions

Talk to your doctor, pharmacist or nurse before you are given this medicine

• if you are trying to become 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 received treatment with a live vaccine
• 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 (symptoms of 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.

In some cases, 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 Venus Pharma

Tell your doctor if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

Special care is needed if you are taking/ other medicines as some could interact with carboplatin, for example:

• medicines which can reduce the number of cells in your blood, 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 see section 2, Do not use this medicine).
• 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) as carboplatin, may increase the risk of a seizure.
• other medicines which decrease the activity of the immune system (e.g. ciclosporin, tacrolimus, sirolimus).

This medicine with food and drink

There is no known interaction between Carboplatin and alcohol. However, you should check with your doctor as carboplatin may affect the liver’s ability to cope with alcohol. 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 you are given this medicine. Pregnancy

Due to the possible risk of birth defects, female patients who are capable of becoming pregnant should use contraception before and during treatment with this medicine. Breast – feeding

It is not known whether carboplatin is excreted into the breast milk. Therefore, during treatment with this medicine you should discontinue breast-feeding. 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. 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 such as nausea, vomiting, worsening of eyesight, or changes to your hearing. The Carboplatin vial stopper contains dry natural rubber (a derivative of latex), which may cause allergic reactions.

3. How to use Carboplatin Venus Pharma

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 carboplatin for you and how often it must be given.

The 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 receive more this medicine 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.

If you have any further question on the use of this product ask your doctor, pharmacist or nurse.

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), 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
• muscle cramping, muscle weakness, confusion, visual loss or disturbances,

1 2 Carboplatin Venus Pharma 10 mg/ml concentrate for solution for Infusion

Carboplatin

Package leaflet: Information for the user 240 x 410 mm (45 gsm)

Tear off Area -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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 Carboplatin. Precipitation can lead to a reduction of the antineoplastic activity.

Shelf life

Unopened

2 years

After dilution

In use: Chemical and physical in-use stability has been demonstrated for 24 hours at room temperature and 30 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, unless dilution has taken place in controlled and validated aseptic conditions.

Special precautions for storage

Keep vial in the outer carton in order to protect from light.

INSTRUCTIONS FOR USE/HANDLING, PREPARATION AND DISPOSAL GUIDE FOR USE WITH CARBOPLATIN

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. 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.

   1. 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
   2. 3. All items used for reconstitution, administration or cleaning (including gloves) should be placed in high- risk, waste-disposal bags for high temperature incineration.
   3. 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 solution or 0.9% sodium chloride solution, to concentrations as low as 0.5 mg/ml (500 micrograms/ml).

Disposal

This medicinal product is for single use only.

Medicines should not be disposed of via waste water 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.

irregular heartbeat, kidney failure or abnormal blood test results (these are symptoms of tumor lysis syndrome which can be caused by the rapid breakdown of tumor cells) (see section 2).

• Blood in the urine or decreased urination. This can be due to haemolytic uraemic syndrome, which causes acute kidney failure.
• Allergic reactions

Tell your doctor immediately if you experience any of the following signs and symptoms that may indicate a serious allergic reaction and chest pain which can be a sign of a potentially serious allergic reaction called Kounis syndrome.

These are serious side effects. You may need urgent medical attention. 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 (myelosuppresion)
• increased 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)

• sign 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)
• 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

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

• temporary sight loss

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)
• 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 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)
  • lung infection
  • muscle cramping, muscle weakness, confusion, visual loss or disturbances, irregular heartbeat, kidney failure or abnormal blood test results (symptoms of tumour 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.

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 Venus Pharma

Keep this medicine out of the sight and reach of children

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

Do not refrigerate or freeze.

Keep vial in the outer carton in order to protect from light.

In use: Chemical and physical in-use stability has been demonstrated for 24 hours at room temperature and 30 hours at 2-8 ºC.

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, unless dilution has taken place in controlled and validated aseptic condition

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

6. Contents of the pack and other information

What Carboplatin Venus Pharma contains

The active substance is carboplatin.

Each 1 ml of concentrate for solution for infusion contains 10 mg carboplatin Each vial of 15 ml of concentrate for solution for infusion contains 150 mg carboplatin Each vial of 45 ml of concentrate for solution for infusion contains 450 mg carboplatin Other ingredients is water for injections

What Carboplatin Venus Pharma looks like and content of the pack

Concentrate for solution for infusion. Carboplatin Venus Pharma is a clear, colourless to faintly yellow solution supplied in 20 ml and 50 ml type I moulded glass vial containing 15 ml and 45 ml concentrate for solution for infusion respectively. Vials are closed using omniflex rubber stoppers and sealed with aluminium flip off seals.

Pack size of 1 vial.

Not all presentations listed above may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Venus Pharma GmbH

Am-Bahnhof 1-3,

59368, Werne,

Germany

Manufacturer

European Pharma Hub Kft.

Gorcsev Ivan Utca 5, Gyal, 2360,

Hungary

This leaflet was last revised in 09/2025

3 4

240 x 410 mm (45 gsm) (Ver. 3.0)

Ref. Src. : Carboplatin Venus Pharma Pharma (UK) Revisions date : 24-11-23, 28-11-23, 20-11-24, 22-11-24, 25-11-24, 13-9-25