Carboplatin Accord 10 mg/ml concentrate for infusion solution EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Carboplatino Accord 10 mg/ml concentrate for solution for infusion EFG

Please read all of this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet; you may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• If you get any side effects, talk to your doctor or nurse, even if they are not listed in this leaflet. See section 4.

Leaflet Contents

1. What Carboplatino Accord is and what it is used for
2. What you need to know before using Carboplatino Accord
3. How to use Carboplatino Accord
4. Possible side effects
5. How to store Carboplatino Accord
6. Contents of the pack and other information

1. What Carboplatino Accord is and what it is used for

Carboplatino Accord is an anticancer medicine. Treatment with an anticancer medicine is sometimes referred to as anticancer chemotherapy.

Carboplatino Accord is used in adults for the treatment of certain types of lung cancer and ovarian cancer.

2. What you need to know before using Carboplatino Accord

Do not use Carboplatino Accord

• If you are allergic to carboplatin or to any of the other ingredients of this medicine (listed in section 6).
• if you have previously had hypersensitivity to similar medicines containing platinum.
• if you have severe kidney problems.
• if you have lower than normal blood cell counts (your doctor will check this with a blood test).
• if you have bleeding tumours.
• if you are due to receive or have recently received the yellow fever vaccine.

Talk to your doctor if any of the above apply to you before using this medicine.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before receiving carboplatin infusion if:

• You are pregnant or think you might be pregnant.
• You are breastfeeding.
• You have mild kidney disease. Your doctor will monitor you more regularly.
• You are elderly (over 65 years of age).
• You experience any hearing problems.
• You have previously been treated with cisplatin or other similar anticancer medicines, as carboplatin may cause nervous system abnormalities such as tingling or hearing and vision problems. Your doctor will monitor you regularly.
• You have headache, altered mental function, seizures, or abnormal vision ranging from blurred vision to loss of vision.
• You experience extreme tiredness and difficulty breathing, with a reduced number of red blood cells (haemolytic anaemia), alone or combined with low platelet count, abnormal bruising (thrombocytopenia), and kidney disease with reduced or no urine output (symptoms of haemolytic-uraemic syndrome).
• You develop fever (temperature greater than or equal to 38°C) or chills, which could be signs of infection. You may be at risk of developing a blood infection.

During treatment with carboplatin, you will be given medicines to help reduce a potentially life-threatening complication known as tumour lysis syndrome, caused by chemical changes in the blood due to the breakdown of cancer cells that die and release their contents into the bloodstream.

Children and adolescents

The safety and efficacy of carboplatin in children and adolescents have not yet been established.

Other medicines and Carboplatino Accord

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

• Medicines that may reduce blood cell counts, when used together with carboplatin, may require adjustments in the dose and frequency of carboplatin treatment.
• Certain antibiotics called aminoglycosides, vancomycin, or capreomycin, when used at the same time as carboplatin, may increase the risk of kidney or hearing problems.
• Certain water tablets (diuretics), when used simultaneously with 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 Carboplatino Accord”)

• Anticoagulants such as warfarin, when used together with carboplatin, may require more frequent monitoring of blood clotting.
• Phenytoin and fosphenytoin (used to treat various types of seizures and fits), when used with carboplatin, may increase the risk of seizures.
• Other medicines that suppress the immune system (e.g. cyclosporine, tacrolimus, or sirolimus).

Tell your doctor if you are using, have recently used, or might need to take any other medicines, including those obtained without a prescription.

Use of Carboplatino Accord with alcohol

No interaction between carboplatin and alcohol is known. However, you should discuss this with your doctor, as carboplatin may affect the liver's ability to process alcohol.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before receiving this medicine.

Contraception in men and women

Women of childbearing potential must avoid becoming pregnant and use effective contraceptive methods during treatment and for at least 6 months after the last dose. Inform your doctor immediately if you become pregnant during this period.

Men must use effective contraception and avoid fathering a child during treatment and for 3 months after the last dose.

Pregnancy

This medicine should not be used during pregnancy unless considered necessary by your doctor. This medicine may cause severe birth defects.

Breastfeeding

You must not breastfeed during treatment and for at least one month after the last dose.

Fertility in men and women

Treatment with this medicine may temporarily or permanently reduce fertility in men and women. Talk to your doctor about fertility preservation before starting treatment.

Driving and use of machines

Do not drive or operate machinery if you experience any adverse effects that may impair your ability to do so, such as nausea, vomiting, worsening of vision, or changes in vision and hearing.

3. How to use Carboplatino Accord

This medicine will be administered by intravenous infusion (drip), lasting between 15 and 60 minutes.

Dosage

Your doctor will calculate the correct dose of carboplatin for you and how frequently it will be given.

The dose will depend on your physical condition, body weight, and kidney function. Your doctor will assess your kidney function through blood and urine tests. You will have blood tests performed after your dose of carboplatin. You will also be monitored for nerve damage and hearing loss.

There will typically be an interval of approximately 4 weeks between each dose of carboplatin.

If you use more Carboplatino Accord than you should

This medicine will be administered in a hospital setting under the supervision of a doctor. It is unlikely that you will receive too much or too little. However, if you have any doubts, consult your doctor or nurse.

If you interrupt treatment with Carboplatino Accord

If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

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

• unusual bruising, bleeding, or signs of infection such as sore throat and fever (very common, may affect more than 1 in 10 people)
• severe allergic reactions (anaphylaxis/anaphylactic reactions) – you may experience sudden itchy rash (urticaria), swelling of the hands, feet, ankles, face, lips or throat (which may cause difficulty swallowing or breathing), and you may feel faint (common, may affect up to 1 in 10 people)
• haemolytic uraemic syndrome (a disease characterized by acute kidney failure), reduced urination or blood in the urine (not known, frequency cannot be estimated from available data)
• muscle cramps, muscle weakness, confusion, vision disturbances or loss of vision, irregular heartbeat, kidney failure or abnormal blood test results (symptoms of tumour lysis syndrome, which may be caused by the rapid breakdown of tumour cells) (see section 2) (not known, frequency cannot be estimated from available data)
• stroke (sudden numbness or weakness in the face, arm or leg, especially on one side of the body) (not known, frequency cannot be estimated from available data)
• blockage of a blood vessel (embolism and veno-occlusive disease), swelling or tenderness in the arm or leg (not known, frequency cannot be estimated from available data)
• chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome (not known, frequency cannot be estimated from available data)
• skin swelling, often affecting the face and lips (angioedema) (rare, may affect up to 1 in 1,000 people)

These are serious adverse effects. You may require urgent medical attention.

Other adverse effects that may occur:

Very common (may affect more than 1 in 10 patients):

• Tiredness, breathlessness and paleness due to anaemia (a condition in which the number of red blood cells is reduced)
• Feeling sick (nausea) or being sick (vomiting)
• Stomach pain and cramps

Blood tests may also show:

• Changes in red blood cells, white blood cells and platelets (myelosuppression)
• Increased blood urea levels
• Decreased levels of sodium, potassium, calcium and magnesium in the blood
• Reduced renal creatinine clearance
• Abnormal liver enzyme levels

Common (may affect up to 1 in 10 patients):

• Diarrhoea or constipation
• Skin rash and/or itching
• Ringing in the ears or changes in hearing
• Hair loss
• Flu-like symptoms
• Infections
• Tingling and/or numbness in the hands, feet, arms or legs
• Burning or prickling sensations
• Reduced tendon reflexes
• Taste disturbances or loss of taste
• Temporary visual disturbances or changes in vision
• Heart disorders
• Chest pressure or wheezing
• Interstitial lung disease (a group of lung disorders in which deep lung tissue becomes inflamed)
• Pain in the lips or mouth ulcers (mucosal disorders)
• Pain or discomfort in bones, joints, muscles or adjacent structures (musculoskeletal disorders)
• Problems with your kidneys or urine
• Extreme tiredness/weakness (asthenia)

Blood tests may also show:

• Increased levels of bilirubin and creatinine in the blood
• Increased levels of uric acid in the blood, which may cause gout

Rare (may affect less than 1 in 1,000 patients):

• Temporary loss of vision
• Skin peeling (exfoliative dermatitis)

Very rare (may affect up to 1 in 10,000 patients):

• Lung scarring causing breathing difficulties and/or cough (pulmonary fibrosis)

Not known (cannot be estimated from available data):

• Cancer caused by carboplatin treatment (secondary neoplasms)
• Feeling unwell with fever due to low white blood cell counts (febrile neutropenia)
• Bone marrow failure (the bone marrow does not produce enough blood cells)
• Dry mouth, tiredness and headache due to excessive loss of body water (dehydration)
• Loss of appetite, anorexia
• Severe liver function impairment, liver cell damage or death
• Heart failure
• Changes in blood pressure (hypertension or hypotension)
• Skin disorders such as urticaria, rash, skin redness (erythema), and itching
• Swelling or pain at the injection site
• A group of symptoms including headache, altered mental function, seizures and abnormal vision (from blurred vision to vision loss). These are symptoms of posterior reversible encephalopathy syndrome, a rare neurological disorder
• Pancreatitis
• Pain or inflammation inside the mouth (stomatitis)
• Lung infection
• Brain disorders (encephalopathy)
• Anaemia due to abnormal breakdown of red blood cells (haemolytic anaemia)

Carboplatin may cause blood, liver and kidney problems. Your doctor will perform blood tests to monitor for these issues.

Reporting of adverse effects:

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Carboplatin Accord

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

Do not use Carboplatin Accord after the expiry date stated on the packaging after CAD or EXP. The expiry date refers to the last day of the month indicated.

Store below 25°C. Do not refrigerate or freeze. Keep the vial in the outer packaging to protect it from light.

In-use storage: Physicochemical stability under use conditions has been demonstrated for 24 hours at room temperature and for 30 hours at 2-8°C.

From a microbiological standpoint, the product should be used immediately. If not used immediately, storage times and conditions prior to use shall be the responsibility of the user and, under normal circumstances, shall not exceed 24 hours at 2-8°C, except when dilution has taken place under controlled and validated aseptic conditions.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Additional Information

Composition of Carboplatin Accord

The active substance in Carboplatin Accord is carboplatin.

Each ml of concentrate for solution for infusion contains 10 mg of carboplatin.

Each 5 ml vial contains 50 mg of carboplatin.

Each 15 ml vial contains 150 mg of carboplatin.

Each 45 ml vial contains 450 mg of carboplatin.

Each 60 ml vial contains 600 mg of carboplatin.

The other component is water for injections.

Appearance of the product and contents of the container

Concentrate for solution for infusion.

Carboplatin Accord is a clear, particle-free solution ranging from colourless to pale yellow.

It is supplied in a type I amber glass vial of 5 ml, 15 ml, 50 ml or 100 ml containing 5 ml, 15 ml, 45 ml or 60 ml of concentrate for solution, respectively. The vials are closed with a grey chlorobutyl rubber stopper or a grey pre-washed siliconised rubber stopper (Westar) and sealed with an aluminium cap.

Only some pack sizes may be marketed.

Marketing Authorisation Holder

Accord Healthcare, S.L.U.

World Trade Center

Moll de Barcelona, s/n

Edifici Est, 6th floor

08039 Barcelona

Manufacturer

Accord Healthcare Polska Sp. z o.o.,

ul. Lutomierska 50,

95-200 Pabianice

Poland

or

Accord Healthcare Single Member S.A.

64th Km National Road Athens, Lamia, 32009,

Greece

This medicinal product is authorised in the Member States of the European Economic Area under the following names

Member State	Medicinal Product Name
Austria	Carboplatin Accord 10 mg/ml concentrate for solution for infusion
Belgium	Carboplatin Accord Healthcare 10 mg/ml concentrate for solution for infusion
Czech Republic	Carboplatin Accord 10 mg/ml concentrate for solution for infusion
Germany	Carboplatin Accord 10 mg/ml concentrate for solution for infusion
Denmark	Carboplatin Accord 10 mg/ml concentrate for infusion solution
Estonia	Carboplatin Accord 10 mg/ml concentrate for infusion solution
Spain	Carboplatin Accord 10 mg/ml concentrate for solution for infusion EFG
Finland	Carboplatin Accord 10 mg/ml concentrate for infusion solution
Hungary	Carboplatin Accord 10 mg/ml concentrate for infusion solution
Ireland	Carboplatin 10 mg/ml Concentrate for Solution for Infusion
Italy	Carboplatin AHCL 10 mg/ml Concentrate for solution for infusion
Lithuania	Carboplatin Accord 10 mg/ml concentrate for infusion solution
Latvia	Carboplatin Accord 10 mg/ml concentrate for preparation of infusion solution
Netherlands	Carboplatin Accord 10 mg/ml concentrate for solution for infusion
Norway	Carboplatin Accord 10 mg/ml concentrate for infusion solution
Poland	Carboplatin Accord
Portugal	Carboplatin Accord 10 mg/ml concentrate for solution for infusion
Sweden	Carboplatin Accord 10 mg/ml concentrate for infusion solution
Slovak Republic	Carboplatin Accord 10 mg/ml infusion concentrate
United Kingdom (NI)	Carboplatin 10 mg/ml concentrate for solution for infusion
Cyprus	Carboplatin Accord 10 mg/ml concentrate for solution for infusion
Croatia	Carboplatin Accord 10 mg/ml concentrate for infusion solution
Romania	Carboplatin Accord 10 mg/ml concentrate for perfusion solution
Slovenia	Carboplatin Accord 10 mg/ml concentrate for infusion solution

This patient information leaflet was approved in June 2024

Up-to-date detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es

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This information is intended for healthcare professionals only:

Instructions for use – Cytotoxic

The recommended dose of carboplatin in adult patients not previously treated and with normal renal function, i.e., creatinine clearance > 60 ml/min, is 400 mg/m² as a single intravenous dose administered over a short-term infusion lasting between 15 and 60 minutes. Alternatively, the Calvert formula indicated below may be used to determine the dose:

Dose (mg) = target AUC (mg/ml x min) x [GFR ml/min + 25]

Dose (mg) = target AUC (mg/ml x min) x [GFR ml/min + 25]
Target AUC	Scheduled Chemotherapy	Patient Treatment Status
5-7 mg/ml·min	Carboplatin as single agent	Previously untreated
4-6 mg/ml·min	Carboplatin as single agent	Previously untreated
4-6 mg/ml·min	Carboplatin plus cyclophosphamide	Previously untreated

Note: With the Calvert formula, the total dose of carboplatin is calculated in mg, not in mg/m². The Calvert formula should not be used in patients who have previously received intensive treatment**

**Patients will be considered to have previously received intensive treatment if they have been treated with any of the following regimens:

• Mitomycin C
• Nitrosourea
• Combination therapy with doxorubicin/cyclophosphamide/cisplatin,
• Combination therapy with 5 or more agents,
• Radiotherapy ≥ 4,500 rad, focused on a field of 20 x 20 cm or on more than one treatment field.

Carboplatin treatment should be discontinued in the case of resistant tumor, progressive disease, and/or occurrence of intolerable adverse effects.

Treatment should not be repeated until at least 4 weeks have elapsed since the last administration of carboplatin and/or until the neutrophil count is at least 2,000 cells/mm³ and the platelet count is at least 100,000 cells/mm³.

A 20%-25% reduction of the initial dose is recommended in patients presenting risk factors such as prior myelosuppressive therapy and poor performance status (ECOG/Zubrod 2-4 or Karnofsky < 80).

It is recommended to determine the nadir hematological levels by weekly blood counts during the initial cycles of carboplatin treatment for future dose adjustments.

Renal impairment:

Patients with creatinine clearance values below 60 ml/min have an increased risk of developing myelosuppression.

Optimal use of carboplatin in patients with renal impairment requires appropriate dose adjustments and frequent monitoring of nadir hematological levels and renal function.

In cases of glomerular filtration rate < 20 ml/min, carboplatin must not be administered under any circumstances.

Combination therapy:

Optimal use of carboplatin in combination with other myelosuppressive drugs requires dose adjustments depending on the regimen and treatment schedule adopted.

Pediatric population:

The safety and efficacy of carboplatin in children and adolescents have not yet been established. No data are available. Since sufficient experience with carboplatin in children and adolescents is lacking, specific dosage recommendations cannot be provided.

Elderly patients:

Dose adjustment may be necessary, either initially or subsequently, depending on the patient's physical condition.

Dilution and reconstitution:

The product must be diluted prior to starting the infusion, using 5% dextrose solution (50 mg/ml) or 0.9% sodium chloride solution (9 mg/ml), to achieve concentrations as low as 0.5 mg/ml.

Method of administration

Carboplatin must only be administered intravenously.

Incompatibilities

Intravenous needles or equipment containing aluminum parts that may come into contact with Carboplatino Accord must not be used in the preparation or administration of Carboplatino Accord.

This medicinal product must not be mixed with any other medicinal product except 5% dextrose solution or 0.9% sodium chloride solution.

Carboplatin may react with aluminum to form a black precipitate. Needles, syringes, catheters, or intravenous equipment containing aluminum parts that may come into contact with carboplatin must not be used during the preparation or administration of carboplatin.

Shelf life and storage

Carboplatino Accord is for single use only.

Before opening

Store below 25°C. Do not refrigerate or freeze. Keep the vial in the outer packaging to protect it from light.

After dilution

In-use stability: Physicochemical stability under conditions of use has been demonstrated for 24 hours at room temperature and for 30 hours at 2–8°C.

From a microbiological standpoint, the product should be used immediately. If not used immediately, the storage times under conditions of use and the conditions prior to use are the responsibility of the user and generally should not exceed 24 hours at 2–8°C, unless the dilution was carried out under controlled and validated aseptic conditions.

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

Handling of carboplatin

As with other antineoplastic agents, carboplatin must be prepared and handled with caution.

The following protective measures should be followed when handling carboplatin.

Personnel must be trained in appropriate techniques for reconstitution and handling.

1. Carboplatin must be prepared for administration only by personnel trained in the safe handling of chemotherapeutic agents. Personnel handling Carboplatino Accord must wear protective clothing: goggles, gown, disposable gloves, and masks.
2. A designated area should be established for syringe preparation (preferably under a laminar flow system), and the work surface should be protected with absorbent paper lined with disposable plastic.
3. All materials used for reconstitution, administration, or cleaning (including gloves) must be placed in high-risk waste bags for high-temperature incineration.
4. Spills or leaks should be treated with diluted sodium hypochlorite solution (1% available chlorine), preferably by soaking, followed by rinsing with water. All contaminated and cleaning materials must be placed in high-risk waste bags for high-temperature incineration. Accidental skin or eye contact must be immediately treated by thorough washing with water, or with water and soap, or sodium bicarbonate solution. However, avoid scrubbing the skin with a brush. Medical attention must be sought. Always wash hands after removing gloves.

Preparation of infusion solution

The product must be diluted before use. It may be diluted with dextrose or sodium chloride to concentrations as low as 0.5 mg/ml (500 micrograms/ml).

Disposal

Medicines must not be disposed of via wastewater or household waste. All materials used in the preparation, administration, or that otherwise come into contact with carboplatin must be disposed of in accordance with local regulations for handling cytotoxic compounds.