Carboplatin Accord

Leaflet accompanying the packaging: patient information

Carboplatin Accord, 10 mg/mL, concentrate for solution for infusion

Carboplatin

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or nurse.
• This medicine has been prescribed specifically for one person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects not mentioned in this leaflet, they should inform their doctor or nurse. See section 4.

Table of contents of the leaflet:

• 1. What is Carboplatin Accord and what is it used for
• 2. Important information before using Carboplatin Accord
• 3. How to use Carboplatin Accord
• 4. Possible side effects
• 5. How to store Carboplatin Accord
• 6. Contents of the packaging and other information

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

Carboplatin Accord is an anticancer medicine. Treatment with anticancer medicines is sometimes called chemotherapy.
Carboplatin Accord is used in adults to treat certain types of lung cancer and ovarian cancer.

2. Important information before using Carboplatin Accord

When not to use Carboplatin Accord

• in patients with severe kidney disease,

If any of the above applies to the patient, they should tell their doctor before taking this medicine.

Warnings and precautions

Before starting treatment with Carboplatin Accord, the patient should discuss with their doctor, pharmacist, or nurse:

• if the patient is breastfeeding,

During treatment with carboplatin, medicines will be given to help reduce the likelihood of a life-threatening complication known as tumor lysis syndrome, caused by biochemical disturbances in the blood caused by the breakdown of dying cancer cells, which release their contents into the bloodstream.

Children and adolescents

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

Carboplatin Accord and other medicines

The patient should tell their doctor, pharmacist, or nurse about all medicines they are taking, have recently taken, or plan to take, including:

• medicines that may reduce the number of blood cells, taken at the same time as carboplatin: it may be necessary to change the dosage and frequency of carboplatin treatment,
• certain antibiotics called aminoglycosides, vancomycin, or capreomycin, given at the same time as carboplatin: may increase the risk of kidney damage or hearing disturbances,
• certain diuretics, given at the same time as carboplatin: may increase the risk of kidney damage or hearing disturbances,
• live or live, attenuated vaccines (against yellow fever, see section 2, When not to use Carboplatin Accord),
• anticoagulant medicines, such as warfarin, taken at the same time as carboplatin: may require more frequent monitoring of blood clotting parameters,
• phenytoin and fosphenytoin (used to treat various types of seizures), given at the same time as carboplatin: may increase the risk of seizures,
• other medicines that suppress the immune system (e.g., cyclosporine, tacrolimus, sirolimus).

The patient should tell their doctor about all medicines they are taking, have recently taken, or plan to take, including those available without a prescription.

Carboplatin Accord with alcohol

The interaction between Carboplatin Accord and alcohol is not known. The patient should consult their doctor about the possibility of consuming alcohol during treatment with Carboplatin Accord, as the medicine may affect the liver's ability to process alcohol.

Contraception in men and women

Women of childbearing age should avoid becoming pregnant and use effective contraception during treatment and for at least 7 months after the last dose. If the patient becomes pregnant during this period, they should immediately inform their doctor.
Men should use effective contraception and not father a child during treatment and for up to 4 months after the last dose.

Pregnancy

This medicine should not be used during pregnancy, unless the doctor considers it necessary. The medicine may cause serious birth defects.

Breastfeeding

The patient should not breastfeed during treatment and for at least 1 month after the last dose.

Fertility in men and women

The use of this medicine may temporarily or permanently reduce fertility in men and women. Before starting treatment, the patient should consult their doctor about the possibility of preserving fertility.

Driving and using machines

The patient should not drive or operate machines if they experience any side effects that may reduce their ability to do so, such as nausea, vomiting, impaired vision, or hearing and vision disturbances.

3. How to use Carboplatin Accord

This medicine is given as an intravenous infusion (drip) lasting from 15 to 60 minutes.

Dose:

The doctor will determine the appropriate dose of carboplatin and its frequency.
The dose depends on the patient's health, height, and weight, as well as kidney function. The doctor will inform the patient about their kidney function after a blood or urine test.
After each dose of carboplatin, the patient will have regular blood tests. The patient may also have tests to detect nerve damage and hearing loss. Carboplatin doses are usually given at 4-week intervals.

Using a higher dose of Carboplatin Accord than recommended

The medicine is given in a hospital, under the supervision of a doctor, so it is unlikely that the patient will receive too much or too little of the medicine. However, the patient should inform their doctor or nurse if they have any doubts.

Stopping treatment with Carboplatin Accord

In case of doubts about treatment, the patient should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The patient should immediately inform their doctorif they notice any of the following symptoms:

• Unexpected bruising, bleeding, or signs of infection, such as sore throat and high temperature (very common, may occur in more than 1 in 10 patients).
• Severe allergic reactions (anaphylactic reactions/anaphylaxis): may cause sudden itchy rash (hives), swelling of hands, feet, ankles, face, lips, mouth, or throat (which may cause difficulty swallowing or breathing) and a feeling of losing consciousness (common, may occur in up to 1 in 10 patients).
• Hemolytic-uremic syndrome (a disease characterized by acute kidney failure), decreased urine output, or blood in the urine (frequency not known, frequency cannot be estimated from available data).
• Muscle spasms, muscle weakness, disorientation, loss of vision, or vision disturbances, irregular heartbeat, kidney failure, or abnormal blood test results (symptoms of tumor lysis syndrome, which may be caused by the rapid breakdown of dying cancer cells) (see section 2) (frequency 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) (frequency not known, frequency cannot be estimated from available data).
• Blockage of blood vessels (thromboembolism and thrombophlebitis), swelling, or tenderness of the leg and (or) arm (frequency 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 (frequency not known, frequency cannot be estimated from available data).
• Swelling of the skin, often on the face and lips (angioedema) (rare, may occur in up to 1 in 1000 patients).

These are serious side effects, and the patient may need urgent medical attention.
Other side effects that may occur:

Very common side effects (may occur in more than 1 in 10 patients):

• Fatigue, shortness of breath, and pale skin due to anemia (a condition in which there is a decrease in the number of red blood cells).
• Nausea and vomiting.
• Abdominal pain and cramps.

Tests may also show:

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

Common side effects (may occur in up to 1 in 10 patients)

• Diarrhea or constipation.
• Rash and (or) itching of the skin.
• Ringing in the ears or hearing disturbances.
• Hair loss.
• Flu-like symptoms.
• Infections.
• Numbness or tingling of hands, feet, arms, or legs.
• Feeling of burning or stinging.
• Weakness of reflexes.
• Disturbances or loss of taste.
• Periodic worsening of vision or vision disturbances.
• Heart diseases.
• Chest tightness or wheezing.
• Interstitial lung diseases (a group of lung diseases in which there is inflammation of the deep lung tissues).
• Pain or discomfort in the mouth or lips (mucosal disorders).
• Pain or discomfort in the bones, joints, muscles, or surrounding structures (musculoskeletal disorders).
• Kidney function disorders or urination disorders.
• Extreme fatigue/weakness (asthenia).

Tests may also show:

• Increased bilirubin and creatinine levels in the blood.
• Increased uric acid levels in the blood, which may lead to the development of gout.

Rare side effects (may occur in up to 1 in 1000 patients):

• Periodic loss of vision.
• Peeling of the skin (exfoliative dermatitis).

Very rare side effects (may occur in up to 1 in 10,000 patients):

• Pulmonary fibrosis, which causes shortness of breath and (or) cough (pulmonary fibrosis).

Frequency not known (cannot be estimated from available data)

• Treatment-related tumors (secondary tumors).
• Poor condition with high temperature due to a low number of white blood cells (neutropenia with fever).
• Bone marrow failure (bone marrow does not produce enough blood cells).
• Dryness in the mouth, fatigue, and headaches due to excessive water loss from the body (dehydration).
• Lack of appetite, anorexia.
• Severe liver function disorders, liver damage, or cell death.
• Heart failure.
• Changes in blood pressure (hypertension or hypotension).
• Skin diseases, such as hives, rash, redness of the skin (erythema), and itching.
• Swelling or pain at the injection site.
• A group of symptoms, such as headache, mental disorders, seizures, and vision disturbances from blurred vision to loss of vision. These are symptoms of reversible posterior leukoencephalopathy syndrome; a rare neurological disorder.
• Pancreatitis.
• Pain or inflammation in the mouth (stomatitis).
• Lung infection.
• Brain disorders (encephalopathy).
• Anemia caused by abnormal breakdown of red blood cells (hemolytic anemia).

Carboplatin may cause blood, liver, and kidney disorders. The doctor will order blood tests to check for these disorders.

Reporting side effects

If the patient experiences any side effects, including those not mentioned in the leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
tel.: + 48 22 49 21 301
fax: + 48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Carboplatin Accord

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the label and carton after EXP.
The expiry date refers to the last day of the month.
Store in a temperature below 25°C. Do not store in the refrigerator or freeze.
Store the vial in the outer packaging to protect from light.
In use: The chemical and physical stability of the medicine has been demonstrated for 24 hours at room temperature and for 30 hours at 2-8°C.
From a microbiological point of view, the product should be used immediately. If not, the responsibility for the storage time and conditions of the prepared solution lies with the user.
Normally, the storage time should not exceed 24 hours at 2-8°C, unless the dilution was performed under controlled and validated aseptic conditions.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Carboplatin Accord contains

The active substance of the medicine is carboplatin.
One mL of the 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 ingredient is water for injections.

What Carboplatin Accord looks like and contents of the pack

Concentrate for solution for infusion
Carboplatin Accord is a clear and colorless to pale yellow solution without particles.
5 mL, 15 mL, 45 mL, or 60 mL of the concentrate for solution for infusion in a vial made of orange glass type I with a capacity of 5 mL, 15 mL, 50 mL, or 100 mL, respectively.
The vials are closed with a gray rubber stopper or a rubber stopper coated with silicon with an aluminum seal.
Not all pack sizes may be marketed.

Marketing authorization holder

Accord Healthcare Polska Sp. z o.o.
ul. Taśmowa 7
02-677 Warsaw
Tel: + 48 22 577 28 00

Manufacturer/Importer

Accord Healthcare Polska Sp. z o.o.
ul. Lutomierska 50
95-200 Pabianice
Accord Healthcare Single Member S.A.
64th Km National Road Athens
32009 Lamia
Greece

This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Austria
Carboplatin Accord 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung
Carboplatin Accord Healthcare 10mg/ml concentré pour solution de perfusion/ concentraat voor oplossing voor infusie/ Konzentrat zur Herstellung einer Infusionslösung
Czech Republic
Carboplatin Accord 10 mg/ml koncentrát pro přípravu infuzního roztoku
Denmark
Carboplatin Accord 10mg/ml koncentrat til infusionsvæske, opløsning
Estonia
Carboplatin Accord 10 mg/ml infusioonilahuse kontsentraat
Belgium
Finland
Carboplatin Accord 10 mg/ml infuusiokonsentraatti, liuosta varten/ koncentrat till infusionsvätska, lösning
Spain
Carboplatin Accord 10 mg/ml Concentrado para solución para perfusión
EFG
Netherlands
Carboplatin Accord 10 mg/ml concentraat voor oplossing voor infusie
Ireland
Carboplatin 10 mg/ml Concentrate for Solution for Infusion
Lithuania
Carboplatin Accord 10mg/ml koncentratas infuziniam tirpalui
Latvia
Carboplatin Accord 10 mg/ml koncentrāts infūziju šķīduma pagatavošanai
Germany
Carboplatin Accord 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung
Norway
Carboplatin Accord 10 mg/ml konsentrat til infusjonsvæske
Poland
Carboplatin Accord
Portugal
Carboplatina Accord 10 mg/ml concentrado para solução para perfusão
Slovakia
Carboplatin Accord 10 mg/ml infúzny koncentrá
Sweden
Carboplatin Accord 10 mg/ml koncentrat till infusionsvätska, lösning
United Kingdom
(Northern Ireland)
Carboplatin 10 mg/ml concentrate for solution for infusion
Italy
Carboplatino AHCL 10 mg/ml Concentrato per soluzione per infusione
Hungary
Carboplatin Accord 10 mg/ml koncentrátum oldatos infúzióhoz

Date of last revision of the leaflet: January 2025 -------------------------------------------------------------------------------------------------------------------------

The following information is intended for healthcare professionals only:

Instructions for use - cytotoxic drugs

The recommended dose of carboplatin for previously untreated adults with normal renal function, i.e., with creatinine clearance > 60 mL/min, is 400 mg/m² body surface area, given as a single dose in a short intravenous infusion lasting from 15 to 60 minutes. An alternative method of dosing may be to use the Calvert formula (see below):
Dose (mg) = target AUC (mg/mL x min) x [GFR mL/min + 25]
Note: Based on the Calvert formula, the total dose of carboplatin is calculated in mg, not in mg/m² body surface area.
Treatment should not be repeated until at least 4 weeks have elapsed from the previous course of carboplatin treatment and until the neutrophil count is at least 2000 cells/mm³ and the platelet count is at least 100,000 cells/mm³.
A dose reduction of 20-25% is recommended for patients with risk factors such as previous myelosuppressive treatment and low performance status (ECOG-Zubrod score 2-4 or Karnofsky score below 80).
It is recommended to determine the lowest values of blood morphology (nadir) by performing weekly counts during the initial courses of carboplatin treatment to better adjust the dosing in the future.
Kidney function disorders:
In patients with kidney function disorders, the dose of carboplatin should be reduced (using the Calvert formula) and the lowest hematological values (nadir) and kidney function should be monitored.
In patients with creatinine clearance values less than 60 mL/min, there is an increased risk of bone marrow suppression.
The incidence of severe leukopenia, neutropenia, or thrombocytopenia was approximately 25% according to the following dosing recommendations:
Combination treatment:
The optimal use of carboplatin in combination with other myelosuppressive agents requires adjustment depending on the chosen treatment regimen and schedule.
Children and adolescents:
The safety and efficacy of carboplatin in children and adolescents have not been established.
There are no data available. Due to the lack of sufficient data on the use of carboplatin in children and adolescents, no specific dosing recommendations can be provided.
Elderly patients:
In patients over 65 years of age, dose adjustment of carboplatin is necessary at the start of treatment and during subsequent treatment courses.
Dilution and preparation of the solution:
The product should be diluted before use. It can be diluted with 5% (50 mg/mL) glucose solution or 0.9% (9 mg/mL) sodium chloride solution to a final concentration of 0.5 mg/mL (500 micrograms/mL).

Pharmaceutical incompatibilities

Carboplatin may react with aluminum, forming a black precipitate. Needles, syringes, catheters, or intravenous sets containing aluminum parts that may come into contact with the medicine should not be used to prepare or administer carboplatin. The precipitate may lead to a decrease in the anticancer effect.

Shelf life and storage

The medicine is for single use only.
Before opening
Do not store above 25°C. Do not store in the refrigerator or freeze.
Store the vial in the outer packaging to protect from light.
After dilution
In use: The chemical and physical stability of the medicine has been demonstrated for 24 hours at room temperature and for 30 hours at 2-8°C.
From a microbiological point of view, the product should be used immediately. If not, the responsibility for the storage time and conditions of the prepared solution lies with the user.
Normally, the storage time should not exceed 24 hours at 2-8°C, unless the dilution was performed under controlled and validated aseptic conditions.

INSTRUCTIONS FOR PREPARATION OF CARBOPLATIN ACCORD FOR ADMINISTRATION AND DISPOSAL OF ITS RESIDUES

Instructions for preparation of Carboplatin Accord

As with other anticancer medicines, caution should be exercised when handling and preparing Carboplatin Accord for administration.
The following procedures should be used when handling carboplatin:

• 1. Carboplatin should be prepared for administration only by personnel qualified in the safe handling of cytotoxic medicines. Personnel handling Carboplatin Accord should wear appropriate protective clothing, including protective eyewear, gowns, gloves, and masks.
• 2. Preparation of the syringe should be performed in a designated area (preferably using a laminar flow system). The work surface should be covered with absorbent paper with a plastic backing.
• 3. All materials used during preparation, administration, or cleaning (including gloves) should be placed in high-risk waste bags for incineration at high temperatures.
• 4. Liquid waste can be treated with a diluted sodium hypochlorite solution (1% available chlorine), preferably by soaking, and then rinsed with water. All contaminated and used cleaning materials should be placed in high-risk waste bags. In case of accidental contact of the medicine with the skin or eyes, immediate flushing with plenty of water, soap and water, or sodium bicarbonate solution should be performed. The skin should not be scrubbed with a brush. Medical attention should be sought. After removing gloves, hands should always be washed.

Preparation of the infusion solution

The product should be diluted before use. It can be diluted with glucose or sodium chloride solution to a final concentration of 0.5 mg/mL (500 micrograms/mL).

Disposal of residues

Medicines should not be disposed of via wastewater or household waste. All materials used during preparation, administration, or cleaning that have come into contact with carboplatin should be disposed of in accordance with local regulations for the disposal of cytotoxic waste.