CARBOPLATIN Pharmacia 10 mg/ml Concentrate for Infusion Solution

Introduction

Package Leaflet: Information for the Patient

Carboplatin Pharmacia 10 mg/ml Concentrate for Solution for Infusion EFG

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 further questions, ask your doctor, pharmacist, or nurse.
• 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, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

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

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

Carboplatin Pharmacia is a medicine used to treat different types of tumors. Carboplatin works by preventing the proliferation of cancer cells.

Carboplatin Pharmacia can be used alone or in combination with other medicines for the treatment of the following types of tumors:

• Advanced ovarian cancer
• Small cell lung cancer
• Advanced head and neck cancer
• Invasive and advanced bladder cancer

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

Do not use Carboplatin Pharmacia

• If you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6), or to any platinum compound.
• If you have severe kidney problems.
• If you have reduced bone marrow function.
• If you have significant bleeding associated with tumors.
• If you are going to be vaccinated against yellow fever (see "Using Carboplatin Pharmacia with other medicines").

Warnings and Precautions

Consult your doctor, pharmacist, or nurse before starting treatment with Carboplatin Pharmacia.

• If you have headaches, alterations in mental functions, seizures, and visual disturbances that can range from blurred vision to loss of vision.
• If during treatment you experience bone marrow alterations associated with a decrease in the number of white blood cells (leukopenia, neutropenia) and platelets (thrombocytopenia). This alteration and/or kidney function impairment may be worsened if you have received or are receiving treatment with other cancer medicines (particularly cisplatin) or radiation.
• If during treatment you experience a decrease in the number of red blood cells in the blood (anemia).
• If during treatment you develop extreme fatigue with a decrease in the number of red blood cells in the blood and difficulty breathing (hemolytic anemia), alone or in combination with low platelet counts and abnormal bruising (thrombocytopenia) and kidney disease characterized by little or no urination (symptoms of hemolytic uremic syndrome).
• If you have a fever (temperature of 38°C or higher), or chills, which can be signs of infection. This may pose a risk of developing a blood infection.
• If you have kidney problems and have received previous treatment with other cancer medicines or other medicines that may affect kidney function.
• If you have liver problems.
• If during treatment you develop any signs or symptoms of nerve damage such as tingling (paresthesia) or decreased reflexes, especially if you are over 65 years old or have received previous treatment with other cancer medicines like cisplatin.
• If during treatment you experience visual disturbances (especially if you have kidney problems).
• If during treatment you start to notice hearing problems, consult your doctor, as you may need to adjust the dose or interrupt treatment.
• If during treatment you experience vomiting. Since carboplatin can cause vomiting, your doctor may administer medication before treatment to prevent or reduce its incidence and intensity.
• If you experience symptoms of an allergic reaction to the medicine.
• If you need to be vaccinated while undergoing treatment with this medicine, as live or attenuated virus vaccines should not be administered, and the response to killed or inactivated vaccines may be reduced (see "Using Carboplatin Pharmacia with other medicines").
• If you are an elderly patient and are receiving treatment in combination with a medicine called cyclophosphamide, as you may develop a more severe decrease in platelet count (thrombocytopenia).

If you are in any of the above cases, consult your doctor before using Carboplatin Pharmacia.

During treatment with carboplatin, you will be given medicines to help reduce the risk of developing a potentially life-threatening complication known as tumor lysis syndrome, which is caused by chemical changes in the blood due to the destruction of dead cancer cells that release their contents into the blood.

Effective contraceptive methods should be used during and after treatment with carboplatin. If patients wish to have children after completing treatment, genetic counseling is recommended (see Pregnancy, Breastfeeding, and Fertility).

Your doctor will regularly check your condition to see if Carboplatin is having the expected effect.

Before starting treatment and while you are undergoing treatment with Carboplatin, your doctor may perform periodic blood tests, kidney and liver function tests, neurological and auditory examinations (audiometry).

Other Medicines and Carboplatin Pharmacia

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Carboplatin may increase the adverse effects and/or modify the action of other medicines, such as some medicines used for cancer treatment, radiation therapy, or medicines that affect blood coagulation (anticoagulants).

Yellow fever vaccine should not be administered during treatment with carboplatin.

Live attenuated virus vaccines (except yellow fever vaccine) and medicines for the treatment of epilepsy (phenytoin and fosphenytoin) are not recommended during treatment with carboplatin.

Your doctor will assess the administration of medicines that suppress bone marrow activity (cyclosporin, tacrolimus, and sirolimus), certain types of antibiotics (aminoglycosides), and certain types of diuretics (loop diuretics) during treatment with carboplatin.

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy:

Do not use Carboplatin Pharmacia during pregnancy. Your doctor will inform you of the potential risks of using Carboplatin Pharmacia during pregnancy.

Breastfeeding:

Do not breastfeed while undergoing treatment with Carboplatin Pharmacia and for at least one month after the last dose.

Fertility:

Due to the possible risk of serious birth defects, women of childbearing age should always use effective contraceptive methods during treatment with Carboplatin Pharmacia and for at least seven months after the last dose.

Male patients undergoing treatment with carboplatin should use effective contraceptive measures during treatment and for up to 4 months after completion of treatment, as well as receive counseling before starting treatment regarding sperm preservation, due to the possibility of irreversible infertility caused by carboplatin treatment.

Talk to your doctor about the contraceptive methods that are suitable for you and your partner.

Driving and Using Machines

No studies have been conducted on the influence of carboplatin on the ability to drive and use machines. However, since carboplatin can cause nausea, vomiting, visual disturbances, and hearing disturbances (ototoxicity), it is not recommended to drive vehicles or operate machinery after administration of the medicine.

3. How to Use Carboplatin Pharmacia

Carboplatin is administered solely by intravenous route and under the supervision of a doctor with experience in the use of this type of treatment. In case of doubt, consult your doctor or pharmacist again.

Your doctor will determine the most suitable dose and duration of treatment for you, based on your height and weight, the state of your blood system (hematopoietic), the state of your kidneys, and your response to treatment. You will undergo regular tests to monitor your disease.

Your doctor will indicate the number of treatment cycles you need. Normally, there will be an interval of 4 weeks between each carboplatin dose.

If you use more Carboplatin Pharmacia than you should

Although unlikely, if you receive more carboplatin than you should, your doctor will interrupt treatment and treat the symptoms.

If you miss a dose of Carboplatin Pharmacia

It is very unlikely that you will miss a dose because your doctor will have instructions on when to administer the medicine. If you think you have missed a dose, contact your doctor as soon as possible.

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

4. Possible Side Effects

Tell your doctor immediately if you experience any of the following signs and symptoms that may indicate a severe allergic reaction:

• Chest pain that can be a sign of a potentially severe allergic reaction called Kounis syndrome

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

Very common side effects (may affect more than 1 in 10 people):

• Decrease in platelets (thrombocytopenia), decrease in different types of white blood cells (neutropenia, leukopenia), decrease in red blood cells (anemia).
• Vomiting, nausea, abdominal pain.
• Alterations in blood tests (decrease in creatinine clearance, increase in blood urea levels, increase in alkaline phosphatase levels, increase in aspartate aminotransferase, decrease in sodium levels, decrease in potassium levels, decrease in calcium levels, decrease in magnesium levels) and alterations in liver function tests.

Common side effects (may affect up to 1 in 10 people):

• Infections.
• Bleeding.
• Hypersensitivity and allergic reactions (anaphylactic).
• Nervous system disorders (peripheral neuropathy), tingling (paresthesia), decreased reflexes, sensory disturbances, decreased taste (dysgeusia).
• Visual disturbances, loss of vision.
• Hearing disturbances (ototoxicity).
• Heart disorders.
• Respiratory disorders, lung disorders (interstitial lung disease), bronchospasm.
• Diarrhea, constipation, alteration of mucous membranes.
• Hair loss (alopecia), skin disorders.
• Musculoskeletal disorders.
• Genitourinary disorders.
• Fatigue (asthenia).
• Alterations in blood tests (increase in bilirubin, increase in creatinine, increase in uric acid).

Uncommon side effects (frequency cannot be estimated from the available data):

• Certain types of leukemia (such as acute myeloid leukemia) and myelodysplastic syndromes.
• Bone marrow failure, decreased white blood cells with fever (febrile neutropenia), a disorder that occurs when a gastrointestinal infection produces toxic substances that destroy red blood cells and cause kidney damage (hemolytic uremic syndrome), decreased red blood cells and difficulty breathing (hemolytic anemia).
• Dehydration, loss of appetite (anorexia), decreased sodium levels in the blood (hyponatremia).
• Decreased blood flow to the brain (stroke).
• Heart failure, chest pain, which can be a sign of a potentially severe allergic reaction called Kounis syndrome.
• Blood clots or air bubbles in the circulation (embolism), increased and decreased blood pressure.
• Mouth mucosa inflammation (stomatitis).
• Hives, rash, redness (erythema), itching (pruritus).
• Tissue damage at the injection site, reaction at the injection site, leakage of the medicine from the injection site, redness (erythema) at the injection site, discomfort.
• Blindness caused by damage to certain areas of the brain (cortical blindness) in patients with kidney problems.
• Partial loss of hearing (hypacusis), ringing in the ears (tinnitus).
• Inflammatory skin disorder (exfoliative dermatitis).
• Muscle pain (myalgia) and joint pain (arthralgia).
• Liver damage that can be fatal (fulminant hepatic necrosis).
• Fever.
• Chills.
• Symptoms such as headache, alterations in mental functions, seizures, and visual disturbances that can range from blurred vision to loss of vision (symptoms of posterior reversible leukoencephalopathy syndrome, a rare neurological disorder).
• Pancreatitis.
• Lung infection.
• Muscle cramps, muscle weakness, confusion, vision loss or disturbances, irregular heartbeats, kidney failure, or abnormal blood test results (symptoms of tumor lysis syndrome, which can be caused by the rapid destruction of tumor cells) (see section 2).

Reporting of Side Effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible that they are not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Carboplatin Pharmacia

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

Do not store above 25°C. Do not refrigerate or freeze. Keep in the original packaging to protect from light.

Do not use this medicine after the expiry date which is stated on the outer packaging and on the label after EXP. The expiry date is the last day of the month shown.

Do not use any packaging that is damaged or open.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Container Contents and Additional Information

Composition ofCarboplatin Pharmacia

• The active ingredient is carboplatin.
• The other components (excipients) are: water for injectable preparations.

Appearance of the Product and Container Contents

Carboplatin Pharmacia 10 mg/ml concentrate for solution for infusion EFG is presented in containers containing a single 15 ml or 45 ml Type I transparent glass vial with a chlorobutyl stopper.

Each 15 ml vial contains 150 mg of the active ingredient carboplatin.

Each 45 ml vial contains 450 mg of the active ingredient carboplatin.

Only certain package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Pharmacia Nostrum, S.A.

Avda. de Europa, 20 B

Parque Empresarial La Moraleja

28108 Alcobendas (Madrid)

Manufacturer:

Pfizer Service Company BV

Hoge Wei 10

1930 Zaventem

Belgium

or

Hospira Australia Pty Ltd

1-5, 7-23, 25-39 Lexia Place

Mulgrave 3170

Victoria

Australia

Date of Last Revision of this Leaflet: October 2023

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es.gob/

IMPORTANT INFORMATION FOR HEALTHCARE PROFESSIONALS

Preparation for Administration

Carboplatin Pharmacia does not contain any preservative or bacteriostatic agent. The vials are for single use only, and the unused portion must be discarded.

Carboplatin can be diluted in 0.9% saline solution or 5% dextrose solution, up to concentrations of 0.5 mg/ml. To reduce the microbiological risk, dilution should be performed immediately before use. A visual inspection of the solution is recommended prior to administration to ensure that the solution is free of particles. The infusion should be completed within the first 24 hours after preparation, and the unused portion should be discarded.

The use of Luer-Lock syringes and large-diameter needles is recommended to minimize pressure and potential aerosol formation. Aerosols can also be reduced by using a vented needle during preparation.

Precautions for Long-Term Infusion Administration of the Concentrate for Solution for Infusion:

When Carboplatin Pharmacia concentrate for solution for infusion is dissolved in 0.9% saline solution and stored for 24 hours at 25°C, a 5% degradation of the active ingredient from the initial concentration occurs. Therefore, dissolving Carboplatin Pharmacia in 0.9% saline solution for long-term infusions is not considered suitable, as it may result in loss of active ingredient and conversion of carboplatin to cisplatin, increasing the risk of toxicity.

Needles or intravenous administration devices containing aluminum parts that may come into contact with carboplatin should not be used for preparation or administration. Carboplatin interacts with aluminum, producing precipitate formation and/or loss of potency.

Protective Measures

1. Handling of carboplatin should be performed by trained healthcare personnel experienced in the use of chemotherapeutic agents.
2. Pregnant women should avoid handling this medication.
3. Trained healthcare personnel handling carboplatin should wear protective clothing: protective glasses, gown, gloves, and disposable masks.
4. Dilution should be performed in a designated area (preferably under a laminar flow system). The work surface should be protected with absorbent, plasticized, and disposable paper.
5. All material used for reconstitution, administration, or cleaning should be disposed of in high-risk residual material bags for destruction by high-temperature incineration.
6. Any spill or leak should be treated with diluted sodium hypochlorite solution (1% available chlorine), preferably by soaking, and then with water.
7. All cleaning materials should be disposed of as indicated above.
8. In case of accidental contact with the eyes or skin, wash immediately with plenty of water, with soap and water, or with sodium bicarbonate solution, and seek medical attention. A mild cream can be used to treat transient skin itching. If the eyes are affected, consult a doctor.
9. Always wash hands after removing gloves.

Elimination

Elimination of unused medication and all materials that have come into contact with it should be performed in accordance with local regulations.