Carboplatin Kabi

Package Leaflet: Information for the User

Carboplatin Kabi, 10 mg/mL, Concentrate for Solution for Infusion

Carboplatin

Read the Package Leaflet Carefully Before Using the Medication, as it Contains Important Information for the Patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or nurse.
• If you experience any side effects, including those not listed in this package leaflet, inform your doctor or nurse. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Carboplatin Kabi and What is it Used For
• 2. Important Information Before Using Carboplatin Kabi
• 3. How to Use Carboplatin Kabi
• 4. Possible Side Effects
• 5. How to Store Carboplatin Kabi
• 6. Contents of the Package and Other Information

1. What is Carboplatin Kabi and What is it Used For

What is Carboplatin Kabi

Carboplatin Kabi contains carboplatin, which belongs to a group of substances known as platinum coordination compounds, used in cancer treatment.

What is Carboplatin Kabi Used For

Carboplatin Kabi is used to treat advanced ovarian cancer and small cell lung cancer.

2. Important Information Before Using Carboplatin Kabi

When Not to Use Carboplatin Kabi:

• if you are allergic to carboplatin or any of the other ingredients of this medication (listed in section 6);
• in patients with severe kidney function disorders (creatinine clearance equal to or less than 30 mL/min);
• if you have an abnormal blood cell count (severe bone marrow suppression);
• if you have a bleeding tumor;
• concomitantly with yellow fever vaccine.

In case of any of the above-mentioned symptoms that have not been previously discussed with your doctor or nurse, inform your doctor or nurse as soon as possible before receiving the infusion.
Carboplatin is usually administered to patients in a hospital. Patients should not handle the medication.
The medication will be administered by a doctor or nurse who will closely and frequently monitor the patient's condition during and after treatment. Blood tests are usually performed before each administration of the medication.

Warnings and Precautions

Before starting treatment with Carboplatin Kabi, consult your doctor or nurse:

• if you are pregnant or think you may be pregnant;
• if you are breastfeeding;
• if there is a possibility that you will consume alcohol during treatment. If you experience headache, confusion, seizures, and vision disturbances (from blurred vision to loss of vision), consult your doctor. Consult your doctor in case of extreme fatigue and shortness of breath, along with a decrease in red blood cells (symptoms of hemolytic anemia), with or without a decreased platelet count, abnormal bruising (thrombocytopenia), and kidney disease characterized by a small amount of urine excreted or its absence (symptoms of hemolytic-uremic syndrome). If you have a fever (body temperature equal to or higher than 38°C) or chills, which may be symptoms of infection, contact your doctor immediately. There may be a risk of blood infection.

In patients with impaired kidney function, the effect of Carboplatin Kabi on the blood (hematopoietic system) is increased and prolonged compared to patients with normal kidney function. The doctor will monitor the patient more frequently if they have kidney function disorders.
During carboplatin treatment, medications will be administered to 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.
In case of any of the above-mentioned symptoms that have not been previously discussed with your doctor or nurse, inform your doctor or nurse as soon as possible before receiving the infusion.
The medication may be diluted with another solution before administration. Discuss this with your doctor and ensure it is suitable for you.

Carboplatin Kabi and Other Medications

Tell your doctor about all medications you are currently taking or have recently taken, as well as any medications you plan to take.
Inform your doctor if you are taking any of the following medications, as they may interact with carboplatin:

• medications with known toxic effects on the kidneys (e.g., aminoglycoside antibiotics);
• medications known to damage hearing or balance (e.g., aminoglycoside antibiotics, furosemide (used to treat heart failure and edema));
• medications that suppress the immune system (e.g., cyclosporine, tacrolimus, sirolimus, and other anticancer medications);
• yellow fever vaccine and other live vaccines;
• blood thinners (e.g., warfarin);
• phenytoin and fosphenytoin (used to treat various types of seizures and epilepsy);
• chelating agents (substances that bind to carboplatin, leading to a decrease in its effect);
• loop diuretics (used to treat hypertension and edema).

Carboplatin Kabi with Food, Drink, and Alcohol

The interaction between Carboplatin Kabi and alcohol is not known. Consult your doctor about consuming alcohol during treatment with Carboplatin Kabi, as the medication may affect the liver's ability to process alcohol.

Pregnancy, Breastfeeding, and Fertility

During pregnancy, breastfeeding, or if you suspect you are pregnant, or plan to have a child, consult your doctor before using this medication.
In case of any of the above-mentioned conditions that have not been previously discussed with your doctor or nurse, it is recommended that the patient inform the doctor or nurse as soon as possible before receiving the infusion.

Pregnancy

Carboplatin should not be used during pregnancy, unless your doctor explicitly indicates otherwise. Animal studies have shown a possible risk of fetal development abnormalities. If you are pregnant and taking carboplatin, discuss the possible risk of the medication's effect on the unborn child with your doctor. Women of childbearing age must use effective contraception during and for at least 6 months after completing carboplatin treatment.
Given that carboplatin can cause genetic damage, if you become pregnant during carboplatin treatment, genetic counseling is recommended. Genetic counseling is also recommended for patients planning to have children after completing treatment with Carboplatin Kabi.

Breastfeeding

It is not known whether carboplatin passes into breast milk. Therefore, breastfeeding should be discontinued during carboplatin treatment.

Fertility

Carboplatin may cause genetic damage. Women should be advised to avoid becoming pregnant by using effective contraception during treatment. Women who are pregnant or become pregnant during treatment should be provided with genetic counseling. It is recommended that men treated with carboplatin do not plan to have children during and for at least 3 months after completing treatment. They should also consult their doctor before treatment regarding sperm storage, due to the possibility of irreversible infertility.

Driving and Using Machines

Carboplatin does not affect the ability to drive and use machines. However, be cautious when driving or operating machinery, especially during the first administration, if you experience dizziness or do not feel secure.

3. How to Use Carboplatin Kabi

The medication is administered by a doctor or nurse through a drip into a vein in a slow infusion, which usually lasts from 15 to 60 minutes. If you need additional information, consult your doctor or nurse who will administer or has administered the infusion. The dose depends on your height, weight, blood system function, and kidney function. Your doctor will choose the most suitable dose of the medication for each patient individually. The medication is usually diluted before use.

Adults

The usual dose is 400 mg/m² body surface area (calculated based on height and weight).

Elderly Patients

The usual dose for adults may be used, although the doctor may decide to use a different dose.

Patients with Kidney Function Disorders

The administered dose may be changed, depending on kidney function. If you have kidney function disorders, your doctor may reduce the dose of the medication and perform frequent blood morphology tests and monitor kidney function. The medication will be administered by a doctor with experience in cancer treatment.

Children and Adolescents

There is insufficient data on the use of Carboplatin Kabi in children, which does not allow for specific dose recommendations.
During treatment with Carboplatin Kabi, you may experience nausea. Before using Carboplatin Kabi, your doctor may administer another medication to reduce these side effects.
A 4-week interval is usually used between consecutive doses of Carboplatin Kabi.
Your doctor may order weekly blood morphology tests after each administration of Carboplatin Kabi.
This will allow your doctor to decide whether to adjust the next dose of the medication.

Using a Higher Than Recommended Dose of Carboplatin Kabi

There is a small possibility that you may receive too high a dose of Carboplatin Kabi.
However, if this happens, kidney, liver, vision, and hearing disorders may occur, as well as a low white blood cell count. If you have any doubts about the dose you have received or any questions about the dose you are taking, consult your doctor who administers the medication.

Missing a Dose of Carboplatin Kabi

There is a very small possibility that you will miss a dose of the medication, as your doctor will monitor the administration schedule. If you suspect you have missed a dose of the medication, inform your doctor or nurse.
If you have any further doubts about using this medication, consult your doctor or nurse.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everybody gets them.
Inform your doctor immediately if you notice any of the following symptoms:

• unexpected bruising, bleeding, or signs of infection, such as sore throat and high temperature;
• severe itching of the skin (with visible lumps) or swelling of the face, lips, tongue, and/or throat, which may cause difficulty swallowing or breathing (angioedema) and a feeling of losing consciousness;
• mouth inflammation and/or mucositis (e.g., pain in the lips or mouth ulcers).

Very Common (May Affect More Than 1 in 10 Patients):

• bone marrow suppression characterized by a significant decrease in white blood cells, which increases the risk of infection (leukopenia, neutropenia);
• decrease in platelet count, which increases the risk of bruising and bleeding (thrombocytopenia);
• anemia (a condition in which there is a decrease in red blood cells, which leads to fatigue);
• kidney function impairment (increased creatinine and urea levels in the blood) - your doctor may monitor your condition;
• mild hearing loss (high-frequency hearing loss);
• abnormal liver enzyme activity and abnormal liver function test results - your doctor may monitor your condition;
• increased uric acid levels in the blood, which may lead to gout (hyperuricemia);
• nausea and vomiting;
• abdominal pain and cramps;
• unexplained fatigue or weakness;
• decrease in blood electrolyte levels (sodium, potassium, calcium, and magnesium) - your doctor may monitor your condition.

Common (May Affect Up to 1 in 10 Patients):

• unexpected bruising or bleeding (hemorrhagic complication);
• diarrhea, constipation, mouth pain, or mouth ulcers (mucositis);
• allergic reactions including rash, hives, redness, itching, high temperature;
• ringing in the ears (tinnitus), hearing disturbances, and hearing loss;
• tingling sensation (peripheral neuropathy), weakness, numbness;
• hair loss;
• malaise;
• flu-like symptoms;
• loss of strength;
• lung disease, scarring, and thickening in the lungs, accompanied by breathing difficulties, sometimes fatal (interstitial lung disease), breathing difficulties;
• decreased deep tendon reflexes;
• infections;
• sensory disturbances;
• taste disturbances;
• vision disturbances, including temporary loss of vision;
• cardiovascular disorders;
• skin disorders;
• itchy rash (hives);
• itching sensation (pruritus),
• red rash (erythematous rash);
• musculoskeletal disorders;
• urinary tract and genital disorders (urinary and genital disorders);
• increased creatinine, bilirubin, and uric acid levels in the blood. Your doctor will monitor these changes.

Uncommon (May Affect Up to 1 in 100 Patients):

• chemo- or radiotherapy-induced tumors (secondary tumors);
• fever and chills without visible signs of infection;
• redness, swelling, pain, or necrosis of the skin at the injection site (reaction at the injection site).

Rare (May Affect Up to 1 in 1,000 Patients):

• feeling of malaise with high temperature due to a low white blood cell count (febrile neutropenia);
• loss of appetite (anorexia);
• severe liver function disorders, liver damage, or liver cell death - your doctor may monitor your condition;
• optic neuritis, which may cause complete or partial loss of vision;
• severe allergic reactions (anaphylactic and/or anaphylactoid reactions);
• symptoms of severe allergic reactions include wheezing or chest tightness, swelling of the eyelids, face, or lips, sudden redness of the face, low blood pressure, tachycardia, hives, shortness of breath, dizziness, and anaphylactic shock;
• low sodium levels in the blood (hyponatremia).

Very Rare (May Affect Up to 1 in 10,000 Patients):

• heart failure;
• bleeding in the brain, which may lead to stroke or loss of consciousness;
• sudden blockage of an artery (embolism), high blood pressure, low blood pressure.

Frequency Not Known (Cannot be Estimated from the Available Data):

• hemolytic-uremic syndrome (a disease characterized by acute kidney failure, decreased red blood cell count (microangiopathic hemolytic anemia), and low platelet count);
• unexpected bruising, bleeding, or signs of infection;
• dehydration;
• mouth pain or mouth ulcers (mouth inflammation);
• muscle spasms, muscle weakness, confusion, 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 death of cancer cells) (see section 2);
• a group of symptoms such as headache, confusion, seizures, and vision disturbances (from blurred vision to loss of vision) (symptoms of posterior reversible leukoencephalopathy syndrome, a rare neurological disorder);
• pancreatitis;
• lung infection;
• chest pain, which may be a symptom of a potentially serious allergic reaction called Kounis syndrome.

Reporting Side Effects

If you experience any side effects, including those not listed in this package leaflet, inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Medicinal Product Monitoring, 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 gather more information on the safety of the medication.

5. How to Store Carboplatin Kabi

Store the medication out of sight and reach of children.
Do not use this medication after the expiration date stated on the label and carton after EXP.
The expiration date refers to the last day of the month.
Vial before opening: Store in a temperature below 25°C.
Store the vial in the outer packaging to protect it from light.
After dilution: The chemical and physical stability of the medication has been demonstrated after dilution with 5% glucose solution for 96 hours at a temperature of 2°C to 8°C and at a temperature of 20°C to 25°C.
The chemical and physical stability of the medication has been demonstrated after dilution with 0.9% sodium chloride solution for 24 hours at a temperature of 2°C to 8°C and for 8 hours at a temperature of 20°C to 25°C.
From a microbiological point of view, the medication should be used immediately. Otherwise, the responsibility for the storage time and conditions of the prepared solution lies with the user.
Usually, the storage time should not exceed 24 hours at a temperature of 2°C to 8°C, unless the dilution is performed under controlled and validated aseptic conditions.
Do not use Carboplatin Kabi if visible signs of decomposition are present.
Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the Package and Other Information

What Carboplatin Kabi Contains:

• The active substance of the medication is carboplatin. 1 mL of the concentrate for solution for infusion contains 10 mg of carboplatin. Each 5 mL vial of the concentrate for solution for infusion contains 50 mg of carboplatin. Each 15 mL vial of the concentrate for solution for infusion contains 150 mg of carboplatin. Each 45 mL vial of the concentrate for solution for infusion contains 450 mg of carboplatin. Each 60 mL vial of the concentrate for solution for infusion contains 600 mg of carboplatin.
• The other ingredient is water for injection.

What Carboplatin Kabi Looks Like and Contents of the Package

Carboplatin Kabi is a clear, colorless to pale yellow solution, free from visible particles.
1 mL of the concentrate for solution for infusion contains 10 mg of carboplatin.
1 vial of 6 mL capacity containing 5 mL of the concentrate (50 mg of carboplatin).
The vial is made of colorless glass (type I) with a chlorobutyl or bromobutyl rubber stopper, with an aluminum flip-off seal and a green PP cap, in a cardboard box.
1 vial of 20 mL capacity containing 15 mL of the concentrate (150 mg of carboplatin).
The vial is made of colorless glass (type I) with a chlorobutyl or bromobutyl rubber stopper, with an aluminum flip-off seal and a blue PP cap, in a cardboard box.
1 vial of 50 mL capacity containing 45 mL of the concentrate (450 mg of carboplatin).
The vial is made of colorless glass (type I) with a chlorobutyl or bromobutyl rubber stopper, with an aluminum flip-off seal and a red PP cap, in a cardboard box.
1 vial of 100 mL capacity containing 60 mL of the concentrate (600 mg of carboplatin).
The vial is made of colorless glass (type I) with a chlorobutyl or bromobutyl rubber stopper, with an aluminum flip-off seal and a yellow PP cap, in a cardboard box.
The vial may be packaged in a protective foil and may be placed in a plastic container.
Not all pack sizes may be marketed.

Marketing Authorization Holder

Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw

Manufacturer

Fresenius Kabi Deutschland GmbH
Pfingstweide 53
61169 Friedberg
Germany
To obtain more detailed information, contact the marketing authorization holder:
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw
tel.: +48 22 345 67 89

This Medication is Authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) Under the Following Names:

Date of Last Revision of the Package Leaflet:26.06.2024
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Information Intended for Healthcare Professionals Only:

The medication is intended for single use only. Any unused solution should be discarded.

Instructions for Dilution

Carboplatin interacts with aluminum, resulting in the formation of a black precipitate and/or a decrease in carboplatin activity. Therefore, needles, syringes, catheters, and other components of intravenous infusion sets containing aluminum should not be used to administer carboplatin.
Before infusion, the medication should be diluted with 5% glucose solution for infusion or 0.9% sodium chloride solution for infusion to a concentration of 0.5 mg/mL (500 micrograms/mL).
The chemical and physical stability of the medication has been demonstrated after dilution with 5% glucose solution for 96 hours at a temperature of 2°C to 8°C and at a temperature of 20°C to 25°C.
The chemical and physical stability of the medication has been demonstrated after dilution with 0.9% sodium chloride solution for 24 hours at a temperature of 2°C to 8°C and for 8 hours at a temperature of 20°C to 25°C.
From a microbiological point of view, the medication should be used immediately. Otherwise, the responsibility for the storage time and conditions of the prepared solution lies with the user.
Usually, the storage time should not exceed 24 hours at a temperature of 2°C to 8°C, unless the dilution is performed under controlled and validated aseptic conditions.
Before use, the solution should be inspected for visible particles and color changes. Only use the solution if it is clear, colorless, and free from visible particles.

Guidelines for Safe Handling of Anticancer Medications

• 1. Carboplatin should be prepared for administration only by personnel qualified in the safe handling of chemotherapeutic agents.
• 2. Preparation of the medication should be performed in a designated area.
• 3. Wear appropriate protective gloves, masks, and clothing.
• 4. Take precautions to avoid accidental contact of the medication with the eyes. In case of eye contact, rinse with water and/or physiological saline solution.
• 5. Pregnant women should not perform tasks involving cytotoxic medications.
• 6. Be careful and take appropriate precautions when disposing of materials (syringes, needles, etc.) used to prepare cytotoxic medications. Dispose of unused materials and biological waste by placing them in double-sealed polyethylene bags and incinerating at 1000°C.
• 7. Cover the work surface with single-use absorbent paper coated with plastic on one side.
• 8. Use Luer-lock connections for all syringes and sets. It is recommended to use large-diameter needles to minimize pressure and potential aerosol formation. Aerosol formation can also be prevented by using a needle with a vent.

Disposal

Any unused medication or waste should be disposed of in accordance with local regulations.