Carboplatin kabi

Package leaflet: Information for the user

Carboplatin Kabi, 10 mg/mL, concentrate for solution for infusion
Carboplatinum
Please read all of this leaflet carefully before using this medicine, because it contains important information for the patient.

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

Contents of the leaflet

1. What Carboplatin Kabi is and what it is 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 pack and other information

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

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

What Carboplatin Kabi is used for
Carboplatin Kabi is used in the treatment of advanced ovarian cancer and small cell lung cancer.

2. Important information before using Carboplatin Kabi

When not to use Carboplatin Kabi:

• if the patient is allergic to carboplatin or any of the other ingredients of this medicine (listed in section 6);
• in patients with severe kidney function disorders (creatinine clearance equal to or less than 30 mL/min);
• if the patient has abnormal blood cell counts (severe bone marrow suppression);
• if the patient has a bleeding tumour;
• concurrently with the yellow fever vaccine.

If any of the above symptoms have not previously been discussed with the doctor or nurse, the patient must inform the doctor or nurse as quickly as possible before receiving the infusion.
Carboplatin is usually administered to patients in a hospital. Patients must not handle the medicine themselves.
The medicine 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 dose.

Warnings and precautions
Before starting treatment with Carboplatin Kabi, consult the doctor or nurse:

• if the patient is pregnant or suspects she may be pregnant;
• if the patient is breastfeeding;
• if there is a possibility that the patient will consume alcohol during treatment.

If the patient experiences headache, confusion, seizures, or visual disturbances (from blurred vision to loss of vision), medical advice must be sought.
Seek medical advice if the patient experiences extreme fatigue and shortness of breath, along with a low red blood cell count (symptoms of haemolytic anaemia), with or without low platelet count, abnormal bruising (thrombocytopenia), and kidney disease manifested by reduced urine output or anuria (symptoms of haemolytic-uremic syndrome).
If the patient develops fever (body temperature equal to or above 38°C) or chills, which may be signs of infection, immediate contact with the doctor is required. There may be a risk of blood infection.

In patients with impaired kidney function, the effect of Carboplatin Kabi on the blood (haematopoietic system) is intensified and prolonged compared to patients with normal kidney function. The doctor will monitor the patient more frequently if kidney function disorders are present.
During carboplatin treatment, additional medicines may be administered to help reduce the risk of a potentially life-threatening complication known as tumour lysis syndrome, caused by biochemical disturbances in the blood due to the breakdown of dying cancer cells releasing their contents into the bloodstream.

If any of the above symptoms have not previously been discussed with the doctor or nurse, the patient must inform the doctor or nurse as quickly as possible before receiving the infusion.
The medicine may be diluted with another solution prior to administration. This should be discussed with the doctor to ensure it is appropriate for the patient.

Carboplatin Kabi and other medicines
Inform the doctor about all medicines currently used, recently used, or planned for use.
Inform the doctor if the patient is taking any of the following medicines, as they may interact with carboplatin:

• medicines known to have nephrotoxic effects (e.g. aminoglycoside antibiotics);
• medicines known to damage hearing or balance (e.g. aminoglycoside antibiotics, furosemide (used in the treatment of heart failure and oedema));
• medicines that suppress the immune system (e.g. cyclosporine, tacrolimus, sirolimus, and other anticancer medicines);
• yellow fever vaccine and other live vaccines;
• anticoagulant medicines (e.g. warfarin);
• phenytoin and fosphenytoin (used to treat various types of seizures and epilepsy);
• chelating agents (substances that bind carboplatin, leading to reduced efficacy);
• loop diuretics (used in the treatment of hypertension and oedema).

Carboplatin Kabi with food, drink, and alcohol
The interaction between Carboplatin Kabi and alcohol is not known. Patients should consult their doctor about alcohol consumption during treatment with Carboplatin Kabi, due to the potential effect of the medicine on the liver's ability to metabolize alcohol.

Pregnancy, breastfeeding, and effects on fertility

During pregnancy, breastfeeding, if pregnancy is suspected, or when planning to have a child, consult the doctor before using this medicine.
If any of the above conditions have not previously been discussed with the doctor or nurse, the patient is advised to inform the doctor or nurse as quickly as possible before receiving the infusion.

Pregnancy
Carboplatin must not be used during pregnancy unless specifically indicated by the doctor. Animal studies have shown a potential risk of fetal developmental abnormalities. If a patient becomes pregnant while taking carboplatin, she should discuss the potential risks of the medicine on the unborn child with her doctor. Women of childbearing potential must use effective contraception during treatment and for at least 6 months after completion of carboplatin therapy.
Because carboplatin may cause genetic damage, genetic counselling is recommended for patients who become pregnant during treatment. Genetic counselling is also recommended for patients planning to have children after completing treatment with Carboplatin Kabi.

Breastfeeding
It is not known whether carboplatin passes into human milk. Therefore, breastfeeding must be discontinued during carboplatin treatment.

Fertility
Carboplatin may cause genetic damage. Women should be advised to avoid pregnancy by using effective contraceptive methods during treatment. Women who are pregnant or become pregnant during treatment should be offered genetic counselling.
Men undergoing carboplatin treatment should not plan to have children during treatment and for at least 3 months after treatment ends. They should also seek advice before treatment regarding sperm banking due to the risk of irreversible infertility.

Consult the doctor or nurse before using any medicine.

Driving and operating machinery
Carboplatin does not affect the ability to drive or operate machinery. However, particular caution should be exercised during the first administration, especially if the patient experiences dizziness or feels unsteady.

3. How to use Carboplatin Kabi

The medicine is administered by a doctor or nurse through an intravenous infusion, which usually lasts from 15 to 60 minutes. If you need further information, please consult the doctor or nurse administering or who administered the infusion. The dose depends on the patient's height and body weight, blood (haematopoietic) system function, and kidney function. The doctor will determine the most appropriate dose individually for each patient. The medicine is usually diluted before use.

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

Elderly patients
The usual adult dose may be used, although the doctor may decide to use a different dose.

Patients with impaired kidney function
The administered dose may be adjusted depending on kidney function. If the patient has impaired kidney function, the doctor may reduce the dose and perform frequent blood tests, as well as monitor kidney function. The medicine will be administered by a doctor experienced in cancer treatment.

Children and adolescents
There is insufficient data on the use of Carboplatin Kabi in children, therefore specific dosage recommendations cannot be provided.

During treatment with Carboplatin Kabi, patients may experience nausea. Before starting treatment with Carboplatin Kabi, the doctor may administer another medicine to reduce this adverse effect.

A four-week interval is usually maintained between consecutive doses of Carboplatin Kabi. The doctor may order weekly blood tests after each administration of Carboplatin Kabi. This allows the doctor to decide whether the next dose should be adjusted.

Administration of a higher than recommended dose of Carboplatin Kabi
It is unlikely that a patient will receive too high a dose of Carboplatin Kabi. Nevertheless, if this occurs, kidney and liver dysfunction, vision and hearing disturbances, and low white blood cell count may occur. If there is any suspicion of overdose or if you have any questions regarding the administered dose, consult the doctor administering the medicine.

Missed dose of Carboplatin Kabi
It is very unlikely that a patient will miss a dose, as the doctor will control the timing of administration. If a patient suspects that a dose has been missed, they should inform the doctor or nurse.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
You should 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 distinct lumps) or swelling of the face, lips, tongue and (or) throat, which may cause difficulty in swallowing or breathing (angioedema), and a feeling as if you were about to lose consciousness;
• inflammation of the mouth and (or) mucosal inflammation (e.g. lip pain or mouth ulcers).

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

• bone marrow suppression characterized by a marked decrease in white blood cells, increasing the likelihood of infection (leukopenia, neutropenia);
• reduced platelet count, increasing the risk of bruising and bleeding (thrombocytopenia);
• anaemia (a condition in which there is a reduction in red blood cells, leading to fatigue);
• impaired kidney function (increased blood creatinine and urea levels) – your doctor may monitor your condition;
• slight hearing loss (loss of hearing in the high-frequency range);
• abnormal liver enzyme activity and abnormal liver function test results – your doctor may monitor your condition;
• increased blood uric acid levels, which may lead to gout (hyperuricaemia);
• nausea and vomiting;
• abdominal pain and cramps;
• unexplained feeling of fatigue or weakness;
• decreased concentration of blood salts (sodium, potassium, calcium and magnesium) – your doctor may monitor your condition.

Common (may affect 1 in 10 patients):

• unexpected bruising or bleeding (haemorrhagic complications);
• diarrhoea, constipation, lip pain or mouth ulcers (mucosal inflammation);
• allergic reactions including rash, urticaria, skin redness, itching, high temperature;
• sensation of ringing in the ears (tinnitus), hearing disturbances and hearing loss;
• tingling sensation (peripheral neuropathy), weakness, numbness;
• hair loss;
• malaise;
• influenza-like symptoms;
• loss of or lack of strength;
• lung disease, scarring and thickening in the lungs, associated with breathing difficulties, sometimes fatal (interstitial lung disease), difficulty breathing;
• reduced bone and joint reflexes;
• infections;
• sensory disturbances;
• taste disturbances;
• visual disturbances, including temporary loss of vision;
• cardiovascular disorders;
• skin disorders;
• itchy rash (urticaria);
• itching sensation (pruritus);
• red rash (erythematous rash);
• musculoskeletal disorders;
• urinary and genital disorders (urinary and genital system disorders);
• increased blood levels of creatinine, bilirubin and uric acid. Your doctor will monitor these changes.

Uncommon (may affect 1 in 100 patients):

• tumours caused by chemotherapy or radiotherapy (secondary tumours);
• fever and chills without visible signs of infection;
• redness, swelling, pain or tissue necrosis at the injection site (injection site reaction).

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

• feeling unwell with high temperature due to low white blood cell count (febrile neutropenia);
• loss of appetite (anorexia);
• severe liver function disorders, liver cell damage or necrosis – your doctor may monitor your condition;
• optic neuritis, which may cause complete or partial vision loss;
• severe allergic reactions (anaphylactic and (or) anaphylactoid reactions);
• symptoms of severe allergic reactions include wheezing or chest tightness, eyelid, facial or lip swelling, sudden facial redness, hypotension, tachycardia, urticaria, shortness of breath, dizziness and anaphylactic shock;
• low blood sodium levels (hyponatremia).

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

• heart failure;
• brain haemorrhage, which may lead to stroke or loss of consciousness;
• sudden arterial blockage (embolism), high blood pressure, low blood pressure.

Frequency unknown (cannot be estimated from available data):

• haemolytic-uraemic syndrome (a disease characterized by acute kidney failure, reduced number of red blood cells (microangiopathic haemolytic anaemia) and low platelet count);
• unexpected bruising, bleeding or signs of infection;
• dehydration;
• lip pain or mouth ulcers (stomatitis);
• muscle cramps, muscle weakness, confusion, vision loss or visual disturbances, irregular heartbeat, kidney failure or abnormal blood test results (symptoms of tumour lysis syndrome, which may be caused by rapid breakdown of tumour cells) (see section 2);
• a group of symptoms such as headache, altered consciousness, seizures and visual disturbances from blurred vision to vision loss (symptoms of reversible posterior 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 of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Carboplatin Kabi

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and carton following EXP.
The expiry date refers to the last day of the stated month.
Unopened vial: Store below 25°C.
Store the vial in its outer packaging to protect from light.
After dilution: Chemical and physical stability of the diluted solution has been demonstrated
for 96 hours when diluted with 5% glucose solution and stored at temperatures between 2°C and 8°C,
as well as between 20°C and 25°C.
Chemical and physical stability of the solution diluted with 0.9% NaCl has been demonstrated
for 24 hours at temperatures between 2°C and 8°C and for 8 hours at temperatures between 20°C and 25°C.
From a microbiological point of view, the product should be used immediately. Otherwise,
the user is responsible for the duration and conditions of storage of the prepared solution.
Generally, storage should not exceed 24 hours at 2°C to 8°C, unless dilution has been carried out
under controlled and validated aseptic conditions.
Do not use Carboplatin Kabi if visible signs of degradation are present.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Carboplatin Kabi contains:

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

What Carboplatin Kabi looks like and contents of the pack
Carboplatin Kabi is a clear, colourless to slightly yellow solution, free from visible solid particles.
1 mL of concentrate for solution for infusion contains 10 mg of carboplatin.
1 vial of 6 mL capacity containing 5 mL of concentrate (50 mg carboplatin).
Vial made of colourless glass (type I) with a stopper made of chlorobutyl or bromobutyl rubber,
with an aluminium flip-off seal and a green polypropylene (PP) cap, in a cardboard box.
1 vial of 20 mL capacity containing 15 mL of concentrate (150 mg carboplatin).
Vial made of colourless glass (type I) with a stopper made of chlorobutyl or bromobutyl rubber,
with an aluminium flip-off seal and a blue polypropylene (PP) cap, in a cardboard box.
1 vial of 50 mL capacity containing 45 mL of concentrate (450 mg carboplatin).
Vial made of colourless glass (type I) with a stopper made of chlorobutyl or bromobutyl rubber,
with an aluminium flip-off seal and a red polypropylene (PP) cap, in a cardboard box.
1 vial of 100 mL capacity containing 60 mL of concentrate (600 mg carboplatin).
Vial made of colourless glass (type I) with a stopper made of chlorobutyl or bromobutyl rubber,
with an aluminium flip-off seal and a yellow polypropylene (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 Authorisation Holder
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw
Poland

Manufacturer
Fresenius Kabi Deutschland GmbH
Pfingstweide 53
61169 Friedberg
Germany

For further information, contact the Marketing Authorisation Holder:
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw
Poland
Tel.: +48 22 345 67 89

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

Information intended exclusively for healthcare professionals:

The medicinal product is intended for single use only. Any unused portions of the solution must be discarded.
Dilution instructions
Carboplatin reacts with aluminium, resulting in the formation of a black precipitate and/or reduced carboplatin activity. Therefore, needles, syringes, catheters, and other components of intravenous infusion sets containing aluminium must not be used for administering carboplatin.
Prior to infusion, the medicinal product should be diluted with 5% glucose infusion solution or 0.9% sodium chloride infusion solution to achieve a concentration of 0.5 mg/mL (500 micrograms/mL).
Chemical and physical stability of the diluted product has been demonstrated when diluted 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.
Chemical and physical stability of the diluted product has been demonstrated when diluted with 0.9% NaCl 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 standpoint, the product should be used immediately. If not used immediately, the user is responsible for the storage duration and conditions of the prepared solution. Generally, storage should not exceed 24 hours at a temperature of 2°C to 8°C, unless dilution has been carried out under controlled and validated aseptic conditions.
Prior to use, the solution should be inspected visually for particulate matter and discoloration. Only clear, colorless solution free from visible particles should be used.
Guidelines for safe handling of cytotoxic medicinal products

1. Carboplatin should be prepared for administration only by personnel trained and qualified in the safe handling of chemotherapeutic agents.
2. Preparation of the medicinal product should be performed in a designated area.
3. Appropriate protective gloves, masks, and protective clothing must be worn.
4. Precautions should be taken to avoid accidental contact of the medicinal product with the eyes. In case of contact with the eyes, they should be rinsed thoroughly with water and/or physiological saline solution.
5. Pregnant women should not perform tasks involving cytotoxic medicinal products.
6. Care and appropriate precautions must be taken when disposing of waste materials (e.g., syringes, needles, etc.) used during the preparation of cytotoxic medicinal products. Excess materials and biological waste should be discarded by placing them in double-sealed polyethylene bags and incinerated at 1000°C.
7. The work surface should be covered with disposable absorbent paper, plastic-backed on one side.
8. Luer-lock connections should be used for all syringes and infusion sets. Large-bore needles are recommended to minimize pressure and potential aerosol formation. Aerosol formation can also be prevented by using vented needles.

Disposal
Any unused medicinal product or waste material must be disposed of in accordance with local regulations.