Carboplatin Pfizer

Package Leaflet: Information for the Patient

Carboplatin Pfizer, 10 mg/ml, Solution for Injection

Carboplatin

Read All of This Leaflet Carefully Before Using This Medicine.

• You should keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Pack

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

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

Carboplatin Pfizer is an anti-cancer medicine.
Carboplatin Pfizer is used to treat:

• advanced ovarian cancer (including second-line treatment in patients who have previously received cisplatin-containing chemotherapy regimens),
• small cell lung cancer.

2. Before You Use Carboplatin Pfizer

When Not to Use Carboplatin Pfizer

• if you are allergic to carboplatin or any of the other ingredients of this medicine (listed in section 6) and other platinum-containing compounds,
• in patients with severe renal impairment prior to initiation of therapy,
• in patients with severe bone marrow suppression (reduced number of bone marrow cells),
• concomitantly with yellow fever vaccine,
• in patients with clinically significant bleeding,
• in pregnant or breastfeeding women.

Warnings and Precautions

Treatment with Carboplatin Pfizer should be carried out in specialized centers with adequate equipment for the treatment and prevention of potential complications. The medicine should only be administered under the constant supervision of experienced physicians in the field of chemotherapy and only when the expected benefits of treatment outweigh the risks.

• During treatment, leukopenia (reduced number of white blood cells), neutropenia (reduced number of neutrophils), and thrombocytopenia (reduced number of platelets) may occur. The doctor will order blood morphology tests. Usually, subsequent courses of injections should not be repeated until the number of leukocytes, neutrophils, and platelets returns to normal values. Treatment should not be repeated earlier than 4 weeks after the previous course of treatment and/or until the neutrophil count is at least 2,000 cells/mm³ and the platelet count is at least 100,000 cells/mm³.

4 weeks after the previous course of treatment and/or until the neutrophil count is at least 2,000 cells/mm³ and the platelet count is at least 100,000 cells/mm³.

• Anemia often occurs. The severity of the harmful effect of the medicine on the bone marrow is greater in patients who have previously received chemotherapy (especially cisplatin) and/or have impaired renal function.
• During treatment with carboplatin, 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 resulting from the breakdown of dying cancer cells that release their contents into the bloodstream.
• Carboplatin is mainly excreted in the urine. Patients receiving Carboplatin Pfizer should have their renal function monitored. Despite the harmful effect of the medicine on the kidneys, it is usually not necessary to reduce the dose of the medicine. Unlike cisplatin therapy, pre- and post-treatment hydration is not required, although some patients may experience a decrease in creatinine clearance.
• Renal impairment following administration of Carboplatin Pfizer occurs more frequently in patients with pre-existing renal impairment due to previous chemotherapy. In patients with impaired renal function, the effect of the medicine on the hematopoietic system is more pronounced and longer-lasting than in patients with normal renal function.
• During and after treatment with Carboplatin Pfizer, the doctor may recommend regular neurological examinations, especially in patients who have previously been treated with cisplatin and in patients over 65 years of age. Administration of Carboplatin Pfizer in doses higher than recommended, in patients with impaired renal function, may rarely lead to visual disturbances, including complete loss of vision. Usually, several weeks after discontinuation of the medicine, there is complete recovery of vision or a significant part of it.
• During treatment with Carboplatin Pfizer, hearing disturbances have been reported. Significant hearing impairment may require modification of doses or discontinuation of the medicine. The doctor will order a hearing test before starting treatment, during treatment, or in case of hearing impairment.
• Animal studies have shown that Carboplatin Pfizer causes changes in the structure of genetic material and has a teratogenic effect (causing fetal developmental abnormalities). However, a carcinogenic effect of carboplatin has not been confirmed, although compounds with a similar mechanism of action to carboplatin have shown this effect.
• Allergic reactions to Carboplatin Pfizer have been reported, requiring discontinuation of the medicine and administration of appropriate symptomatic treatment.
• Carboplatin Pfizer may cause vomiting. The frequency and severity of vomiting can be reduced by using antiemetic medications or by administering Carboplatin Pfizer as a continuous intravenous infusion over a period of 24 hours, or by administering the medicine intravenously in divided doses over 5 consecutive days, instead of a single intravenous infusion.
• If the patient experiences headache, altered consciousness, seizures, and visual disturbances (from blurred vision to loss of vision), they should inform their doctor.
• If the patient experiences severe fatigue with reduced red blood cell count and shortness of breath (hemolytic anemia), which may be accompanied by a low platelet count, abnormal bruising (thrombocytopenia), and kidney disease, during which the patient urinates very small amounts or not at all (symptoms of hemolytic-uremic syndrome), they should inform their doctor.
• If the patient has a fever (temperature above or equal to 38°C) or chills, which may be symptoms of infection, they should immediately inform their doctor. The patient is at risk of developing a blood infection.
• In elderly patients, a decrease in renal function often occurs, so the doctor will take this into account when determining the dose.
• During treatment with Carboplatin Pfizer, the patient should not be vaccinated with live vaccines. Inactivated or killed vaccines can be administered, but the response to them may be reduced.

Carboplatin Pfizer and Other Medicines

Tell your doctor about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Concomitant use of Carboplatin Pfizer and other medicines that suppress bone marrow function may require dose modification to limit the cumulative toxic effect.
In case of concomitant use of oral anticoagulants with anticancer medicines, the doctor will order frequent monitoring of the INR (International Normalized Ratio).
Inform your doctor about the use of the following medicines:

• yellow fever vaccine
• live attenuated vaccines
• phenytoin, fosphenytoin (used to treat seizures)
• cyclosporine, tacrolimus, sirolimus
• aminoglycoside antibiotics, e.g., streptomycin, gentamicin, neomycin, kanamycin (used to treat infections)
• loop diuretics, e.g., furosemide.

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 nurse for advice before using this medicine.
Pregnancy
Carboplatin Pfizer should not be used in pregnant women due to fetal harm.
The use of this medicine in pregnant women or if pregnancy occurs during treatment may be associated with risk to the fetus.
Women of Childbearing Age
Women of childbearing age should always use effective contraception during treatment with Carboplatin Pfizer and for at least 7 months after the last dose.
Contraception in Men
Men should always use effective contraception during treatment and for at least 4 months after the end of treatment and should consult about sperm storage before starting therapy, due to the possibility of irreversible infertility.

Talk to Your Doctor About the Contraception Methods That Are Suitable for You and Your Partner.

Breastfeeding
Do not breastfeed while using Carboplatin Pfizer and for at least 1 month after the last dose.
Fertility
Carboplatin Pfizer may affect fertility in both men and women. Before starting treatment, both men and women should consult about the possibility of preserving fertility.
In female patients receiving anticancer treatment, amenorrhea (absence of menstruation) may occur, and in male patients, azoospermia (absence of sperm in the semen).

Driving and Using Machines

There are no available data on the effect of Carboplatin Pfizer on the ability to drive and use machines. However, this medicine may cause nausea, vomiting, visual disturbances, and ototoxicity, which may affect the ability to drive and use machines.

3. How to Use Carboplatin Pfizer

Use this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Carboplatin Pfizer can be used alone (as a single medicine) or in combination with other anticancer medicines. The medicine is intended for intravenous use only.
The recommended dose of Carboplatin Pfizer in previously untreated adult patients with normal renal function is 400 mg/m², administered as a single dose in an intravenous infusion lasting from 15 to 60 minutes. Subsequent courses of treatment should be administered after an interval of 4 weeks from the previous course of treatment and/or until the neutrophil count is at least 2,000 cells/mm³ and the platelet count is at least 100,000 cells/mm³.
In patients with risk factors, such as previous treatment with toxic effects on the bone marrow, radiation therapy, advanced age, or low performance status, the doctor will recommend a reduction of the initial dose by 20-25%.
Dosing should be modified based on weekly blood test results, which determine the time of maximum bone marrow suppression (reduced number of bone marrow cells).
Patients with Renal Impairment
Due to the fact that Carboplatin Pfizer is excreted by the kidneys and has a harmful effect on the kidneys, optimal dosing should be determined based on frequent monitoring of hematological parameters and renal function parameters. The recommended dosing in patients with impaired renal function depends on the creatinine clearance value and should be calculated using the Calvert formula.
Patients with Bone Marrow Impairment
To adjust the dose of the medicine, it is recommended to determine the maximum decrease in hematological parameters during carboplatin treatment. In patients who experience moderate or severe hematological toxicity (i.e., platelet and neutrophil counts decrease below 50,000/mm³ and 500/mm³, respectively), the doctor will consider reducing the dose by 25% or discontinuing treatment.
Combination Therapy
Carboplatin Pfizer can be used in combination with other anticancer medicines in dosing regimens depending on the chosen treatment regimen. The doctor determines the dosing based on the adopted treatment regimen and laboratory blood test results.
Elderly Patients
In patients over 65 years of age, the doctor will adjust the dose of Carboplatin Pfizer according to the patient's overall condition.
Children and Adolescents
There is insufficient data to recommend dosing in children and adolescents.

Overdose of Carboplatin Pfizer

The medicine is administered under strict medical supervision, and overdose is unlikely. However, if overdose is suspected, consult a doctor or nurse. Expected complications after overdose will be related to bone marrow suppression and liver, kidney, and hearing disorders.
Administration of Carboplatin Pfizer in doses higher than recommended has been associated with loss of vision.

Missed Dose of Carboplatin Pfizer

The medicine is administered under strict medical supervision, and missed dose is unlikely. However, if a missed dose is suspected, always inform your doctor or nurse.

Discontinuation of Carboplatin Pfizer

Discontinuation of treatment is decided by the doctor. Do not stop treatment without consulting your doctor.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible Side Effects

Like all medicines, Carboplatin Pfizer can cause side effects, although not everybody gets them.

If You Experience Any of the Following Side Effects, Contact Your Doctor Immediately:

• unusual bruising, bleeding, or signs of infection, such as sore throat and high temperature.
• severe allergic reaction - may cause sudden itchy rash (hives), redness of the skin (flushing), swelling of the hands, feet, ankles, face, lips, mouth, or throat (which may cause difficulty in swallowing or breathing). May cause dizziness and chest pain, which may be symptoms of a potentially severe allergic reaction called Kounis syndrome.
• mucositis (inflammation of the mucous membranes)/stomatitis (inflammation of the mouth).

These are serious side effects. You may need urgent medical attention.

Side Effects Include:

Very Common(may affect more than 1 in 10 people):

• thrombocytopenia (reduced number of platelets)
• neutropenia (reduced number of neutrophils)
• leukopenia (reduced number of white blood cells)
• anemia
• subclinical reduction in high-frequency hearing (4000-8000 Hz)
• vomiting
• nausea
• abdominal pain and cramps
• pain
• reduced creatinine clearance
• increased blood urea nitrogen
• increased alkaline phosphatase
• increased aspartate aminotransferase
• abnormal liver function tests
• reduced sodium levels in the blood
• reduced potassium levels in the blood
• reduced calcium levels in the blood
• reduced magnesium levels in the blood.

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

• infections (leading to death in less than 1% of cases)
• bleeding (leading to death in less than 1% of cases)
• hypersensitivity
• pseudoanaphylactic reactions
• peripheral neuropathy (inflammation of the peripheral nerves)
• paresthesia (abnormal sensations)
• reduced reflexes
• disturbances of sensation
• disturbances of taste
• visual disturbances
• rare cases of loss of vision
• tinnitus (ringing in the ears)
• hearing loss
• cardiovascular disorders (leading to death in less than 1% of cases)
• respiratory disorders
• interstitial lung disease
• bronchospasm
• diarrhea
• constipation
• mucositis
• esophagitis
• liver function disorders
• alopecia (hair loss)
• skin disorders
• musculoskeletal disorders
• muscle and joint pain
• urinary tract disorders
• asthenia (weakness)
• fever
• chills
• increased bilirubin levels in the blood
• increased creatinine levels in the blood
• increased uric acid levels in the blood.

Uncommon(may affect up to 1 in 100 people):

• transient loss of vision
• injection site reactions (redness, swelling, and pain)
• flu-like syndrome.

Rare(may affect up to 1 in 1,000 people):

• septicemia (severe systemic reaction to infection)
• cortical blindness (visual disturbance due to damage to the visual cortex)
• arrhythmias (heart rhythm disorders)
• acute renal failure.

Frequency Not Known(cannot be estimated from the available data):

• pneumonitis (inflammation of the lungs)
• secondary malignant tumors associated with treatment
• bone marrow suppression
• febrile neutropenia
• hemolytic-uremic syndrome
• hemolytic anemia (sometimes fatal)
• dehydration
• anorexia
• hyponatremia (reduced sodium levels in the blood)
• muscle cramps, muscle weakness, confusion, loss of vision, or visual disturbances, irregular heartbeat, renal failure, or abnormal blood test results (symptoms of tumor lysis syndrome, which may be caused by rapid destruction of dying cancer cells that release their contents into the bloodstream) (see section 2)
• stroke (leading to death in less than 1% of cases)
• a syndrome of symptoms including headache, altered consciousness, seizures, and visual disturbances from blurred vision to loss of vision (symptoms of a rare neurological disorder - reversible posterior leukoencephalopathy syndrome)
• heart failure (leading to death in less than 1% of cases)
• ischemic heart disorders (e.g., myocardial infarction, cardiac arrest, angina pectoris, myocardial ischemia)
• chest pain, which may be a symptom of a potentially severe allergic reaction - Kounis syndrome
• thromboembolism (leading to death in less than 1% of cases)
• hypertension
• hypotension
• stomatitis (inflammation of the mouth)
• pancreatitis (inflammation of the pancreas)
• urticaria (hives)
• rash
• flushing
• pruritus (itching)
• injection site necrosis (death of tissue at the injection site)
• injection site reaction
• injection site extravasation (leakage of medicine into the surrounding tissue)
• injection site redness
• malaise (feeling unwell).

Reporting of Side Effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. Side effects can also be reported 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
Phone: +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 or its representative.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to Store Carboplatin Pfizer

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
Store in a refrigerator (2°C - 8°C).
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the Pack and Other Information

What Carboplatin Pfizer Contains

• The active substance is carboplatin. 1 ml of the solution contains 10 mg of carboplatin (Carboplatinum).One 5 ml vial contains 50 mg of carboplatin. One 15 ml vial contains 150 mg of carboplatin. One 45 ml vial contains 450 mg of carboplatin.
• The other ingredients are: water for injections.

What Carboplatin Pfizer Looks Like and Contents of the Pack

Carboplatin Pfizer is a clear, colorless or pale yellow solution without visible particles.
Packaging:
Vials made of type I glass, closed with a chlorobutyl rubber stopper and an aluminum flip-off cap, in a cardboard box.
The pack contains: 1 vial of 5 ml, 15 ml, or 45 ml of solution.

Marketing Authorization Holder:

Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Brussels, Belgium

Importer:

Pfizer Service Company BV, Hoge Wei 10, 1930 Zaventem, Belgium

For More Information, Contact the Representative of the Marketing Authorization Holder:

Pfizer Polska Sp. z o.o.
phone: 22 335 61 00

Date of Last Revision of the Leaflet:

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Information Intended for Healthcare Professionals Only:

Method of Administration

After dilution, the product can be stored for up to 8 hours at a temperature below 25°C or up to 24 hours in a refrigerator.
Special precautions for prolonged intravenous infusion
Carboplatin Pfizer diluted in 0.9% sodium chloride solution and stored at 25°C undergoes degradation within 24 hours by about 5% compared to the initial concentration.
It is also considered that 0.9% sodium chloride solutions are not suitable for infusion with carboplatin, not only due to the loss of the active substance but also due to the possible conversion to cisplatin, which may increase toxicity.
Therefore, it is recommended not to dilute carboplatin in 0.9% sodium chloride solution in the case of prolonged intravenous infusion.
Carboplatin Pfizer is a cytostatic medicine, and appropriate safety measures should be taken during its use.
Carboplatin Pfizer, solution for injection 10 mg/ml, can be diluted directly before administration in water for injections, 0.9% sodium chloride solution, or 5% glucose solution to prepare a solution for short-term intravenous infusionwith final concentrations as low as 0.5 mg/ml. To minimize the risk of microbial contamination, further dilution should be carried out immediately before use, and the infusion should be started as soon as possible after preparation of the solution. The infusion should be completed within 24 hours of preparation of the solution, and any remaining solution should be discarded.
Like all other anticancer medicines, Carboplatin Pfizer can only be prepared for administration by trained personnel in a designated area (preferably a laminar flow cabinet adapted for the preparation of cytostatic medicines).
Personnel should wear protective gloves. In case of contact of the medicine with the skin or mucous membranes, the area should be rinsed immediately with a large amount of water and soap.
It is recommended that pregnant women in the personnel avoid any contact with cytostatic medicines, such as carboplatin.
It is recommended to use syringes with Luer-Lock connectors. Preference should be given to the use of needles with a large diameter to minimize pressure differences and prevent the formation of gas bubbles.
All equipment used to prepare Carboplatin Pfizer solutions or used to collect human waste should be disposed of in polyethylene bags that can be sealed twice and incinerated at 1100°C.
Carboplatin Pfizer interacts with aluminum, resulting in the formation of a black precipitate.
Therefore, needles, syringes, catheters, and other components of infusion sets containing aluminum should not be used to administer carboplatin.

Procedure in Case of Accidental Spill

In case of spillage of the solution, it is essential to limit access to the area. Personnel should wear two pairs of gloves (latex), a breathing mask, and protective clothing and eyewear. The spread of the spilled liquid should be contained using absorbent material, such as paper, sawdust, or absorbent granules (animal bedding). You can also use: 3-molar sulfuric acid, 0.3-molar potassium permanganate (2:1), or 5% sodium hypochlorite. The absorbent material and all remaining materials should be collected, placed in plastic containers, sealed, and labeled accordingly.
Waste containing cytostatics is considered hazardous or toxic and should be clearly labeled with the following text: "CYTOSTATIC WASTE. INCINERATE AT 1100°C". Waste should be disposed of at 1100°C for at least one second. The area where the medicine was spilled should be washed with a large amount of water.