Carboplatin Aurovitas 10 mg/ml concentrate for solution for infusion EFG

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the User

Carboplatin Aurovitas 10 mg/ml concentrate for solution for infusion EFG

Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet; you may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Carboplatino Aurovitas is and what it is used for

What Carboplatino Aurovitas is

This medicine contains carboplatin, which belongs to a group of medicines called platinum coordination complexes, used for the treatment of cancer.

What Carboplatino Aurovitas is used for

This medicine is used to treat advanced ovarian cancer and small cell lung cancer.

2. What you need to know before using Carboplatino Aurovitas

Do not use Carboplatino Aurovitas

• If you are allergic to carboplatin or to any of the other ingredients of this medicine (listed in section 6).
• If you have severe kidney problems (creatinine clearance of 30 ml/min or lower).
• If you have a blood cell count disorder (severe myelosuppression).
• If you have a bleeding tumor.
• Concurrently with the yellow fever vaccine.

If you are in any of these situations and have not already discussed them with your doctor or nurse, it is recommended that you inform your doctor or nurse as soon as possible and before receiving the infusion.

Carboplatin is usually administered to patients in hospital. Generally, you should not handle this medicine yourself. Your doctor or nurse will administer the medicine and will closely monitor your condition frequently during and after treatment. Blood tests are usually required before each administration.

Warnings and precautions

Talk to your doctor or nurse before starting carboplatin:

• If you are pregnant or if there is any possibility that you may be pregnant.
• If you are breastfeeding.
• If you are likely to consume alcoholic beverages during treatment with this medicine.
• If you experience headache, mental function disturbances, seizures, or abnormal vision ranging from blurred vision to vision loss, inform your doctor.
• Inform your doctor if you feel extreme fatigue with a decrease in red blood cells and shortness of breath (symptoms of hemolytic anemia), alone or combined with a decrease in platelets, abnormal bruising (thrombocytopenia), and kidney disease leading to reduced or no urine output (symptoms of hemolytic uremic syndrome).
• If you have fever (temperature greater than or equal to 38°C) or chills, which could be signs of infection, inform your doctor immediately. You may be at risk of developing a blood infection.

If your kidneys are not functioning properly, the effects of carboplatin on the blood (hematopoietic system) are increased and prolonged compared to patients with normal renal function. Your doctor will perform regular checks if your kidneys are not working properly.

During treatment with carboplatin, you will be given medications to help reduce the risk of 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 releasing their contents into the bloodstream.

If you are in any of these situations and have not already discussed them with your doctor or nurse, it is recommended that you inform your doctor or nurse as soon as possible and before receiving this medicine.

This medicine may be diluted with another solution before administration. You should discuss this with your doctor and ensure it is appropriate for you.

Other medicines and Carboplatino Aurovitas

Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might need to take any other medicines.

You should inform your doctor if you are taking any of the following medicines, as they may interact with carboplatin:

• Other medicines that are toxic to your kidneys (e.g., aminoglycoside antibiotics).
• Other medicines that damage hearing or balance functions in the ear (e.g., aminoglycoside antibiotics, furosemide (used to treat heart failure and edema)).
• Other medicines that suppress the immune system (e.g., cyclosporine, tacrolimus, sirolimus, and other anticancer medicines).
• The yellow fever vaccine and other live vaccines.
• Medicines used to prevent blood clotting, e.g., warfarin.
• Phenytoin and fosphenytoin (used to treat various types of seizures and fits).
• Chelating agents (substances that bind to carboplatin, reducing its effect).
• Loop diuretics (used to treat hypertension and edema).

Use of Carboplatino Aurovitas with food, drinks, and alcohol

No interaction between carboplatin and alcohol is known. However, you should discuss this with your doctor, as carboplatin may affect the liver's ability to process alcohol.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

If you are in any of these situations and have not already discussed them with your doctor or nurse, it is recommended that you inform your doctor or nurse as soon as possible and before receiving this medicine.

Pregnancy

You should not be treated with carboplatin during pregnancy unless clearly indicated by your doctor.

Animal studies have shown a potential risk of fetal abnormalities. If you are being treated with carboplatin while pregnant, you should discuss the possible risks to the fetus with your doctor. Women of childbearing potential should use an effective method of contraception before and during treatment with carboplatin. Since carboplatin may cause genetic damage, if pregnancy occurs during treatment with carboplatin, genetic counseling is recommended. Genetic counseling is also recommended for patients who wish to have children after treatment with carboplatin.

Breastfeeding

It is unknown whether carboplatin is excreted in human breast milk. Therefore, breastfeeding must be discontinued during treatment with carboplatin.

Fertility

Carboplatin may cause genetic damage. Women are advised to avoid pregnancy during treatment by using an effective contraceptive method. Women who are pregnant or become pregnant during treatment should receive genetic counseling.

Men treated with carboplatin are advised to avoid conceiving a child during and for up to 6 months after treatment. Advice on sperm preservation should be sought before treatment, as carboplatin may cause irreversible infertility.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Carboplatin does not affect the ability to drive or operate machinery. However, you should exercise special caution when first receiving carboplatin, especially if you feel dizzy or unsteady.

3. How to use Carboplatino Aurovitas

This medicine will always be administered by a nurse or doctor. It is usually given as an intravenous infusion over a period of 15 to 60 minutes. If in doubt, consult your doctor or the nurse administering the infusion. Your dose will depend on your height and weight, the condition of your blood (haematopoietic) system, and your kidney function. Your doctor will select the optimal dose for you. The infusion is normally diluted before use.

Adults

The usual dose is 400 mg/m² of body surface area (calculated from your weight and height).

Elderly patients

The standard adult dose may be used, although the doctor may choose to use a different dose.

Renal impairment

The dose administered may vary depending on renal function. If you have kidney problems, your doctor may reduce the dose and may carry out frequent blood tests and monitor your kidney function. The infusion will be administered by a physician experienced in the use of cancer treatments.

Use in children and adolescents

There is insufficient experience with carboplatin in children to allow a specific dosage recommendation.

You may feel dizzy during treatment with carboplatin. Your doctor may give you another medicine to reduce these effects before treating you with this medicine.

There is usually an interval of 4 weeks between each carboplatin dose. Your doctor will perform weekly blood tests after administration to determine the appropriate next dose for you.

If you receive more Carboplatino Aurovitas than you should

It is unlikely that you will be given too much carboplatin. However, if this were to happen, you might develop kidney, liver, vision, or hearing problems, and you may have a low white blood cell count. If you are concerned that you have been given too high a dose, or if you have any doubts about the dose administered, discuss this with the doctor giving you the medicine.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount administered.

If you have any further questions about using this medicine, ask your doctor or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Immediately inform your doctor if you notice any of the following reactions:

• Unusual bruising, bleeding, or signs of infection such as sore throat and fever.
• Severe itching of the skin (with lumps) or swelling of the face, lips, tongue and/or throat, which may cause difficulty swallowing or breathing (angioedema), and chest pain, which may be a sign of a serious allergic reaction called Kounis syndrome, and feeling faint.
• Stomatitis/mucositis (irritated lips or mouth ulcers).

Very common: may affect more than 1 in 10 people

• Bone marrow suppression characterized by a marked decrease in white blood cells, making you more susceptible to infections (leukopenia, neutropenia).
• Reduction in platelet count, increasing the risk of bruising and bleeding (thrombocytopenia).
• Anemia (a disorder in which red blood cells are reduced, causing fatigue).
• Decreased kidney function (increased levels of creatinine and urea in your blood). You may require medical monitoring.
• Mild hearing loss (high-frequency hearing loss).
• Abnormal liver enzyme levels and abnormal liver function tests. You may require medical monitoring.
• Increased levels of uric acid in the blood, which may lead to gout (hyperuricemia).
• Dizziness or nausea.
• Abdominal pain and cramps.
• Unusual feelings of tiredness or weakness.
• Decreased levels of salts in your blood (sodium, potassium, calcium, magnesium). You may require medical monitoring.

Common: may affect up to 1 in 10 people

• Unusual bruising or bleeding (hemorrhagic complications).
• Diarrhea, constipation, chapped lips or mouth sores (mucositis).
• Allergic reactions, including skin rash, hives, skin redness, itching, fever.
• Ringing in the ears (tinnitus), hearing disturbances, and hearing loss.
• Tingling (peripheral neuropathy), weakness, tingling or numbness.
• Hair loss.
• Feeling unwell.
• Pseudoflu-like syndrome.
• Loss of or lack of body strength.
• Lung disorders, lung scarring and thickening causing difficulty breathing, sometimes fatal (interstitial lung disease), shortness of breath.
• Reduced bone and tendon reflexes.
• Infections.
• Sensory disturbances.
• Altered taste.
• Visual disorders, including temporary loss of vision.
• Cardiovascular disorders.
• Skin disorders.
• Itchy skin rash (urticaria).
• Itching sensation (pruritus).
• Red rash (erythematous rash).
• Musculoskeletal disorders.
• Conditions affecting the urinary and genital tracts (urogenital disorders).
• Increased levels of creatinine, bilirubin, and uric acid in the blood. Your doctor may monitor you.

Uncommon: may affect up to 1 in 100 people

• Cancer caused by chemotherapy or radiation (secondary malignant neoplasms).
• Fever and chills without signs of infection.
• Redness, swelling, pain, or dead skin around the injection site (injection site reaction).

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

• Feeling unwell with fever due to low white blood cell counts (febrile neutropenia).
• Loss of appetite (anorexia).
• Severe liver function disorder, liver cell damage or death. You may require medical monitoring.
• Inflammation of the optic nerve that may cause partial or total vision loss (optic neuritis).
• Severe allergic reactions (anaphylaxis/anaphylactoid reactions).
• Symptoms of a severe allergic reaction include wheezing or sudden chest tightness, swelling of the eyelids, face or lips, facial flushing, hypotension, tachycardia, hives, dyspnea, dizziness, and anaphylactic shock.
• Low sodium levels in the blood (hyponatremia).

Very rare: may affect up to 1 in 10,000 people

• Heart failure.
• Brain hemorrhage, which may lead to stroke or loss of consciousness.
• Sudden blockage of an artery (embolism), high blood pressure, low blood pressure.

Adverse effects of unknown frequency (cannot be estimated from available data):

• Hemolytic uremic syndrome (a disease characterized by acute kidney failure/low urine output or no urine production, reduced number of red blood cells with extreme fatigue, and low platelet count).
• Bruising or abnormal bleeding and signs of infection.
• Dehydration.
• Pain in the lips or mouth ulcers (stomatitis).
• Muscle cramps, muscle weakness, confusion, loss or changes in vision, irregular heartbeat, kidney failure, or abnormal blood test results (symptoms of tumor lysis syndrome, which may be caused by the rapid destruction of tumor cells) (see section 2).
• A group of symptoms such as headache, altered mental function, seizures, and vision disturbances ranging from blurred vision to vision loss (symptoms of posterior reversible encephalopathy syndrome, a rare neurological disorder).
• Pancreatitis.
• Pulmonary infection.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Carboplatin Aurovitas

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

Do not use this medicine after the expiry date stated on the carton and vials after EXP. The expiry date refers to the last day of the month indicated.

Store below 30°C.

Keep the vial in the outer packaging to protect it from light.

Carboplatin must not come into contact with the eyes or skin. If accidental spillage occurs, inform the doctor or nurse immediately.

After completion of the infusion, carboplatin must be handled and disposed of carefully by the doctor or nurse.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Pack contents and additional information

Composition of Carboplatino Aurovitas

• The active substance is carboplatin. 1 ml of concentrate for infusion solution contains 10 mg of carboplatin. Available in vials containing 50 mg, 150 mg, 450 mg and 600 mg of carboplatin, respectively.
• The other components are mannitol and water for injections.

Appearance of the product and contents of the container

Concentrate for infusion solution.

Clear, colourless or slightly yellowish solution, essentially free from visible particles. Each vial contains 5 ml, 15 ml, 45 ml or 60 ml of carboplatin concentrate for infusion solution, respectively.

Pack sizes: 1 vial and 10 vials.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Eugia Pharma (Malta) Limited
Vault 14, Level 2, Valletta Waterfront
Floriana, FRN 1914
Malta

Manufacturer

APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta

Or

Generis Farmacêutica, S.A.
Rua João de Deus, nº 19, Venda Nova
2700-487 Amadora
Portugal

Or

Arrow Génériques
26 Avenue Tony Garnier
69007 Lyon
France

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Aurovitas Spain, S.A.U.
Avda. de Burgos, 16-D
28036 Madrid
Spain

This medicinal product is authorised in the European Economic Area member states under the following names:

Germany: Carboplatin PUREN 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung
Belgium: Carboplatin Eugia 10 mg/ml concentraat voor oplossing voor infusie / solution à diluer pour perfusion / Konzentrat zur Herstellung einer Infusionslösung
Spain: Carboplatino Aurovitas 10 mg/ml concentrado para solución para perfusión EFG
France: Carboplatine Arrow Lab 10 mg/ml, solution à diluer pour perfusion
Italy: Carboplatino Aurobindo Italia
Poland: Carboplatin Eugia
Portugal: Carboplatina Generis

Date of the most recent revision of this leaflet: July 2023

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

This information is intended for healthcare professionals only:

The medicine is for single use only. Unused infusion solution must be discarded.

Dilution instructions

Carboplatin may react with aluminium, forming a black precipitate and/or losing potency. Needles, syringes, catheters or intravenous administration sets containing aluminium parts that may come into contact with carboplatin must not be used during the preparation or administration of carboplatin.

The product must be diluted prior to infusion with either 5% glucose injection solution or 0.9% sodium chloride injection solution to achieve concentrations as low as 0.5 mg/ml (500 micrograms/ml).

Carboplatin may be further diluted with 5% glucose and administered as an intravenous infusion. Chemical and physical in-use stability has been demonstrated for 56 days at final concentrations of 0.2 mg/ml and 3.5 mg/ml when stored at 2–8°C in non-PVC (polyolefin) infusion bags protected from light.

Carboplatin may also be further diluted with 0.9% sodium chloride and administered as an intravenous infusion. Chemical and physical in-use stability has been demonstrated at final concentrations of 0.2 mg/ml and 3.5 mg/ml for 24 hours at 2–8°C and up to 8 hours at 22°C in non-PVC (polyolefin) infusion bags protected from light.

However, from a microbiological standpoint, the product should be used immediately. If not used immediately, storage times and conditions prior to use are the responsibility of the user and should normally not exceed 24 hours at 2–8°C, unless dilution has been carried out under validated, controlled aseptic conditions.

The solution should be inspected visually for particles and discoloration prior to administration. The solution should only be used if it is clear and free from particles.

Guidelines for safe handling of antineoplastic agents:

1. Carboplatin should only be prepared for administration by healthcare professionals trained in the safe use of chemotherapeutic agents.
2. This should be performed in a designated area.
3. Protective gloves, mask, and appropriate protective gown must be worn.
4. Precautions should be taken to avoid accidental contact of the drug with the eyes. In case of eye contact, rinse thoroughly with water and/or saline solution.
5. Cytotoxic preparations must not be handled by pregnant personnel.
6. Care and appropriate precautions must be taken when disposing of materials (syringes, needles, etc.) used to reconstitute cytotoxic drugs. Leftover materials and body waste may be disposed of by placing them in double-sealed polyethylene bags and incinerating at 1,000°C.
7. The work surface should be covered with absorbent paper lined with disposable plastic.
8. Use Luer-Lock type connectors on syringes and administration sets. Use of large-bore needles is recommended to reduce pressure and potential aerosol formation. Aerosol formation may also be reduced by using a vented needle.

Disposal

Disposal of unused medicine and of materials used for reconstitution, dilution and administration must be carried out in accordance with hospital procedures for antineoplastic agents, taking into account local regulations for the disposal of hazardous waste.