CARBOPLATIN HIKMA 10 mg/mL SOLUTION FOR INFUSION

2. What you need to know before you are given Carboplatin Hikma

NarboplatinH

• if you are allergic (hypersensitive) to carboplatin or any of the other ingredients of this medicine (listed in section 6);
• if you have severe kidney problems;
• if you have a blood cell disorder (your doctor will monitor this);
• if you are breastfeeding;
• if you have bleeding tumors;
• if you have received the yellow fever vaccine

Warnings and precautions

Talk to your doctor or nurse before you are given Carboplatin Hikma:

• If you have a headache, altered mental function, seizures, or abnormal vision from blurred vision to loss of vision.
• If you develop extreme fatigue and difficulty breathing with a decrease in the number of red blood cells (symptoms of hemolytic anemia), alone or combined with a low platelet count, abnormal bruising (thrombocytopenia), and kidney disease with little or no urine (symptoms of hemolytic-uremic syndrome).
• If you have a fever (temperature equal to or greater than 38 °C), cramps, which can be signs of infection. Or you may be developing a blood infection.

Carboplatin should be administered with particular caution in:

• Patient with myelosuppression (decrease in the number of red blood cells produced by the bone marrow). Combination treatment with other myelosuppressive substances (leading to a decrease in red blood cells) may require a dose adjustment;
• Patient with hematologic toxicity (decrease in red blood cell production);
• Patient with impaired renal function;
• Patient with allergic reactions to platinum drugs;
• Patient over 65 years and/or patients previously treated with cisplatin (medication used to treat cancer);
• Patient receiving treatment with live vaccines;
• Pediatric patient. In this population, follow-up audiometry is recommended.

Carboplatin may react with aluminum, so aluminum-containing needles, syringes, catheters, or intravenous administration systems should not be used for the preparation or administration of carboplatin, in order to avoid interactions.

During treatment with carboplatin, medications that help reduce potentially fatal complications known as tumor lysis syndrome, caused by chemical changes in the blood given by the breakdown of dead cancer cells that release their contents into the bloodstream, may be administered.

Using Carboplatin Hikma with other medicines

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

Treatment of patients with oral anticoagulants involves a decrease in the frequency of monitoring of the International Normalized Ratio (INR).

Administration with Carboplatin Hikma:

• Is contraindicated with concomitant use with the yellow fever vaccine
• Is not recommended with concomitant use with other live vaccines (except yellow fever), phenytoin, and fosphenytoin (used to treat various types of seizures and attacks).
• Should be administered with particular caution in concomitant use with cyclosporin, tacrolimus, and sirolimus (medicines that decrease natural defenses against external substances), aminoglycosides, vancomycin, or capreomycin (antibiotics), phenytoin, and fosphenytoin (used to treat various types of seizures and attacks), and loop diuretics (used to treat hypertension and edema).

Combination treatment with other myelosuppressive agents (medicines that lead to a reduction in red blood cells) may require a dose adjustment.

Pregnancy, breastfeeding, and fertility

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

Pregnancy

The safe use of carboplatin during pregnancy is unknown, but it is suspected to cause serious birth defects when administered during pregnancy. Carboplatin is not indicated in pregnant women or women of childbearing age who wish to become pregnant, unless the potential benefits to the mother are greater than the possible risks to the fetus.

If you are being treated with carboplatin while pregnant, you should discuss the possible risks to the fetus with your doctor.

Women of childbearing age should be informed about the possible risk to the fetus and should be advised to avoid pregnancy and take effective contraceptive measures during treatment and at least 7 months after cessation of therapy.

Men of sexual maturity treated with carboplatin are advised not to father a child during treatment and should use effective contraceptive methods during treatment and for 4 months after the end of treatment.

F

Gonadal suppression resulting in amenorrhea or azoospermia may occur in patients receiving antineoplastic therapy. These effects appear to be related to the dose and duration of therapy and may be irreversible. Predicting the degree of functional testicular or ovarian impairment is complicated by the frequent use of combinations of several antineoplastics, making it difficult to evaluate the effects of individual agents.

Before initiating therapy, both male and female patients should seek advice on the preservation of their fertility due to the possibility of irreversible infertility from carboplatin therapy.

L

E

Driving and using machines

Carboplatin does not affect the ability to drive and use machines. However, carboplatin may cause nausea, vomiting, vision problems, and ototoxicity, so patients should be informed of the potential effects on the ability to drive or operate machines.

3. How to use Carboplatin Hikma

Always use this medicine exactly as your doctor has told you. If you are not sure, check with your doctor.

The dose you have been prescribed depends on your age, health, and the correct functioning of your kidneys and other medicines you are taking.

The product must be diluted with glucose (sugar solution) or sodium chloride (saline) before administration. It will be administered slowly, usually by intravenous drip infusion, and will last between 15 and 60 minutes. You may receive another dose of this medicine in 4 weeks.

While you are receiving carboplatin, your doctor must perform regular blood tests. This will allow him to evaluate the functioning of the medicine and if additional doses are needed.

This medicine will be administered to you during your hospital stay, so it is unlikely that you will receive more or less of a dose, however, ask your doctor or pharmacist if you have any doubts.

The safety measures used in the preparation and administration of substances classified as hazardous must be applied. Preparation must be carried out by trained professionals for safe use, using protective glasses, mask, and protective clothing.

If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

U

There is not enough data on the use of carboplatin in children, so its use is not recommended.

SarboplatinH

This medicine will be administered to you in the hospital, under the supervision of a doctor. Therefore, it is unlikely that you will be given too little or too much of the medicine. Nevertheless, consult your doctor or nurse who administers the medicine or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount administered.

There is no known antidote for carboplatin overdose.

No cases of overdose have been reported during clinical trials. If it occurs, the patient may require adequate supportive treatment for complications related to myelosuppression, altered kidney, liver, and hearing function.

Cases have been reported of patients who felt extremely ill, had diarrhea, and alopecia when administered doses of up to 1,600 mg/m2. The use of doses above the recommended carboplatin doses has been associated with vision loss.

4. Possible side effects

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

The frequency of side effects observed is defined as:

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

Common (may affect up to 1 in 10 people)

Uncommon (may affect up to 1 in 100 people)

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

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

Not known (cannot be estimated from the available data)

Tell your doctor immediately if you notice any of the following side effects:

• Abnormal bruising, bleeding, or signs of infection such as sore throat and high fever;
• Severe allergic reaction (anaphylaxis/anaphylactoid reactions) - you may experience a severe skin rash, itching (urticaria), swelling of the face, lips, mouth, or throat (which may cause difficulty in swallowing or breathing), you may feel like you are going to faint; - chest pain that can be a sign of a potentially serious allergic reaction called Kounis syndrome;
• Stomatitis/mucositis (e.g., cracked lips or mouth ulcers);
• Hemolytic-uremic syndrome (a disease characterized by acute kidney failure), decreased urination, or blood in the urine;
• Muscle cramps, muscle weakness, confusion, vision loss or changes, irregular heartbeats, or abnormal blood test results (symptoms of tumor lysis syndrome that can be caused by the rapid breakdown of cancer cells) (see section 2);
• Stroke (sudden numbness or weakness in the face, arm, or leg, especially on one side of the body);
• Blockage in a blood vessel (embolism and veno-occlusive disease), swelling, or sensitivity in the leg/arm.

And

Other side effects may be detected during treatment are:

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

• Thrombocytopenia (reduction of platelets in the blood), neutropenia, and leucopenia (reduction of white blood cell count in the blood), anemia (decrease in the number of red blood cells);
• Decreased creatinine clearance;
• High levels of urea, alkaline phosphatase, aspartate aminotransferase;
• Abnormal liver function tests in blood;
• Decrease in the level of salts in your blood (sodium, potassium, calcium, magnesium);
• Vomiting, nausea, abdominal pain.

Common (may affect up to 1 in 10 people)

• Infection;
• Bleeding;
• Hypersensitivity (allergies);
• Peripheral neuropathy, decreased osteotendinous reflexes (related to bones and tendons), change in sensitivity;
• Paresthesia (tingling or numbness), dysgeusia (altered perception of taste and flavor of food);
• Visual disturbances (including rare cases of vision loss);
• Tinnitus (ringing in the ears), hearing impairment, and hearing loss;
• Cardiovascular problems;
• Respiratory problems, interstitial lung disease (inflammatory lung disease), bronchospasm (contraction of bronchial muscle that causes difficulty breathing);
• Diarrhea, constipation;
• Hair loss (alopecia), skin problems;
• Musculoskeletal disorders;
• Disorders of the urinary tract or reproductive system;
• Asthenia (extreme fatigue)
• ; Increase in bilirubin, creatine, and uric acid in blood

P

• Symptoms of the central nervous system, often associated with medications used to control nausea or vomiting;
• Muscle pain, joint pain;
• Symptoms similar to those of the flu, chills, headache.

R

• Temporary loss of vision;
• Disease of the white blood cells that originates in the bone marrow (acute myeloid leukemia);
• Disease of the bone marrow in which the production of blood cells is interrupted (myelodysplastic syndrome (MDS));
• Fever, sepsis/septic shock;
• Angioedema (swelling);
• Dermatitis with peeling skin.

M)

• Scarring of the lungs that causes difficulty breathing and/or coughing (pulmonary fibrosis)

E

• Cancers caused by past treatments with carboplatin and reirradiation (secondary neoplasia);
• Suppression of the bone marrow (decrease in the ability to produce blood cells);
• Febrile neutropenia (fever accompanied by low levels of white blood cells);
• Disease with loss of red blood cells due to damage to small blood vessels (hemolytic-uremic syndrome);
• Decrease in red blood cells due to their excessive breakdown (hemolytic anemia);
• Mental changes (encephalopathy);
• Blockage in a blood vessel (embolism and veno-occlusive disease), swelling, or sensitivity in the leg/arm;
• Dehydration, anorexia (loss of appetite), hyponatremia (low sodium levels);
• Stomatitis (inflammation of the mouth);
• A set of symptoms, such as headache, altered mental function, cramps, and abnormal vision from blurred vision to loss of vision (symptoms of posterior reversible leukoencephalopathy syndrome, a rare neurological disorder);
• Inflammation of the optic nerve;
• Vision loss due to brain damage;
• Stroke (stroke);
• Heart failure (abnormal heartbeat - faster, slower, or irregular - or chest pain);
• Coronary artery disease (e.g., myocardial infarction, cardiac arrest, angina pectoris, myocardial ischemia), allergic angina (Kounis syndrome);
• Hypertension (blood pressure higher than normal), hypotension (blood pressure lower than normal);
• Pancreatitis;
• Pulmonary infection;
• Urticaria, rash, erythema (redness), pruritus (itching);
• Muscle cramps, muscle weakness, confusion, vision loss or changes, irregular heartbeats, or abnormal blood test results (symptoms of tumor lysis syndrome that can be caused by the rapid breakdown of cancer cells) (see section 2);
• Redness, pain, or swelling at the injection site, discomfort.

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Carboplatin Hikma

Store below 25°C.

Do not refrigerate or freeze.

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

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 is the last day of the month stated.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

Composition of Carboplatin Hikma

The active substance is carboplatin. Each ml of solution for infusion contains 10 mg of carboplatin.

• Each 5 ml vial contains 50 mg of carboplatin.
• Each 15 ml vial contains 150 mg of carboplatin.
• Each 45 ml vial contains 450 mg of carboplatin.
• Each 60 ml vial contains 600 mg of carboplatin.

The other ingredients are water for injections, hydrochloric acid (pH adjustment), and sodium hydroxide (pH adjustment).

A

Carboplatin Hikma is a clear, colorless solution contained in amber glass vials with a rubber stopper and an aluminum sealing cap.

The packs contain a vial of 5 ml, 15 ml, 45 ml or 60 ml of solution for infusion, respectively.

Only some pack sizes may be marketed.

Marketing Authorization Holder

Hikma Pharmaceuticals (Portugal) S.A.

Estrada do Rio da Mó, 8, 8A and 8B, Fervença

2705-906 Terrugem SNT

Portugal

Manufacturer:

Thymoorgan Pharmazie GmbH

Schiffgraben 23, 38690 Goslar

Germany

Further information about this medicinal product can be obtained from the local representative of the Marketing Authorization Holder:

Hikma Spain, S.L.U.

Calle Anabel Segura nº11, Edificio A, 1st floor, office 2

28108 - Alcobendas, Madrid

Spain

Date of the last revision of this leaflet:May 2025

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