Trabectedin Sun 0.25 mg powder for concentrate for solution for infusion EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Trabectedina Sun 0.25 mg powder for concentrate for solution for infusion EFG

Trabectedina Sun 1 mg powder for concentrate for solution for infusion EFG

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor.
• If you experience any adverse reactions, consult your doctor, even if they are not listed in this leaflet. See section 4.

Leaflet contents

1. What Trabectedina Sun is and what it is used for

2. What you need to know before using Trabectedina Sun

3. How to use Trabectedina Sun

4. Possible side effects

5. Storage of Trabectedina Sun

6. Contents of the pack and other information

1. What Trabectedina Sun is and what it is used for

Trabectedina Sun contains trabectedin as the active substance. Trabectedin is an anticancer medicine that works by preventing the multiplication of tumour cells.

Trabectedin is used to treat patients with advanced soft tissue sarcoma when previous treatment with other medicines has not worked or when patients cannot be treated with other medicines. Soft tissue sarcoma is a malignant neoplasm that originates in soft tissues, such as muscles, fat, or other tissues (e.g., cartilage or blood vessels).

Trabectedin, in combination with pegylated liposomal doxorubicin (PLD, another antitumour medicine), is used to treat patients with ovarian cancer who have relapsed after at least one prior treatment and who are not platinum-resistant.

2. What you need to know before using Trabectedin Sun

Do not use Trabectedin Sun

• if you are allergic to trabectedin or to any of the other ingredients of this medicine (listed in section 6);
• if you have a severe infection;
• if you are breastfeeding;
• if you are due to receive the yellow fever vaccine.

Warnings and precautions

Talk to your doctor before starting treatment with trabectedin.

You must not use trabectedin or its combination with PLD if you have severe liver, kidney, or heart problems.

Talk to your doctor before starting treatment with trabectedin if you know or suspect you have:

• Liver or kidney problems.
• Heart problems or a history of heart problems.
• A left ventricular ejection fraction (LVEF) below the lower limit of normal.
• Have previously received treatment with high doses of anthracyclines.

Seek immediate medical attention if any of the following occur:

• If you develop fever, as trabectedin can cause side effects affecting the blood and liver.
• If, despite taking anti-nausea medication, you experience nausea, vomiting, or are unable to drink fluids and consequently urinate less, seek immediate medical attention.
• If you experience severe muscle pain or weakness, as this could be a sign of muscle damage (rhabdomyolysis; see section 4).
• If the trabectedin infusion leaks out of the vein during administration. This could damage or destroy cells in nearby tissues (tissue necrosis; see also section 4), which may require surgical intervention.
• If you have an allergic reaction (hypersensitivity). In this case, you may experience one or more of the following symptoms: fever, difficulty breathing, skin redness or rash, nausea, or feeling unwell (vomiting; see section 4).
• If you notice unexplained generalized or localized swelling (edema), possibly accompanied by dizziness, vertigo, or thirst (low blood pressure). This could indicate a disorder (capillary leak syndrome) that causes excessive fluid accumulation in your tissues and requires urgent clinical evaluation by your doctor.

Children and adolescents

Trabectedin must not be used in children under 18 years of age with pediatric sarcomas.

Other medicines and Trabectedin Sun

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

You must not use trabectedin if you are due to receive the yellow fever vaccine. It is also not recommended to use trabectedin if you are to receive a vaccine containing live virus particles. The use of medications containing phenytoin (for epilepsy) together with trabectedin is not recommended, as the effect of phenytoin may be reduced.

If you are taking any of the following medicines during your treatment with trabectedin, you need to be closely monitored, as they may alter the effects of trabectedin:

• Reduced (e.g., medicines containing rifampicin (for bacterial infections), phenobarbital (for epilepsy), or St. John’s wort (Hypericum perforatum, a herbal remedy used for depression)), or
• Increased (e.g., medicines containing ketoconazole or fluconazole (for fungal infections), ritonavir (for human immunodeficiency virus [HIV] infection), clarithromycin (for bacterial infections), aprepitant (to prevent nausea and vomiting), cyclosporine (immunosuppressants), or verapamil (for hypertension and other heart conditions)).

The use of trabectedin with any of these medicines should be avoided if possible.

If you are receiving another medicine capable of causing liver or muscle damage (rhabdomyolysis) at the same time as trabectedin or the combination of trabectedin and PLD, you may be closely monitored, as this could increase the risk of liver or muscle injury. Medicines containing statins (to reduce cholesterol levels and prevent cardiovascular disease) are an example of medicines that can cause muscle damage.

Use of Trabectedin Sun with alcohol

Alcohol consumption should be avoided during treatment with trabectedin, as it may damage the liver.

Pregnancy, breastfeeding, and fertility

Pregnancy

Trabectedin must not be used during pregnancy. If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

Women of childbearing potential must use effective contraception during treatment with trabectedin and for 8 months after treatment ends.

If you become pregnant, inform your doctor immediately. Genetic counseling is also recommended, as trabectedin may cause genetic damage to the fetus.

Breastfeeding

Trabectedin must not be administered to patients who are breastfeeding. Therefore, you must stop breastfeeding before starting treatment and must not resume until your doctor confirms it is safe to do so.

Fertility

Men of reproductive age must use effective contraception during treatment with trabectedin and for 5 months after treatment ends.

Because there is a risk that treatment with trabectedin may cause irreversible infertility, patients are advised to seek counseling regarding the possibility of preserving their eggs or sperm before treatment begins.

Genetic counseling is also recommended for patients who wish to have children after treatment.

Driving and use of machines

You may feel tired and experience loss of strength during treatment with trabectedin. Do not drive or operate tools or machinery if you experience any of these side effects.

Trabectedin Sun contains potassium

This medicine contains less than 1 mmol (39 mg) of potassium per vial, which is essentially “potassium-free”.

3. How to use Trabectedin Sun

Trabectedin must be administered under the supervision of a physician experienced in the use of chemotherapy. Its use should be restricted to qualified oncologists and other healthcare professionals specialized in the administration of cytotoxic drugs.

For the treatment of soft tissue sarcoma, the usual dose is 1.5 mg/m² of body surface area. During the treatment period, your doctor will monitor you closely and determine the most appropriate dose of trabectedin for you. The recommended dose in Japanese patients is lower than the usual dose for other races and is 1.2 mg/m² of body surface area.

For the treatment of ovarian cancer, the usual dose is 1.1 mg/m² of body surface area following the administration of 30 mg/m² of body surface area of DLP.

Before administration, trabectedin must be reconstituted and diluted for intravenous use. Each time trabectedin is administered for the treatment of soft tissue sarcoma, it will take approximately 24 hours for the entire solution to enter your bloodstream. The treatment for ovarian cancer will last 3 hours.

To avoid irritation at the injection site, it is recommended that trabectedin be administered through a central venous line.

To protect the liver and reduce the risk of adverse effects such as nausea and vomiting, you will be given other medications before treatment with trabectedin and whenever needed during treatment.

You will receive an infusion every 3 weeks, although occasionally your doctor may recommend delaying doses to ensure you receive the most appropriate dose of trabectedin.

The total duration of treatment will depend on your response and how you feel. Your doctor will inform you how long your treatment may last. If you have any further questions about the use of this medicine, ask your doctor.

4. Possible adverse effects

Like all medicines, this medicine or its combination with DLP may cause adverse effects, although not everyone will experience them.

If you are unsure about the meaning of the following adverse effects listed below, please ask your doctor to explain them in more detail.

Serious adverse effects caused by treatment with trabectedin:

Very common: may affect more than 1 in 10 people

• You may have elevated levels of the yellow pigment bilirubin in the blood, which could lead to jaundice (yellowing of the skin, mucous membranes, and eyes).

• Your doctor will regularly request blood tests to detect any blood abnormalities.

Common: may affect up to 1 in 10 people

• You may develop blood infections (sepsis) if your immune system is severely compromised. If you develop fever, contact your doctor immediately.

• You may also experience muscle pain (myalgia). You may also suffer nerve damage, which causes muscle pain, weakness, and numbness. You may experience general swelling or swelling of the limbs and a tingling sensation on the skin.

• You may experience a reaction at the injection site. Trabectedin infusion may leak out of the vein during administration, causing injury and destruction of cells in nearby tissues (tissue necrosis; see also section 2 “Warnings and precautions”), which may require surgical intervention.

• You may experience an allergic reaction. In this case, you may have fever, difficulty breathing, redness or flushing of the skin or rash, general discomfort (nausea), or a feeling of malaise (vomiting).

• When trabectedin is used in combination with DLP, you may experience fainting or collapse. Additionally, you may notice your heart beating too strongly or too rapidly (palpitations), weakness in the ventricles—the main pumping chambers of the heart (left ventricular dysfunction), or sudden blockage of a pulmonary artery (pulmonary embolism).

Uncommon: may affect up to 1 in 100 people

• You may experience severe muscle pain, pain, stiffness, and muscle weakness. You may also notice darkening of the urine. All of the above could be signs of muscle damage (rhabdomyolysis).

• Your doctor may request blood tests in certain situations to prevent muscle damage (rhabdomyolysis). In some very severe cases, such muscle damage could lead to kidney failure. If you experience severe muscle pain or weakness, contact your doctor immediately.

• You may experience difficulty breathing, irregular heartbeat, reduced urine output, sudden changes in mental status, mottled skin areas, very low blood pressure associated with abnormal laboratory results (decreased platelet count). If you experience any of these symptoms or signs, contact your doctor immediately.

• You may develop abnormal fluid accumulation in the lungs, which in turn causes swelling (pulmonary edema).

• You may notice general or localized swelling without apparent cause (edema), possibly accompanied by dizziness, vertigo, or thirst (low blood pressure). This could be a manifestation of a disorder (capillary leak syndrome) that may cause excessive fluid accumulation in your tissues. If this occurs, contact your doctor immediately.

• You may notice that the trabectedin infusion is leaking out of your vein during administration (extravasation). Therefore, you may experience redness, swelling, itching, and discomfort at the injection site. If you experience any of these symptoms or signs, inform your doctor or nurse immediately.

This could lead to damage and death of surrounding tissue cells at the injection site (tissue necrosis), which may require surgery.

Some symptoms or signs of extravasation may not become visible until several hours after it occurred. Blisters, skin peeling, and skin darkening may appear at the site. Several days may pass before the full extent of tissue damage becomes visible. If you experience any of these symptoms or signs, contact your doctor immediately.

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

• You may experience yellowing of the skin and whites of the eyes (jaundice), pain in the upper right part of the abdomen, nausea, vomiting, general malaise, difficulty concentrating, disorientation, or confusion, and drowsiness. These signs may indicate the liver’s inability to perform its normal function. If you experience any of these symptoms or signs, contact your doctor immediately.

Other less serious adverse effects:

Very common: may affect more than 1 in 10 people

• You may:
  • feel tired
  • experience shortness of breath and cough
  • feel back pain
  • retain excess fluid in the body (edema)
  • develop bruises (hematomas) more easily
  • have nosebleeds
  • be more prone to infections. An infection may also cause fever.

If you experience any of these symptoms, contact your doctor immediately.

• You may also experience gastrointestinal symptoms such as decreased appetite, nausea or vomiting, abdominal pain, diarrhea, or constipation. If you continue to have nausea, vomit, or are unable to drink fluids despite taking anti-nausea medication, and therefore urinate less, contact your doctor immediately.

• You may experience headache.

• You may develop mucositis, which presents as redness and swelling inside the mouth leading to painful ulcers and sores (stomatitis), or as inflammation of the gastrointestinal tract when trabectedin is used in combination with DLP.

• Female patients receiving trabectedin with DLP for ovarian cancer may also develop hand-foot syndrome. This presents as redness of the skin on the palms of the hands, fingers, and soles of the feet, which may later swell and turn purplish. Lesions may be dry and peeling or appear as blisters with ulceration.

Common: may affect up to 1 in 10 people

• You may experience fluid loss, weight loss, gastrointestinal discomfort, and altered sense of taste.

• You may lose hair (alopecia).

• You may also experience dizziness, low blood pressure, hot flashes, or skin rash.

• Increased skin pigmentation may occur in patients receiving trabectedin with DLP for ovarian cancer.

• You may feel joint pain.

• You may experience sleep disturbances.

Reporting of adverse effects

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

5. Storage of Trabectedin Sun

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 and on the label of the vial after CAD or EXP. The expiry date refers to the last day of the month indicated.

Store in a refrigerator (between 2°C and 8°C).

Information on the stability of reconstituted and diluted solutions is included in the section for medical and healthcare professionals.

Do not use this medicine if visible particles are observed after reconstitution or dilution of the medicine.

Any unused medicine and materials that have come into contact with it should be disposed of in accordance with local regulations for cytotoxic medicinal products.

6. Contents of the pack and other information

Composition of Trabectedina Sun

• The active substance is trabectedin.
  1. Trabectedina Sun 0.25 mg: each vial of powder contains 0.25 mg of trabectedin.
  2. Trabectedina Sun 1 mg: each vial of powder contains 1 mg of trabectedin.
• The other components are sucrose, potassium dihydrogen phosphate, phosphoric acid (to adjust pH), and potassium hydroxide (to adjust pH).

Appearance of the product and contents of the container

Trabectedina Sun is a powder for concentrate for solution for infusion. The powder is white or almost white and is supplied in a glass vial.

Each pack contains 1 vial of 0.25 mg or 1 vial of 1 mg of trabectedin. Vials are available with or without plastic overwrap (plastic film).

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Sun Pharmaceutical Industries Europe B.V.,

Polarisavenue 87

2132JH Hoofddorp

The Netherlands

Manufacturer

Sun Pharmaceutical Industries Europe B.V.,

Polarisavenue 87

2132JH Hoofddorp

The Netherlands

OR

Terapia S.A.

Str. Fabricii nr. 124

400632, Cluj-Napoca

Romania

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

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya, 53-55

08007 – Barcelona

Spain

Tel.: +34 93 342 78 90

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Germany Trabectedin SUN 0.25 mg powder for concentrate for solution for infusion

Trabectedin SUN 1 mg powder for concentrate for solution for infusion

Austria Trabectedin SUN 0.25 mg powder for concentrate for solution for infusion

Trabectedin SUN 1 mg powder for concentrate for solution for infusion

Belgium Trabectedine SUN 0.25 mg powder for concentrate for solution for infusion

Trabectedine SUN 1 mg powder for concentrate for solution for infusion

Denmark Trabectedin SUN

France TRABECTEDINE SUN 0.25 mg, poudre pour solution à diluer pour perfusion

TRABECTEDINE SUN 1 mg, poudre pour solution à diluer pour perfusion

Italy Trabectedina SUN

Spain Trabectedina SUN 0.25 mg powder for concentrate for solution for infusion EFG

Trabectedina SUN 1 mg powder for concentrate for solution for infusion EFG

Sweden Trabektedin SUN 0.25 mg pulver till koncentrat till infusionsvätska, lösning

Trabektedin SUN 1 mg pulver till koncentrat till infusionsvätska, lösning

Date of the most recent revision of this package leaflet: January 2026

Other sources of information

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/)

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This information is intended for healthcare professionals only:

Instructions for use, preparation, handling, and disposal

Appropriate procedures for safe handling and disposal of cytotoxic medicinal products must be followed. Any unused medicinal product or waste materials that have come into contact with it should be disposed of in accordance with local regulations for cytotoxic agents.

Healthcare professionals must be trained in the correct techniques for reconstitution and dilution of trabectedin, or its combination with DLP. During reconstitution and dilution, protective clothing including mask, safety goggles, and gloves must be worn. Accidental contact with skin, eyes, or mucous membranes should be immediately rinsed with copious amounts of water. Pregnant individuals must not handle this medicinal product.

Preparation for intravenous infusion

Trabectedina Sun must be reconstituted and subsequently diluted before intravenous infusion (see also section 3).

Appropriate aseptic techniques must be used.

Trabectedina Sun must not be administered mixed with other medicinal products except the diluent in the same infusion. No incompatibilities have been observed between trabectedin and type I glass vials, polyvinyl chloride (PVC) and polyethylene (PE) bags and tubing, polyisoprene reservoirs, or titanium implantable vascular access systems.

When trabectedin is used in combination with DLP, the intravenous line must be thoroughly flushed with 50 mg/ml (5 %) glucose solution for infusion after administration of DLP and before administration of trabectedin. Using a diluent other than 50 mg/ml (5 %) glucose solution for infusion may cause precipitation of DLP. (See also section 4.2 and the DLP product information, which contains specific instructions for its handling.)

Instructions for reconstitution

Trabectedina Sun 0.25 mg: inject 5 ml of sterile water for injection into the vial.

Trabectedina Sun 1 mg: inject 20 ml of sterile water for injection into the vial.

Use a syringe to inject the correct volume of sterile water for injection into the vial. Shake the vial until the drug is completely dissolved. The reconstituted solution is clear, colourless or slightly yellowish, and free from visible particles.

The reconstituted solution has a concentration of 0.05 mg/ml of trabectedin. Further dilution is required, and the solution is intended for single use only.

Instructions for dilution

Dilute the reconstituted solution with 9 mg/ml (0.9 %) sodium chloride solution for infusion or 50 mg/ml (5 %) glucose solution for infusion. Calculate the required volume as follows:

Volume (ml) = BSA (m²) × individual dose (mg/m²)