Trabectedin EVER Pharma

Trabectedin EVER Pharma is a cancer medicine that stops cancer cells from growing, used to treat soft tissue sarcoma and ovarian cancer.

Form
kuiva-aine välikonsentraatiksi infuusionestettä varten, liuos
Strength
1 mg
Active Ingredient
Trabectedin
Manufacturer
EVER Valinject GmbH

How to Use

Dosage

Your dose depends on your body size. For soft tissue sarcoma, it's usually 1.5 mg per square meter of body surface (or 1.2 mg/m² for Japanese patients). For ovarian cancer, it's 1.1 mg/m² when given with another medicine called PLD. Your doctor will determine your exact dose.

Method

The medicine is given as a drip (infusion) directly into a vein, usually through a central line in your chest. The infusion takes about 24 hours for soft tissue sarcoma and about 3 hours for ovarian cancer.

Important

This medicine is not given daily. It is given as an infusion every three weeks, and your doctor will decide the correct timing and dose for your treatment cycle.

Possible Side Effects

COMMON
  • Yellow skin and eyes (jaundice) due to increased bilirubin.
  • Feeling very tired or weak (fatigue).
  • Trouble breathing and cough.
  • Back pain.
  • Swelling in the body due to fluid buildup.
  • Bruising more easily than usual.
  • Nosebleeds.
  • Increased risk of infections, possibly with fever.
  • Digestive problems like poor appetite, nausea, vomiting, stomach pain, diarrhea, or constipation.
  • Headache.
  • Mouth sores or inflammation in the digestive tract.
  • Hand-foot syndrome (redness, swelling, or blisters on hands/feet), especially when used with PLD.
  • Blood infections (sepsis).
  • Muscle pain, weakness, numbness, general or limb swelling, or a creepy-crawly sensation on the skin.
  • Reaction at the injection site, including redness, swelling, itching, discomfort, and tissue damage if the infusion leaks out of the vein.
  • Allergic reaction, which may include fever, difficulty breathing, skin redness or rash, general discomfort (malaise), and vomiting.
  • Fainting, feeling your heart beat too hard or too fast (palpitations), weakened heart chambers, or a sudden blockage in a lung artery (pulmonary embolism), especially when used with PLD.
  • Dehydration, weight loss, indigestion, and altered taste.
  • Hair loss.
  • Dizziness, low blood pressure, flushing (redness of the face/neck), or rash.
  • Increased skin pigmentation, especially when used with PLD.
  • Joint pain.
  • Sleep problems.
RARE
  • Severe muscle damage (rhabdomyolysis), with symptoms like severe muscle pain, stiffness, weakness, and dark urine.
  • Difficulty breathing, irregular heartbeat, reduced urination, sudden mood changes, blotchy red skin, or very low blood pressure with abnormal lab results (e.g., low platelet count).
  • Abnormal fluid buildup in the lungs (pulmonary edema), leading to swelling.
  • Unexplained partial or general swelling (edema) with dizziness, lightheadedness, or thirst (capillary leak syndrome).
  • Liver failure, with symptoms such as yellow skin and eyes, upper right abdominal pain, nausea, vomiting, general malaise, difficulty concentrating, confusion, or drowsiness.

Important Warnings

  • Do not use this medicine if you are allergic to trabectedin or any other ingredient in this medicine.
  • Do not use if you have a serious infection or if you are getting a yellow fever vaccine.
  • Do not use if you are pregnant, planning to become pregnant, or breastfeeding. Women and men of childbearing age must use effective contraception during and after treatment (women for 3 months, men for 5 months).
  • Avoid use if you have severe liver, kidney, or heart damage. Tell your doctor about any past or current liver, kidney, or heart problems.
  • Avoid alcohol during treatment as it can harm your liver.
Show 2 more warnings
  • Do not drive or operate machinery if you feel tired or weak from the medicine.
  • Seek immediate medical attention if you have fever, severe nausea or vomiting, severe muscle pain or weakness, leakage at the injection site, or an allergic reaction (fever, difficulty breathing, rash).