Trabectedin STADA

Trabectedin Stada is a cancer medicine that stops cancer cells from growing.

Form
kuiva-aine välikonsentraatiksi infuusionestettä varten, liuos
Strength
0.25 mg
Active Ingredient
Trabectedin
Manufacturer
STADA Arzneimittel AG

How to Use

Dosage

For soft tissue sarcoma, the typical dose is 1.5 mg per square meter of body surface area; for ovarian cancer, it is 1.1 mg per square meter after another medicine (PLD).

Method

This medicine is given as an infusion directly into a vein. For soft tissue sarcoma, the infusion takes about 24 hours. For ovarian cancer, it takes about 3 hours. A central venous catheter is recommended.

Important

This medicine is typically given every three weeks.

Possible Side Effects

COMMON
  • Increased bilirubin (a yellow pigment) in your blood, which can cause yellowing of the skin, mucous membranes, and whites of the eyes (jaundice).
  • Blood infections (sepsis) if your immune system is severely weakened.
  • Muscle pain (myalgia), weakness, numbness, general swelling or swelling in limbs, tingling sensation in the skin.
  • Injection site reaction, tissue damage and tissue death (necrosis) if the infusion leaks outside the vein.
  • Allergic reaction with fever, difficulty breathing, skin redness or flushing, rash, feeling unwell (nausea) or vomiting.
  • Fainting spells, palpitations (heart beating too hard or fast), weakening of heart pumping function (left ventricular dysfunction), or sudden blockage of a lung artery (pulmonary embolism or blood clot) when used with PLD.
  • Tiredness.
  • Difficulty breathing and cough.
  • Back pain.
  • Fluid retention in the body (swelling).
  • Easier bruising.
  • Nosebleeds.
  • Increased susceptibility to infections, including fever.
  • Digestive problems such as reduced appetite, nausea, vomiting, abdominal pain, diarrhea, or constipation.
  • Headache.
  • Inflammation of mucous membranes, swelling and redness inside the mouth, painful mouth sores (stomatitis), or inflammation of the gastrointestinal tract when used with PLD.
  • Hand-foot syndrome (redness, swelling, blueness, dryness, peeling, blisters, or sores on palms, fingers, and soles of feet), when used with PLD.
  • Dehydration, weight loss, indigestion, changes in taste.
  • Hair loss.
  • Dizziness, low blood pressure, flushing, or rash.
  • Increased skin pigmentation (darker skin) when used with PLD for ovarian cancer.
  • Joint pain.
  • Difficulty sleeping.
RARE
  • Severe muscle pain, stiffness, or weakness; dark urine. These can be signs of muscle damage (rhabdomyolysis).
  • Difficulty breathing, irregular heartbeat, decreased urine output, sudden mood changes, patchy skin redness, very low blood pressure, unusual lab results (e.g., low platelet count).
  • Abnormal fluid buildup in the lungs, leading to swelling (pulmonary edema).
  • Unexplained partial or general swelling (edema) with possible dizziness, lightheadedness, or thirst (low blood pressure), which can be a sign of capillary leak syndrome where too much fluid collects in tissues.
  • Blistering, peeling skin, darkening of the skin at the injection site (extravasation symptoms may appear hours or days later).
  • Yellowing of skin and whites of eyes (jaundice), pain in the upper right abdomen, nausea, vomiting, general malaise, difficulty concentrating, disorientation, confusion, drowsiness (signs of liver failure).

Important Warnings

  • Do not use if you are allergic to trabectedin or any other ingredient in this medicine.
  • Do not use if you have a serious infection.
  • Do not use if you are breastfeeding.
  • Do not use if you are receiving a yellow fever vaccine.
  • Do not use if you have severe liver, kidney, or heart damage.
Show 4 more warnings
  • This medicine should not be used during pregnancy. Women who can become pregnant must use effective contraception during treatment and for 3 months after. Men must use effective contraception during treatment and for 5 months after.
  • Avoid alcohol during treatment, as it can harm your liver.
  • This medicine can make you feel tired or weak. Do not drive or use machines if you experience these side effects.
  • Contact your doctor immediately if you develop a fever, severe muscle pain or weakness, persistent nausea/vomiting, less urination than usual, swelling, dizziness, lightheadedness, thirst, difficulty breathing, skin redness/rash, or if the infusion leaks outside the vein.