Trabectedin STADA
Trabectedin STADA is a cancer medicine that works by stopping cancer cells from growing.
Form
kuiva-aine välikonsentraatiksi infuusionestettä varten, liuos
Strength
1 mg
Active Ingredient
Trabectedin
Manufacturer
STADA Arzneimittel AG
How to Use
Dosage
Your doctor will decide your dose based on your body surface area. For soft tissue sarcoma, the usual dose is 1.5 mg per square meter (m²) of body surface area, or 1.2 mg/m² for Japanese patients. For ovarian cancer, the usual dose is 1.1 mg/m² after receiving another medicine called PLD.
Method
This medicine is given as an infusion into a vein. For soft tissue sarcoma, the infusion takes about 24 hours. For ovarian cancer, it takes about 3 hours. It is recommended to give the infusion through a central venous catheter to prevent irritation at the injection site.
Important
Your doctor will closely monitor you and decide the most suitable dose and treatment schedule for you, typically every three weeks. There is no specific maximum daily dose mentioned; the doctor will determine your overall treatment plan.
Possible Side Effects
COMMON
- •Yellowing of the skin, mucous membranes, and whites of the eyes (jaundice) due to increased bilirubin in the blood.
- •Blood infections (sepsis), especially if your immune system is weak.
- •Muscle pain, weakness, numbness, general or limb swelling, or a creeping feeling on the skin.
- •Reaction at the injection site, where the infusion may leak outside the vein.
- •Allergic reaction with symptoms like fever, difficulty breathing, skin redness or rash, feeling sick (nausea) or vomiting.
- •Fainting spells (syncope) or heart problems such as pounding heart (palpitations), weakened heart chambers, or a blocked lung artery (pulmonary embolism), especially when used with PLD.
- •Tiredness or fatigue.
- •Difficulty breathing and cough.
- •Back pain.
- •Fluid buildup in the body (edema) or swelling.
- •Easier bruising.
- •Nosebleeds.
- •Increased risk of infections, possibly with fever.
- •Digestive problems such as poor appetite, nausea, vomiting, stomach pain, diarrhea, or constipation.
- •Headache.
- •Inflammation of mucous membranes, which can lead to swelling and redness inside the mouth, painful sores (stomatitis), or inflammation in the digestive tract.
- •Hand-foot syndrome (redness, swelling, blueness, dryness, peeling, blisters on palms, fingers, and soles of feet), especially in patients treated for ovarian cancer with PLD.
- •Dehydration, weight loss, indigestion, and changes in taste.
- •Hair loss.
- •Dizziness, low blood pressure, flushing, or skin rash.
- •Stronger skin pigmentation, especially in patients treated for ovarian cancer with PLD.
- •Joint pain.
- •Sleep problems.
RARE
- •Severe muscle pain, stiffness, weakness, or dark urine (signs of rhabdomyolysis, which can lead to kidney failure). Seek immediate medical help.
- •Breathing difficulties, irregular heartbeat, reduced urination, sudden mood changes, patchy skin redness, very low blood pressure, or unusual lab test results (like low platelet count). Seek immediate medical help.
- •Abnormal fluid buildup in the lungs, leading to swelling (pulmonary edema).
- •Unexplained partial or general swelling, possibly with dizziness, lightheadedness, or thirst (signs of capillary leak syndrome). Seek immediate medical help.
- •Severe liver problems, indicated by yellow skin/eyes, upper right abdominal pain, nausea, vomiting, general discomfort, difficulty concentrating, disorientation, confusion, or drowsiness. Seek immediate medical help.
Important Warnings
- Do not use this medicine if you are allergic to trabectedin or any other ingredient in this medicine.
- Do not use this medicine if you have a serious infection.
- Do not use this medicine if you are breastfeeding.
- Do not use this medicine if you are receiving a yellow fever vaccine.
- Do not use this medicine if you have severe liver, kidney, or heart damage.
Show 12 more warnings
- Seek immediate medical help if you develop a fever, as this medicine can affect your blood and liver.
- Seek immediate medical help if you have severe nausea or vomiting, or cannot drink enough liquids, or urinate less often, even if you have taken anti-nausea medicine.
- Seek immediate medical help if you develop severe muscle pain or weakness, as this could be a sign of muscle damage.
- Seek immediate medical help if you notice the infusion leaking outside the vein at the injection site, as this can cause cell damage and tissue death.
- Seek immediate medical help if you have an allergic reaction with symptoms like fever, difficulty breathing, skin redness or rash, or feeling sick (nausea) or vomiting.
- Seek immediate medical help if you notice unexplained swelling, dizziness, lightheadedness, or extreme thirst, as this could be a sign of a condition called capillary leak syndrome.
- Avoid alcohol during treatment as it can harm your liver.
- Do not use this medicine if you are pregnant or planning to become pregnant. Women who can get pregnant must use effective birth control during treatment and for 3 months after.
- Men who can father children must use effective birth control during treatment and for 5 months after.
- Talk to your doctor about preserving eggs or sperm before treatment, as there is a risk of permanent infertility.
- Do not drive or use machines if you feel tired or weak during treatment.
- This medicine should not be given to children under 18 years old who have childhood sarcomas.