TRABECTEDIN-PROMOMED is an antitumor drug that prevents the proliferation of malignant cells.

The drug TRABECTEDIN-PROMOMED is indicated for adults over the age of 18.

TRABECTEDIN-PROMMED is used to treat patients with advanced soft tissue sarcoma in cases where previous medications were ineffective or patients have contraindications to their use. (Soft tissue sarcoma is a malignant tumor that develops in soft tissues such as muscles, fat, or other tissues such as cartilage or blood vessels.) TRABECTEDIN-PROMOMED as part of combination therapy with pegylated liposomal doxorubicin (PLD) (PLD is another antitumor drug) is used to treat patients with ovarian cancer that has recurred (recurred) after at least one previous therapy, and when patients are insensitive to antitumor drugs containing platinum compounds.

Data on the effects of an overdose of trabectedin are very limited. The main symptoms of overdose are adverse reactions from the gastrointestinal tract, impaired production of blood cells (inhibition of hematopoiesis) and impaired liver function (hepatotoxicity).

Like all medications, the drug TRABECTEDIN-PROMOMED can cause undesirable reactions, but they do not occur in everyone.
Severe undesirable effects may develop. Tell your doctor immediately if you notice the following symptoms:
Very often – may occur in more than 1 person out of 10
- A tendency to infections. The infection can also cause fever (neutropenic infection).
If you develop any of the symptoms of infection, you should seek medical attention immediately.
- Yellowing of the skin, mucous membranes and eyes, increased bilirubin content in the blood test (hyperbilirubinemia).
Your doctor will order regular blood tests to detect any abnormalities in your blood.
Often – may occur in no more than 1 person out of 10
- Fever, blood infections (sepsis), if there are significant disorders of the immune system.
- Muscle pain (myalgia). There may also be nerve damage, which can lead to muscle pain, weakness, and numbness. You may experience general swelling or swelling of the extremities and a crawling sensation on the skin (peripheral sensory neuropathy).
- Reaction at the injection site. The solution of the drug TRABECTEDIN-PROMMED may flow out of the vein during administration, which leads to damage and death of tissue cells around the injection site (tissue necrosis, see also section 2 "What to know before using the drug TRABECTEDIN-PROMMED", subsection "Special instructions and precautions"), which may require surgical intervention. - Fever, shortness of breath, redness or flushing of the skin or rash, nausea or vomiting (allergic reaction).
- If you experience nausea, vomiting, or cannot drink fluids and therefore urinate less, despite taking medications for nausea, you should seek medical attention immediately, as this will lead to fluid loss from the body (dehydration).
- Fainting (syncope) may occur when taking the drug TRABECTEDIN-PROMMED in combination with PLD, in addition, you may feel that your heart is beating too hard or too fast in your chest (palpitations), you may have weakness in the ventricles, the main pumping chambers of the heart (left ventricular dysfunction) or a sudden blockage of the pulmonary arteries (pulmonary embolism).

(For more information about all possible adverse reactions, see the leaflet)

Do not use the drug TRABECTEDIN-PROMOMED in the following cases::

• if you are allergic to trabectedin or any other components of the drug listed in section 6 of the leaflet;
• if you have an active serious or uncontrolled infection;
• if you are pregnant or breastfeeding.

Tell your doctor or pharmacy employee that you are taking, have recently taken, or may start taking any other medications.
It is not recommended to use TRABECTEDIN-PROMOMED if vaccination against yellow fever or a vaccine containing live virus particles is planned.
It is not recommended to use TRABECTEDIN-PROMOMED with medications containing phenytoin (for the treatment of epilepsy), as this leads to a decrease in the effect of phenytoin.

Registration certificate holder
JSC Biochemist, Russian Federation
15A Vasenko St., Saransk, Republic of Mordovia, 430030
Manufacturer
JSC Biochemist, Russian Federation
Address: 15A Vasenko str., Saransk, 430030, Republic of Mordovia
Phone number: +7 (8342) 38 03 68
Email: biohimic@promomed.pro
Internet address: promomed.ru
Organization that accepts consumer claims
JSC Biochemist, Russian Federation
Address: 15A Vasenko str., Saransk, 430030, Republic of Mordovia
Phone number: 8 800 222 95 63; 8 800 777 86 04 ( around the clock)
Email: hot_line@promomed.pro

The drug TRABECTEDIN-PROMOMED is not intended for use in children and adolescents under the age of 18 years.

Store and transport in the refrigerator (2-8 °C). Store in the original packaging (pack). After dissolution and dilution, the solution is chemically and physically stable for 30 hours at 25 °C. After dissolution, the solution should be diluted immediately. The total time from dissolution to the end of administration to the patient should not exceed 30 hours.