Trabectedin

Trabectedin is used in the treatment of some kinds of cancers. It is used in patients with advanced soft tissue sarcoma, when previous medicines have been unsuccessful. It is used with other medicines as part of combination therapy to treat ovarian cancer that has come back. Trabectedin is given as an injection under the medical supervision of a doctor. Your doctor will decide what dose is necessary and how often you need to take it. This will depend on what you are being treated for and may change from time to time. You should take it exactly as your doctor has advised. Taking it in the wrong way or taking too much can cause very serious side effects. It may take several weeks or months for you to see or feel the benefits but do not stop taking it unless your doctor tells you to. The most common side effects of this medicine include headache, fatigue, vomiting, weakness and increased liver enzyme. This medicine may reduce the number of blood cells (decrease red blood and white blood cells) in your blood, thereby, increasing the susceptibility to infections. Regular blood tests are required to check your blood cells along with heart, liver and kidney. Generally, avoid alcohol consumption while on treatment. Before taking it, tell your doctor if have heart disease, liver, or kidney problems or are taking any medicines to treat infections. Many other medicines can affect, or be affected by, this medicine so let your doctor know all medications you are using.This medicine is not recommended during pregnancy or while breastfeeding. Use of effective contraception by both males and females during treatment is important to avoid pregnancy. .

• Soft tissue sarcoma

Alkylating drug that binds guanine residues in the minor groove of DNA, forming adducts and resulting in a bending of the DNA helix toward the major groove Adduct formation triggers a cascade of events that can affect the subsequent activity of DNA-binding proteins, including some transcription factors, and DNA repair pathways, resulting in perturbation of the cell cycle and eventual cell death

Adult Dose: Soft Tissue Sarcoma Indicated for unresectable or metastatic liposarcoma or leiomyosarcoma in patients who have received a prior anthracycline-containing regimen Premedicate with dexamethasone prior to each dose 1.5 mg/m² IV q3wk until disease progression or unacceptable toxicity Infuse over 24 hr via a central venous line Hepatic impairment Moderate hepatic impairment (bilirubin levels 1.5 times to 3 times upper limit of normal, and AST and ALT < 8 times upper limit of normal): 0.9 mg/ m² Renal Dose: Renal impairment Mild-to-moderate (CrCl 30-89 mL/min): No dose adjustment required Severe (CrCl <30 mL/min) or ESRD: Not studied

Your doctor or nurse will give you this medicine. Kindly do not self administer.

Common: • Headache • Fatigue • Vomiting • Weakness • Nausea • Increased liver enzymes • Low blood platelets • Increased creatine phosphokinase (CPK) level in blood • Decreased white blood cell count (neutrophils) • Decreased appetite • Constipation

[UNSAFE] Trabectedin may cause side effects which could affect your ability to drive. Trabectedin may make you feel tired and experience a loss of strength which may affect your ability to drive.

Known hypersensitivity, including anaphylaxis, to trabectedin

Potent CYP3A4 inhibitors (oral ketoconazole, fluconazole, ritonavir, clarithromycin, aprepitant; dexamethasone; potent CYP3A4 inducers (rifampicin, phenobarb, St. John's wort); P-gp inhibitors (cyclosporine, verapamil).

[UNSAFE] It is unsafe to consume alcohol with Trabectedin.

[CONSULT YOUR DOCTOR] Information regarding the use of Trabectedin during pregnancy is not available. Please consult your doctor.

[CONSULT YOUR DOCTOR] Information regarding the use of Trabectedin during breastfeeding is not available. Please consult your doctor.

[CAUTION] Trabectedin should be used with caution in patients with kidney disease. Dose adjustment of Trabectedin may be needed. Please consult your doctor. [CAUTION] Trabectedin should be used with caution in patients with liver disease. Dose adjustment of Trabectedin may be needed. Please consult your doctor.