Yondelis Infusion
Trabectedin
1mg
Janssen Pharmaceutica N.V.
| Pack size | 1 Glass Vial (Powder) |
|---|---|
| Dispensing mode | POM |
| Source | BELGIUM |
| Agent | CITY MEDICAL STORE |
| Retail Price | 12232.00 AED |
Indications
Yondelis Infusion is used for:
Advanced soft tissue sarcoma, after failure of anthracyclines & ifosfamide.
Relapsed platinum-sensitive ovarian cancer, in combination w/ pegylated liposomal doxorubicin (PLD).
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
Child Dose
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
Administration
Contra Indications
Known hypersensitivity, including anaphylaxis, to trabectedin
Precautions
Hepatic or renal impairment, neutropenia & thrombocytopenia, nausea & vomiting, rhabdomyolysis & severe CPK elevations (>5 times ULN), hepatic function test abnormalities, inj site reactions; concomitant use w/ CYP3A4 inhibitors, drugs associated w/ hepatotoxicity, alcohol, phenytoin or live attenuated vaccines. May affect ability to drive or operate machinery. Pregnancy.
Pregnancy-Lactation
Pregnancy
Based on its mechanism of action, trabectedin can cause fetal harm when administered during pregnancy
There are no available data on trabectedin use during pregnancy
Animal reproductive and developmental studies at relevant doses have not been conducted with trabectedin; however, placental transfer of trabectedin was demonstrated in pregnant rats
Contraception
Females: Advise female patients of reproductive potential to use effective contraception during and for 2 months after the last dose
Males: May damage spermatozoa, resulting in possible genetic and fetal abnormalities; advise males with a female sexual partner of reproductive potential to use effective contraception during and for 5 months after the last dose
Infertility
May result in decreased fertility in males and females
Lactation
Unknown if distributed in human breast milk
Because of the potential for serious adverse reactions from trabectedin in breastfed infants, advise a nursing woman to discontinue nursing during treatment
Interactions
Potent CYP3A4 inhibitors (oral ketoconazole, fluconazole, ritonavir, clarithromycin, aprepitant; dexamethasone; potent CYP3A4 inducers (rifampicin, phenobarb, St. John's wort); P-gp inhibitors (cyclosporine, verapamil).
Adverse Effects
Side effects of Trabectedin :
>10%
Nausea, all grades (75%)
Fatigue, all grades (69%)
Vomiting, all grades (46%)
Constipation, all grades (37%)
Decreased appetite, all grades (37%)
Diarrhea, all grades (35%)
Peripheral edema, all grades (28%)
Dyspnea, all grades (25%)
Headache, all grades (25%)
Arthralgia, all grades (15%)
Insomnia, all grades (15%)
Myalgia, all grades (12%)
Mechanism of Action
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
Note
Yondelis 1mg Infusion manufactured by Janssen Pharmaceutica N.V.. Its generic name is Trabectedin. Yondelis is availble in United Arab Emirates.
Farmaco UAE drug index information on Yondelis Infusion is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.