Alternate Name(s):
Yondelis, ET-743, Ecteinascidin 743, NSC# S648766
Classification:
Antineoplastic
Original Date:
May 2009
Indications:
- Recurrent rhabdomyosarcoma, ewing sarcoma or non-rhabdomyosarcomatous soft tissue sarcomas
THIS MEDICATION IS TO BE ADMINISTERED BY A CHEMO-TRAINED NURSE. IF THE NURSE IS NOT CHEMO-TRAINED, THEY ARE TO CONTACT THE UNIT NURSE EDUCATOR OR ADVANCED PRACTICE NURSE.
Reconstitution and Stability:
- Available as 0.25 mg or 1 mg vials of sterile lyophilized powder in sucrose 10%
- Refrigerate vials in outer carton
- Protect from light
- Use closest number of vial sizes to avoid wasting -allow to stand at room temperature for 15 minutes (in or out of individual cartons) before reconstitution
- Reconstitute within 2 hours of removal from fridge.
- Reconstitute 0.25 mg vials with 5 mL sterile water for injection and 1 mg vials with 20 mL sterile water for injection to get a 0.05 mg/mL solution
- Shake manually for 10 seconds to complete mixing.
- Dilute dose in 250 - 500 mL NS -withdraw & discard volume of NS equal to volume of drug to be added -use caution to prevent formation of product aerosols
- Time from reconstitution to end of infusion should NOT exceed 30 hours -if exceeded , a new diluted solution must be prepared to complete the administration cycle
- Compatible with PVC and polyethylene tubing
Compatibility:
-Solutions Compatible: NS
Incompatible: do not mix with any other drugs
Administration:
(For approved routes of administration by nursing personnel, refer to Policy for the Administration of Intravenous Medications.)
| SC | NO |
| IM | NO |
|
IV Push |
NO |
| IV Intermittent Infusion | NO |
| IV Continuous Infusion | YES -over 24 hours via Central Line -strongly recommended |
Dosage:
(For neonatal dosages, refer to Neonatal IV Drug Manual.)
Pediatric:
- 1.3 mg/m 2 or 1.5 mg/m2 every 21 days -dose defined at study entry
Potential hazards of parenteral administration:
Immediate (within 1-2 days of receiving drug):
- common -nausea, vomiting, constipation, anorexia, headache, dyspnea
- occasional - injection site phlebitis and bruising, diarrhea, dehydration, dry mouth, salivary hypersecretion
Prompt (within 2-3 weeks, prior to next cycle):
- common -neutropenia, transaminitis, abdominal pain, respiratory tract infections, fatigue, asthenia
- occasional -anemia, thrombocytopenia, febrile neutropenia, muscle weakness, weight loss, paresthesias, increase/decrease in serum electrolytes, increased CPK, increased alkaline phosphatase, increased creatinine, hyperbilirubinemia, alopecia
Rare
- rhabdomyolysis
- renal -failure, proteinuria, dysuria, polyuria, urinary retention
- liver -failure
- respiratory -failure, hypoxia, pleural effusion, pulmonary edema
- gastrointestinal - esophagitis, mucositis
- cardiac -congestive heart failure, cardiomyopathy
-Patients must meet specific criteria for hepatic, renal and cardiac function to receive Trabectedin
-Treatment for unusual side effects are available through the study chair identified on the front page of the protocol and/or pharmacy
Notes:
- Labeling should include a statement that Trabectedin is an experimental drug
- All patients will receive dexamethasone the evening before, immediately prior to Trabectedin and on days 1-3 of each cycle. This provides anti-emetic prophylaxis and hepatoprotective effects
- Extensively metabolized by CYP-3A4-potent inducers and inhibitors (avoid aprepitant, erythromycin, clarithromycin, azithromycin, rifampin, fluconazole, ketoconazole, itraconazole, cannabinoids, leukotriene inhibitors
- Anticonvulsants - avoid Trabectedin any sooner then 14 days after discontinuation of enzyme-inducing anticonvulsants (carbamazepine, phenobarbital, phenytoin)
- Avoid warfarin and prochlorperazine 48 hours beforeto 72 hours after Trabectedin administration
- Concomitant use of dexamethasone increased the plasma clearance of Trabectedin by 20%
- CONTRAINDICATIONS -hypersensitivity to Trabectedin or any of its excipients, concurrent serious or uncontrolled infection, combination with yellow fever vaccine