Generic Name and Formulations:
Trabectedin 1mg; per vial; lyophilized pwd for IV infusion after reconstitution and dilution; contains sucrose.
Janssen Pharmaceuticals, Inc.
Indications for YONDELIS:
Treatment of unresectable or metastatic liposarcoma or leiomyosarcoma in patients who have received prior anthracycline-containing regimen.
Give by IV infusion over 24hrs. 1.5mg/m2 every 21 days until disease progression or unacceptable toxicity. Moderate hepatic impairment: 0.9mg/m2 every 21 days. Premedicate 30 mins prior to each dose with IV dexamethasone 20mg. Delay, reduce, or permanently discontinue dose according to severity of adverse reactions: see full labeling. Do not increase dose in subsequent cycles once reduced.
<18yrs: not established.
Assess neutrophil count prior to each dose and periodically during the cycle; withhold if <1,500 cells/μL on day of dosing; permanently reduce dose if life-threatening or prolonged, severe neutropenia occurs in prior cycle. Assess CPK levels prior to each dose; withhold if serum CPK >2.5XULN; permanently discontinue if rhabdomyolysis occurs. Assess LFTs prior to each dose and as indicated based on pre-existing hepatic impairment; interrupt, reduce, or permanently discontinue dose based on severity/duration. Assess LVEF by echocardiogram or MUGA scan prior to initiation and every 2–3 months thereafter until discontinued; withhold if LVEF below LLN; permanently discontinue if symptomatic cardiomyopathy occurs or persistent LV dysfunction not recover to LLN within 3 weeks. Monitor for capillary leak syndrome; discontinue and treat promptly if occurs. Severe hepatic impairment: not recommended. Embryo-fetal toxicity. Pregnancy. Females of reproductive potential should use effective contraception during and for 2 months and males (for 5 months) after final dose. Nursing mothers: not recommended.
Avoid concomitant strong CYP3A inhibitors (eg, oral ketoconazole, itraconazole, posaconazole, voriconazole, clarithromycin, telithromycin, indinavir, lopinavir, ritonavir, boceprevir, nelfinavir, saquinavir, telaprevir, nefazodone, conivaptan), grapefruit or grapefruit juice; if short-term use (<14 days) necessary, give inhibitor 1 week after infusion and discontinue the day prior to next infusion. Avoid concomitant strong CYP3A inducers (eg, rifampin, phenobarbital, St. John’s wort).
Nausea, fatigue, vomiting, constipation, decreased appetite, diarrhea, peripheral edema, dyspnea, headache, neutropenia, increased ALT, thrombocytopenia, anemia, increased AST and CPK; anaphylaxis, neutropenic sepsis, rhabdomyolysis, hepatotoxicity, cardiomyopathy, capillary leak syndrome, extravasation resulting in tissue necrosis, infertility.
Psychiatry Advisor Articles
- Anxiety Prevention Interventions: How Effective Are They?
- ADHD, Comorbid Bipolar Disorder Share Similar Neurocognitive Profiles
- Antidepressant Use and Dementia Risk in the Elderly
- Risk for Adverse Outcomes With Antidepressants in Dementia
- Chronic Alcohol Use Disorder Symptoms Occur Regardless of Social Status
- Suicidal Behavior, Thoughts Associated With Perfectionist Tendencies
- CBT, Acceptance Commitment Therapy Helpful for Those With Chronic Pain
- Physicians Spend Nearly 6 Hours on EHR Tasks Per Day
- Depression Reduced by Social Belonging, Feelings of Inclusion
- Sleep Disturbance May Be Causal Factor in Psychotic Experiences
- Buprenorphine, Methadone Combined With CNS Depressants May Lead to SAEs
- Vagus Nerve Stimulation in HIV-Associated Depression
- Depression Profiles in Patients With Type 1 Diabetes vs Type 2 Diabetes
- Purpose, Questions of Social Interaction Lead Physicians to Delay Retirement
- Retirement Saving Behavior Associated With Psychological Distress