Drug Interaction:
CYP3A4 inhibitors or inducers, alcohol, inhibitors of P-gp , phenytoin, live vaccines,
statins, hepatoxic drugs,
Indication:
YONDELIS (trabectedin) for injection, for intravenous use
Initial U.S. Approval: 2015
New Drugs Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
1.Trabectedin Powder 20-03-2010
For Conc. Solution for Infusion
Addl.Indcn
In combination with Pegylated Somal Doxorubicin ,
Indicated for the Treatment of Patients with Relapsed Platinum
Sensitive Ovarian Cancer
2.Trabectedin Powder 30-03-2009
For Concentrate Solution for infusion
1mg/ml
For the Treatment of Patients with Advanced Soft Tissue Sarcoma,
after failure of Antracyclines or who are unsuited to receive these agents
NEW MOLECULAR ENTITY AND NEW THERAPEUTIC BIOLOGICAL
PRODUCTS APPROVED FOR 2015
Certain drugs are classified as New molecular Emtities- NME- for FDA review
Many of these products contain active moieties that have not been approved
by FDA previously, either as a single ingredient or as part of a combination
products; these products frequently provide important new therapies for the
patients.
Some drugs are characterized as NMEs for administrative purposes ,but
nonetheless contain certain active moieties in products that have been
previously approved by FDA. For example, CDER classifies biological
products submitted in an application under section 351(a) of the Public
Service Act as NME for purposes of FDA review, regardless of whether
the agency previously approved a related active moiety in a different
product.
FDAs classification of a drug as an -NME- for review purposes is distinct
from FDAs determination of whether a drug is a - New Chemical Entity or - NCE-
within the meaning of the Federal Food,Drug, and Cosmetic Act
No.31
Drug Name - Trabectedin
Active Ingredient- Yondelis
Date of approval - 10/23/2015
FDA-approved use - To treat specific soft tissue sarcomas(STS) -
Liposarcoma and Leiomyosarcoma - that
cannot be removed by surgery (unresctable)
or is advanced (metastatic)
Approved by US FDA on 10/23/2015- (Ref- FDA approved List- 2015)
Advanced soft tissue sarcoma
Adverse Reaction:
Blood dyscrasis, headache, peripheral neuropathy, dysgeusia, dizziness, parathesia,
Dyspnoea, cough, GI upset, stomatitis, alopecia, musculoskeletal pain, anorexia,
Dehydration, hypokalemia, infections, hypotension, flushing, asthenia, pyrexia, odema,
Inj site reactions, altered LFTs insomnia, weight loss, skin reactions, increased creatinine
kinase and creatinine
Contra-Indications:
Absolute neutrophil count, < 1500/mm2 , platelet < 100.000 /mm2, bilirubin > ULN,
albumin 25g/l serum creatinase > 1.5mg/dl
hemoglobin 9g/dl , creatinine kinase , alkaline phosphatase, ALT, or AST > 2.5x ULN
serious uncontrolled infection, renal impairment CrCl 30ml/min in sarcoma
and 60ml/min in ovarian cancer
Lactation during and for 3 months after treatment.
Special precautions-
Hepatic impairment
Monitor FBC including diferential and platelet at baseline, weekly for first 3 cycles.
Monitor hepatic and renal function before and during treatment
Risk of rhabdomylosis, discontinue until recovery if occurs.
Pregnancy- ensure adequate contraception for 3 months after treatment in women
and for 5 months after treatment in men
Risk of irreversible infertility in men
Dosages/ Overdosage Etc:
Indication-
Advanced soft tissue sarcoma
Dosage-
Sarcoma -1.5mg/m2 by i.v. infusion via central line over 24 hours every 3 weeks
Ovarian cancer - 1.1mg/m2 infusion via central line over 3 hours every 3 weeks , immediately after
PLD 30mgmg/m2 by i.v. infusion at initial max ,rate of 1mg/mm
adjust dose according to toxicity
Give dexamethasone 20mg i/v. 30 minutes before tracetedin in sarcoma or before PLD in ovarian
cancer
Below 18 years not recommended
INDICATIONS AND USAGE
YONDELIS is an alkylating drug indicated for the treatment of patients with
unresectable or metastatic liposarcoma or leiomyosarcoma who received
a prior anthracycline-containing regimen
DOSAGE AND ADMINISTRATION
Administer at 1.5 mg/m2 body surface area as a 24-hour intravenous infusion,
every 3 weeks through a central venous line
Premedication: dexamethasone 20 mg IV, 30 min before each infusion
DOSAGE FORMS AND STRENGTHS
For injection: 1 mg sterile lyophilized powder in a single-dose vial
Patient Information:
PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Myelosuppression:
Inform patients of the risks of myelosuppression. Instruct patients to immediately
contact their healthcare provider for fever or unusual bruising, bleeding,
tiredness, or paleness.
Rhabdomyolysis:
Advise patients to contact their healthcare provider if they experience severe
muscle pain or weakness.
Hepatotoxicity: Advise patients to contact their healthcare provider immediately
for yellowing of skin and eyes (jaundice), pain in the upper right quadrant,
severe nausea or vomiting, difficulty in concentrating, disorientation, or confusion.
Cardiomyopathy:
Advise patients to contact their healthcare provider for new onset chest pain,
shortness of breath, fatigue, lower extremity edema, or heart palpitations.
Hypersensitivity:
Advise patients to seek immediate medical attention for symptoms of allergic
reactions including difficulty breathing, chest tightness, wheezing,
severe dizziness or light-headedness, swelling of the lips or skin rash.
Extravasation:
Inform patients of the risks of extravasation and to notify their healthcare
provider for redness, swelling, itchiness and discomfort or leakage
at the injection site.
Embryofetal toxicity:
Advise pregnant women of the potential risk to a fetus. Advise females to contact
their healthcare provider if they become pregnant, or if pregnancy is suspected,
during treatment with YONDELIS .
Females and males of reproductive potential:
Advise females of reproductive potential to use effective contraception during
treatment with YONDELIS and for at least 2 months after last dose.
Advise males with female partners of reproductive potential to use effective
contraception during treatment with YONDELIS and for at least 5 months
after the last dose
Lactation:
Advise females not to breastfeed during treatment with YONDELIS
Manufactured by: Baxter Oncology GmbH, Halle/Westfalen Germany
Manufactured for: Janssen Products, LP, Horsham, PA For more information,
call 1-800-526-7736 or go to www.YONDELIS.com.
This Patient Information has been approved by the U.S. Food and Drug
Administration. Issued: October/2015
Pregnancy and lactation:
Use contra- indicated. Observe caution
Manufacturer Details