Evdi

Do not take it if

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

• Administer at 1.5 mg/m 2 as a 24-hour intravenous infusion, every 3 weeks through a central venous line ( 2.1 , 2.5 ) Premedication:
• dexamethasone 20 mg intravenously, 30 min before each infusion ( 2.2 ) Hepatic Impairment:
• Administer at 0.9 mg/m 2 as a 24-hour intravenous infusion, every 3 weeks through a central venous line in patients with moderate hepatic impairment ( 2.1 )
• 2.1 Recommended Dosage The recommended dose is 1.5 mg/m 2 administered as an intravenous infusion over 24 hours through a central venous line every 21 days (3 weeks), until disease progression or unacceptable toxicity.
• 2.2 Recommended Dosage in Patients with Hepatic Impairment The recommended dosage of EVDI in patients with moderate hepatic impairment (bilirubin levels greater than 1.5 times to 3 times the upper limit of normal, and AST and ALT less than 8 times the upper limit of normal) is 0.9 mg/m 2 every 21 days (3 weeks).
• Do not administer EVDI to patients with severe hepatic impairment (bilirubin levels above 3 times the upper limit of normal, and any AST and ALT) [see Use in Specific Populations (8.6) and Clinical Pharmacology ( 12.3 )].
• 2.3 Premedication Administer dexamethasone 20 mg intravenously 30 minutes prior to each dose of EVDI.
• 2.4 Dosage Modifications for Adverse Reactions Permanently discontinue EVDI for:
• Persistent adverse reactions requiring a delay in dosing of more than 3 weeks.
• Adverse reactions following the second dosage reduction of EVDI (1.0 mg/m 2 for patients with normal hepatic function or at 0.3 mg/m 2 for patients with pre-existing moderate hepatic impairment).
• Severe liver dysfunction:
• bilirubin two times the upper limit of normal, and AST or ALT three times the upper limit of normal, and alkaline phosphatase less than two times the upper limit of normal in the prior treatment cycle for patients with normal liver function at baseline.
• Exacerbation of liver dysfunction in patients with pre-existing moderate hepatic impairment.
• Capillary leak syndrome.
• Rhabdomyolysis.
• Grade 3 or 4 cardiac adverse events (AEs) indicative of cardiomyopathy or for subjects with an LVEF that decreases below the lower limit of normal.
• The recommended dosage modifications for adverse reactions are listed in Table 1.
• Once reduced, the dose of EVDI should not be increased in subsequent treatment cycles.
• Table 1:
• Recommended Dosage Modification Laboratory Result or Adverse Reaction DELAY next dose of EVDI for up to 3 weeks REDUCE next dose of EVDI by one dose level for adverse reaction(s) during prior cycle Platelets Less than 100,000 platelets/microliter Less than 25,000 platelets/microliter Absolute neutrophil count Less than 1,500 neutrophils/microliter Less than 1,000 neutrophils/microliter with fever/infection Less than 500 neutrophils/microliter lasting more than 5 days Total bilirubin Greater than the upper limit of normal Greater than the upper limit of normal Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) More than 2.5 times the upper limit of normal More than 5 times the upper limit of normal Alkaline phosphatase (ALP) More than 2.5 times the upper limit of normal More than 2.5 times the upper limit of normal Creatine phosphokinase More than 2.5 times the upper limit of normal More than 5 times the upper limit of normal Other non-hematologic adverse reactions Grade 3 or 4 Grade 3 or 4 The recommended starting doses and dose reductions for EVDI are listed in Table 2:
• Table 2:
• Recommended Starting Doses and Dose Reductions Starting Dose and Dose Reduction For patients with normal hepatic function or mild hepatic impairment* prior to initiation of EVDI treatment For patients with moderate hepatic impairment** prior to initiation of EVDI treatment Starting Dose 1.5 mg/m 2 0.9 mg/m 2 Dose Reduction First dose reduction 1.2 mg/m 2 0.6 mg/m 2 Second dose reduction 1.0 mg/m 2 0.3 mg/m 2 * Including patients with bilirubin greater than 1 to 1.5 times the upper limit of normal, and any AST or ALT. ** Including patients with bilirubin levels greater than 1.5 times to 3 times the upper limit of normal, and AST and ALT less than 8 times the upper limit of normal.
• 2.5 Preparation for Administration EVDI is a hazardous drug.
• Follow applicable special handling and disposal procedures. 1 Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
• The solution is clear colorless to pale brownish yellow.
• Discard the vial if particles are observed.
• Withdraw the calculated volume of trabectedin and dilute in 500 mL of 0.9% Sodium Chloride Injection, USP or in 500 mL of 5% Dextrose Injection, USP.
• Discard any unused portion left in the vial(s).
• EVDI diluted solution is compatible with Type I colorless glass vials, polyvinylchloride (PVC) and polyethylene (PE) bags and tubing, PE and polypropylene (PP) mixture bags, polyethersulfone (PES) in-line filters, titanium, platinum or plastic ports, silicone and polyurethane catheters, and pumps having contact surfaces made of PVC, PE, or PE/PP.
• Do not mix EVDI with other drugs.
• The diluted EVDI infusion solution may be stored at room temperature 20°C to 25°C (68°F to 77°F) for up to 30 hours.
• 2.6 Administration Infuse the diluted solution over 24 hours through a central venous line using an infusion set with a 0.2 micron polyethersulfone (PES) in-line filter.
• Discard any unused portion of the infusion solution.
• Complete infusion within 30 hours of initial dilution.
• Discard any unused portion of the infusion solution after 30 hours.

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

Quoted from the official label, section “Drug Interactions”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

Quoted from the official label, section “Overdosage”.

Use in children

• Safety and effectiveness of EVDI in pediatric patients have not been established.
• Safety (n=61) and efficacy (n=58) of trabectedin were assessed across five open-label studies (NCT00006463, NCT01453283, NCT00005625, NCT00070109, and ET-B-023-00) in pediatric patients (aged 2 to <17 years) with pediatric histotypes of sarcoma (predominantly rhabdomyosarcoma, osteosarcoma, Ewing sarcoma, and non-rhabdomyosarcoma soft tissue sarcoma).
• No new safety signals were observed in pediatric patients across these studies.
• Pharmacokinetic parameters in 17 pediatric patients (aged 3 to 17 years) were within the range of values previously observed in
• adults given the same dose per body surface area.

Quoted from the official label, section “Pediatric Use”.

Use in older people

Clinical studies of trabectedin did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

Quoted from the official label, section “Geriatric Use”.

Side effects

• The following adverse reactions are discussed in more detail in other sections of the labeling:
• Anaphylaxis [see Contraindications (4) ] Neutropenic Sepsis [see Warnings and Precautions (5.1) ] Rhabdomyolysis [see Warnings and Precautions (5.2) ] Hepatotoxicity [see Warnings and Precautions (5.3) ] Cardiomyopathy [see Warnings and Precautions (5.4) ] Capillary Leak Syndrome [see Warnings and Precautions (5.5) ] Extravasation Resulting in Tissue Necrosis [see Warnings and Precautions (5.6) ] The most common (≥20%) adverse reactions are nausea, fatigue, vomiting, constipation, decreased appetite, diarrhea, peripheral edema, dyspnea, and headache.
• The most common (≥5%) grades 3 to 4 laboratory abnormalities are:
• neutropenia, increased ALT, thrombocytopenia, anemia, increased AST, and increased creatine phosphokinase.
• ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Apotex Corp at 1-800-706-5575 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
• 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
• The data described below reflect exposure to trabectedin in 755 patients with soft tissue sarcoma including 197 (26%) patients exposed to trabectedin for greater than or equal to 6 months and 57 (8%) patients exposed to trabectedin for greater than or equal to 1 year.
• The safety of trabectedin was evaluated in six open-label, single-arm trials, in which 377 patients received trabectedin and one open-label, randomized, active-controlled clinical trial in which 378 patients received trabectedin (Trial ET743-SAR-3007).
• All patients received trabectedin at the recommended dosing regimen of 1.5 mg/m 2 administered as an intravenous infusion over 24 hours once every 3 weeks (q3wk, 24-h).
• The median age was 54 years (range:
• 18 to 81 years), 63% were female, and all patients had metastatic soft tissue sarcoma.
• Tables 3 and 4 present selected adverse reactions and laboratory abnormalities, respectively, observed in Trial ET743-SAR-3007, an open-label, randomized (2:1), active-controlled trial in which 550 patients with previously treated leiomyosarcoma or liposarcoma (dedifferentiated, myxoid round cell, or pleomorphic) received trabectedin 1.5 mg/m 2 intravenous infusion over 24 hours once every 3 weeks (n=378) or dacarbazine 1,000 mg/m 2 intravenous infusion over 20 to 120 minutes once every 3 weeks (n=172) [see Clinical Studies ( 14 )] .
• All patients treated with trabectedin were required to receive dexamethasone 20 mg intravenous injection 30 minutes prior to start of the trabectedin infusion.
• In Trial ET743-SAR-3007, patients had been previously treated with an anthracycline- and ifosfamide-containing regimen or with an anthracycline-containing regimen and one additional cytotoxic chemotherapy regimen.
• The trial excluded patients with known central nervous system metastasis, elevated serum bilirubin or significant chronic liver disease, such as cirrhosis or active hepatitis, and history of myocardial infarction within 6 months, history of New York Heart Association Class II to IV heart failure, or abnormal left ventricular ejection fraction at baseline.
• The median age of patients in Trial ET743-SAR-3007 was 57 years (range:
• 17 to 81 years), with 69% female, 77% White, 12% Black or African American, 4% Asian, and <1% American Indian or Alaska Native.
• The median duration of exposure to trabectedin was 13 weeks (range:
• 1 to 127 weeks) with 30% of patients exposed to trabectedin for greater than 6 months and 7% of patients exposed to trabectedin for greater than 1 year.
• In Trial ET743-SAR-3007, adverse reactions resulting in permanent discontinuation of trabectedin occurred in 26% (98/378) of patients; the most common were increased liver tests (defined as ALT, AST, alkaline phosphatase, bilirubin) (5.6%), thrombocytopenia (3.4%), fatigue (1.6%), increased creatine phosphokinase (1.1%), and decreased ejection fraction (1.1%).
• Adverse reactions that led to dose reductions occurred in 42% (158/378) of patients treated with trabectedin; the most common were increased liver tests (24%), neutropenia (including febrile neutropenia) (8%), thrombocytopenia (4.2%), fatigue (3.7%), increased creatine phosphokinase (2.4%), nausea (1.1%), and vomiting (1.1%).
• Adverse reactions led to dose interruptions in 52% (198/378) of patients treated with trabectedin; the most common were neutropenia (31%), thrombocytopenia (15%), increased liver tests (6%), fatigue (2.9%), anemia (2.6%), increased creatinine (1.1%), and nausea (1.1%).
• The most common adverse reactions (≥20%) were nausea, fatigue, vomiting, constipation, decreased appetite, diarrhea, peripheral edema, dyspnea, and headache.
• The most common laboratory abnormalities (≥20%) were increases in AST or ALT, increased alkaline phosphatase, hypoalbuminemia, increased creatinine, increased creatine phosphokinase, anemia, neutropenia, and thrombocytopenia.
• Table 3:
• Selected Adverse Reactions a Occurring in ≥10% of Patients Receiving Trabectedin and at a Higher Incidence than in the Control Arm - Trial ET743-SAR-3007 System Organ Class Adverse Reaction Trabectedin (N=378) Dacarbazine (N=172) All Grades b (%) Grades 3 to 4 (%) All Grades (%) Grades 3 to 4 (%) Gastrointestinal disorders Nausea 75 7 50
• Vomiting 46 6 22
• 1.2 Constipation 37 0.8 31
• 0.6 Diarrhea 35 1.6 23 0 General disorders and administration site conditions Fatigue c 69 8 52
• 1.7 Peripheral edema 28 0.8 13
• 0.6 Metabolism and nutrition disorders Decreased appetite 37 1.9 21
• 0.6 Respiratory, thoracic and mediastinal disorders Dyspnea 25 4.2 20
• 1.2 Nervous system disorders Headache 25 0.3 19 0 Musculoskeletal and connective tissue disorders Arthralgia 15 0 8
• 1.2 Myalgia 12 0 6 0 Psychiatric disorders Insomnia 15 0.3 9 0 a Limited to adverse reactions at a rate of ≥10% in the trabectedin arm and at a rate higher in the trabectedin arm compared with dacarbazine arm by ≥5% in overall incidence or by ≥2% for Grade 3 to 4 adverse reactions. b Toxicity grade is based on NCI common toxicity criteria, version 4.0. c Fatigue is a composite of the following adverse event terms:
• fatigue, asthenia, and malaise.
• Other clinically important adverse reactions observed in <10% of patients (N=755) with soft tissue sarcoma receiving trabectedin were:
• Nervous system disorders :
• peripheral neuropathy, paresthesia, hypoesthesia.
• Respiratory, thoracic, and mediastinal disorders : pulmonary embolism.
• General disorders and administration site conditions :
• mucosal inflammation Table 4:
• Incidence of Selected Treatment-Emergent Laboratory Abnormalities a -Trial ET743-SAR-3007 Laboratory Abnormalities Trabectedin Dacarbazine All Grades (%) Grades 3 to 4 (%) All Grades (%) Grades 3 to 4 (%) Chemistry Increased ALT 90 31 33
• Increased AST 84 17 32
• 1.2 Increased alkaline phosphatase 70 1.6 60
• 0.6 Hypoalbuminemia 63 3.7 51
• 3.0 Increased creatinine 46 4.2 29
• 1.2 Increased creatine phosphokinase 33 6.4 9
• 0.6 Hyperbilirubinemia 13 1.9 5
• 0.6 Hematology Anemia 96 19 79 12 Neutropenia 66 43 47 26 Thrombocytopenia 59 21 57 20 a Treatment-emergent laboratory abnormalities including those higher in the trabectedin arm compared with the dacarbazine arm by ≥5% (all Grades) or by ≥2% (Grade 3 to 4).
• Incidence based on number of patients who had both baseline and at least one on-study laboratory measurement.
• Trabectedin group (range:
• 373 to 377 patients) and dacarbazine group (range:
• 166 to 168 patients).
• 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of trabectedin.
• Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
• Vascular disorders: capillary leak syndrome

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

• 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 [see Warnings and Precautions ( 5.1 )].
• Rhabdomyolysis :
• Advise patients to contact their healthcare provider if they experience severe muscle pain or weakness, or if they experience reddish-brown urine [see Warnings and Precautions ( 5.2 )].
• 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 [see Warnings and Precautions ( 5.3 )].
• Cardiomyopathy :
• Advise patients to contact their healthcare provider immediately for new onset chest pain, shortness of breath, fatigue, lower extremity edema, or heart palpitations [see Warnings and Precautions ( 5.4 )].
• Capillary leak syndrome:
• Advise patients to report symptoms such as edema with or without hypotension [see Warnings and Precautions ( 5.5 ), Adverse Reactions (6.2)] 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 [see Warnings and Precautions ( 5.6 )].
• 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 [see Contraindications ( 4 )].
• 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 EVDI [see Warnings and Precautions (5.7) and Use in Specific Populations (8.1) ] .
• Females and males of reproductive potential :
• Advise females of reproductive potential to use effective contraception during treatment with EVDI and for at least 8 months after last dose.
• Advise males with female partners of reproductive potential to use effective contraception during treatment with EVDI and for at least 5 months after the last dose [see Warnings and Precautions (5.7) and Use in Specific Populations (8.3) ] .
• Lactation :
• Advise females not to breastfeed during treatment with EVDI and for 3 months after the last dose [see Use in Specific Populations ( 8.2 )].
• APOTEX INC EVDI, 1 mg Manufactured by: Manufactured for: Latina Pharma S.P.A.
• Via Murillo, 7, Sermoneta, (LT) 04013, Italy (ITA) Apotex Corp.
• Weston, Florida 33326

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

• FORMS AND STRENGTHS Injection:
• 1 mg/20 mL (0.05 mg/mL) sterile clear colorless to pale brownish yellow solution in a single-dose vial. Injection:
• 1 mg/20 mL (0.05 mg/mL) solution in a single dose vial ( 3 )

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

• EVDI is supplied in a glass vial containing 1 mg/20 mL (0.05 mg/mL) solution.
• Each carton contains one single-dose vial (NDC: 60505-6423-0).
• Storage and Handling Store EVDI vials refrigerated at 2°C to 8°C (36°F to 46°F) in original carton to protect from light.
• EVDI is a hazardous drug.
• Follow applicable special handling and disposal procedures. 1

Quoted from the official label, section “How Supplied”.

How to store it

Store EVDI vials refrigerated at 2°C to 8°C (36°F to 46°F) in original carton to protect from light. EVDI is a hazardous drug. Follow applicable special handling and disposal procedures. 1

Quoted from the official label, section “Storage and Handling”.

What is in it

• Trabectedin is an alkylating drug with the chemical name (1' R ,6 R ,6a R ,7 R ,13 S ,14 S ,16 R )-5- (acetyloxy)-3',4',6,6a,7,13,14,16-octahydro-6',8,14-trihydroxy-7',9-dimethoxy-4,10,23-trimethyl- spiro[6,16-(epithiopropanoxymethano)-7,13-imino-12 H -1,3-dioxolo[7,8]isoquino[3,2- b ][3]benzazocine-20,1'(2' H )-isoquinolin]-19-one.
• The molecular formula is C 39 H 43 N 3 O 11 S.
• The molecular weight is 761.84 g/mol.
• The chemical structure is shown below:
• Trabectedin is hydrophobic and has a low solubility in water.
• EVDI (trabectedin) injection is supplied as a sterile clear, colorless to pale brownish-yellow solution in a single-dose vial.
• Each single-dose vial contains 1 mg of trabectedin in 20 mL solution (0.05 mg/mL), glycine 50 mg, lactic acid 10 mg (for pH adjustment to 3.5 to 4.2), propylene glycol 1.04 g and Water for Injection, q.s. structure.jpg

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

Same active substance, strength and form in other countries

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Details

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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