Note: This document contains side effect information about trabectedin. Some dosage forms listed on this page may not apply to the brand name Yondelis.

Summary

Common side effects of Yondelis include: increased creatine phosphokinase in blood specimen, increased liver enzymes, increased serum alanine aminotransferase, increased serum alkaline phosphatase, increased serum aspartate aminotransferase, increased serum bilirubin, and neutropenia. Other side effects include: febrile neutropenia, cardiomyopathy, and fever. Continue reading for a comprehensive list of adverse effects.

Applies to trabectedin: intravenous powder for solution.

Serious side effects of Yondelis

Along with its needed effects, trabectedin (the active ingredient contained in Yondelis) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking trabectedin:

More common

• Chest discomfort or pain
• difficulty breathing
• dizziness
• faintness
• fast irregular or pounding heartbeat
• swelling of the feet or lower legs
• unusual tiredness or weakness

Less common

• Dark-colored urine
• fever
• muscle cramps or spasms
• muscle pain or stiffness

Rare

• Abdominal or stomach pain or tenderness
• clay colored stools
• decreased appetite
• headache
• itching or skin rash
• loss of appetite
• nausea and vomiting
• swelling of the feet or lower legs
• yellow eyes or skin

Incidence not known

• Black, tarry stools
• chills
• cough
• difficulty with swallowing
• hives
• lower back or side pain
• painful or difficult urination
• pale skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• sore throat
• tightness in the chest
• ulcers, sores, or white spots in the mouth
• unusual bleeding or bruising

Other side effects of Yondelis

Some side effects of trabectedin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Diarrhea
• difficulty having a bowel movement (stool)
• decreased appetite
• headache
• trouble sleeping

Incidence not known

• Pain at the injection site

For Healthcare Professionals

Applies to trabectedin: intravenous powder for injection.

Hepatic

Very common (10% or more): Increased ALT (up to 96.1%), increased AST (up to 89.5%), increased alkaline phosphatase (up to 70%), hyperbilirubinemia (up to 25.2%), increased gamma-glutamyltransferase (% unavailable)

Common (1% to 10%): Drug-induced liver injury

Uncommon (0.1% to 1%): Hepatotoxicity

Frequency not reported: Hepatic failure, increased conjugated bilirubin^[Ref]

Hematologic

Very common (10% or more): Anemia (up to 96%), neutropenia (up to 91.6%), leukopenia (up to 94.9%), thrombocytopenia (up to 63.7%)

Common (1% to 10%): Febrile neutropenia, neutropenic sepsis, pancytopenia, bone marrow failure, granulocytopenia

Uncommon (0.1% to 1%): Neutropenic infection^[Ref]

Gastrointestinal

Very common (10% or more): Nausea (up to 75%), vomiting (up to 51.7%), constipation (up to 37%), diarrhea (up to 35%), stomatitis (up to 19.2%),

Common (1% to 10%): Abdominal pain, dyspepsia, upper abdominal pain^[Ref]

Other

Very common (10% or more): Fatigue/asthenia/malaise (up to 69%), peripheral edema (up to 28%), mucosal inflammation (up to 11.4%), pyrexia (up to 10.2%)

Common (1% to 10%): Infection, edema, injection site reaction

Uncommon (0.1% to 1%): Septic shock

Frequency not reported: Multi-organ failure, catheter site reactions

Postmarketing reports: Extravasation/tissue necrosis^[Ref]

Metabolic

Very common (10% or more): Hypoalbuminemia (up to 63%), decreased appetite (up to 37%), anorexia (up to 28.8%)

Common (1% to 10%): Dehydration, hypokalemia, decreased weight^[Ref]

Renal

Very common (10% or more): Increased creatinine (up to 46%)

Common (1% to 10%): Renal failure^[Ref]

Musculoskeletal

Very common (10% or more): Elevated creatine phosphokinase (up to 33%), arthralgia (up to 15%), myalgia (up to 12%)

Common (1% to 10%): Back pain

Uncommon (0.1% to 1%): Rhabdomyolysis

Frequency not reported: Musculoskeletal pain^[Ref]

Respiratory

Very common (10% or more): Dyspnea (up to 25%)

Common (1% to 10%): Cough, pulmonary embolism

Uncommon (0.1% to 1%): Pulmonary edema^[Ref]

Nervous system

Very common (10% or more): Headache (up to 25%)

Common (1% to 10%): Peripheral neuropathy, dysgeusia, dizziness, paresthesia

Uncommon (0.1% to 1%): Syncope

Frequency not reported: Hypoesthesia^[Ref]

Dermatologic

Very common (10% or more): Palmar-plantar erythrodysesthesia (up to 24%), alopecia (up to 12%)

Common (1% to 10%): Rash, skin hyperpigmentation^[Ref]

Psychiatric

Very common (10% or more): Insomnia (up to 15%)^[Ref]

Cardiovascular

Common (1% to 10%): Cardiomyopathy, decreased ejection fraction, hypotension, flushing

Uncommon (0.1% to 1%): Left ventricular dysfunction^[Ref]

Hypersensitivity

Common (1% to 10%): Hypersensitivity reactions^[Ref]