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Trabectedin Side Effects

For the Consumer

Applies to trabectedin: intravenous powder for solution

Along with its needed effects, trabectedin 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

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]

References

1. "Product Information. Yondelis (trabectedin)." Janssen Pharmaceuticals, Titusville, NJ.

Some side effects of trabectedin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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