Yondelis is used with pegylated liposomal doxorubicin to treat ovarian cancer that has relapsed come back after previous treatment and is sensitive to medicines containing platinum. Yondelis is also used to treat adults with advanced soft-tissue sarcoma.
It is used when the cancer had started to spread and treatment with anthracyclines and ifosfamide other cancer medicines have stopped working, or in patients who cannot be given these medicines. More information about Yondelis is available. This type of procedure is triggered for medicines that have been authorised via the centralised procedure in case of quality, safety or efficacy issues.
Please do not include any personal data , such as your name or contact details. Skip to main content. Veterinary regulatory Overview Research and development Marketing authorisation Post-authorisation. Table of contents Overview Key facts All documents. Current status. Authorised uses of cancer medicine Yondelis unchanged following review of new data On 23 July , EMA recommended that the use of Yondelis trabectedin in treating ovarian cancer remain unchanged following a review of a study that investigated Yondelis as a third-line treatment in patients with ovarian cancer.
Expand section Collapse section. EMA had looked at results from a study with Yondelis in ovarian cancer because of concerns that the medicine could be less effective than previously thought. Yondelis can therefore continue to be as used as normal.
Yondelis is authorised for treating ovarian cancer that has relapsed come back after previous treatment and is sensitive to medicines containing platinum. If you have any concerns or questions about your treatment, please talk to your doctor.
To prevent vomiting and to protect the liver, patients must receive an infusion of corticosteroids such as dexamethasone before treatment.
For more information, see the summary of product characteristics also part of the EPAR. Cancer is a disease where cells divide too quickly, usually because the way their genes work is faulty.
Trabectedin works by attaching to the DNA, the chemical molecule that makes up genes, and preventing some genes in human cells from increasing their activity. This can prevent the cells from dividing too quickly, slowing down the growth of various types of cancer.
All of the patients had been treated previously with an anthracycline and ifosfamide but this treatment had stopped working. The study compared two different dosing schedules of Yondelis: three times per month, or once every three weeks.
For ovarian cancer, Yondelis in combination with PLD was compared with PLD alone in one main study involving women whose disease had come back or got worse after previous treatment. Around two-thirds of the patients had cancer that was sensitive to platinum-containing medicines. In both studies, the main measure of effectiveness was how long the patients lived without their disease getting worse.
For soft-tissue sarcoma, Yondelis was more effective when it was given once every three weeks than when it was given with the alternative dosing schedule.
Patients receiving it once every three weeks lived for an average of 3. For ovarian cancer, the combination of Yondelis and PLD was more effective than PLD alone: patients receiving the combination treatment lived for an average of 7. The effect of Yondelis was more pronounced in the women whose cancer was sensitive to platinum-containing medicines. Most patients treated with Yondelis can be expected to have side effects. The most common side effects of any severity were neutropenia low levels of neutrophils, a type of white blood cell , nausea feeling sick , vomiting, increase in liver enzymes, anaemia low red blood cell counts , tiredness, thrombocytopenia low blood platelet counts , loss of appetite and diarrhoea.
Fatal side effects have occurred in 1. For the full list of all side effects reported with Yondelis, see the package leaflet. Yondelis must not be used in patients who have any serious or uncontrolled infection, in combination with the vaccine for yellow fever, or in breast-feeding women.
For the full list of restrictions, see the package leaflet. A risk management plan has been developed to ensure that Yondelis is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Yondelis, including the appropriate precautions to be followed by healthcare professionals and patients. The European Commission granted a marketing authorisation valid throughout the European Union for Yondelis on 17 September For more information about treatment with Yondelis, read the package leaflet also part of the EPAR or contact your doctor or pharmacist.
Inspect for particulate matter and discoloration prior to further dilution. Discard vial if particles or discoloration are observed. Immediately following reconstitution, withdraw the calculated volume of trabectedin and further dilute in mL of 0.
Discard any remaining solution within 30 hours of reconstituting the lyophilized powder. Complete infusion within 30 hours of initial reconstitution. Discard any unused portion of the reconstituted product or of the infusion solution. For injection: 1 mg, lyophilized powder in single-dose vial for reconstitution. 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.
Gastrointestinal disorders Nausea 75 7 50 1. Incidence based on number of patients who had both baseline and at least one on-study laboratory measurement. Chemistry Increased ALT 90 31 33 0. Vascular disorders: capillary leak syndrome. Specific Populations The following population characteristics are not associated with a clinically significant effect on the pharmacokinetics of trabectedin: sex, age 19 to 83 years , body weight 36 to kg , body surface area 0.
Food and Drug Administration. YONDELIS is a prescription medicine used to treat people with liposarcoma or leiomyosarcoma that: cannot be treated with surgery or has spread to other areas of the body, and who have received treatment with certain other medicines. Before receiving YONDELIS, tell your healthcare provider about all of your medical conditions, including if you: have liver or kidney problems are pregnant or plan to become pregnant. Tell your healthcare provider about all the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Your healthcare provider may decrease your dose or delay doses if you have certain side effects. Your healthcare provider may do certain tests while you are receiving YONDELIS to check you for side effects, and to see how well you respond to the treatment.
Your healthcare provider may need to decrease your dose of YONDELIS, delay or stop your treatment, if your white blood cell count is too low or you get a serious infection. Call your healthcare provider right away if you develop fever or other signs of infection. Severe muscle problems rhabdomyolysis.
Tell your healthcare provider right away if you have severe muscle pain or weakness. Liver problems, including liver failure. Tell your healthcare provider right away if you get: yellowing of your skin and whites of your eyes pain in your upper right stomach-area abdomen nausea vomiting generally do not feel well problem with concentration confusion sleepiness Heart muscle problems, including heart failure.
Tell your healthcare provider right away if you develop new chest pain, shortness of breath, tiredness, swelling of your legs, ankles, or feet, or heart palpitations.
You may need to have surgery to remove any dead tissue. Tell your healthcare provider right away if you see any YONDELIS leaking out of your vein or around the catheter during your infusion, or if you notice any redness, swelling, itching or discomfort at the infusion site at any time. Some of these reactions were severe. Signs of an allergic reaction can include: difficulty breathing, chest tightness, wheezing, swelling of the lips, or skin rash.
CLS can cause you to have symptoms that may lead to death. Tell your healthcare provider right away if you develop swelling, dizziness or lightheadedness with or without a sudden drop in blood pressure. The most common side effects of YONDELIS include : nausea tiredness vomiting constipation decreased appetite diarrhea swelling of your hands, ankles, or feet shortness of breath headache decreased red cell count cells which carry oxygen in the blood.
Tell your healthcare provider if you feel more tired than usual or look pale. Tell your healthcare provider if you bruise easily or have bleeding. Call your doctor for medical advice about side effects. Active ingredient : trabectedin Inactive ingredients : potassium dihydrogen phosphate, sucrose, phosphoric acid and potassium hydroxide. Rx only Single-dose vial Discard any unused portion Cytotoxic.
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NDC 1 Gastrointestinal disorders. General disorders and administration site conditions. Metabolism and nutrition disorders. Respiratory, thoracic and mediastinal disorders.
Musculoskeletal and connective tissue disorders. Progression-free survival. This Patient Information has been approved by the U.
Tell your healthcare provider right away if you get:.
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