CABAZITAXEL PACKAGE INSERT PDF

solvent, there is solution containing 10 mg/ml cabazitaxel. The printed package leaflet of the medicinal product must state the name and address of the. See JEVTANA 20 mg/m² recommended dosing and dose modifications (every 3 weeks with prednisone 10 mg daily). 25 mg/m² can be considered in select. Package leaflet: Information for the patient. JEVTANA® 60 mg concentrate and solvent for solution for infusion. cabazitaxel. Read all of this leaflet carefully.

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Men who are 65 years or older may be more likely to have Show More. You may need to read it again. See a doctor immediately if you notice any of the following side effects:.

Healthcare Professionals I am a U. Febrile neutropenia or neutropenic infection.

What is a Patient Information Leaflet and why is it useful? Primary prophylaxis with G-CSF is recommended in patients with high-risk clinical features.

Cabazitaxel (Jevtana) | – A Hematology Oncology Wiki

Tell your HCP right away if you develop any new or worsening symptoms, including: The concentrate is a clear yellow to brownish yellow oily solution. All of the early infection-related deaths occurred in patients greater than 60 years of age. If you are interested in helping the Publications Committee with creating. Call your doctor for medical advice about side effects.

Your doctor will monitor your blood and general condition for signs of infections. You are advised not to father a child during and up to 6 months after treatment and to seek advice on conservation of sperm prior to treatment because JEVTANA may alter male fertility. These measures will help to protect the environment.

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Low white blood cells, which can cause you to get serious infections, and may lead to death. The product code s for this leaflet is: Overall Survival Tumor Response. The active substance is cabazitaxel. Find out more here. This includes medicines obtained without a prescription. On September 14,the U. This is very common may affect more than 1 in 10 people. You are leaving www. Reporting of side effects If you get any side effects, talk to your doctor.

JEVTANA can cause a leak in the stomach or intestine, intestinal blockage, infection, and bleeding in the stomach or intestine. It belongs to a group of medicines called “taxanes” used to treat cancers. This may affect your ability to father a child. Possible side effects 5.

The most common reasons for dose discontinuation were fatigue and hematuria. Sanofi Genzyme’s privacy procedures do not apply to the owners of a non-Sanofi Genzyme website. Antihistamine dexchlorpheniramine 5 mg or diphenhydramine 25 mg or equivalent antihistamine Corticosteroid dexamethasone 8 mg or equivalent steroid H 2 antagonist ranitidine 50 mg or equivalent H 2 antagonist Antiemetic prophylaxis is recommended and can be given orally or intravenously as needed.

Dosing and Dose Modifications. This can occur if you have a hole in the stomach, food pipe, gut or bowel gastrointestinal perforation. Severe vomiting and diarrhea with JEVTANA can lead to loss of too much body fluid dehydrationor too much of your body salts electrolytes. Obtain frequent inser counts to monitor for neutropenia.

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One single use clear glass vial, closed with a grey chlorobutyl rubber closure sealed by a gold colour aluminium cap with a colourless plastic flip-off cover, containing 4.

You may need to go to the hospital for treatment. Healthcare Professionals Only Sanofi Genzyme.

The solvent is a clear and colourless solution. The earliest sign of infection may be fever, so if you experience fever, tell your doctor right away.

This can occur if you have severe or long-lasting diarrhoea, or fever, or if you are being sick vomiting.

Dosing and Dose Modifications

Symptoms of anemia include shortness of breath and tiredness. Read all of this leaflet carefully before you start using this medicine because it contains important information for you. Older patients Poor performance status Previous episodes of febrile neutropenia.

This medicine may be harmful for those suffering from alcoholism. Below is a text only representation of the Patient Information Leaflet. Your doctor will calculate your body surface area in square meters m 2 and will decide the dose you should have. Richard Pazdur to inform oncologists and professionals in oncology-related fields in a timely manner.

To email a medicine you must sign up and log in. Based on the per-protocol population, the estimated median OS was