Afinitor is a prescription medicine used to treat advanced hormone receptorpositive, her2negative breast cancer along with the medicine exemestane, in postmenopausal women who have already. Individuals using assistive technology may not be able to fully access the information contained in this file. Keep sutent and all medicines out of the reach of children. Additional copies of the febridx package insert can be found on the downloads page at.
Read the medication guide that comes with sutent before you start taking it and each time you get a refill. One of the worlds premier biopharmaceutical companies. Until recently, these patients faced limited treatment options and typically a median survival of less than 2 years 14. The recommended dosing schedule is 3 mgkg administered intravenously over a 90minute period every 3 weeks for a total of 4 doses1 assess patients for signs and symptoms of enterocolitis, dermatitis, neuropathy, and endocrinopathy and evaluate clinical chemistries including lfts and thyroid function tests at baseline and before each dose.
The ph of the final product is maintained between 7. Sutent will be approved based on both of the following criteria. Sutent is indicated for the treatment of gastrointestinal stromal tumor after disease progression on or intolerance to imatinib mesylate. Pancreatic neuroendocrine tumors pnets are diagnosed in one of every 300,000 people per year. Fatal cardiac failure was reported in sutent sunitinib malate capsules are supplied as printed hard shell capsules containing sunitinib malate equivalent to 12. It may occur as early as the first week after start of therapy.
General information about the safe and effective use of sutent. The test measures a clinically significant immune response to a. Sutent is a kinase inhibitor indicated for the treatment of. Connect the diluent syringe to the vial adapter by inserting the tip of the syringe into the adapter opening while firmly pushing and turning the syringe clockwise until the connection is secured. If dose is increased, the patient should be monitored carefully for toxicity see drug interactions 7. Manifestations may include generalized signs and symptoms such as fever, abdominal pain, malaise, back pain, and increased inflammatory markers e. Hepatotoxicity hepatotoxicity has been observed in clinical trials and postmarketing experience. Please see patient medication guide and full prescribing information. The following boxed warning and safety information has been added to the pi for sutent. Sunitinib sutent, pfizer is a recently fdaapproved, multitargeted tki that prolongs survival in patients with gist and rcc. Ascorbic acid injection is a clear, colorless to slightly yellow sterile solution of ascorbic acid in water for injection, for intravenous, intramuscular or subcutaneous use. Highlights of prescribing information patients at risk. In the majority of presentations, the tumor is metastatic and unresectable. Highlights of prescribing information these highlights do not include all the information needed to use.
Assess if antidiabetic drug dosage needs to be adjusted to. Sutent is used to treat advanced kidney cancer advanced renal cell carcinoma or rcc. Use standard precautions for collecting and handling a blood sample. Qtern dapagliflozin and saxagliptin is indicated as an adjunct to diet and exercise to. You wont find pdf packages in acrobat 9, but youre sure to find a terrific substitute in pdf portfolio, available for acrobat 9 standard and up. Instead of building an interface pdf file and then adding bookmark or link navigation to bring together a collection of files, all it took was a few mouse clicks and file selections. Full prescribing information 1 indications and usage tecfidera is indicated for the treatment of relapsing forms of multiple sclerosis ms, to include clinically isolated syndrome, relapsingremitting disease, and active secondary progressive disease, in adults. Highlights of prescribing information these highlights do. Hepatotoxicity has been observed in clinical trials and postmarketing experience. Get emergency help right away if you get symptoms such as chest pain, shortness of breath, racing heartbeat, swelling in lower legs, feet and abdomen, feel lightheaded or faint, tiredness, nausea, vomiting, or sweat a lot. Clinical outcomes for patients with metastatic renal cell. Prescribing information update for sutent sunitinib malate.
Dosing info mrcc sutent sunitinib malate for hcp safety info. Using molecular glues to hijack the bodys garbage disposal system. For gist and mrcc, the recommended dose of sutent is 50 mg taken orally once. In patients treated with sutent n7527 for gist, advanced rcc, adjuvant treatment of rcc and pnet, 3% of patients experienced heart failure. Tarceva is not recommended for use in combination with platinumbased chemotherapy see clinical studies 14. The enbreletanercept instructions for use insert for each presentation contains more detailed instructions on injection site selection and the preparation of enbrel. Keep the febridx test card in the sealed foil pouch until just before use. Sutent also inhibits other targets important to tumor growth, including kit, flt3 and ret. Assess if antidiabetic drug dosage needs to be adjusted to minimize the risk of. Highlights of prescribing information these highlights do not include all the information needed to use sutent safely and effectively. Sutent, innsunitinib european medicines agency europa eu. Hepatotoxicity see full prescribing information for complete boxed warning.
Everolimus and sunitinib for advanced pancreatic neuroendocrine tumors. Prescribing information update for sutent sunitinib. Pdf everolimus and sunitinib for advanced pancreatic. Highlights of prescribing information these highlights do not include all the information needed to use votrient safely and effectively. Sutent is used to treat a type of pancreatic cancer known as pancreatic. In the event of toxicity, doses may be delayed, but all treatment must be administered within 16 weeks of the first dose see clinical studies 14. Aortitis has been reported in patients receiving filgrastim products.
This letter is to inform you of an important update to the sutent prescribing. Lift the package away from the adapter and discard the package. This letter is to inform you of an important update to the sutent prescribing information pi. Intended use febridx is a rapid immunoassay for the visual, qualitative, in vitro detection of elevated levels of both mxa and crp directly from peripheral whole blood. Food and drug administration approves pfizers inlyta. Do not use the febridx test card or the buffer solution past the expiration date. A novel approach to drug discovery called targeted protein degradation seeks. Cardiotoxicity associated with the tyrosine kinase. This study aimed to indirectly compare overall and progressionfree among everolimus, sunitinib and. Each vial contains 10 mg of pentostatin and 50 mg of mannitol, usp. Learn about the indications for sutent sunitinib malate on the official patient.
Everolimus and sunitinib have been approved for the treatment advanced pancreatic neuroendocrine tumors, but have not been compared to each other in a randomized trial and have not demonstrated prolonged overall survival compared to placebo. Check blood glucose levels regularly during and after discontinuation of treatment with sutent. Sutent is used in the treatment of renal cell carcinoma, a. Find recommended dosing information for sutent for the treatment of. Sutent is used to treat adults with kidney cancer that has not spread localized and who are at high risk of rcc coming back again after having kidney surgery. Pfizers butterflies offer support during breast cancer. In 2011, two biologicallytargeted therapies, everolimus and sunitinib, were. These highlights do not include all the information needed to use.
Gastrointestinal stromal tumor gist after disease progression on or intolerance to imatinib mesylate. Medicines are sometimes prescribed for purposes other than those listed in a medication guide. Gist support international sometimes poses questions about imatinib gleevec to novartis, the manufacturer of the drug. Sutent works by blocking multiple molecular targets implicated in the growth, proliferation and spread of cancer. Monitor liver function tests including alt, ast, and total bilirubin every 2 weeks during the first 3 months of treatment, then once a month and as clinically indicated, with more frequent testing in patients who develop transaminase and bilirubin elevations. Do not restart sutent if patients experience severe changes in liver. A read is counted each time someone views a publication summary such as the title, abstract, and list of authors, clicks on a figure, or views or downloads the fulltext. The butterfly club is a support network of pfizer employees who are living with or have survived breast cancer. Dosage and administration, recommended dose for adjuvant treatment of. The recommended dose of yervoy ipilimumab is 3 mgkg administered intravenously iv over 90 minutes every 3 weeks for a maximum of 4 doses. Individuals using assistive technology may not be able to. According to the description section of the gleevec package insert.
585 1528 1505 520 1162 89 423 718 253 187 119 1482 399 888 972 1245 20 1409 1158 3 1094 1333 574 321 892 451 110 143 1369 1473 417 35 184 430 1294