所属类别： 20毫克/毫升 1毫升/瓶
包装规格： 20毫克/毫升 1毫升/瓶
原产地英文商品名：FOLOTYN 20MG/ML 1ML SDV 1/EA
中文参考商品译名：FOLOTYN注射剂 20毫克/毫升 1毫升/瓶
FOLOTYN的推荐剂量为30mg/m2静脉推超过3至5分钟一次，连续6周，每周7周周期管理。患者补充维生素B12 1毫克肌注，每8-10周和叶酸1.0〜1.25毫克，每天口服。可能需要中断治疗或降低剂量为20 mg/m2，管理的不良反应。
FOLOTYN 20MG/ML 1ML SDV 1/EA
FOLOTYN (Pralatrexate Solution for Intravenous Injection)HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use FOLOTYN® safely and effectively. See full prescribing information for FOLOTYN.FOLOTYN (pralatrexate injection)Solution for intravenous injectionInitial U.S. Approval: 2009RECENT MAJOR CHANGESWarnings and Precautions, Mucositis (5.2)4/2010Warnings and Precautions, Dermatologic Reactions (5.3)1/2011Warnings and Precautions, Tumor Lysis Syndrome (5.4) 1/2011INDICATIONS AND USAGEFOLOTYN is a folate analog metabolic inhibitor indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). This indication is based on overall response rate. Clinical benefit such as improvement in progression-free survival or overall survival has not been demonstrated. (1)DOSAGE AND ADMINISTRATIONThe recommended dose of FOLOTYN is 30 mg/m2 administered as an intravenous push over 3 to 5 minutes once weekly for 6 weeks in 7-week cycles. (2.1)Supplement patients with vitamin B12 1mg intramuscularly every 8-10weeks and folic acid 1.0-1.25 mg orally on a daily basis. (2.2)Treatment interruption or dose reduction to 20 mg/m2 may be needed to manage adverse drug reactions. (2.5)DOSAGE FORMS AND STRENGTHSSterile, single-use vials containing pralatrexate at a concentration of 20mg/mL in the following presentations:- 20mg of pralatrexate in 1 mL solution in a vial (20 mg / 1 mL)- 40mg of pralatrexate in 2 mL solution in a vial (40 mg / 2 mL) (3)CONTRAINDICATIONSNone. (4)WARNINGS AND PRECAUTIONSThrombocytopenia, neutropenia, and anemia may occur. Monitor blood counts and omit or modify dose for hematologic toxicities. (2.5, 5.1)Mucositis may occur. If ≥ Grade 2 mucositis is observed, omit or modify dose. (2.5, 5.2)Fatal dermatologic reactions may occur. Dermatologic reactions may be progressive and increase in severity with further treatment. Patients with dermatologic reactions should be monitored closely, and if severe, FOLOTYN should be withheld or discontinued. (5.3)Tumor lysis syndrome may occur. Monitor patients and treat if needed. (5.4)FOLOTYN can cause fetal harm. Women should avoid becoming pregnant while being treated with FOLOTYN, and pregnant women should be informed of the potential harm to the fetus. (5.6, 8.1)Use caution in patients with moderate to severe renal function impairment. (5.7)Elevated liver function test abnormalities may occur. If liver function test abnormalities are ≥ Grade 3, omit or modify dose. (2.5, 5.8)ADVERSE REACTIONSMost common adverse reactions are mucositis, thrombocytopenia, nausea, and fatigue. Most common serious adverse reactions are pyrexia, mucositis, sepsis, febrile neutropenia, dehydration, dyspnea, and thrombocytopenia. (6)To report SUSPECTED ADVERSE REACTIONS, contact Allos Therapeutics, Inc at 1-888-ALLOS88 (1-888-255-6788) or www.FOLOTYN.com or FDA at 1-800-FDA-1088 orwww.fda.gov/medwatchDRUG INTERACTIONSCo-administration with probenecid, NSAIDs, and trimethoprim/sulfamethaxazole may result in delayed renal clearance. (7)USE IN SPECIFIC POPULATIONSWomen should be advised against breastfeeding while being treated with FOLOTYN. (8.3)See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labelingRevised: 08/2011IMPORTANT SAFETY INFORMATION ABOUT FOLOTYN•Low Blood Cell Counts: Patients may experience low blood cell counts. Your doctor will do weekly blood tests to check your blood counts.•Low Platelet Count: Lower platelets may cause unusual bleeding, such as nosebleeds, or abnormal bruising. Talk to your doctor right away if this happens.•Low White Blood Cell Count: Lower white blood cell counts can reduce the body’s defenses against infection. If you have any of the following signs or symptoms of infection (fever, chills, cough, shortness of breath, pain or burning on urination), tell your doctor right away. Serious illness or death could result if such infections are not treated when white blood cell counts are very low.•Low Red Blood Cell Count: Lower red blood cell counts may make you feel weak, feel tired, and get tired easily. You may appear pale and be short of breath. Contact your doctor if you experience any of these symptoms following treatment with FOLOTYN.•Mucositis: Patients may develop mucositis, which is redness and/or sores in the mucous membranes including the mouth, lips, throat, and other areas along the digestive tract and genitals. Discomfort or pain due to mucositis may occur as early as a few days after treatment with FOLOTYN. Talk with your doctor about ways to reduce your risk of developing mucositis, and/or ways to maintain nutrition and control the discomfort if you develop it. It is important to take folic acid and vitamin B12 during your treatment with FOLOTYN. Your doctor will give you specific instructions for vitamin supplementation.•Severe Skin Reactions: Severe skin reactions may happen after treatment with FOLOTYN, which can be fatal. Tell your doctor right away if you have of any of the following skin reactions: rash, peeling and loss of skin, sores, or blisters.•Tumor Lysis Syndrome (TLS): FOLOTYN can cause the fast breakdown of certain types of cancer cells. This can lead to TLS. Your doctor may do blood tests to check you for TLS and treat you for TLS if needed.•Pregnancy and Nursing: Tell your doctor if you are pregnant or plan to become pregnant. FOLOTYN can harm your unborn baby. FOLOTYN has not been studied in pregnant women. Tell your doctor if you are breastfeeding or plan to breast-feed. It is not known if FOLOTYN will pass into your breast milk. Talk to your doctor about whether you should discontinue breast-feeding.•Fever: Fever is often one of the most common and earliest signs of infection. Follow your doctor’s instructions about how often to take your temperature, especially during the days after treatment with FOLOTYN. If you have a fever, tell your doctor or nurse right away.•Loss of too much fluid from the body (dehydration): If you feel tired and weak this could be a sign of dehydration. Follow your doctor’s instructions for what to do to help prevent or treat dehydration.•Shortness of breath: Tell your doctor if this is a problem for you.•Nausea, Vomiting, Diarrhea and Constipation Patients may experience nausea, vomiting, abdominal pain, diarrhea, and/or constipation. Medicines can be given that may help reduce these symptoms. If you experience any of these symptoms, tell your doctor.•Other side effects may include:◦Dizziness, lightheadedness, and fainting spells◦Fatigue, weakness, and lethargy◦Rash, itching or swelling◦Loss of appetite and weight loss◦Joint and muscle painThese are not all of the potential side effects of FOLOTYN. If you have any side effect that bothers you or that doesn’t go away, be sure to talk with your healthcare professional.Tell your doctor about you medical conditions,including liver and kidney problems.Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Some medicines may affect how FOLOTYN works, and FOLOTYN may affect how other medicines work. Especially tell your doctor if you take: sulfamethoxazole trimethoprim (Bactrim®, Septra®, Septra DS, Sulfatrim Pediatric, Sulfamethoprim, Sulfamethoprim-DS), non-steroidal anti-inflammatory drugs (NSAIDs), probenecid (Probalan, Col-Probenecid). Ask your doctor or pharmacist if you are not sure if your medicine is listed above. Know the medicines you take. Keep a list of them and show it to your doctor or pharmacist each time you start a new medicine.Please see patient information within the full Prescribing Information for FOLOTYN.