Quốc gia: Hoa Kỳ
Ngôn ngữ: Tiếng Anh
Nguồn: NLM (National Library of Medicine)
ERYTHROPOIETIN (UNII: 64FS3BFH5W) (ERYTHROPOIETIN - UNII:64FS3BFH5W)
Janssen Products, LP
Erythropoietin
Erythropoietin 2000 [iU] in 1 mL
INTRAVENOUS
PRESCRIPTION DRUG
PROCRIT is indicated for the treatment of anemia due to chronic kidney disease (CKD), including patients on dialysis and not on dialysis to decrease the need for red blood cell (RBC) transfusion. PROCRIT is indicated for the treatment of anemia due to zidovudine administered at ≤ 4200 mg/week in patients with HIV-infection with endogenous serum erythropoietin levels of ≤ 500 mUnits/mL. PROCRIT is indicated for the treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy. PROCRIT is indicated to reduce the need for allogeneic RBC transfusions among patients with perioperative hemoglobin > 10 to ≤ 13 g/dL who are at high risk for perioperative blood loss from elective, noncardiac, nonvascular surgery. PROCRIT is not indicated for patients who are willing to donate autologous blood pre-operatively. PROCRIT has not been shown to improve quali
PROCRIT (epoetin alfa) injection is a sterile, clear, and colorless solution available as: Preservative-free, single-dose vials (in citrate-buffered formulation) : 2,000 Units/mL (NDC 59676-302-01), 3,000 Units/mL (NDC 59676-303-01), 4,000 Units/mL (NDC 59676-304-01), or 10,000 Units/mL (NDC 59676-310-01) supplied in cartons, each carton containing six 1 mL single-dose vials. Preservative-free, single-dose vials (in citrate-buffered formulation) : 10,000 Units/mL (NDC 59676-310-02) supplied in dispensing packs (tray) containing 25 single-dose 1 mL vials. Preservative-free, single-dose vials (in phosphate-buffered formulation) : 40,000 Units/mL (NDC 59676-340-01) supplied in dispensing packs containing four 1 mL single-dose vials. Preserved, multiple-dose vials : 20,000 Units/2mL (10,000 Units/mL) (NDC 59676-312-04) supplied in dispensing packs containing four 2 mL multiple-dose vials. Preserved, multiple-dose vials : 20,000 Units/mL (NDC 59676-320-04) supplied in dispensing packs containing four 1 mL multiple-dose vials. Store at 36°F to 46°F (2°C to 8°C). Do not freeze. Do not shake. Do not use PROCRIT that has been shaken or frozen. Store PROCRIT vials in the original carton until use to protect from light.
Biologic Licensing Application
Janssen Products, LP ---------- This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised 9/2017 MEDICATION GUIDE PROCRIT ®(PRO'–KRIT) (epoetin alfa) Read this Medication Guide: • before you start PROCRIT. • if you are told by your healthcare provider that there is new information about PROCRIT. • if you are told by your healthcare provider that you may inject PROCRIT at home, read this Medication Guide each time you receive a new supply of medicine. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or your treatment. Talk with your healthcare provider regularly about the use of PROCRIT and ask if there is new information about PROCRIT. What is the most important information I should know about PROCRIT? PROCRIT may cause serious side effects that can lead to death, including: For people with cancer: • Your tumor may grow faster and you may die sooner if you choose to take PROCRIT. Your healthcare provider will talk with you about these risks. For all people who take PROCRIT, including people with cancer or chronic kidney disease: • Serious heart problems, such as heart attack or heart failure, and stroke.You may die sooner if you are treated with PROCRIT to increase red blood cells (RBCs) to near the same level found in healthy people. • Blood clots.Blood clots may happen at any time while taking PROCRIT. If you are receiving PROCRIT for any reason and you are going to have surgery, talk to your healthcare provider about whether or not you need to take a blood thinner to lessen the chance of blood clots during or following surgery. Blood clots can form in blood vessels (veins), especially in your leg (deep venous thrombosis or DVT). Pieces of a blood clot may travel to the lungs and block the blood circulation in the lungs (pulmonary embolus). • Call your healthcare provider or get medical help right away if you have any of these symptoms: • Chest pain • Trouble breathing or shortness of breath • Đọc toàn bộ tài liệu
PROCRIT- ERYTHROPOIETIN INJECTION, SOLUTION JANSSEN PRODUCTS, LP ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE PROCRIT SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR PROCRIT. PROCRIT (EPOETIN ALFA) INJECTION, FOR INTRAVENOUS OR SUBCUTANEOUS USE INITIAL U.S. APPROVAL: 1989 WARNING: ESAS INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ _CHRONIC KIDNEY DISEASE:_ IN CONTROLLED TRIALS, PATIENTS EXPERIENCED GREATER RISKS FOR DEATH, SERIOUS ADVERSE CARDIOVASCULAR REACTIONS, AND STROKE WHEN ADMINISTERED ERYTHROPOIESIS-STIMULATING AGENTS (ESAS) TO TARGET A HEMOGLOBIN LEVEL OF GREATER THAN 11 G/DL ( 5.1). NO TRIAL HAS IDENTIFIED A HEMOGLOBIN TARGET LEVEL, ESA DOSE, OR DOSING STRATEGY THAT DOES NOT INCREASE THESE RISKS ( 2.2). USE THE LOWEST PROCRIT DOSE SUFFICIENT TO REDUCE THE NEED FOR RED BLOOD CELL (RBC) TRANSFUSIONS ( 5.1). _CANCER:_ ESAS SHORTENED OVERALL SURVIVAL AND/OR INCREASED THE RISK OF TUMOR PROGRESSION OR RECURRENCE IN CLINICAL STUDIES OF PATIENTS WITH BREAST, NON-SMALL CELL LUNG, HEAD AND NECK, LYMPHOID, AND CERVICAL CANCERS ( 5.2). USE THE LOWEST DOSE TO AVOID RBC TRANSFUSIONS ( 2.4). USE ESAS ONLY FOR ANEMIA FROM MYELOSUPPRESSIVE CHEMOTHERAPY ( 1.3). ESAS ARE NOT INDICATED FOR PATIENTS RECEIVING MYELOSUPPRESSIVE CHEMOTHERAPY WHEN THE ANTICIPATED OUTCOME IS CURE ( 1.5). DISCONTINUE FOLLOWING THE COMPLETION OF A CHEMOTHERAPY COURSE ( 2.4). _PERISURGERY:_ DUE TO INCREASED RISK OF DEEP VENOUS THROMBOSIS (DVT), DVT PROPHYLAXIS IS RECOMMENDED ( 5.1). RECENT MAJOR CHANGES Dosage and Administration, Patients with Chronic Kidney Disease ( 2.2) 9/2017 Warnings and Precautions, Increased Mortality and/or Increased Risk of Tumor Progression or Recurrence in Patients With Cancer ( 5.2) 7/2018 Warnings and Precautions, Severe Cutaneous Reactions ( 5.8) 9/2017 Warnings and Precaut Đọc toàn bộ tài liệu