Blood Conservation Out-Patient Order Set Epoetin Alfa (Procrit … Two PROCRIT® dosing regimens may be used in adults; 150 Units/kg SC TIW or 40,000 Units SC Weekly. 18-20 There was no accumulation of serum erythropoietin after the 2 dosing regimens during the study period. Patients may also undergo physical examinations, scans or other measures to assess side effects and response to therapy. Erythropoietin for zidovudine-associated anemia in children with HIV infection. However, due to insufficient monitoring and data collection, reliable comparisons cannot be made concerning the effect of Epoetin alfa on overall time to disease progression, progression-free survival, and Are there any special precautions patients should be aware of before starting treatment? Correction of the Anemia of End-Stage Renal Disease with Recombinant Human Erythropoietin. A theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD) also is considered extremely remote. The basis for this apparent pre-existing hypersensitivity to components of the PROCRIT® formulation is unknown, but may be related to HIV-induced immunosuppression or prior exposure to blood products. each PROCRIT® vial is designed to be used only once. PROCRIT® is indicated for the treatment of anemia related to therapy with zidovudine in HIV-infected patients. Epoetin injection is a man-made version of human erythropoietin (EPO).
Blood pressure may rise in the perioperative period in patients being treated with PROCRIT®. Among 1051 patients enrolled in the 5 clinical trials of PROCRIT® for reduction of allogeneic blood transfusions in patients undergoing elective surgery 745 received PROCRIT® and 306 received placebo.
Procrit medication guide – Food and Drug Administration Multidose, Preserved Vial: Muller-Wiefel DE, Scigalla P. Specific problems of renal anemia in childhood. PROCRIT Indication.
The dose should be adjusted for each patient to achieve and maintain a target hemoglobin not to exceed 12 g/dL.
Thrombotic Events: PROCRIT® is produced in mammalian cells that have been genetically altered by the addition of a gene of the natural substance erythropoietin. • Wear sunscreen and protective clothing and try to minimize sun exposure. However, in a double-blind, placebo-controlled trial, hypertensive adverse events were not reported at an increased rate in the group treated with PROCRIT® (150 Units/kg TIW) relative to the placebo group. Hypertensive encephalopathy and seizures have been observed in patients with CRF treated with PROCRIT®. Do not use PROCRIT® if the contents of the vial appear discolored or cloudy, or if the vial appears to contain lumps, flakes, or particles. ESA THERAPY* Refer to Procrit black box warning. Anemia of End-Stage Renal Disease (ESRD). Do not use any vials exhibiting particulate matter or discoloration. as they may interfere with treatment. • Noticeable changes in heart rate or rhythm Hematocrit is the proportion of red blood cells that are in blood.
Besarab A, Bolton WK, Browne JK, et al. Erythropoietin signals the bone marrow to make more oxygen-carrying red bloodcells. Unless you are using a Multidose vial, Physicians will continue to schedule blood draws throughout treatment with Procrit, as patient needs may change in response to chemotherapy or specific conditions. Iron deficiency: Virtually all patients will eventually require supplemental iron therapy (see IRON EVALUATION ). The air injected into the vial will allow PROCRIT® to be easily withdrawn into the syringe. In contrast to CRF patients, PROCRIT® therapy has not been linked to exacerbation of hypertension, seizures, and thrombotic events in HIV-infected patients.
• Patients should check with their physician before starting any new drug or nutritional supplement. the three times weekly (T.I.W.) Known hypersensitivity to mammalian cell-derived products. What is the mechanism of action? Overall mortality was significantly higher at 12 months in the Epoetin alfa arm (See WARNINGS ; Thrombotic Events and Increased Mortality ). Your doctor has instructed you on how to give yourself the correct dosage of PROCRIT®.
11. You may also be instructed to have certain laboratory tests, such as additional hematocrit or iron level measurements, done more frequently. During the dose adjustment phase of therapy, the hemoglobin should be monitored weekly.
Based on Kaplan-Meier estimates, the proportion of subjects surviving at 12 months after randomization was lower in the Epoetin alfa group than in the placebo group (70% vs 76%), p = 0.012, log rank. Response to PROCRIT® was consistent across all studies. The PROCRIT liquid in the vial is clear and colorless. Increases in dose should not be made more frequently than once a month. Laupacis A. Single-dose, Preservative-free Vial: Geva P, Sherwood JB. Granulocyte-colony stimulating factor and erythropoietin therapy in children with human immunodeficiency virus infection. • Swelling of the hands or feet This product's label may have been revised after this insert was used in production. 3. It is important to use some kind of birth control while undergoing treatment. The incidence of adverse events was similar in both treatment and placebo arms. If after 4 weeks of treatment, the patient's hemoglobin level did not increase by >= 1 g/dL, the Epoetin alfa dose was increased to 80,000 Units every 2 weeks. PROCRIT® is indicated for the treatment of anemia associated with CRF, including patients on dialysis (ESRD) and patients not on dialysis.
Erythropoietin Therapy for the Anemia Associated with AIDS and AIDS Therapy and Cancer. Includes Procrit side effects, interactions and indications. Procrit – MDwise.org With one hand, stabilize the previously cleansed skin by spreading it or by pinching up a large area with your free hand.
For pediatric patients, see PRECAUTIONS : PEDIATRIC USE . Erythropoietin and the Control of Red Cell Production. 6 If the hemoglobin exceeds 13 g/dL, the dose should be discontinued until the hemoglobin drops to 12 g/dL.
PROCRIT® (PRO′−KRIT). The reason for these symptoms is that there is a lack of red blood cells. Messing RO, Simon RP.
Prior to and during PROCRIT® therapy, the patient's iron status, including transferrin saturation (serum iron divided by iron binding capacity) and serum ferritin, should be evaluated. Peripheral white blood cell and platelet counts are unchanged following PROCRIT® therapy. Each 1 mL of solution contains 40,000 Units of Epoetin alfa, 2.5 mg Albumin (Human), 1.2 mg sodium phosphate monobasic monohydrate, 1.8 mg sodium phosphate dibasic anhydrate, 0.7 mg sodium citrate, 5.8 mg sodium chloride, and 6.8 mcg citric acid in Water for Injection, USP (pH 6.9 ± 0.3). By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. This dosage will usually be measured in Units per milliliter or cc's. (2- to 3-fold), higher AUC The benzyl alcohol in the bacteriostatic saline acts as a local anesthetic which may ameliorate SC injection site discomfort. Mar 18, 2013 … Procrit Marketed and Distributed by: Janssen Products, LP … dispense in a private practice setting includes dispensing for administration in a. PROCRIT® (epoetin alfa) for Injection HIGHLIGHTS OF … 1/2 Among patients who received 36 weeks of PROCRIT®, hemodialysis patients required a higher median maintenance dose (167 Units/kg/week [n = 28] vs 76 Units/kg/week [n = 36]) and took longer to achieve a hematocrit of 30% to 36% (median time to response 69 days vs 32 days) than patients undergoing peritoneal dialysis. Published literature
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