personalised presents [0.1%:< 2%), and fever (nine infusions; 1%). Table 4 Adverse Drug Reactions with an Incidence 5% of Patients Body System Adverse Event All Studies Children Adults # of Patients (%) Body as a Whole Headache 18 (11) 8 (11) 10 (12) Chills 13 (8) 4 (5) 9 (10) Fever 9 (6) 5 (7) 4 (5) Asthenia 6 (4) 2 (3) 4 (5) Infection 4 (3) 4 (5) 0 (0) Nervous System Dizziness 6 (4) 2 (3) 4 (5) In four clinical trials of patients treated with the recommended initial intravenous dose of 250 international unit/kg (50 mcg/kg), the mean maximum decrease in hemoglobin was 1.70 g/dL (range: +0.40 to 6.1g/dL). At a reduced dose, ranging from 125 to 200 international unit/kg (25 to 40 mcg/kg), the mean maximum decrease in hemoglobin was 0.81 g/dL (range: +0.65 to 1.9 g/dL). Only 5/137 (3.7%) of patients had a maximum decrease in hemoglobin of greater than 4 g/dL (range: 4.2 to 6.1 g/dL). Suppression of Rh Isoimmunization In the clinical trial of 1,186 Rh o (D)-negative pregnant women, no adverse reactions were reported to Rh o (D) IGIV. Post-marketing Experience Because post-marketing adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to product exposure. The following adverse reactions have been identified during the post-approval use of WinRho SDF. Treatment of ITP These adverse reactions are classified by system organ class. Intravascular hemolysis (IVH) leading to death has been reported in patients treated with WinRho SDF for immune thrombocytopenic purpura (ITP). Serious complications including severe anemia, acute renal insufficiency, renal failure and disseminated intravascular coagulation (DIC) have also been reported. Infusion Reactions: Anaphylactic reaction, Hypersensitivity Hematologic: Intravascular hemolysis, Disseminated Intravascular Coagulation, Hemoglobinemia Cardiac: Cardiac arrest, Cardiac failure, Myocardial infarction, Tachycardia Gastrointestinal: Nausea General: Chest pain, Fatigue, Edema Hepatologic: Jaundice Musculoskeletal: Myalgia, Muscle spasm, Pain in extremities Renal: Renal failure, Renal impairment, Anuria, Chromaturia, Hemoglobinuria, Hematuria Respiratory: Acute respiratory distress syndrome, Transfusion related acute lung injury Integumentary: Hyperhidrosis Suppression of Rh Isoimmunization Infusion Reactions: Hypersensitivity, anaphylactic reaction, induration, pruritus or swelling at injection site Integumentary: Pruritus, Rash Healthcare professionals should report serious adverse reactions following the administration of WinRho SDF to Aptevo BioTherapeutics at 1-844-859-6675 or FDA s MedWatch reporting system by phone (1-800-FDA-1088). Drug Interactions Live Virus Vaccines Administration of WinRho SDF concomitantly with other drugs has not been evaluated. Passive transfer of antibodies may transiently impair the immune response to live attenuated virus vaccines such as measles, mumps, rubella, and varicella ( see Patient Counseling Information [17.1] ). Do not give immunization with live vaccines within 3 months after WinRho SDF administration. USE IN SPECIFIC POPULATIONS Pregnancy Pregnancy category C. Animal reproduction studies have not been conducted with WinRho SDF. It is also not known whether WinRho SDF can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. WinRho SDF should be given to a pregnant woman only if clearly needed. Treatment of ITP WinRho SDF has not been evaluated in pregnant women with ITP. Suppression of Rh Isoimmunization The available evidence suggests that WinRho SDF does not harm the fetus or affect future pregnancies or reproduction capacity when given to pregnant Rh o (D)-negative women for suppression of Rh isoimmunization. 12 Nursing Mothers Treatment of ITP WinRho SDF has not been evaluated in nursing mothers with ITP. Suppression of Rh Isoimmunization It is not known whether WinRho SDF is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when WinRho SDF is administered to nursing women. Pediatric Use The safety and effectiveness of WinRho has been evaluated for the treatment of chronic or acute ITP in children and in children (] FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only C Pregnancy Category Risk cannot be ruled out N/A CSA Schedule Not a controlled drug Drug Class Immune globulins Related Drugs immune globulins Gammagard , RhoGAM , Hizentra , Synagis , Gamunex , Privigen Idiopathic Thrombocytopenic Purpura prednisone , triamcinolone , dexamethasone , Decadron , Deltasone , cortisone , Promacta , Kenalog-40 , Gammagard , RhoGAM , Gamunex , More... Rh-Isoimmunization RhoGAM , MICRhoGAM , Rhophylac , WinRho SDF , More... Rho (d) immune globulin Rating 3 User Reviews 5.2 /10 3 User Reviews 5.2 Rate it! the reality
big WinRho a lot of people
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