ADVERSE REACTIONS
Treatment of ITP
In clinical trials of subjects (n=161) with childhood acute ITP, adults and children with chronic ITP, and adults and children with ITP secondary to HIV, 60/848 (7%) of infusions were associated with at least one adverse event that was considered to be related to the study medication. The most common adverse events were headache (19 infusions; 2%), chills (14 infusions; <2%), and fever (nine infusions; 1%). All are expected adverse events associated with infusions of immunoglobulins.
WinRho SDF®, Rho(D) Immune Globulin Intravenous (Human), is administered to Rho(D) positive patients with ITP. Therefore, side effects related to the destruction of Rho(D) positive red blood cells, most notably a decreased hemoglobin, can be expected. In four clinical trials of patients treated with the recommended initial intravenous dose of 50 µg/kg (250 IU/kg), the mean maximum decrease in hemoglobin was 1.70 g/dL (range: +0.40 to -6.1 g/dL). At a reduced dose, ranging from 25 to 40 µg/kg (125 to 200 IU/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).
In most cases, the RBC destruction is believed to occur in the spleen. However, signs and symptoms consistent with IVH, including back pain, shaking chills, and/or hemoglobinuria, have been reported, occurring within 4 hours of WinRho administration. IVH-related complications that have been reported include death (four cases reported between May 1996 and April 1999), acute onset or exacerbation of anemia, and acute onset or exacerbation of renal insufficiency. One patient died from complications secondary to IVH-induced exacerbation of anemia after administration of WinRho for treatment of ITP. Although the primary cause of death in the other three ITP patients treated with WinRho was related to underlying disease, the extent to which IVH-related clinical complications exacerbated their conditions and contributed to their deaths is unknown.
The mean maximum decrease in hemoglobin in patients who were not transfused with PRBCs was 3.7 g/dL (range: 0.0-7.6 g/dL). Transfusions for treatment-associated anemia were administered within hours to days of the onset of IVH and consisted of between 1-6 units of PRBCs. Acute renal insufficiency was noted within 2 to 48 hours of the onset of IVH. The mean maximum increase in serum creatinine was 3.5 mg/dL (range: 0.8-10.3 mg/dL) and occurred within 2-9 days. The renal insufficiency in all surviving patients resolved with medical management, including dialysis, within 4-23 days.
The etiology of IVH following WinRho administration is unknown. No known risk factors associated with this adverse event have yet been identified from among those examined, which included age, gender, pre-treatment renal function, pre-treatment hemoglobin, concomitantly administered PRBCs, or WinRho dose.
Suppression of Rh Isoimmunization
Adverse reactions to Rho(D) Immune Globulin Intravenous (Human) are infrequent in Rho(D) negative individuals. In the clinical trial24 of 1,186 Rho(D) negative pregnant women, no adverse events were attributed to Rho(D) IGIV. Discomfort and slight swelling at the site of injection and slight elevation in temperature have been reported in a small number of cases. A post-marketing survey conducted since the Canadian licensure of Rho(D) IGIV in 1980 for this indication included data obtained from 31,059 injections (25,068 for routine Rh prophylaxis and 5,991 following abortions, amniocentesis, chorionic villus sampling and antepartum hemorrhage). There were 9,905 Rho(D) negative women who delivered Rho(D) positive infants, almost all of whom had received antenatal as well as postnatal prophylaxis. Of the patients followed in this survey, there were 26 reported treatment failures that resulted in the development of Rho(D) antibodies. There were no adverse experiences related to Rho(D) IGIV reported in this survey.
General Adverse Reactions
In addition to the adverse reactions described above, the following have been reported infrequently in clinical trials and/or postmarketing experience, in patients treated for ITP or the suppression of Rh isoimmunization, and are thought to be temporally associated with WinRho SDF®, Rho(D) Immune Globulin Intravenous (Human), use: asthenia, abdominal or back pain, hypotension, pallor, diarrhea, increased LDH, arthralgia, myalgia, dizziness, hyperkinesia, somnolence, vasodilation, pruritus, rash, and sweating.
As is the case with all drugs of this nature, there is a remote chance of an idiosyncratic or anaphylactic reaction with WinRho SDF® in individuals with hypersensitivity to blood products.
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REPORTS OF SUSPECTED WINRHO SDF SIDE EFFECTS / ADVERSE REACTIONS
Below is a sample of reports where side effects / adverse reactions may be related to Winrho SDF. The information is not vetted and should not be considered as verified clinical evidence.
Possible Winrho SDF side effects / adverse reactions in 38 year old male
Reported by a individual with unspecified qualification from Canada on 2011-12-19
Patient: 38 year old male weighing 86.0 kg (189.2 pounds)
Reactions: Anti-Erythrocyte Antibody Positive, Haemolytic Anaemia
Suspect drug(s):
Winrho SDF
Other drugs received by patient: Piperacillin and Tazobactam; Cyclomen; Acetaminophen; Tranexamic Acid; Furosemide; Nadolol
Possible Winrho SDF side effects / adverse reactions in 4 year old female
Reported by a physician from United States on 2012-02-22
Patient: 4 year old female
Reactions: Haemoglobin Decreased, Anaemia
Suspect drug(s):
Winrho SDF
Possible Winrho SDF side effects / adverse reactions in 81 year old female
Reported by a physician from United States on 2012-04-12
Patient: 81 year old female
Reactions: Thrombosis, Abdominal Pain, Pneumonia Aspiration, Drug Ineffective, Mental Status Changes, Prothrombin Time Prolonged, Cerebral Haemorrhage, Cardio-Respiratory Arrest, Platelet Morphology Abnormal, Fibrin D Dimer Increased, Chest Pain, Embolic Stroke, International Normalised Ratio Increased, Cerebral Atrophy, Encephalopathy, Status Epilepticus, Cerebellar Haemorrhage, Blood Fibrinogen Increased, Brain Stem Syndrome, Intravascular Haemolysis, Infection
Adverse event resulted in: death, hospitalization
Suspect drug(s):
Winrho SDF
Other drugs received by patient: Iron; Methylprednisolone
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