Pediatric ITP
Response rate vs. IVIG in children with ACUTE ITP
• In a pivotal trial (N=146), there was no significant difference in response rates† between WinRho® [Rho(D) Immune Globulin Intravenous (Human)] (84.2%), low-dose IVIG (90.0%) or high-dose IVIG (93.1%)1,2†
† Non-splenectomized patients aged ≥ 6 months to ≤ 18 years; 64 percent presented with ITP after a viral infection. Study performed using WinRho. Patients received WinRho 25 µg/kg on days 1 and 2; IVIG 1.0 g/kg on days 1 and 2; or IVIG 0.8 g/kg on day 1. Response defined as an increase in absolute platelet count to ≥50,000/mm3.Response rate in children with CHRONIC ITP
Duration of response in children with CHRONIC ITP
• In a clinical study the mean duration of response§ was 36.5 days2.
§Duration of response defined as days from administration of last infusion to the occurrence of first platelet count <150,000/mm3 over baseline levels or to end of observation period.
Study performed using WinRho.
WinRho SDF Liquid is Bioequivalent to WinRho SDF Lyophilized1
In two comparative pharmacokinetic studies (n=101), the formulations were bioequivalent following IV administration based on the area under the curve to 84 days and had comparable pharmacokinetics following IM administration. Both formulations also had similar elimination half-lives. WinRho SDF must be administered via the intravenous route for the treatment of ITP.
WARNING: INTRAVASCULAR HEMOLYSIS (IVH)
Intravascular hemolysis (IVH) leading to death has been reported in patients treated with WinRho® SDF for immune thrombocytopenic purpura (ITP).
IVH can lead to clinically compromising anemia and multi-system organ failure including acute respiratory distress syndrome (ARDS).
Serious complications including severe anemia, acute renal insufficiency, renal failure and disseminated intravascular coagulation (DIC) have also been reported.
Closely monitor patients treated with WinRho® SDF for ITP in a healthcare setting for at least eight hours after administration. A dipstick urinalysis to monitor for hematuria and hemoglobinuria is to be performed at baseline and then after administration at 2 hours, 4 hours and prior to the end of the monitoring period. Alert patients and monitor the signs and symptoms of IVH including back pain, shaking chills, fever, and discolored urine or hemoglobinuria. Absence of these signs and/or symptoms of IVH within eight hours do not indicate IVH cannot occur subsequently. If signs and/or symptoms of IVH are present or suspected after WinRho® SDF administration, post-treatment laboratory tests should be performed including plasma hemoglobin, haptoglobin, LDH, and plasma bilirubin (direct and indirect).
For use in the treatment of ITP, do not use WinRho in:
• Patients who have had known anaphylactic or severe systemic reaction to the administration of human immune globulin products.
• IgA deficient patients with antibodies to IgA and a history of hypersensitivity.
• Patients with autoimmune hemolytic anemia, with pre‑existing hemolysis or at high risk for hemolysis.
The liquid formulation of WinRho® SDF contains maltose. Maltose in IGIV products has been shown to give falsely high blood glucose levels in certain types of blood glucose testing systems. Due to the potential for falsely elevated glucose readings, only testing systems that are glucose-specific should be used to test or monitor blood glucose levels in patients receiving WinRho® SDF Liquid.
WinRho® SDF is made from human plasma. It may carry a risk of transmitting infectious agents, e.g. viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
The safety and efficacy of WinRho® have not been evaluated in clinical trials for patients with non-ITP causes of thrombocytopenia or in previously splenectomized patients or in patients who are Rho(D)-negative.
Acute renal dysfunction/failure, osmotic nephropathy, and death may occur upon use of Immune Globulin Intravenous (IGIV) products, including WinRho® SDF.2 Ensure that patients are not volume depleted before administering WinRho® SDF. For patients at risk of renal dysfunction or failure, including those with any degree of pre‑existing renal insufficiency, diabetes mellitus, advanced age (above 65 years of age), volume depletion, sepsis, paraproteinemia, or receiving known nephrotoxic drugs, administer WinRho® SDF at the minimum infusion rate practicable.
In Rho(D)-positive patients with ITP, side effects related to the destruction of Rho(D)-positive red blood cells, most notably decrease hemoglobin, can be expected. In most cases, the red blood cell destruction is believed to occur in the spleen.
Thrombotic events may occur following treatment with WinRho® SDF and other IGIV products.
Noncardiogenic pulmonary edema [Transfusion-related Acute Lung Injury (TRALI)] may occur in patients following IGIV treatment.
General adverse reactions associated with the use of WinRho® SDF include body weakness, abdominal or back pain, low blood pressure, paleness, diarrhea, abnormal blood work, joint pain, muscle pain, dizziness, abnormal movement, sleepiness, itchiness, rash, and sweating. In the treatment of ITP, the most common adverse events (≤ 2% of infusions) were headache, chills, and fever.
Please see full Important Risk Information for more detailed risk information and Boxed Warning
Please see WinRho SDF Prescribing Information for full prescribing details
References: 1. WinRho SDF Prescribing Information, December 2010. 2. Data on file, Cangene Corporation.