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References
1. WinRho SDF Prescribing Information, Kamada Therapeutics, June 2018.
2. Papagianni A, Economou M, Tragiannidis A, et al. Standard-dose intravenous anti-D immunoglobulin in the treatment of newly diagnosed childhood primary immune thrombocytopenia. J Pediatr Hematol Oncol. 2011;33:265-269.
3. Gaines AR. Acute onset hemoglobinemia and/ or hemoglobinuria and sequelae following Rho(D) immune globulin intravenous administration in immune thrombocytopenic purpura patients. Blood. 2000;95:2523-2529.
4. Gaines AR. Disseminated intravascular coagulation associated with acute hemoglobinemia or hemoglobinuria following Rho(D) immune globulin intravenous administration for immune thrombocytopenic purpura. Blood. 2005;106:1532-1537.
5. Data on file. Kamada Therapeutics.
6. Despotovic JM, Lambert MP, Herman JH, et al. RhIG for the treatment of immune thrombocytopenia: consensus and controversy. Transfusion. 2011;1537-2995.
WinRho® SDF-helping physicians achieve their treatment goals for pediatric and adult patients with Immune Thrombocytopenic Purpura (ITP) patients for over 20 years.
Please scroll down to view complete Important Safety Information including BOX WARNING.
Important Safety Information
WARNING: INTRAVASCULAR HEMOLYSIS (IVH)
Intravascular hemolysis leading to death has been reported in patients treated for ITP with WinRho® SDF.
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. Perform a dipstick urinalysis to monitor for hematuria and hemoglobinuria at baseline and 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 hematuria. Absence of these signs and/or symptoms of IVH within eight hours does 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).
INDICATION
WinRho® SDF is a Rho(D) Immune Globulin Intravenous (Human) product indicated for use in clinical situations requiring an increase in platelet count to prevent excessive hemorrhage in the treatment of non-splenectomized, Rho(D)-positive:
- Children with chronic or acute immune thrombocytopenia (ITP)
- Adults with chronic ITP
- Children and adults with ITP secondary to HIV infection
The safety and efficacy of WinRho® SDF 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.
Important Safety Information
For use in the treatment of ITP, do not use WinRho SDF 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® SDF 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. 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 decreased 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 Prescribing Information for complete prescribing details.
WinRho® SDF [RHo(D) Immune Globulin (Human)] and all Kamada brand, product, service and feature names, logos, and slogans are trademarks or registered trademarks of Kamada in the United States and/or other countries. Copyright 2018 Kamada Pharmaceuticals.All rights reserved.