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WINRHO
Overview
What is WINRHO?
WinRho
SDF is a sterile, liquid gamma globulin (IgG) fraction containing antibodies to the Rh
(D) antigen (D antigen). WinRho
SDF is to be administered intravenously for the treatment of ITP and either intravenously or intramuscularly for the suppression of Rh isoimmunization.
WinRho
SDF is prepared from human plasma by an anion-exchange column chromatography method. The manufacturing process includes two steps implemented specifically for viral clearance. The solvent detergent treatment step (using tri-n-butyl phosphate and Triton
X-100) is effective in inactivating lipid enveloped viruses such as hepatitis B, hepatitis C, and HIV. Virus filtration, using a Planova™ 20N virus filter is effective in the removal of some non-lipid enveloped viruses. These two processes are designed to increase product safety by reducing the risk of transmission of enveloped and non-enveloped viruses, respectively. In addition to the two specific steps, the anion-exchange chromatography step contributes to the removal of small non-lipid enveloped viruses.
The inactivation and reduction of known enveloped and non-enveloped model viruses were validated in laboratory studies as summarized in
.
* The PRV was retained by the 0.1 µm pre-filter during the virus validation. Since manufacturing employs a 0.1 µm pre-filter before the 20N filter, the claim of ≥5.6 reduction is considered applicable.
Abbreviations:
HIV-1: human immunodeficiency virus-1; relevant virus for human immunodeficiency virus-1 and model for HIV-2.
BVDV: bovine viral diarrhea virus; model virus for hepatitis C virus (HCV) and West Nile virus (WNV)
PRV: pseudorabies virus; model for large enveloped DNA viruses, including herpes
HAV: human hepatitis A virus; relevant virus for HAV and model for small non-enveloped viruses in general
EMC: encephalomyocarditis virus; model for HAV and for small non-enveloped viruses in general
MMV: murine minute virus; model for human parvovirus B19 and for small non-enveloped viruses in general
PPV: porcine parvovirus; model for human parvovirus B19 and for small non-enveloped viruses in general
n.e.: not evaluated
The product potency is expressed in international units by comparison to the World Health Organization (WHO) standard. In the past, a full dose of Rh
(D) Immune Globulin (Human) has traditionally been referred to as a “300 microgram” dose. Potency and dosing recommendations are now expressed in international units by comparison to the WHO anti-Rh
(D) standard. The conversion of “microgram” to “international units” is: 1 microgram = 5 international units. A 1,500 international unit (300 microgram [mcg]) vial contains sufficient anti-Rh
(D) to effectively suppress the immunizing potential of approximately 17 mL of Rh
(D) (D-positive) RBCs.
The liquid formulation is stabilized with 10% maltose and 0.03% polysorbate 80. There are no preservatives in the formulation. WinRho
SDF does not contain mercury. This product contains approximately 5 micrograms/mL IgA.
What does WINRHO look like?
What are the available doses of WINRHO?
WinRho
SDF is a ready to use solution in single dose vials of 600 international unit (120 mcg), 1,500 international unit (300 mcg), 2,500 international unit (500 mcg), 5,000 international unit (1000 mcg) and 15,000 international unit (3,000 mcg).
What should I talk to my health care provider before I take WINRHO?
ITP
How should I use WINRHO?
WinRho
SDF is an Rh
(D) Immune Globulin Intravenous (Human) (anti-D) product that is indicated for the treatment of ITP in Rh
(D)-positive patients and for the suppression of Rh isoimmunization in non-sensitized Rh
(D)-negative patients.
Note:
®
What interacts with WINRHO?
Sorry No Records found
What are the warnings of WINRHO?
Sorry No Records found
What are the precautions of WINRHO?
Sorry No Records found
What are the side effects of WINRHO?
Sorry No records found
What should I look out for while using WINRHO?
WinRho
SDF is contraindicated in:
This warning does not apply to Rh
(D)-negative patients treated for the suppression of Rh isoimmunization.
What might happen if I take too much WINRHO?
Treatment of ITP and Suppression of Rh Isoimmunization
In post-marketing spontaneous reporting, there has been a limited number of medication error reports related to dosage calculations in which higher doses than that recommended for WinRho
SDF were administered (doses > 60 mcg/kg). Signs and laboratory findings of overdosage in Rh positive (ITP) patients have included hemoglobin decreases in excess of 1.2 g/dL. For the suppression of Rh isoimmunization, hemolytic reactions have been reported in cases of mis-matched blood transfusions where very large doses of WinRho SDF were administered.
In one ITP case report that involved an overdose due to confusion between mcg and international unit, a patient with significant co-morbidities developed IVH and had a fatal outcome. In the event of overdose, monitor patients closely for signs and symptoms of hemolysis and initiate symptomatic and supportive treatment.
How should I store and handle WINRHO?
StorageStore at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature].Store diluted infusion solution under refrigeration at 2° to 8°C (36° to 46°F) for no longer than 24 hours. Do not freeze.StorageStore at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature].Store diluted infusion solution under refrigeration at 2° to 8°C (36° to 46°F) for no longer than 24 hours. Do not freeze.StorageStore at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature].Store diluted infusion solution under refrigeration at 2° to 8°C (36° to 46°F) for no longer than 24 hours. Do not freeze.WinRho SDF is available in packages containing: LiquidNDC Number Product Description53270-3120-1 53270-3300-1 53270-3500-153270-3100-1 53270-3000-1 WinRho SDF is available in packages containing: LiquidNDC Number Product Description53270-3120-1 53270-3300-1 53270-3500-153270-3100-1 53270-3000-1 WinRho SDF is available in packages containing: LiquidNDC Number Product Description53270-3120-1 53270-3300-1 53270-3500-153270-3100-1 53270-3000-1 WinRho SDF is available in packages containing: LiquidNDC Number Product Description53270-3120-1 53270-3300-1 53270-3500-153270-3100-1 53270-3000-1 WinRho SDF is available in packages containing: LiquidNDC Number Product Description53270-3120-1 53270-3300-1 53270-3500-153270-3100-1 53270-3000-1 WinRho SDF is available in packages containing: LiquidNDC Number Product Description53270-3120-1 53270-3300-1 53270-3500-153270-3100-1 53270-3000-1 WinRho SDF is available in packages containing: LiquidNDC Number Product Description53270-3120-1 53270-3300-1 53270-3500-153270-3100-1 53270-3000-1 WinRho SDF is available in packages containing: LiquidNDC Number Product Description53270-3120-1 53270-3300-1 53270-3500-153270-3100-1 53270-3000-1
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Treatment of ITP
WinRho
SDF has been shown to increase platelet counts in non-splenectomized, Rh
(D)-positive patients with ITP. Platelet counts usually rise within one to two days and peak within seven to 14 days after initiation of therapy. The mechanism of action is not completely understood, but is thought to be due to the formation of anti-Rh
(D)-coated RBC complexes, which are preferentially removed by the reticuloendothelial system, particularly the spleen. This results in Fc receptor blockade, thus sparing antibody-coated platelets.
Suppression of Rh Isoimmunization
The mechanism by which Rh
(D) immune globulin suppresses immunization to Rh
(D)-positive RBCs is not completely understood.
WinRho
SDF when administered within 72 hours of a full-term delivery of a Rh
(D)-positive infant by a Rh
(D) negative mother will reduce the incidence of Rh isoimmunization from 12-13% to 1-2%. The 1-2% is, for the most part, due to isoimmunization during the last trimester of pregnancy. When treatment is given both antenatally, at 28 weeks gestation, and postpartum, the Rh immunization rate drops to about 0.1%.
When 600 international unit (120 mcg) of WinRho
SDF is administered to pregnant women, passive anti-Rh
(D) antibodies are not detectable in the circulation for more than six weeks and therefore a dose of 1,500 international unit (300 mcg) should be used for antenatal administration.
Non-Clinical Toxicology
WinRho SDF is contraindicated in:This warning does not apply to Rh (D)-negative patients treated for the suppression of Rh isoimmunization.
The administration of local anesthetic solutions containing epinephrine or norepinephrine to patients receiving monoamine oxidase inhibitors, tricyclic antidepressants or phenothiazines may produce severe prolonged hypotension or hypertension.
Concurrent use of these agents should generally be avoided. In situations when concurrent therapy is necessary, careful patient monitoring is essential.
Concurrent administration of vasopressor drugs and ergot-type oxytocic drugs may cause severe, persistent hypertension or cerebrovascular accidents.
As the Lidocaine and Epinephrine Injections contain a vasoconstrictor (epinephrine), concurrent use of either with a Beta-adrenergic blocking agent (propranolol, timolol, etc.) may result in dose-dependent hypertension and bradycardia with possible heart block.
5.1.1 Hypersensitivity
Severe hypersensitivity reactions may occur [see ] If symptoms of allergic or early signs of hypersensitivity reactions (including generalized urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis) occur, discontinue WinRho SDF infusion immediately and institute appropriate treatment. Have medications such as epinephrine available for immediate treatment of acute hypersensitivity reactions.
WinRho SDF contains approximately 5 micrograms/mL IgA [see ]. Patients with known antibodies to IgA have a greater risk of developing potentially severe hypersensitivity and anaphylactic reactions. WinRho SDF is contraindicated in patients with antibodies against IgA and a history of hypersensitivity reaction [see ].
5.1.2 Transmissible Infectious Agents
Because 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 risk of transmitting an infectious agent has been reduced by screening plasma donors for prior exposure to certain pathogens, testing for the presence of certain current viral infections, and including virus inactivation/removal steps in the manufacturing process [see ]
Report all infections thought to have been transmitted by WinRho SDF to Cangene Corporation at 1-800-768-2304. The physician should discuss the risks and benefits of this product with the patient.
5.1.3 Interference with Blood Glucose Testing: False High Blood Glucose Levels
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 [for example, by systems based on glucose dehydrogenase pyrroloquinolinequinone (GDH-PQQ) or glucose-dye-oxidoreductase methods]. Due to the potential for falsely elevated glucose readings, only use testing systems that are glucose-specific to test or monitor blood glucose levels in patients receiving maltose-containing parenteral products, including WinRho SDF Liquid.
Carefully review the product information of the blood glucose testing system, including that of the test strips, to determine if the system is appropriate for use with maltose-containing parenteral products. If any uncertainty exists, contact the manufacturer of the testing system to determine if the system is appropriate for use with maltose-containing parenteral products.
5.1.4 Renal Dysfunction/Failure
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.
Assess renal function, including measurement of blood urea nitrogen (BUN) and serum creatinine, before the initial infusion of WinRho SDF.
5.1.5 Thromboembolic Events
Thromboembolic events may occur during or following treatment with WinRho SDF and other IGIV products. Patients at risk include those with a history of atherosclerosis, multiple cardiovascular risk factors, advanced age, impaired cardiac output, coagulation disorders, prolonged periods of immobilization, and/or known/suspected hyperviscosity.
Consider baseline assessment of blood viscosity in patients at risk for hyperviscosity including those with cryoglobulins, fasting chylomicronemia/markedly high triacylglycerols (triglycerides), or monoclonal gammopathies. For patients who are at risk of developing thromboembolic events, administer WinRho SDF at the minimum rate of infusion practicable.
5.1.6 Interference with Serological Testing
After administration of WinRho SDF, a transitory increase of various passively transferred antibodies in the patient’s blood may yield positive serological testing results, with the potential for misleading interpretation. Passive transmission of antibodies to erythrocyte antigens (e.g., A, B, C and E) and other blood group antibodies [for example, anti Duffy, anti Kidd (anti JKa) antibodies] may cause a positive direct or indirect (Coombs’) test.
A large fetomaternal hemorrhage late in pregnancy or following delivery may cause a weak mixed field positive D test result. Assess such an individual for a large fetomaternal hemorrhage and adjust the dose of WinRho SDF accordingly. The presence of passively administered anti Rh (D) in maternal or fetal blood can lead to a positive direct Coombs’ test. If there is an uncertainty about the father’s Rh group or immune status, administer WinRho SDF to the mother.
5.1.7 Transfusion-Related Acute Lung Injury (TRALI)
Non-cardiogenic pulmonary edema may occur in patients following IGIV treatment, including WinRho SDF. TRALI is characterized by severe respiratory distress, pulmonary edema, hypoxemia, normal left ventricular function, and fever. Symptoms typically appear within 1 to 6 hours following administration of blood products.
Monitor patients for pulmonary adverse reaction. If TRALI is suspected, perform appropriate tests for the presence of anti-neutrophil antibodies and anti-HLA antibodies in both the product and patient serum. TRALI may be managed using oxygen therapy with adequate ventilatory support.
5.1.8 Monitoring Laboratory Tests
Serious adverse reactions, some of these cases resulted in fatal outcome, have been observed in patients receiving WinRho SDF for the treatment of ITP. These include: intravascular hemolysis (IVH), clinically compromising anemia, acute renal insufficiency and DIC [see ].
The most common adverse reactions observed for indications are: headache, chills, fever, asthenia, pallor, diarrhea, nausea, vomiting, arthralgia, myalgia, dizziness, hyperkinesia, abdominal or back pain, hypotension, hypertension, increased LDH, somnolence, vasodilation, pruritus, rash and sweating. All adverse reactions listed occurred in ≤ 2% of WinRho doses administered in clinical trials.
Adverse reactions observed in the use of WinRho SDF for Suppression of Rh Isoimmunization are <0.1% in Rh (D)-negative individuals.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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