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PageTopContent
Pathology and Laboratory Medicine
Product Catalogue
FloatingContent1
PageMiddleContent RH Immune Globulin
Transfusion Medicine
Class:
Rh D Immune Globulin (Human)
| Alternate Product Name:
- Rh (D) Immune Globulin (Human)
- Rhlg
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Company/Supplier:
Saol Therapeutics Research Ltd. (Emergent BioSolutions Canada)
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Routes
| Intravenous
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Other
| Direct IV
| IV Infusion
| Continuous
Infusion
| Subcutaneous
| Intramuscular
| Other
| Acceptable Routes
| Yes
| Yes
| No
| Yes*
| Yes**
| N/A
|
Description
| - WinRho® is an Rh Immunoglobulin (Rhlg). it is a sterile liquid gamma globulin (IgG) fraction prepared from pooled human plasma containing antibodies to the Rho (D) antigen found on Rh D antigen positive red cells.
- Viral reduction steps include filtration and solvent/detergent treatment
- One 1500 units (300 mcg) vial contains sufficient IgG antibody against the D antigen (anti-D) to effectively suppress the immunizing potential of approximately 15 mL of Rh positive packed red blood cells (or 30 mL of Rh positive whole blood)
- Latex free
| Availability
| - Available in sizes of: 600 units (120 mcg), 1500 units (300 mcg) and 500 units (1000 mcg) single use vials
- Supplied by Canadian Blood Services (CBS)
- Contact your local laboratory/transfusion laboratory service regarding in house stock availability at your site
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Indications
| - Prophylaxis of Rh Hemolytic Disease of the Newborn in Pregnancy
- All Rh negative expectant patients at 23-32 weeks gestation (preferred practice is 26-28 weeks), unless they have already formed anti-D, should receive routine antenatal prophylaxis with Rhlg
- Routine antenatal prophylaxis with Rhlg should be administered regardless of, and in addition to, any Rhlg administered for a potentially sensitizing event
- An Rh negative expectant patient who currently demonstrates a passive anti-D (due to prior Rhlg injections) may require another Rhlg dose, depending on the diagnosis and how much time has elapsed since the initial injection
- All Rh negative expectant patients should receive Rhlg within 72 hours of a potentially sensitizing event
List of sensitizing events for RhD negative expectant patients necessitating Rhlg administration: Delivery
| Spontaneous/Therapeutic abortion (medical or surgical)*
| Antepartum hemorrhage
| Ectopic pregnancy
| Chorionic Villus Sampling (CVS)
| Amniocentesis
| External Cephalic Version (ECV)
| Abdominal trauma
| Cordocentesis
| Intrauterine Fetal Death
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* For early loss or termination of pregnancy with confirmed dating by ultrasound, Rhlg administration may be omitted
- If continued or intermittent bleeding is present, additional doses of Rhlg at 3 week intervals may be indicated. Repeat dosing for additional procedures or risks is recommended if 3 or more weeks have elapsed since the last dose
- All Rh negative post-partum patients of Rh positive or variant D positive babies should ideally receive Rhlg within 72 hours of delivery. If more than 72 hours have elapsed, Rhlg should be administered as soon as possible, up to 28 days after delivery. Additional dosing will be recommended if the initial fetal-maternal hemorrhage screen is positive and quantitative testing shows greater than 30 mL of fetal whole-blood in maternal circulation.
- Incompatible Blood Transfusions
- Rh negative components should be transfused to all Rh negative females of childbearing potential (less than or equal to 50 years of age) whenever possible
- Rhlg should be considered whenever Rh negative females of child bearing potential are exposed to Rh positive donor red blood cells or platelets
- It is generally not necessary to administer Rhlg to females over 50 years of age or to males who receive Rh positive components. However, in certain circumstances (e.g., repeated future transfusions anticipated) it may be considered
- Treatment of Immune Thrombocytopenic Purpura (ITP)
- Rhlg may be considered as an alternative to intravenous immunoglobulin (IVIg) in a non-splenectomised Rh positive patient only
- Rhlg for treatment of ITP must be requested by a Hematologist and approved by the Transfusion Medicine Physician on-call
| Contraindications | - Prophylaxis of RhD Immunization
- Rhlg should NOT be administered to:
- Rh positive patients (including babies)
- Rh negative females of childbearing potential or expectant patients who are RhD sensitized, and confirmed by transfusion medicine laboratory testing to have an allogeneic anti-D
- Patients with a history of anaphylactic or other severe systemic reaction to immune globulin concentrates
- Patients hypersensitive to product or to any component of its formulation
- Treatment of ITP
- Rhlg should NOT be administered to:
- Rh negative patients
- Splenectomised patients
- Patients with a history of anaphylactic or other severe systemic reaction to immune globulin concentrates
- Patients hypersensitive to product or to any component of its formulation
| Warnings
| - WinRho® SDF liquid contains maltose, which can give falsely high blood glucose levels in certain types of blood glucose test systems
- Immunoglobulin administration may impair the efficacy of live attenuated virus vaccines (measles, mumps, rubella, and varicella). Vaccination with live virus vaccines should be deferred until approximately 3 months after administration of Rhlg. Patients who have received Rhlg after live virus vaccination should be re-vaccinated 3 months after the administration of Rhlg
- When Rhlg is used for the treatment of ITP, a decrease in the patient hemoglobin level may occur when using for the treatment of ITP, since passively administered anti-D attaches to the D antigen on the recipients own red cells. Hemoglobin concentration should be monitored in these patients
- The mean maximum decrease in hemoglobin in this setting is 17 g/L
| Dosage
| - Prophylaxis of Rh Hemolytic Disease of the Newborn in Pregnancy
- 1500 units (300 mcg) is standard dose. if gestational age is known to be less than 12 weeks, a 600 unit (120 mcg) dose is sufficient for a potentially sensitizing event
- Requests for any other dose will automatically be substituted with the standard dose, unless cleared through the Transfusion Medicine Physician on call
- Exception: For possible sensitizing events at or after 20 weeks gestation, or following delivery of an Rh positive infant by an Rh negative female, screening for fetal-maternal hemorrhage should be performed and may indicated the need for additional Rhlg. Transfusion Medicine Laboratory staff will calculate and communicate a recommended dose
WinRho® Dosing (Note: 1 mcg = 5 units)
| Clinical Scenarios
| Gestational Age
| WinRho® Dosing | Abortion-medical, surgical or spontaneous; CVS or amniocentesis < 12 weeks
| Less than 12 weeks
| 120 mcg*
| | 12 weeks or more | 300 mcg | Threatened Abortion **
| Less than 12 weeks
| 120 mcg*
| | 12 weeks or more | 300 mcg
| Routine antenatal prophylaxis at 28 weeks
| Approx. 28 weeks
| 300 mcg | Routine postpartum prophylaxis (if Rh positive neonate) **
| At delivery
| 300 mcg
| All other indication ** (e.g.: Trauma, bleeding in pregnancy)
| Less than 12 weeks | 120 mcg*
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* Proceed with 300 mcg if 120 mcg is not stocked ** FMH testing required at or after 20 weeks' gestation - Exposure of Rh Negative females of childbearing potential or Rh Negative allogeneic bone marrow transplant patients to Rh Positive donor red blood cells
- Recommended dose is between 45 units/mL and 120 units/mL of red cells, depending on route of administration
- Consultation with the Transfusion Medicine Physician on-call is required for Rhlg dose determination
- Exposure of Rh Negative females of childbearing potential to Rh Positive donor platelets
- Recommended dose is 120 mcg following transfusion of 1 adult platelet dose (contains a maximum of 2 mL donor red blood cells within the unit)
- Consultation with the Transfusion Medicine Physician on-call is required for Rhlg dose determination in pediatric patients receiving Rh incompatible platelet transfusion
- Treatment of ITP
- Adult recommended initial dose is 125-250 units/kg (25-50 mcg/kg) body weight, depending on hemoglobin. if the patient has a hemoglobin level of 80-100 g/L, a reduced dose of 125-200 units/kg should be considered to reduce the risk of increasing anemia severity due to hemolysis
- Subsequent dosing should be between 125-300 units/kg if required and should be based on the patient's clinical response by assessing platelet counts and screening for hemolytic complications with hemoglobin and reticulocyte counts, haptoglobin, fractionated bilirubin and dipstick urinalysis
- Pediatric ITP recommended dose is 375 units/kg (75 mcg/kg) body weight
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Pre-Administration Testing Requirements
| - ABO/Rh and antibody screen should be performed prior to administration of Rhlg
- In addition, for treatment of ITP or post exposure prophylaxis of Rh Negative females of childbearing potential who have received Rh Positive donor red blood cells:
- Baseline CBC, reticulocyte count, DAT, haptoglobin, fractionated bilirubin, serum creatinine, electrolytes, PTT, INR, fibrinogen and dipstick urinalysis
| Ordering
| - Specify dose required
- ITP requests or dosage request above the standard dose 600 units (120 mcg) or 1500 units (300 mcg) must be approved by the Transfusion Medicine Physician on-call
- To request product from the transfusion medicine laboratory, use the Plasma Protein Product Request Form #103221
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Forms Required
| - Informed Consent for Blood Components and/or Plasma Protein Products #101479
- Plasma Protein Product Request Form #103221
- Transfusion/Infusion Administration and Assessment Record #101059
- Saskatchewan Transfusion Adverse Event Report Form #103695 (only needed if adverse event occurs)
- Notification of Administration of Blood and/or Blood Products Form #103854
- Forms can be located in the Lab Service Manual or Forms on Demand
| Administration
| Pre-Infusion:
Administration:
WinRho® should not be administered concurrently with other products or medications
Prophylaxis of Rh Hemolytic Disease of the Newborn in Pregnancy - IM/IV per most responsible healthcare provider order
- Using a suitable syringe and needle, withdraw the entire contents of the vial to obtain the labelled dosage of the product
- Use aseptic technique when preparing and administering WinRho®
Intravenous (IV) Administration:
- Administer at a rate of injection of 1500 units (300 mcg)/5 to 15 seconds. NOTE: if further dilution of WinRho® is preferred prior to intravenous administration, use Normal Saline as diluent. NO OTHER DILUENT HAS BEEN TESTED
Intramuscular Administration: - Administer the product with the appropriate length needle: 1" for routine, 1.5" for increased BMI patients
- Administer the product to the deltoid (preferred), ventrogluteal or vastus lateralis muscle, ensuring the administration into the muscle. If this cannot be assured, use IV administration
Exposure of Rh Negative females of childbearing potential to Rh positive donor red blood cells
- IV administration is recommended, due to large doses required
- Using a suitable syringe and needle, withdraw the entire contents of the vial to obtain the labelled dosage of the product
- Administer the WinRho ® 3000 units (600 mcg) IV q8h with a rate of injection at 1500 units (300 mcg)/5 to 15 seconds, until the total recommended dose is given. NOTE: if further dilution of WinRho® is preferred prior to intravenous administration, use Normal Saline as diluent. NO OTHER DILUENT HAS BEEN TESTED
- Use aseptic technique when preparing and administering WinRho®
Exposure of Rh Negative females of childbearing potential or Rh Negative allogeneic bone marrow transplant patients to Rh Positive donor platelets
- IM/IV administration per most responsible healthcare provider order
- Refer to detail above within the Prophylaxis or Rh Hemolytic Disease of the Newborn in Pregnancy section
Treatment of ITP
- IV administration is recommended, due to large doses required
- Using a suitable syringe and needle, withdraw the entire contents of the vial to obtain the labelled dosage of the product
- Administer the product intravenously with a rate of injection of 1500 units (300 mcg)/5 to 15 seconds. NOTE: if further dilution of WinRho® is preferred prior to intravenous administration use Normal Saline as a diluent. NO OTHER DILUENT HAS BEEN TESTED
- Use aseptic technique when preparing and administering WinRho®
- Subcutaneous (SC) administration is considered off-label use and may only occur at the direction of the clinical Hematologist for treatment of chronic immune thrombocytopenia (ITP)
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Nursing Implications
| | Adverse Events
| - Patients receiving blood product transfusion must be observed closely for signs of any unexpected or untoward reactions
- Reactions may occur during or after the infusion of blood or blood products and can range in severity from mild to life threatening
- Refer to Nursing Policy and Procedure Blood Components and Plasma Protein Product Administration of #1141 for managing of allergic transfusion reaction and call MRHP
- Document adverse event on Saskatchewan Transfusion Adverse Event Report Form #103695, whether or not the transfusion was discontinued
Adverse reactions with Rhlg administration (usual dose) by any route:
- Common - Pain or discomfort at the injection site, headache
- Uncommon - chills, fever, nausea/vomiting, hypotension, arthralgia, moderate low back pain, rash
Side Effects
- Flushing
- Headache
- Itching and redness at the venipuncture site
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| Action
Slow rate of administration
| Potential Allergic Reaction
- Hives/Severe itching
- Cough
- Chest pain
- Wheezing
- Facial swelling
- Feeling lightheaded/dizzy or fainting
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| Action
- STOP infusion IMMEDIATELY and contact most responsible healthcare provider
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Intravenous Administration of Rhlg in large doses for ITP (Rh Positive patients) or following exposure of Rh Negative females of childbearing potential to Rh Positive donor red blood cells:
- Following administration patients should be closely monitored using clinical and laboratory parameters for at least 8 hours after the final dose of Rhlg for potential adverse reactions including signs and/or symptoms of intravascular red blood cell hemolysis
- Clinical signs and symptoms of hemolysis include pallor, hypotension, tachycardia, hemoglobinuria (red urine)
- Severe clinical complications of hemolysis include renal failure (oliguria or anuria and edema), and coagulopathy (increased bruising or bleeding)
- A dipstick urinalysis should be performed at baseline and then after administration at 2 hours, 4 hours and prior to the end of the monitoring period.
- If signs and/or symptoms of hemolysis are present or suspected after Rhlg administration, the following laboratory tests should be performed:
- CBC, haptoglobin, DAT, fractionated bilirubin
- Serum creatinine, electrolytes
- INR, PTT, fibrinogen
- Urinalysis
- The Transfusion Medicine Physician on-call should be notified in the event of any suspected cases of intravascular hemolysis associated with Rhlg administration
- Prior to discharge, patients should be instructed to self-monitor for signs and symptoms of intravascular red blood cell hemolysis for at least 72 hours, these include symptoms of back pain, discoloration of urine, hematuria, shaking chills and fever and be advised to seek medical attention immediately. (absence of signs and/or symptoms of hemolysis within 8 hours does not guarantee that it cannot occur subsequently).
| Storage and Stability
| - Stored at 2-8⁰C. Do Not Freeze
- Expiration date is indicated on bottle and packaging
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PageBottomContent If you choose to print this information, it is valid only on date of print. Laboratory Controlled Document LSM-66 v9
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