WinRho SDF (Page 2 of 7)

2.2 Preparation

  • Bring WinRho® SDF to room temperature prior to use.
  • Inspect WinRho® SDF for particulate matter and discoloration prior to administration. Do not use if the solution is cloudy or contains particulates.
  • WinRho® SDF is for single use only. Discard any unused portion.
  • The solution is ready to use, no reconstitution required.
  • See Table 4 for the target fill volumes for each of the dosage sizes for WinRho® SDF.
Table 4: Liquid WinRho® SDF Dosage Size and Target Fill Volumes
Dose (IU) Dose (mcg) Target Fill Volume
600 IU 120 mcg 0.5 mL
1,500 IU 300 mcg 1.3 mL
2,500 IU 500 mcg 2.2 mL
5,000 IU 1,000 mcg 4.4 mL
15,000 IU 3,000 mcg 13.0 mL

Note: Remove the entire contents of the vial to obtain the labelled dosage of WinRho® SDF. If partial vials are required for dosage calculation, withdraw the entire contents of the vial to ensure accurate calculation of the dosage requirement. For ease in withdrawing the contents of the vial, draw back the plunger of a sterile syringe (with the needle and needle cover in place) to admit air into the syringe. Depress the plunger of the syringe to inject air into the vial. Invert vial and aspirate contents of vial into syringe.

2.3 Administration

Route of administration depends on the indication as follows:

ITP Intravenous (IV) only
Suppression of Rh Intravenous (IV) or intramuscular (IM)
Incompatible transfusion Intravenous (IV) or intramuscular (IM)

ITP

  • Administer the entire dose of WinRho® SDF into a suitable vein over three to five minutes.
  • Administer WinRho® SDF separately from other drugs.
  • If dilution of WinRho® SDF is preferred prior to intravenous administration, use only normal saline as diluent. Do not use Dextrose (5%) in water (D5W).

Suppression of Rh Isoimmunization

  • For intravenous administration, administer WinRho® SDF separately from other drugs. WinRho® SDF should be administered at a rate of 2 mL per 5 to 15 seconds.
  • For intramuscular administration, administer into the deltoid muscle of the upper arm or the anterolateral aspects of the upper thigh. Due to the risk of sciatic nerve injury, avoid the gluteal region. If the gluteal region is used, use only the upper, outer quadrant.

3 DOSAGE FORMS AND STRENGTHS

WinRho® SDF, Rho (D) Immune Globulin Intravenous (Human), is available as a ready to use solution for injection available in single dose vials of 600 IU (120 mcg), 1,500 IU (300 mcg), 2,500 IU (500 mcg), 5,000 IU (1,000 mcg) and 15,000 IU (3,000 mcg).

4 CONTRAINDICATIONS

WinRho® SDF is contraindicated 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 or a history of hypersensitivity reaction to WinRho® SDF or any of its components.
  • Patients with autoimmune hemolytic anemia, with pre-existing hemolysis or at high risk for hemolysis.
  • Infants for the suppression of Rho (D) isoimmunization.

5 WARNINGS AND PRECAUTIONS

5.1 Hypersensitivity

Severe hypersensitivity reactions may occur [see Contraindications (4)]. 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. WinRho® SDF should be administered in a setting where appropriate equipment, medication such as epinephrine, and personnel trained in the management of hypersensitivity, anaphylaxis and shock are available.

WinRho® SDF contains ≤ 40 mcg/mL IgA [see Description (11)]. Patients with antibodies to IgA have a greater risk of developing potentially severe hypersensitivity and anaphylactic reactions. WinRho® SDF is contraindicated in IgA-deficient patients with antibodies to IgA or a history of hypersensitivity reaction to WinRho® SDF or any of its components [see Contraindications (4)].

WinRho® SDF contains 10% maltose, a disaccharide sugar derived from corn. Patients with corn allergy should avoid using WinRho® SDF due to risk of hypersensitivity. [see Contraindications (4)]

5.2 Intravascular Hemolysis (IVH) for ITP Treatment

IVH 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.7,8

Closely monitor patients treated with WinRho® SDF for ITP in a healthcare setting for at least 8 hours after administration. Perform a dipstick urinalysis to monitor for hematuria and hemoglobinuria at baseline and then after administration at 2 hours, 4 hours and prior to the end of the monitoring period. Alert patients and monitor for 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 if IVH is suspected after WinRho® SDF administration, perform post-treatment laboratory tests including plasma hemoglobin, haptoglobin, LDH, and plasma bilirubin (direct and indirect).

5.3 Hemolysis for ITP Treatment

Although the mechanism of action of WinRho® SDF in the treatment of ITP is not completely understood it is postulated that anti-D binds to the Rho (D) RBC resulting in formation of antibody-coated RBC complexes. Immune-mediated clearance of the antibody-coated RBC complexes would spare the antibody-coated platelets because of the preferential destruction of antibody-coated RBC complexes by the macrophages located in the reticuloendothelial system.9-11 The side effect of this action is a decrease in hemoglobin levels (extravascular hemolysis).7 The pooled data from ITP clinical studies demonstrated a mean decrease from baseline in hemoglobin levels of 1.2 g/dL within 7 days after administration of WinRho® SDF.

In patients with pre-disposing conditions, renal and cardiovascular complications of IVH may occur more frequently. Patients of advanced age (age over 65 years) with co-morbid conditions may be at an increased risk of developing sequelae from acute hemolytic reactions. If a patient has evidence of hemolysis (reticulocytosis greater than 3%) or is at high risk for hemolysis [positive direct antiglobulin test (DAT) not attributed to previous immune globulin administration], alternate therapies must be used.

If the patient has lower than normal hemoglobin levels (less than 10 g/dL), a reduced dose of 125 to 200 IU/kg (25 to 40 mcg/kg) should be given to minimize the risk of increasing the severity of anemia in the patient. Alternative treatments should be used in patients with hemoglobin levels that are less than 8 g/dL due to the risk of increasing the severity of the anemia [see Dose (2.1)].

Significant anemia may present with pallor, hypotension, or tachycardia while acute renal insufficiency may present with oliguria or anuria, edema and dyspnea. Patients with IVH who develop DIC may exhibit signs and symptoms of increased bruising and prolongation of bleeding time and clotting time which may be difficult to detect in the ITP population. Consequently, the diagnosis of this serious complication of IVH is dependent on laboratory testing [see Warnings and Precautions (5.9)]. Previous uneventful administration of WinRho® SDF does not preclude the possibility of an occurrence of IVH and its complications following any subsequent administration of WinRho® SDF. Have confirmatory laboratory testing on ITP patients presenting with signs and/or symptoms of IVH and its complications after anti-D administration [see Warnings and Precautions (5.9)]

If ITP patients are to be transfused, use Rho (D)-negative red blood cells (PRBCs) so as not to exacerbate ongoing hemolysis.

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