WINRHO

WINRHO- human rho(d) immune globulin liquid
Aptevo BioTherapeutics LLC

WARNING: INTRAVASCULAR HEMOLYSIS (IVH)

This warning does not apply to Rho (D)-negative patients treated for the suppression of Rh isoimmunization.

  • 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 8 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 8 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).

1 INDICATIONS AND USAGE

WinRho® SDF is an Rho (D) Immune Globulin Intravenous (Human) (anti-D) product that is indicated for the treatment of ITP in Rho (D)-positive patients and for the suppression of Rh isoimmunization in non-sensitized Rho (D)-negative patients.

1.1 Treatment of ITP

WinRho SDF is 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 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.

1.2 Suppression of Rh Isoimmunization

Pregnancy and Other Obstetric Conditions

WinRho SDF is indicated for the suppression of Rh isoimmunization in non-sensitized, Rho (D)-negative (D-negative) women with an Rh-incompatible pregnancy, including:

  • Routine antepartum and postpartum Rh prophylaxis
  • Rh prophylaxis in cases of:
    Obstetric complication (e.g., miscarriage, abortion, threatened abortion, ectopic pregnancy or hydatidiform mole, transplancental hemorrhage resulting from antepartum hemorrhage)
    Invasive procedures during pregnancy (e.g., amniocentesis, chorionic biopsy) or obstetric manipulative procedures (e.g., external version, abdominal trauma)

An Rh-incompatible pregnancy is assumed if the fetus/baby is either Rho (D)-positive or Rho (D)-unknown or if the father is either Rho (D)-positive or Rho (D)-unknown.

Incompatible Transfusions

WinRho SDF is indicated for the suppression of Rh isoimmunization in Rho (D)-negative individuals transfused with Rho (D)-positive red blood cells (RBCs) or blood components containing Rho (D)-positive RBCs.

WinRho SDF is not indicated for use as immunoglobulin replacement therapy for immune globulin deficiency syndromes.

2 DOSAGE AND ADMINISTRATION

For intravenous or intramuscular use only.

2.1 Dose

Treatment of ITP

ADMINISTER WinRho SDF BY THE INTRAVENOUS ROUTE ONLY.

Proper care should be taken when calculating the dose of WinRho SDF to be administered. A confusion between International Units (IU) and micrograms (mcg) of product (1 mcg = 5 IU), or between pounds (lbs) and kilograms (kg) for the patient’s body weight, could result in either an overdose that could lead to a severe hemolytic reaction or a dose too low to be effective.

Table 1 provides dosing guidelines for ITP patients.

Table 1. Dosing Guidelines for ITP
b Treatment is rarely indicated in patients with platelet counts above 50 x 109 /L1
Initial Dose Schedule
Hemoglobin ≥ 10 g/dL: 250 IU/kg (50 mcg/kg) Single IV dose or may be administered as 2 divided doses given on separate days.
Hemoglobin < 10 g/dL: 125 — 200 IU/kg (25 — 40 mcg/kg)
If Hgb < 8 g/dL: alternative treatments should be used
Subsequent Doses Schedule
Hemoglobin ≥ 10 g/dL: 250 – 300 IU/kg (50 — 60 mcg/kg) Frequency determined by clinical response in platelet countsb , RBC, Hgb and reticulocyte levels.
Hemoglobin 8 – 10 g/dL: 125 – 200 IU/kg (25 to 40 mcg/kg)
Hemoglobin < 8 g/dL: alternative treatments should be used

All patients should be monitored to determine clinical response by assessing platelet counts, RBCs, hemoglobin (Hgb), and reticulocyte levels [see Warnings and Precautions (5.2)] Safety and efficacy of WinRho SDF in the treatment of ITP at doses exceeding 300 IU/kg (60 mcg/kg) has not been established.

To determine the dosage and number of vials needed for the treatment of ITP:

weight in kg X selected IU (mcg) dosing level = dosage

dosage / vial size = number of vials needed

Suppression of Rh Isoimmunization

Intravenous or intramuscular use only.

Pregnancy and other Obstetric Indications

Table 2 provides dosing guidelines based on the condition being treated.

Table 2 Dosing Guidelines for Obstetric Indications
* If WinRho SDF is administered early in the pregnancy, it is recommended that WinRho SDF be administered at 12 week intervals in order to maintain adequate levels of passively acquired anti Rh.
** In the event that the Rh status of the baby is not known at 72 hours, WinRho SDF should be administered to the mother at 72 hours after delivery. If more than 72 hours have elapsed, WinRho SDF should not be withheld but administered as soon as possible up to 28 days after delivery.
†Repeat every 12 weeks during pregnancy
Indication Timing of Administration Dose (Administer IM or IV)
Rh-incompatible Pregnancy:
Routine antepartum prophylaxis 28 weeks gestation* 1,500 IU (300 mcg)
Postpartum (if newborn is Rho (D)-positive) Within 72 hours of birth** 600 IU (120 mcg)
Obstetric Conditions:
Threatened abortion at any time Immediately 1,500 IU (300 mcg)
Amniocentesis and chorionic villus sampling before 34-weeks gestation Immediately after procedure† 1,500 IU (300 mcg)
Abortion, amniocentesis, or any other manipulation after 34-weeksgestation Within 72 hours 600 IU (120 mcg)

Incompatible Transfusion

Administer WinRho SDF within 72 hours after exposure for treatment of incompatible blood transfusions or massive fetal hemorrhage.

Table 3 provides dosing guidelines based on the condition being treated.

Table 3 Dosing Guidelines for Incompatible Transfusion
Route ofAdministration Rate of Administration Dose
If exposed to Rho (D)-Positive Whole Blood: If exposed to Rho (D)-Positive Red Blood Cells:
Intravenous 3,000 IU (600 mcg) every 8 hours 45 IU (9 mcg)/mL blood 90 IU (18 mcg)/mL cells
Intramuscular 6,000 IU (1,200 mcg) every 12 hours 60 IU (12 mcg)/mL blood 120 IU (24 mcg)/mL cells

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