WinRho SDF

WINRHO SDF- human rho(d) immune globulin injection
Saol Therapeutics Inc.

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

1 INDICATIONS AND USAGE

WinRho® SDF is a 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 a 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, transplacental hemorrhage resulting from antepartum hemorrhage)
    Invasive procedures during pregnancy (e.g., amniocentesis, chorionic biopsy) or obstetric manipulative procedures (e.g., external version, abdominal trauma)

A 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), could result in either an overdose that could lead to a severe hemolytic reaction or a dose too low to be effective.

Since Win Rho® SDF is administered on a weight-based regimen per kilogram (kg), patient weight determination must be taken in kilograms (kg) as inappropriate use of pounds (lbs) will result in significant overdosing of WinRho® SDF.

Please note that dose for WinRho® SDF may be calculated using either international units (IU) or micrograms (mcg) per kilograms.

Table 1 provides dosing guidelines for ITP patients.

Table 1: ITP Dosing Guidelines (Intravenous use only)
  • 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.
  • Treatment is rarely indicated in patients with platelet count above 50×109 /L.
  • To determine the dosage and number of vials needed for the treatment of ITP: weight in lbs/2.21 = weight in kg weight in kg X selected IU (mcg) dosing level = dosage dosage / vial size = number of vials needed
Indication Initial Dose(dose in either IU or mcg) Subsequent Doses (dose in either IU or mcg)
ITP(intravenous use only) Single intravenous doseordivided doses given on two separate days Determine frequency by clinical response (platelet counts, RBC, Hgb and reticulocyte count)
Hemoglobin ≥ 10 g/dl 250 IU/kg 50 mcg/kg 250-300 IU/kg 50-60 mcg/kg
Hemoglobin 8 to <10 g/dl (use alternative treatments for Hgb <8 g/dl) 125-200 IU/kg 25-40 mcg/kg 125-200 IU/kg 25-40 mcg/kg

Suppression of Rh Isoimmunization

Table 2: Rh Isoimmunization Dosing Guidelines
  • If the Rh status of the baby is not known at 72 hours, administer WinRho® SDF to the mother at 72 hours after delivery. If more than 72 hours have elapsed, administer as soon as possible up to 28 days after delivery.
  • If WinRho® SDF is administered early in pregnancy for amniocentesis and chorionic villus sampling (before 34 weeks), then administer WinRho® SDF repeatedly at 12-week interval to maintain adequate levels of passively acquired anti-Rh.
Indication Initial Dose (dose in either IU or mcg) Subsequent Doses (dose in either IU or mcg)
Suppression of Rh Isoimmunization (intravenous or intramuscular) Single intravenous or intramuscular dose
Routine antepartum prophylaxis in Rh- incompatible pregnancy (28 weeks gestation) 1,500 IU 300 mcg
Postpartum (within 72 hours of birth of Rh0(D) positive newborn) 600 IU 120 mcg
Threatened abortion (immediately) 1,500 IU 300 mcg
Amniocentesis and chorionic villus sampling before 34 weeks gestation (immediately following procedure, then every 12 weeks during pregnancy) 1,500 IU 300 mcg 1,500 IU (every 12 weeks) 300 mcg (every 12 weeks)
Abortion, amniocentesis, or any other manipulation after 34 weeks gestation (within 72 hours) 600 IU 120 mcg

Incompatible Transfusion

Table 3: Incompatible Transfusion Dosing Guidelines
Indication Dose (dose in either IU or mcg) Frequency
Incompatible Transfusion (intravenous or intramuscular) Begin treatment within 72 hours of exposure
Intravenous
If exposed to Rh0 (D)-Positive Whole Blood 45 IU per ml blood 9 mcg per ml blood Every 8 hours
If exposed to Rh0 (D)-Positive Red Blood Cells 90 IU per ml cells 18 mcg per ml cells
Administer this dose until total dose has been administered 3000 IU 600 mcg Every 8 hours
Intramuscular
If exposed to Rh0 (D)-Positive Whole Blood 60 IU per ml blood 12 mcg per ml blood Every 12 hours
If exposed to Rh0 (D)-Positive Red Blood Cells 120 IU per ml cells 24 mcg per ml cells
Administer this dose until total dose has been administered 6000 IU 1,200 mcg Every 12 hours

For incompatible transfusion or massive fetal hemorrhage, treatment must occur within 72 hours and dose may be intravenous or intramuscular, based on the volume of blood or cells replaced.

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