Winrho

Winrho Manufacturers

• Cangene Biopharma Inc.
  

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  Winrho | Cangene Biopharma Inc.

  

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  2.1 Preparation and Handling 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 1 for the target fill volumes for each of the dosage sizes for WinRho® SDF. Table 1 Liquid WinRho® SDF Dosage size and target fill volumes Vial Size Target Fill Volume 600 international unit (120 mcg) 0.5 mL 1,500 international unit (300 mcg) 1.3 mL 2,500 international unit (500 mcg) 2.2 mL 5,000 international unit (1,000 mcg) 4.4 mL 15,000 international unit (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.

  2.2 Treatment of ITP

  ADMINISTER WinRho®  SDF BY THE INTRAVENOUS ROUTE ONLY (see Preparation and Handling [2.1] ). Do not administer intramuscularly.

  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 normal saline as diluent. Do not use Dextrose (5%) in water (D5W). No other diluents have been tested.

  Initial Dosing: An initial dose of 250 international unit/kg (50 mcg/kg) body weight, given as a single injection is recommended for the treatment of ITP. The initial dose may be administered in two divided doses given on separate days, if desired. If the patient has a hemoglobin level less than 10 g/dL, a reduced dose of 125 to 200 international unit/kg (25 to 40 mcg/kg) should be given to minimize the risk of increasing the severity of anemia in the patient. 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)].

  Subsequent Dosing: If subsequent therapy is required to elevate platelet counts, an intravenous dose of 125 to 300 international unit/kg (25 to 60 mcg/kg) body weight of WinRho® SDF is recommended. The frequency of dosing and the dose used in maintenance therapy should be determined by the patient’s clinical response by assessing platelet counts, RBCs, Hgb, and reticulocyte levels.

  If a patient responded to initial dose with a satisfactory increase in platelets, maintenance dose at 125 to 300 international unit/kg (25 to 60 mcg/kg), individualized based on platelet and Hgb levels. An international consensus report on the investigation and management of primary immune thrombocytopenia states that treatment is rarely indicated in patients with platelet counts above 50 x 109/L and this has been generally accepted as the threshold for satisfactory response.1 Evaluate whether patient responded with a satisfactory increase in platelets based on the clinical situation and bleeding risks for the individual patient.

  If patient did not respond to initial dose, administer a subsequent dose based on Hgb:

  If Hgb between 8-10 g/dL, redose between 125 to 200 international unit/kg (25 to 40 mcg/kg).

  If Hgb >10 g/dL, redose between 250 to 300 international unit/kg (50 to 60 mcg/kg).

  If Hgb < 8 g/dL, alternative treatments should be used.

  The following equations are provided 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 international unit (mcg) dosing level = dosage dosage / vial size = number of vials needed

  Safety and efficacy of WinRho® SDF  in the treatment of ITP at doses exceeding 300 international unit/kg (60 mcg/kg) has not been established.

  2.3 Supression of Rh Isoimmunization

  Intravenous or intramuscular use.

  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.

  Pregnancy and other Obstetric Indications

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

  Table 2 Obstetric Indications and Recommended Dose Indication Timing of Administration

  Dose

  (Administer IM or IV) Rh-incompatible Pregnancy: Routine antepartum prophylaxis 28 weeks gestation* 1,500 international unit (300 mcg)

  Postpartum

  (if newborn is Rho(D)-positive) Within 72 hours of birth** 600 international unit (120 mcg) Obstetric Conditions: Threatened abortion at any time Immediately 1,500 international unit (300 mcg) Amniocentesis and chorionic villus sampling before 34 weeks gestation Immediately after procedure† 1,500 international unit (300 mcg) Abortion, amniocentesis, or any other manipulation after 34 weeks gestation Within 72 hours 600 international unit (120 mcg)

  * 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

   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 Transfusion Indication and Recommended Dose Route of Administration Rate of Administration WinRho® SDF Dose If exposed to Rho(D)-Positive Whole Blood: If exposed to Rho(D)-Positive Red Blood Cells: Intravenous 3,000 international unit (600 mcg) every 8 hours 45 international unit (9 mcg)/mL blood 90 international unit (18 mcg)/mL cells Intramuscular 6,000 international unit (1,200 mcg) every 12 hours 60 international unit (12 mcg)/mL blood 120 international unit (24 mcg)/mL cells

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