WINRHO®

Rho(D) Immune Globulin Intravenous (Human) Intravenous or Intramuscular Injection [Standardized amount of Anti D antibody]

Presentation:

0.5 mL (600IU, 120 mcg), 1.3 mL (1,500 IU, 300 mcg), 2.2 mL (2,500 IU, 500 mcg), 4.4 mL (5,000 IU, 1,000 mcg), and 13.0 mL (15,000 IU, 3,000 mcg) single-dose vial.

Therapeutic Indication:

Pregnancy and other Obstetric Conditions

WinRho SDF, Rho (D) Immunoglobulin (Human) is indicated for the prevention of Rh immunization in Rho (D) negative mothers not previously sensitized to the Rho (D) factor. WinRho SDF is recommended for prevention of Rh immunization of Rho (D) negative women at risk of developing Rh antibodies. Rho (D) Immunoglobulin (Human) prevents the development of Rh antibodies in the Rho (D) negative and previously not sensitized mother carrying a Rho (D) positive fetus, thus preventing the occurrence of hemolytic disease in the fetus or the newborn. The administration of WinRho SDF to women satisfying the above conditions should be done at about 28-weeks gestation when the child’s father is either Rho (D) positive or unknown. WinRho SDF should be administered within 72 hours after delivery if the baby is Rho (D) positive or unknown. WinRho SDF administration is also recommended in these same women within 72 hours after spontaneous or induced abortion, amniocentesis, chorion villus sampling, ruptured tubal pregnancy, abdominal trauma or transplacental hemorrhage, unless the blood type of the fetus or father are confirmed to be Rho (D) negative. It should be administered as soon as possible in the case of maternal bleeding due to threatened abortion.

Transfusion
WinRho SDF is recommended to prevent alloimmunization in Rho (D) negative female children and female adults in their child-bearing years transfused with Rho (D) positive RBCs or blood components with Rho (D) positive RBCs. Treatment should only then be carried out (without preceding exchange transfusion), if the transfused Rho (D) positive blood represents less than 20% of the total circulating red cells.

Immune Thrombocytopenic Purpura (ITP)
WinRho SDF is recommended in the treatment of destructive thrombocytopenia of an immune etiology in situations where platelet counts must be increased to control bleeding. Clinical studies have shown that the peak platelet counts occur about seven days after IV anti-Rho (D) treatment. The effect is not curative but is transient; platelet counts are usually elevated from several days to several weeks. For individuals with chronic ITP, a maintenance dosage is recommended with the dosage schedule determined on an individual basis. WinRho SDF is recommended in clinical situations requiring an increase in platelet count to prevent excessive hemorrhage for the treatment of non-splenectomized Rho (D) positive 1) children with chronic or acute ITP, 2) adults with chronic ITP, or 3) children and adults with ITP secondary to HIV infection. The safety and efficacy of WinRho have not been evaluated in clinical trials for patients with non-ITP causes of thrombocytopenia or in previously splenectomized patients.

Geriatrics (greater than 65 years of age)
Differences in response to treatment in those aged 65 or over as compared to younger subjects cannot be determined due to a limited number of study subjects aged 65 or over enrolled in clinical studies with WinRho SDF. Caution should be used when determining the dose for an elderly patient for the treatment of ITP and should take into account the increased frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy associated with advanced age. Doses starting at the low end of the dosing range should be considered when administering WinRho SDF to those aged 65 or older.

Pediatrics (less than 16 years of age)
WinRho SDF has been evaluated in children for the treatment of chronic or acute ITP and in children with ITP secondary to HIV infection. The dosing recommendation in the treatment of children with ITP is the same as in adults.