Monograph Details

Hematology > Bleeding disorders
WINRHO SDF
Manufacturer
Baxter
Legal Classification
Rx
Generic Name
Rho(D) immune globulin intravenous human 600IU (120micrograms), 1500IU (300micrograms), 2500IU (500micrograms), 5000IU (1000micrograms), 15000IU (3000micrograms); per vial; lyophilized pwd or soln; for IV or IM inj after reconstitution; preservative-free.
Indications
Treatment of non-splenectomized, Rho(D) positive children with acute immune thrombocytopenic purpura (ITP); adults and children with chronic ITP and ITP secondary to HIV infection; in clinical situations requiring an increase in platelet count to prevent excessive hemorrhage.
Adults and Children
Give by IV inj only. Confirm Rho(D) positive prior to treatment. Initially: 250 IU/kg as single dose or 2 divided doses on separate days; if Hgb <10g/dL, reduce to 125–200 IU/kg. Maintenance: 125–300 IU/kg; Hbg >10g/dL: 250–300 IU/kg; Hgb 8–10g/dL: 125–200 IU/kg; Hgb <8g/dL: use with caution. Base frequency and dose on clinical response.
Contraindications
IgA deficiency. Allergy to blood products. Treatment of immune globulin deficiency syndromes.
Precautions
Not for use in Rho(D) negative or splenectomized patients; monitor for intravascular hemolysis, anemia, renal insufficiency; hemoglobin <10g/dL decrease dose, if <8g/dL use extreme caution. Pregnancy (Cat.C).
Interactions
Do not give live vaccines within 3 months.
Adverse Reactions
Headache, chills, fever, local or infusion reactions; see literature.
Extra Text
Note: Report all infections suspected to be transmitted by WinRho SDF to (800) 423-2090.
How Supplied
Single-dose vials (pwd) 600IU, 1500IU, 5000IU—1 (w. diluent)
Single-dose vials (soln) 600IU, 1500IU, 2500IU, 5000IU, 15000IU—1
Additional Resources
Related Prescribing Note