WINRHO SDF Rx

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WINRHO SDF

Bleeding disorders
Immune-mediated blood disorders
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Generic Name and Formulations:

Rho(D) immune globulin intravenous human 600IU (120mcg), 1500IU (300mcg), 2500IU (500mcg), 5000IU (1000mcg), 15000IU (3000mcg); per vial; lyophilized pwd or soln; for IV or IM inj after reconstitution; preservative-free.

Select therapeutic use:

Indications for WINRHO SDF:

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.

Boxed Warning:

Intravascular hemolysis in immune thrombocytopenic purpura (ITP). (Warning does not apply to Rho(D)-negative patients in suppression of Rh isoimmunization).

Warnings/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 full labeling.

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

Indications for WINRHO SDF:

Suppression of Rh isoimmunization in nonsensitized Rho(D)-negative women in appropriate obstetrical conditions, unless the fetus or father is known to be Rho(D)-negative. Suppression of Rh isoimmunization in Rho(D)-negative females after accidental transfusion of Rho(D)-positive blood products.

Adult:

Pregnancy: 1500IU at 28 weeks gestation; if given early in pregnancy, repeat every 12 weeks. Post-delivery: 600IU as soon as possible (preferably within 72 hrs, up to 28 days) of an Rh incompatible delivery. Amniocentesis or other manipulation late in pregnancy (after 34 weeks gestation), abortion: 600IU as soon as possible (within 72 hrs). Chorionic villus sampling, amniocentesis (before 34 weeks gestation), threatened abortion: 1500IU as soon as possible, repeat every 12 weeks during pregnancy. Transfusion: IV route: 3000IU (600micrograms) every 8 hours; or IM route: 6000IU (1200micrograms) every 12 hours; for both: total dose based on exposure (see full labeling); give within 72 hours.

Children:

See full labeling. Do not give to infant for maternal Rh incompatability.

Contraindications:

Rho(D)-positive patients. IgA deficiency. Allergy to blood products. Treatment of immune globulin deficiency syndromes.

Boxed Warning:

Intravascular hemolysis in immune thrombocytopenic purpura (ITP). (Warning does not apply to Rho(D)-negative patients in suppression of Rh isoimmunization).

Warnings/Precautions:

Rho(D)-negative patients who are Rh immunized. Thrombocytopenia. Pregnancy (Cat.C).

Interactions:

Do not give live vaccines within 3 months.

Adverse Reactions:

Local or infusion reactions, fever; see full labeling.

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