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.

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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.

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 literature.

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 literature); give within 72 hours.

Children:

See literature. 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.

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 literature.

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