Usual Adult Dose for Idiopathic (Immune) Thrombocytopenic Purpura

Rhophylac(R): 250 international units (50 mcg) per kg, IV, at 2 mL per 15 to 60 seconds
WinRho(R):

• Initial dose: 250 international units (50 mcg) per kg, IV, over 3 to 5 minutes; may be divided into 2 doses on separate days if desired.
• Maintenance dose: 125 to 300 international units/kg (25 to 60 mcg/kg), IV, over 3 to 5 minutes

Use: Immune thrombocytopenic purpura (ITP):

• Raising platelet counts in Rho (D)-positive, non-splenectomized chronic ITP

Usual Adult Dose for Rh-Isoimmunization

Dose and route varies for each product.

Rh-incompatible pregnancy:
RhoGAM(R): 1500 international units (300 mcg), IM, at gestational week 26 to 28, or within 72 hours of birth of an RHo (D) positive baby.
Rhophylac(R): 1500 international units (300 mcg), IV or IM, at gestational week 29 to 30; repeat dose within 72 hours of birth of an RHo (D) positive baby.
WinRho(R): 1500 international units (300 mcg), IV or IM, at gestational week 28; give an additional 600 international units (120 mcg) dose within 72 hours of birth of an RHo (D) positive baby.

Comments:

• If RhoGAM(R) or WinRho(R) are administered early in pregnancy, administer at 12 week intervals to maintain adequate anti-Rh levels.
• If the Rh status of the baby is not known at 72 hours, administer WinRho(R).

Amniocentesis and chorionic villus sampling before 34 weeks gestation:
RhoGAM(R): 1500 international units (300 mcg), IM
WinRho(R): 1500 international units (300 mcg), IV or IM, immediately after the procedure

Abortion or miscarriage of up to 12 weeks gestation:
BayRho-D Mini-Dose(R): 1 syringe, IM, within 3 hours, or as soon as possible (within 72 hours of pregnancy termination).
HyperRHO S/D Mini-Dose(R): 1 syringe, IM, within 3 hours, or as soon as possible (within 72 hours of pregnancy termination).
MICRhoGAM(R) or RhoGAM(R): 250 international units (50 mcg), IM, within 72 hours of actual or threatened pregnancy termination.

Abortion or miscarriage after 12 weeks gestation:
RhoGAM(R): 1500 international units (300 mcg), IM

Abortion, amniocentesis, or any other manipulation after 34 weeks gestation:
WinRho(R): 600 international units (120 mcg), IV or IM, within 72 hours

Ectopic pregnancy:
RhoGAM(R): 1500 international units (300 mcg), IM

Excessive fetomaternal hemorrhage:
Rhophylac(R): 1500 international units (300 mcg), IV or IM, within 72 hours of complication, plus:

• 100 international units (20 mcg) per mL fetal red blood cells in excess of 15 mL if transplacental bleeding is quantified

OR

• an additional 1500 international units (300 mcg) dose if transplacental bleeding cannot be quantified

Obstetric complications/invasive procedures:
RhoGAM(R): 1500 international units (300 mcg), IM
Rhophylac(R): 1500 international units (300 mcg), IV or IM, within 72 hours of the at-risk event.

Threatened abortion at any time:
WinRho(R): 1500 international units (300 mcg), IV or IM, immediately

Threatened pregnancy loss after 12 weeks gestation with continuation of pregnancy:
RhoGAM(R): 1500 international units (300 mcg), IM

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Incompatible transfusions:
MICRhoGAM(R) or RhoGAM(R):

• Transfusion of less than 2.5 mL of incompatible blood: 250 international units (50 mcg), IM, within 72 hours of exposure

RhoGAM(R):

• Transfusion of 2.5 to 15 mL incompatible blood: 1500 international units (300 mcg), IM, within 72 hours of exposure.
• Transfusion of over 15 mL incompatible blood: 20 mcg per mL transfused blood, IM, within 72 hours of exposure. May be given as a single dose or at spaced intervals within 72 hours of exposure.

Rhophylac(R): 100 international units (20 mcg) per 2 mL transfused blood (or per 1 mL erythrocyte concentrate), IM or IV, within 72 hours of exposure.
WinRho(R):
IV administration:
45 international units (9 mcg) per mL whole blood
90 international units (18 mcg) per mL red blood cells

• Administer 3,000 international units (600 mcg) IV every 8 hours until the total dose (calculated from the above doses) is administered.

IM administration:
60 international units (12 mcg) per mL whole blood
120 international units (24 mcg) per mL red blood cells

• Administer 6000 international units (1200 mcg) IM every 12 hours until the total dose (calculated from the above doses) is administered.

Uses:
Suppression of Rh isoimmunization in:

• Pregnancy and obstetric conditions in non-sensitized, Rho (D)-negative women with an Rh-incompatible pregnancy
• Routine antepartum and postpartum Rh prophylaxis
• Rh prophylaxis in obstetric complications or invasive procedures
• Incompatible transfusions in Rho (D)-negative individuals (given Rho (D)-positive blood cells)

Usual Pediatric Dose for Idiopathic (Immune) Thrombocytopenic Purpura

Rhophylac(R): 250 international units (50 mcg) per kg, IV, at 2 mL per 15 to 60 seconds
WinRho(R):

• Initial dose: 250 international units (50 mcg) per kg, IV, over 3 to 5 minutes; may be divided into 2 doses on separate days if desired.
• Maintenance dose: 125 to 300 international units/kg (25 to 60 mcg/kg), IV, over 3 to 5 minutes

Use: Immune thrombocytopenic purpura (ITP):

• Raising platelet counts in Rho (D)-positive, non-splenectomized acute or chronic ITP

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Dose Adjustments

Exposure to over 15 mL of RHo (D)-positive red blood cells (postpartum prophylaxis/obstetric complications/invasive procedures):
Rhophylac(R): Increase the dose based on guidelines for excessive fetomaternal hemorrhage.

Immune thrombocytopenic purpura (ITP):

• Initial dose if hemoglobin (Hgb) less than 10 g/dL:

WinRho(R): Reduce dose to 125 to 200 international units/kg (25 to 40 mcg/kg), IV, over 3 to 5 minutes

If subsequent therapy is needed to elevate platelet counts:

• Satisfactory increase in platelets with initial dose:

WinRho(R): 125 to 300 international units/kg (25 to 60 mcg/kg), IV, over 3 to 5 minutes

• Patient did not respond to initial dose of WinRho(R), dosing based on hemoglobin:

Hgb under 8 g/dL: Use alternative treatment
Hgb 8 to 10 g/dL: 125 to 200 international units/kg (25 to 40 mcg/kg)
Hgb over 10 g/dL: 250 to 300 international units/kg (50 to 60 mcg/kg)

Precautions

US BOXED WARNING(S): INTRAVASCULAR HEMOLYSIS
This warning does NOT apply to Rho(D)-negative patients treated for the suppression of Rh isoimmunization.

• Intravascular hemolysis (IVH) leading to death has been reported in patients on this drug for immune thrombocytopenic purpura (ITP).
• IVH can lead to clinically compromising anemia and multi-system organ failure including acute respiratory distress syndrome (ARDS).
• Serious complications, including severe anemia, acute renal insufficiency, renal failure, and disseminated intravascular coagulation (DIC) have been reported.

Recommendations:

• Closely monitor patients for ITP in a healthcare setting for at least 8 hours after administration.
• Perform dipstick urinalysis to monitor for hematuria and hemoglobinuria at baseline and then after administration at 2 hours, 4 hours, and prior to the end of the monitoring period.
• Alert patients and monitor for signs and symptoms of IVH including back pain, shaking chills, fever, and discolored urine or hemoglobinuria.
• Absence of these signs or symptoms within 8 hours do not indicate that IVH cannot occur subsequently.
• If signs or symptoms of IVH are present or suspected, perform post-treatment laboratory tests including plasma hemoglobin, haptoglobin, LDH, and plasma bilirubin (direct and indirect).

Several Rho (D) immune globulin products are not for IV use. Verify the recommended route of administration for each product prior to dosing.

Rho (D) immune globulin should not be administered to the infant for the suppression of Rh isoimmunization in the mother.

If the dose requires the use of multiple vials, the dose may be injected at different injection sites at the same time or in intervals. The total dosage must be injected within 72 hours postpartum or after the transfusion accident.

The criteria for the administration of Rho (D) immune globulin for a Rh incompatible pregnancy are:
1. Mother must be Rho (D) negative.
2. The mother should not have been previously sensitized to the Rho (D) factor.
3. The infant must be Rho (D) positive and direct antiglobulin negative.

Babies born of women who have been given Rho (D) immune globulin antepartum may have a weakly positive antiglobulin test at birth.

Clinical response to treatment with Rho (D) IGIV by a patient with ITP should be ascertained by monitoring platelet counts, red cell counts, hemoglobin, and reticulocyte levels.

Maltose in IVIG products, such as the liquid formulation of WinRho SDF, has been shown to give false high blood glucose levels in certain types of blood glucose testing systems. Due to the potential for false elevated glucose readings, only testing systems that are glucose-specific should be used to test or monitor blood glucose levels in patients receiving this product.

Hyper RHO S/D Mini-Dose (R) should never be given intravenously.

Hyper RHO S/D Mini-Dose (R) should not be injected into the gluteal region because of the risk of injury to the sciatic nerve.

Dialysis

Data not available

Other Comments

Administration advice:

• Never administer HyperRHO S/D Mini-Dose(R) or BayRho-D Mini-Dose(R) intravenously.
• Administer separately from other drugs.

Monitoring:

• Observe patients for at least 20 minutes after administration.