RHo (D) immune globulin

Adverse events (AE) after administration of RhoGAM (rho(d) immune globulin (human)) Ultra-Filtered and MICRhoGAM (rho(d) immune globulin (human)) Ultra-Filtered are reported infrequently.

The most frequently reported AEs are anti-D formation and skin reactions, such as swelling, induration, redness and mild pain at the site of injection. Systemic allergic reactions to RhoGAM (rho(d) immune globulin (human)) or MICRhoGAM (rho(d) immune globulin (human)) are extremely rare. There have been no reported fatalities due to anaphylaxis or any other cause related to RhoGAM (rho(d) immune globulin (human)) or MICRhoGAM (rho(d) immune globulin (human)) administration.

As with any Rho(D) Immune Globulin (Human), administration to patients who have received Rh-positive red blood cells may result in signs and symptoms of a hemolytic reaction, including fever, back pain, nausea and vomiting, hypo- or hypertension, hemoglobinuria/emia, elevated bilirubin and creatinine and decreased haptoglobin.

You should not receive this medication if you have ever had an allergic reaction to an immune globulin or if you have immune globulin A (IgA) deficiency with antibody to IgA. You should not receive RHo (D) immune globulin if you have hemolytic anemia (a lack of red blood cells).

Before you receive this medication, tell your doctor if you have heart disease or a history of coronary artery disease, high triglycerides, a bleeding disorder, or immune globulin A (IgA) deficiency.

If you are an Rh-negative woman and you become pregnant, you must tell your doctor if you have ever been exposed to Rh-positive blood in your lifetime. This includes exposure from a mismatched blood transfusion, or exposure during your first pregnancy. Your history of exposure and treatment will be extremely important to each and every one of your pregnancies.

Call your doctor at once if you have a serious side effect such as fever, chills, shaking, back pain, dark colored urine, rapid breathing, feeling short of breath, urinating less than usual, swelling, rapid weight gain, pale skin, easy bruising or bleeding, rapid heart rate, trouble concentrating, feeling light-headed.

Do not receive a "live" vaccine for at least 3 months after treatment with RHo (D) immune globulin. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), Bacillus Calmette-Guérin (BCG), oral polio, rotavirus, smallpox, typhoid, yellow fever, varicella (chickenpox), H1N1 influenza, and nasal flu vaccine.

Call your doctor for instructions if you miss an appointment for your RHo (D) immune globulin injection.

You should not receive this medicine if you have ever had an allergic reaction to an immune globulin, or if you have:

• immune globulin A (IgA) deficiency with antibody to IgA; or

• hemolytic anemia (a lack of red blood cells).

To make sure RHo (D) immune globulin is safe for you, tell your doctor if you have:

• a history of anemia;

• heart disease or a history of coronary artery disease (hardened arteries);

• a bleeding disorder (such as hemophilia);

• high triglycerides (a type of fat in the blood);

• kidney disease; or

• diabetes.

RHo (D) immune globulin is often used during and after pregnancy. This medicine is not known to be harmful to a baby during pregnancy or while breast-feeding.

If you are receiving this medication to treat a mismatched blood transfusion, tell your doctor if you are pregnant or if you ever plan to become pregnant.

If you are an Rh-negative woman and you become pregnant, you must tell your doctor if you have ever been exposed to Rh-positive blood in your lifetime. This includes exposure from a mismatched blood transfusion, or exposure during your first pregnancy. Your history of exposure and treatment will be extremely important to each and every one of your pregnancies.

RHo (D) immune globulin is made from human plasma (part of the blood) which may contain viruses and other infectious agents. Donated plasma is tested and treated to reduce the risk of it containing infectious agents, but there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

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

Live Vaccines

Antibodies present in immune globulin preparations may interfere with the immune response to measles, mumps, and rubella virus vaccine live (MMR), varicella virus vaccine live, and fixed combination of MMR and varicella vaccine (MMRV);1 14 15 16 25 33 no evidence of interference with the immune response to influenza virus vaccine live intranasal, rotavirus vaccine live oral, yellow fever virus vaccine live, typhoid vaccine live oral, or zoster vaccine live.33 (See Specific Drugs and Laboratory Tests under Interactions.)

Postpartum administration of Rho(D) IG has not been shown to reduce the response to rubella vaccine RA27/3 strain.33 Rubella and varicella immunity are important in women of childbearing potential.33 The ACIP recommends administering the appropriate vaccine immediately after delivery in women susceptible to rubella and/or varicella; do not delay administration because the woman received antepartum or postpartum Rho(D) IG.33 If possible, perform serologic tests ≥3 months after vaccination to ensure immunity to rubella and, if necessary, to measles.16 33

Inactivated Vaccines and Toxoids

Immune globulin preparations not expected to have a clinically important effect on immune responses to inactivated vaccines or toxoids; inactivated vaccines, recombinant vaccines, polysaccharide vaccines, and toxoids may be administered simultaneously with (using different syringes and different injection sites) or at any interval before or after Rho(D) IG.33

Specific Drugs and Laboratory Tests

Absorption

Bioavailability

Following IM administration of Rho(D) IG, peak serum concentrations are achieved in 2–7 days.1 16 25

Following IV administration of Rho(D) IG, peak serum concentrations are achieved in 30 minutes.1

Rhophylac: Bioavailability of Rho(D) IG administered IM is approximately 69% of Rho(D) IG administered IV.25

Distribution

Extent

Not known whether distributed into milk.1

Elimination

Half-life

IM administration: 18–31 days.1 16 25

IV administration: Approximately 16–24 days.1 25

• Anti-D Immunoglobulin
• RhIG
• Rho(D) Immune Globulin (Human)
• RhoIGIV
• RhoIVIM

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Solution, Injection:

WinRho SDF: 2500 units/2.2 mL (2.2 mL); 5000 units/4.4 mL (4.4 mL); 1500 units/1.3 mL (1.3 mL); 15,000 units/13 mL (13 mL)

Solution, Injection [preservative free]:

WinRho SDF: 2500 units/2.2 mL (2.2 mL); 5000 units/4.4 mL (4.4 mL); 1500 units/1.3 mL (1.3 mL); 15,000 units/13 mL (13 mL) [contains polysorbate 80]

Solution Prefilled Syringe, Injection [preservative free]:

Rhophylac: 1500 units/2 mL (2 mL)

Solution Prefilled Syringe, Intramuscular:

HyperRHO S/D: 250 units (1 ea [DSC])

Solution Prefilled Syringe, Intramuscular [preservative free]:

HyperRHO S/D: 250 units (1 ea); 1500 units (1 ea) [latex free]

MICRhoGAM Ultra-Filtered Plus: 250 units (1 ea) [latex free, thimerosal free; contains polysorbate 80]

RhoGAM Ultra-Filtered Plus: 1500 units (1 ea) [latex free, thimerosal free; contains polysorbate 80]

Immune thrombocytopenia (ITP): Children and Adolescents: WinRho SDF: Refer to adult dosing.

There are no dosage adjustments provided in the manufacturer’s labeling.