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Rh _o (D) Immune Globulin

( RhIG ) Pronunciation: (ih-MYOON GLOB-yoo-lin)
Class: Immune globulin

Trade Names:
HyperRHO S/D Full-Dose
- Injection 15% to 18% protein

Trade Names:
HyperRHO S/D Mini-Dose
- Injection 15% to 18% protein

Trade Names:
MICRhoGAM
- Injection 250 units (50 mcg)

Trade Names:
RhoGAM
- Injection 1,500 units (300 mcg)

Trade Names:
Rhophylac
- Injection 1,500 units (300 mcg)

Trade Names:
WinRho SDF
- Injection 600 units (120 mcg)
- Injection 1,500 units (300 mcg)
- Injection 2,500 units (500 mcg)
- Injection 5,000 units (1,000 mcg)
- Injection 15,000 units (3,000 mcg)

Pharmacology

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By binding Rh _o (D) antigen on RBCs, RhIG prevents production of anti-Rh _o (D) (anti-D) antibodies in Rh _o (D) antigen–negative patients. Prevention of Rh sensitization, in turn, prevents hemolytic disease of fetus and newborn in subsequent Rh _o (D) antigen–positive children.

Pharmacokinetics

Absorption

Rhophylac

Bioavailability is 69%; C _max is 62 to 84 ng/mL after 1 day (IV); C _max is 7 to 46 ng/mL between 2 and 7 days (IM).

MICRhoGAM , RhoGAM

C _max is 54 ng/mL. T _max is 4 days.

Distribution

MICRhoGAM , RhoGAM

Vd is 7.3 L.

Elimination

The half-life is about 30 days (IM).

Rhophylac

Mean systemic Cl is 0.2 mL/min and t _½ is 16 days (IV); mean apparent Cl is 0.29 mL/min, and t _½ is 18 days (IM).

MICRhoGAM , RhoGAM

Elimination half-life is 30.9 days; Cl is 150.4 mL/day.

Indications and Usage

HyperRHO S/D Full-Dose

Prevention of Rh hemolytic disease of the newborn; suppression of Rh isoimmunization in nonsensitized Rh _o (D)–negative women following spontaneous or induced abortion following ruptured tubal pregnancy, amniocentesis, or abdominal trauma; for prevention of isoimmunization in Rh _o (D)–negative individuals who have been transfused with Rh _o (D)–positive RBCs or blood components containing RBCs.

HyperRHO S/D Mini-Dose , MICRhoGAM Ultra-Filtered Plus

Prevent isoimmunization of Rh _o (D)–negative women at the time of spontaneous or induced abortion of up to 12 weeks' gestation; for prevention of Rh immunization in Rh _o (D)–negative individuals after incompatible transfusion of Rh-positive blood or blood products ( MICRhoGAM only).

RhoGAM Ultra-Filtered Plus

For administration to Rh-negative women not previously sensitized to the Rh _o (D) factor after delivery of an Rh-positive baby irrespective of the ABO groups of the mother and baby, antepartum prophylaxis at 26 to 28 weeks' gestation, antepartum fetomaternal hemorrhage, amniocentesis, chorionic villus sampling, ectopic pregnancy, abdominal trauma, percutaneous umbilical sampling, other obstetrical manipulative procedure, or actual or threatened abortion; for prevention of Rh immunization in any Rh-negative person after incompatible transfusion of Rh-positive blood or blood products (eg, RBCs, platelet concentrates, granulocyte concentrates).

Rhophylac Immune thrombocytopenic purpura (ITP)

To raise platelet counts in Rh _o (D)–positive, nonsplenectomized adult patients with chronic ITP.

Suppression of Rh isoimmunization

Suppression of Rh isoimmunization in nonsensitized Rh _o (D)–negative women, including routine antepartum and postpartum Rh prophylaxis; rhesus prophylaxis in case of obstetric complications (eg, miscarriage, abortion, threatened abortion, ectopic pregnancy or hydatidiform mole, transplacental hemorrhage resulting from antepartum hemorrhage); rhesus prophylaxis in case of invasive procedures during pregnancy (eg, amniocentesis, chorionic biopsy or obstetric manipulative procedures [eg, external version], abdominal trauma).

Transfusion

Suppression of Rh isoimmunization in Rh _o (D)–negative female children and adults during their childbearing years who have been transfused with Rh _o (D)–positive RBCs or blood components containing Rh _o (D)–positive RBCs.

WinRho SDF ITP

Treatment of ITP must be given IV when an increase in platelet count occurs to prevent excessive hemorrhage in treating Rh _o (D)–positive, nonsplenectomized: 1) children with chronic or acute ITP, 2) adults with chronic ITP, or 3) children and adults with ITP secondary to HIV infection.

Suppression of Rh isoimmunization

Suppression of Rh isoimmunization in nonsensitized Rh _o (D)–negative women 72 h after spontaneous or induced abortions, amniocentesis, chronic villus sampling, ruptured tubal pregnancy, abdominal trauma, or transplacental hemorrhage, or in the normal course of pregnancy unless the blood type of fetus or father is known to be Rh _o (D) negative.

Transfusion

Contraindications

Hypersensitivity to any immune globulin or any of the product's components. Do not administer to an infant when used for suppression of Rh isoimmunization; persons deficient in immunoglobulin (Ig) A.

MICRhoGAM , RhoGAM

Rh-positive individuals.

Dosage and Administration

HyperRHO S/D Full-Dose
Pregnancy and Other Obstetric Conditions Adults

Postpartum prophylaxis

Administer 1 HyperRHO S/D Full-Dose syringe, preferably within 72 h of delivery. One full-dose syringe provides sufficient antibody to prevent Rh sensitization if the RBC volume that entered the circulation is 15 mL or less. If a large (more than 30 mL of whole blood or 15 mL of RBCs) fetomaternal hemorrhage is suspected, perform a fetal RBC count by an approved laboratory technique to determine the required immune globulin dose. The RBC volume of the fetomaternal hemorrhage is divided by 15 mL to obtain the number of full-dose syringes to be administered.

Antenatal prophylaxis

Administer 1 syringe (1,500 units) at approximately 26 to 28 weeks' gestation, followed by another full dose, preferably within 72 h following delivery, if the infant is Rh positive.

Threatened abortion

It is recommended that a full dose be given at any stage of gestation with continuation of pregnancy. If more than 15 mL of RBCs is suspected because of fetomaternal hemorrhage, the dose modification previously discussed in postpartum prophylaxis applies.

Miscarriage, abortion, or termination of ectopic pregnancy at or beyond 13 weeks' gestation

It is recommended that a full dose be given. If more than 15 mL of RBCs is suspected because of fetomaternal hemorrhage, the dose modification previously discussed in postpartum prophylaxis applies. If pregnancy is terminated prior to 13 weeks' gestation, a single-dose HyperRHO S/D Mini-Dose may be used instead of HyperRHO S/D Full-Dose .

Amniocentesis

Following amniocentesis at either 13 or 18 weeks' gestation or during the third trimester, or following abdominal trauma in the second or third trimester, obstetrical manipulation, CVS, or percutaneous blood sampling, it is recommended that a full dose be administered within 72 h of exposure. If there is a fetomaternal hemorrhage in excess of 15 mL of RBCs, the dose modification discussed above in postpartum prophylaxis applies. If abdominal trauma, amniocentesis, or other adverse reaction requires giving HyperRHO S/D Full-Dose at 13 to 18 weeks' gestation, give another full dose at 26 to 28 wk. To maintain protection throughout pregnancy, the level of passively acquired anti-Rh _o (D) should not fall below the level required to prevent immune response to Rh-positive red cells. Give a HyperRHO S/D Full-Dose within 72 h after delivery if the baby is Rh positive. If delivery occurs within 3 wk after the last dose, the postpartum dose may be withheld unless there is a fetomaternal hemorrhage in excess of 15 mL of RBCs.

Transfusion

The volume of Rh-positive whole blood given is multiplied by the hematocrit of the donor unit giving the volume of RBC transfused. The volume of RBCs is divided by 15 mL, which provides the number of syringes of HyperRHO S/D Full-Dose to be administered within 72 h.

MICRhoGAM and HyperRHO S/D Mini-dose
Pregnancy and Other Obstetric Conditions Adults

IM Actual or threatened termination of pregnancy (spontaneous or induced) up to 12 weeks' gestation: Administer 50 mcg within 72 h. RhoGAM may be administered if MICRhoGAM is not available.

Transfusion of Rh-incompatible blood or blood products (MICRhoGAM only)

IM Less than 2.5 mL of Rh-positive RBCs: Administer 50 mcg of MICRhoGAM . RhoGAM may be administered if MICRhoGAM is not available.

RhoGAM
Pregnancy and Other Obstetric Conditions Adults

Postpartum

If the newborn is Rh-positive, administer 300 mcg within 72 h of delivery. Additional doses are indicated when the patient has been exposed to more than 15 mL of Rh-positive RBCs. This may be determined by use of qualitative or quantitative tests for fetal-maternal hemorrhage. Antepartum (prophylaxis at 26 to 28 weeks' gestation): Administer within 72 h of suspected or proven exposure to Rh-positive RBCs resulting from amniocentesis, chronic villus sampling, or percutaneous umbilical blood sampling, abdominal trauma or obstetrical manipulation, ectopic pregnancy, threatened pregnancy loss after 12 weeks' gestation with continuation of pregnancy; pregnancy termination [spontaneous or induced] beyond 12 weeks' gestation). Administer 300 mcg. If antepartum prophylaxis is indicated, it is essential that the mother receive a postpartum dose if the infant is Rh-positive. If RhoGAM is administered early in pregnancy (before 26 to 28 wk), there is an obligation to maintain a level of passively acquired anti-D by administration of RhoGAM at 12-wk intervals.

Transfusion

IM 300 mcg. Additional doses are indicated when the patient has been exposed to more than 15 mL of Rh-positive RBCs. Administer 20 mcg of RhoGAM per mL of Rh-positive RBC exposure. Multiple doses may be administered at the same time or at spaced intervals, as long as the total dose is administered within 72 h of exposure.

Rhophylac
ITP

IV 50 mcg/kg. Administer at a rate of 2 mL per 15 to 60 sec.

Suppression of Rh Isoimmunization Pregnancy

IM / IV Administer 300 mcg at 28 to 30 weeks' gestation for routine antepartum prevention or postpartum prevention (within 72 h of birth).

Rh-Incompatible Pregnancy Excessive Fetomaternal Hemorrhage (more than 15 mL)

IM / IV Within 72 h of complications, 300 mcg plus 20 mcg/mL fetal RBCs in excess of 15 mL if excess transplacental bleeding is quantified, or an additional 300 mcg dose if excess transplacental bleeding cannot be quantified.

Other Obstetric Considerations

IM / IV 300 mcg within 72 h of complications or invasive procedures.

Transfusion

IM / IV 20 mcg per 2 mL of transfused blood or per 1 mL of erythrocyte concentrate.

WinRho SDF
ITP

IV Initial dose of 50 mcg/kg as a single injection. The initial dose may be given in 2 divided doses on separate days, if desired. If the hemoglobin level is less than 10 g/dL, reduce the dose to 25 to 40 mcg/kg. If subsequent treatment is needed to elevate platelet counts, an IV dose of 25 to 60 mcg/kg is recommended. If the patient responds to the initial dose with a satisfactory increase in platelets, the maintenance dosing, 25 to 60 mcg/kg, is individualized based on platelet and Hgb levels. If the patient does not respond to the initial dose, give a subsequent dose based on Hgb. If Hgb is between 8 and 10 g/dL, redose between 25 and 40 mcg/kg. If Hgb is more than 10 g/dL, redose between 50 and 60 mcg/kg. If the Hgb is less than 8 g/dL, administer with caution.

Suppression of Rh Isoimmunization Pregnancy

IM / IV 300 mcg at 28 weeks' gestation. If administered early in the pregnancy, administration at 12-wk intervals is recommended. A 120 mcg dose should be given as soon as possible after delivery of a confirmed Rh _o (D)–positive baby and no later than 72 h after delivery. If the Rh status of the baby is not known at 72 h, administer to the mother at 72 h after delivery. If more than 72 h have elapsed, do not withhold but administer as soon as possible up to 28 days after delivery.

Other Obstetric Considerations

IM / IV 120 mcg dose immediately after abortion, amniocentesis (after 34 weeks' gestation), or any other manipulation late in pregnancy (after 34 weeks' gestation) associated with increased risk of Rh isoimmunization. Administration should be within 72 h after the event. Give a 300 mcg dose immediately after amniocentesis (before 34 weeks' gestation) or after chorionic villus sampling. Repeat this dose every 12 wk while pregnant. In case of threatened abortion, give as soon as possible.

Transfusion

IM / IV If exposed to Rh _o (D)–positive whole blood, give 9 mcg/mL of blood IV or 12 mcg/mL of blood IM. If exposed to Rh _o (D)–positive RBCs, give 18 mcg/mL of cells IV or 24 mcg/mL of cells IM.

General Advice

HyperRHO S/D Full-Dose
Do not inject IV. For IM use only, preferably in the anterolateral aspects of the upper thigh and the deltoid muscle of the upper arm.
Do not inject neonate.
The entire contents of a single dose syringe may be injected into the patient.
If the dose consists of multiple syringes, the total volume can be given in divided doses at different sites at one time or the total dose may be divided and injected at intervals, provided the total dosage is given within 72 h of the fetomaternal hemorrhage or transfusion.
If more than 15 mL of D-positive fetal RBCs are present in the mother's circulation, more than a single syringe of HyperRHO S/D Full-Dose is required; failure to recognize this may result in an inadequate dose.

HyperRHO S/D Mini-Dose
Do not inject IV. For IM use only, preferably in the anterolateral aspects of the upper thigh and the deltoid muscle of the upper arm.
Administer only to women post-abortion or post-miscarriage of up to 12 weeks' gestation.

MICRhoGAM , RhoGAM
Do not inject IV. For IM use only.
In the case of postpartum use, the products are intended for maternal administration only. Do not inject the newborn.

Rhophylac , WinRHo SDF
IV: Inject rapidly over 3 to 5 min.
IM: Administer into the deltoid muscle of the upper arm or the anterolateral aspects of the upper thigh.

Storage/Stability

Store at 36° to 46°F. Do not freeze. Protect Rhophylac from light.

Drug Interactions

Live virus vaccines (eg, measles, mumps, polio, rubella)

May interfere with response to live virus vaccines. Postpone dosing of live vaccines for 3 mo.

Incompatibility

Do not coadminister RhIG IV with other products.

Laboratory Test Interactions

Infants born of women given RhIG antepartum may have weakly positive antiglobulin (Coombs) test results at birth. Anti-Rh antibodies may be detected in maternal serum within several wk of RhIG administration. Such findings do not preclude further RhIG doses. Presence of RhIG antibodies in maternal blood sample can affect interpretation of tests to identify patient as candidate for RhIG. In case of doubt as to patient's Rh group or immune status, give RhIG. Fetal-maternal hemorrhage late in pregnancy or following delivery may cause weak, mixed-field positive D ^u test results. If there is any doubt about mother's Rh type, give RhIG. Screening tests for RBCs may help in such cases. WinRho SDF contains maltose, which may give falsely high blood glucose levels when certain types of blood glucose testing are used (eg, glucose-dye-oxidoreductase method). Rh _o (D) immune globulin may affect the results of blood typing, the antibody screening test, and the direct antiglobulin (Coombs) test. Antepartum administration of Rh _o (D) immune globulin to the mother can also affect these tests in the newborn. Rhophylac can contain antibodies to other Rh antigens (eg, anti-C antibodies), which might be detected by sensitive serological tests following administration. WinRho SDF contains trace amounts of anti-A, anti-B, anti-C, anti-E, and other blood group antibodies (eg, anti-Duffy, anti-Kidd antibodies) that may be detectable in direct and indirect antiglobulin (Coombs) tests obtained following RhIG administration. Interpretation of direct and indirect antiglobulin tests must be made in the context of the patient's underlying clinical condition and supporting laboratory data.

Adverse Reactions

Cardiovascular

Hypertension, hypotension, tachycardia, vasodilation.

CNS

Headache (11%); asthenia, dizziness, hyperkinesia, malaise, somnolence, vertigo (postmarketing).

Dermatologic

Cutaneous reactions, pruritus, rash, sweating; erythema (postmarketing).

GI

Abdominal pain, diarrhea, nausea, vomiting.

Genitourinary

Hemoglobinuria.

Hematologic-Lymphatic

Increased blood bilirubin (21%); anemia, DIC, extravascular hemolysis, hemoglobinemia, intravascular hemolysis.

Lab Tests

Bilirubin elevated, creatinine elevated, decreased hemoglobin, haptoglobin decreased, LDH increased.

Local

Discomfort and slight swelling at the injection site, induration, pain, redness, soreness, swelling, warmth (postmarketing).

Musculoskeletal

Arthralgia, back pain, myalgia.

Renal

Acute renal insufficiency.

Respiratory

Dyspnea (postmarketing).

Miscellaneous

Chills (35%); pyrexia (31%); allergic or anaphylactic reactions, body aches, death, dyspnea, fever, pallor, shivering, shock, slight temperature elevation, weakness; hypersensitivity (postmarketing).

Precautions

Monitor

When administering Rhophylac or WinRho SDF to ITP patients, monitor for signs and symptoms of clinically compromising anemia, DIC, intravascular hemolysis, and renal function impairment. WinRho SDF contains maltose, which can cause falsely elevated glucose levels. Use a glucose-specific test or monitor blood glucose levels. Observe patients for at least 20 min after administration.

Pregnancy

Category C .

Lactation

Undetermined.

Children

For suppression of Rh isoimmunization in the mother, do not administer to infants.

Renal Function

Renal function impairment may occur in patients predisposed to acute renal failure or who have renal insufficiency.

Allergy

Allergic response, including anaphylactoid reactions, may occur.

Allergy history

Use with caution in patients with a history of prior systemic allergic reactions following administration of human immunoglobulin preparations.

Hematologic/Lymphatic

Bleeding complications may occur in patients with thrombocytopenia or other bleeding disorders. Use with extreme caution in patients with Hgb less than 8 g/dL.

IgA deficiency

Persons with specific IgA deficiency have increased potential for developing antibodies to IgA and could have anaphylactic reactions to subsequent administration of blood products containing IgA.

IM administration

As with other drugs administered by IM injection, give RhIG with caution to patients on anticoagulant therapy.

Infection

Because RhIG is made from human plasma, there is a risk of transmitting infectious agents (eg, viruses) and, theoretically, Creutzfeldt-Jakob disease.

Intravascular hemolysis

ITP patients presenting with signs and symptoms of intravascular hemolysis and its complications after anti-D administration should have confirmatory laboratory testing that may include, but is not limited to, CBC, haptoglobin, plasma hemoglobin, urine dipstick, assessment of renal function and liver function, and DIC-specific tests.

Rh isoimmunization suppression

Do not administer WinRho SDF to Rh _o (D)–negative persons who are Rh immunized as evidenced by an indirect antiglobulin (Coombs) test revealing the presence of the anti-D antibody.

Transfusion

If ITP patients are to be transfused, Rh _o (D)–negative RBCs should be used so as not to exacerbate ongoing hemolysis.

Overdosage

Symptoms

Risk of hemolytic reaction.

Patient Information

Instruct patient not to receive any live vaccines within 30 days before or 3 mo after administration of drug.
Explain how future Rh _o (D)–positive infants will be protected.
Instruct patients to report the following symptoms to health care provider: abdominal pain, back pain, chills, decreased urine output, discolored urine, fever, fluid retention, lethargy, myalgia, shaking, shortness of breath, and sudden weight loss.