Rh_o(D) Immune Globulin IV (Human) [RhIVIG]

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Rh_o(D) Immune Globulin IV (Human) [RhIVIG]

	Action
	Indications
	Contraindications
	Route/Dosage
	Interactions
	Lab Test Interferences
	Adverse Reactions
	Precautions
Patient Care Considerations
	Administration/Storage
	Assessment/Interventions
	Patient/Family Education

WinRho SDF

Class: Immune globulin

Action By binding Rh_o(D) antigen and red blood cells, RhIGIV prevents production of anti-Rh_o(D) antibodies in Rh_o(D) antigen-negative people, which prevents hemolytic disease of the fetus and newborn in subsequent Rh_o(DP) antigen-positive children. Increases platelets in immune thrombocytopenia purpura (ITP) patients.

Indications Treatment of ITP: Treatment of nonsplenectomized Rh_o(D)-positive children with chronic or acute ITP, adults with chronic ITP, or children and adults with ITP secondary to HIV infection. Suppression of Rh isoimmunization: Pregnancy and other obstetric conditions: Suppression of Rh isoimmunization in nonsensitized, Rh_o(D)-negative women after spontaneous or induced abortions, amniocentesis, chorionic 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. To warrant RhIGIV administration for an Rh-incompatible pregnancy, mother must be Rh_o(D)-negative, mother is carrying a child whose father is Rh_o(D)-positive or Rh_o(D) unknown, baby is Rh_o(D)-positive or Rh_o(D) unknown, and mother must not be previously sensitized to Rh_o(D) factor. Transfusion: Suppression of Rh isoimmunization in Rh_o(D)-negative female children and female adults in their childbearing years transfused with Rh_o(D)-positive RBCs or blood components containing Rh_o(D)-positive RBCs.

Contraindications Individuals known to have had an anaphylactic or severe systemic reaction to human globulin.

Route/Dosage

ITP

IV Initial dose of 50 mcg/kg (250 IU/kg) as a single dose or in 2 divided doses given on separate days; if patient has hemoglobin < 10 g/dL, reduce dose to 25 to 40 mcg/kg (125 to 200 IU/kg). If subsequent therapy is required to elevate platelet count, a dose of 25 to 60 mcg/kg (125 to 300 IU/kg) is recommended.

Pregnancy

IM/IV 300 mcg (1500 IU) given at 28 wk gestation. If administered early in pregnancy, administration at 12-wk intervals is recommended. Administer 120 mcg (600 IU) as soon as possible after delivery of a confirmed Rh_o(D) baby, normally no later than 72 hr after delivery. If Rh status of baby is not known at 72 hr, administer RhIGIV to mother 72 hr after delivery. If > 72 hr have elapsed, administer RhIGIV as soon as possible, up to 28 days after delivery.

Other Obstetric Conditions

IM/IV Administer 120 mcg (600 IU) immediately after abortion, amniocentesis (after 34 wk gestation) or any other manipulation late in pregnancy (after 34 wk gestation), associated with increased risk of Rh isoimmunization. Give RhIGIV within 72 hr after the event. IM/IV Administer 300 mcg (1500 IU) immediately after amniocentesis, before 34 wk gestation, or after chorionic villus sampling; repeat dose q 12 wk while woman is pregnant. In threatened abortion, give RhIGIV as soon as possible.

Transfusion

Administer within 72 hr after exposure for treatment of incompatible blood transfusions or massive fetal hemorrhage. IV When patient is exposed to Rh_o(D)-positive whole blood, administer 600 mcg (3000 IU) q 8 hr, until 9 mcg (45 IU)/mL of blood is given. When patient is exposed to Rh_o(D)-positive red blood cells, administer 600 mcg (3000 IU) q 8 hr, until 18 mcg (90 IU)/mL of cells is given. IM When patient is exposed to Rh_o(D)-positive whole blood, administer 1200 mcg (6000 IU) q 12 hr, until 12 mcg (60 IU)/mL of blood is given. When patient is exposed to Rh_o(D)-positive red blood cells, administer 1200 mcg (6000 IU) q 12 hr, until 24 mcg (120 IU)/mL of cells is given.

Interactions

Live virus vaccines (eg, measles, mumps, polio, rubella): RhIGIV may interfere with the response to live virus vaccines. INCOMPATIBILITIES: Do not administer RhIGIV concurrently with other products.

Lab Test Interferences Treatment of ITP: RhIGIV contains trace amounts of anti-A, anti-B, anti-C, and anti-E antibodies, which may be detectable in direct and indirect antiglobulin (eg, Coombs) tests obtained following RhIGIV administration. Suppression of Rh isoimmunization: Presence of passively administered anti-Rh_o(D) in maternal or fetal blood can lead to a positive direct antiglobulin (eg, Coombs) test.

Adverse Reactions

OTHER: Treatment of ITP: Headache, fever, chills. When RhIGIV is administered to Rh_o(D)-positive patients with ITP, side effects related to the destruction of Rh_o(D)-positive red blood cells (eg, decreased hemoglobin) can be expected. In most cases, RBC destruction is believed to occur in the spleen; however, signs and symptoms consistent with intravascular hemolysis (IVH), including back pain, shaking, chills, and hemoglobinuria may occur. Complications associated with IVH include death, acute onset or exacerbation of anemia, and acute onset or exacerbation of renal insufficiency. Suppression of Rh isoimmunization: Adverse reactions to RhIGIV are infrequent in Rh_o(D)-negative patients. Discomfort and slight swelling at site of injection and slight elevation in temperature have been reported. General: Asthenia; abdominal or back pain; hypotension; pallor; diarrhea; increased LDH; arthralgia; myalgia; dizziness; hyperkinesias; somnolence; vasodilatation; pruritus; rash; sweating; anaphylaxis.

Precautions

Pregnancy: Category C. Children: Do not administer to infants. Lactation: Undetermined. Infection: Because RhIGIV is made from human plasma, there is a risk of transmitting infectious agents (eg, viruses) and theoretically, Creutzfeldt-Jakob disease. Monitoring: When administering RhIGIV to Rh_o(D)-positive ITP patients, monitor for signs and symptoms of IVH, clinically compromising anemia, and renal insufficiency.

PATIENT CARE CONSIDERATIONS

Administration/Storage

Administer IV for treatment of ITP RhIGIV (human).
Use product within 12 hr of reconstitution; discard unused portion.
Infuse IV-administered dose into a suitable vein over 3 to 5 min, separately from other drugs.
Administer IM into deltoid muscle of upper arm or anterolateral aspects of upper thigh.
Administer total dose to patient within 72 hr.
Store in refrigerator; do not freeze.
If reconstituted product is not used immediately, store at room temperature for no longer than 12 hr; do not freeze reconstituted product; discard if not administered within 12 hr.
Confirm mother is Rh_o(D)-negative prior to administration.
Obtain blood type and direct antiglobulin test on infant immediately postpartum, prior to administration.

Assessment/Interventions

Obtain patient history, including drug history and any known allergies.
Observe injection site for tenderness or erythema.
Notify physician if fever, splenomegaly, myalgia, or lethargy develop.

Patient/Family Education

Tell patient to report fever, myalgia, lethargy, or abdominal pain to physician.
Instruct patient not to receive any live vaccines within 30 days before or 3 mo after administration of drug.
Explain how future Rh_o-positive infants will be protected.