rho(d) immune globulin

IM:

REMS

IV: Administered to Rh_o(D)-negative patients who have been exposed to Rh_o(D)-positive blood by:
- Pregnancy or delivery of a Rh_o(D)-positive infant;
- Abortion of a Rh_o(D)-positive fetus;
- Fetal-maternal hemorrhage due to amniocentesis, other obstetrical manipulative procedure, or intra-abdominal trauma while carrying a Rh_o(D)-positive fetus;
- Transfusion of Rh_o(D)-positive blood or blood products to a Rh_o(D)-negative patient.
IV: Management of immune thrombocytopenic purpura (ITP).

Action ⬆ ⬇

Prevent production of anti-Rh_o(D) antibodies in Rh_o(D)-negative patients who were exposed to Rh_o(D)-positive blood.
Increase platelet counts in patients with ITP.

Therapeutic effects:

Prevention of antibody response and hemolytic disease of the newborn (erythroblastosis fetalis) in future pregnancies of women who have conceived a Rh_o(D)-positive fetus.
Prevention of Rh_o(D) sensitization following transfusion accident.
Decreased bleeding in patients with ITP.

Pharmacokinetics ⬆ ⬇

Absorption: IV administration results in complete bioavailability. Well absorbed from IM sites.

Distribution: Unknown.

Metabolism/Excretion: Unknown.

Half-Life: 25–30 days.

Time/Action Profile ⬆ ⬇

(plasma concentrations)

ROUTE	ONSET	PEAK	DURATION
IM	rapid	5–10 days	unknown
IV‡	unknown	2 hr	unknown

‡When given for ITP, platelet counts start to rise in 1–2 days, peak after 5–7 days, and last for 30 days.

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Prior hypersensitivity reaction to human immune globulin;
Rh_o(D)- or Du-positive patients.

Use Cautiously in:

ITP patients with pre-existing anemia (↓ dose if Hgb <10 g/dL). May also cause disseminated intravascular coagulation in ITP patients.

Adv. Reactions/Side Effects ⬆ ⬇

CV: hypertension, hypotension

Derm: rash

GI: diarrhea, nausea, vomiting

GU: acute renal failure

Hemat: anemia, ITPDISSEMINATED INTRAVASCULAR COAGULATION, INTRAVASCULAR HEMOLYSIS

Local: pain at injection site

MS: arthralgia, myalgia

Neuro: dizziness, headache

Misc: fever

Interactions ⬆ ⬇

Drug-drug:

May ↓ antibody response to some live-virus vaccines (measles, mumps, rubella).

Route/Dosage ⬆ ⬇

Rho(D) Immune Globulin (for IM use only)

Following Delivery
IM (Adults ): HyperRHO S/D Full Dose, RhoGAM: 1 vial standard dose (300 mcg) within 72 hr of delivery.
Before Delivery
IM (Adults ): HyperRHO S/D Full Dose, RhoGAM: 1 vial standard dose (300 mcg) at 26–28 wk.
Termination of Pregnancy (<13 wk Gestation)
IM (Adults ): HyperRHO S/D Mini-Dose, MICRhoGAM: 1 vial of microdose (50 mcg) within 72 hr.
Termination of Pregnancy (>13 wk Gestation)
IM (Adults ): RhoGAM: 1 vial standard dose (300 mcg) within 72 hr.
Large Fetal-Maternal Hemorrhage (>15 mL)
IM (Adults ): RhoGAM: 20 mcg/mL of Rh_o(D)-positive fetal RBCs.
Transfusion Accident
IM (Adults ): HyperRHO S/D Full Dose, RhoGAM: (Volume of Rh-positive blood administered × Hct of donor blood)/15 = number of vials of standard dose (300 mcg) preparation (round to next whole number of vials).

Rho(D) Immune Globulin IV (for IM or IV Use)

Following Delivery
IM IV (Adults ): WinRho SDF: 120 mcg within 72 hr of delivery. Rhophylac: 300 mcg within 72 hr of delivery.
Prior to Delivery
IM IV (Adults ): WinRho SDF, Rhophylac: 300 mcg at 28 wk; if initiated earlier in pregnancy, repeat every 12 wk.
Following Amniocentesis or Chorionic Villus Sampling
IM IV (Adults ): WinRho SDF (before 34 wk gestation): 300 mcg immediately; repeat every 12 wk during pregnancy. Rhophylac: 300 mcg within 72 hr of procedure.
Termination of Pregnancy, Amniocentesis, or Any Other Manipulation
IM IV (Adults ): WinRho SDF: 120 mcg within 72 hr after event.
Large Fetal-Maternal Hemorrhage/Transfusion Accident
IM (Adults ): WinRho SDF: 1200 mcg every 12 hr until total dose is given (total dose determined by amount of blood loss/hemorrhage).
IV (Adults ): WinRho SDF: 600 mcg every 8 hr until total dose is given (total dose determined by amount of blood loss/hemorrhage).
Immune Thrombocytopenic Purpura
IV (Adults and Children ): WinRho SDF, Rhophylac: 50 mcg/kg initially (if Hgb <10 g/dL, ↓ dose to 25–40 mcg/kg); further dosing/frequency determined by clinical response (range 25–60 mcg/kg). Each dose may be given as a single dose or in 2 divided doses on separate days.

Availability ⬆ ⬇

Rho(D) Immune Globulin (for IM Use)

Solution for injection (prefilled syringes): 50 mcg (microdose: MICRhoGAM, HyperRHO S/D Mini-Dose); 300 mcg (standard dose: RhoGAM, HyperRHO S/D Full Dose)

Rho(D) Immune Globulin Intravenous (for IM or IV Use)

Injection: 300 mcg/vial; 500 mcg/vial; 3000 mcg/vial
Prefilled syringes: 300 mcg/2 mL

Assessment ⬆ ⬇

IV: Assess vital signs periodically during therapy in patients receiving IV Rh_o(D) immune globulin.
ITP: Monitor for signs/symptoms of intravascular hemolysis (back pain, shaking chills, fever, hemoglobinuria), anemia, and renal impairment. If transfusions are required, use Rh_o(D)-negative packed red blood cells to prevent exacerbation of intravascular hemolysis.

Lab Test Considerations:

Pregnancy: Type and crossmatch of mother and newborn’s cord blood must be performed to determine need for medication. Mother must be Rh_o(D)-negative and Du-negative. Infant must be Rh_o(D)-positive. If there is doubt regarding infant’s blood type or if father is Rh_o(D)-positive, medication should be given.
- An infant born to a woman treated with Rh_o(D) immune globulin antepartum may have a weakly positive direct Coombs test result on cord or infant blood.
- ITP: Monitor platelets, RBCs, hemoglobin, and reticulocytes to determine effectiveness of therapy.

Implementation ⬆ ⬇

Do not give to infant, to Rh_o(D)-positive individual, or to Rh_o(D)-negative individual previously sensitized to the Rh_o(D) antigen. However, there is no more risk than when given to a woman who is not sensitized. When in doubt, administer Rh_o(D) immune globulin.
Do not confuse IM and IV formulations. Rh immune globulin for IV administration is labeled "Rh Immune Globulin Intravenous." Rh Immune Globulin Intravenous may be given IM; however, Rh Immune Globulin (microdose and standard dose) is for IM use only and cannot be given IV.
- When using prefilled syringes, allow solution to reach room temperature before administration.
IM: Reconstitution: Reconstitute Rho(D) immune globulin IV for IM use immediately before use with 1.25 mL of 0.9% NaCl. Inject diluent onto inside wall of vial and wet pellet by gently swirling until dissolved. Do not shake.
- Administer into the deltoid muscle. Dose should be given within 3 hr but may be given up to 72 hr after delivery, miscarriage, abortion, or transfusion.

IV Administration:

Patient/Family Teaching ⬆ ⬇

Pregnancy: Explain to patient that the purpose of this medication is to protect future Rh_o(D)-positive infants.
ITP: Explain purpose of medication to patient.
Advise patient to notify health care provider if presence of dark urine, back pain, fever, chills, less urine passed, swelling, sudden weight gain, shortness of breath, rash, dizziness, or shaking. Symptoms can happen within 4–8 hr and up to 72 hr after dose.
Advise patient to notify health care provider of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care provider before taking other medications.

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Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇