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|Rho

Rh _o (D) Immune Globulin

Trade Names:
HyperRHO S/D Mini-Dose
- Solution for injection 15% to 18% protein, with glycine 0.21 to 0.32 M

Trade Names:
MICRhoGAM
- Solution for injection ultra-filtered 50 mcg

Trade Names:
RhoGAM
- Solution for injection ultra-filtered 300 mcg

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

Trade Names:
WinRho SDF
- Powder for injection, lyophilized 600 units (120 mcg)
- Powder for injection, lyophilized 1,500 units (300 mcg)
- Powder for injection, lyophilized 5,000 units (1,000 mcg)
- Liquid for injection 600 units (120 mcg)
- Liquid for injection 1,500 units (300 mcg)
- Liquid for injection 2,500 units (500 mcg)
- Liquid for injection 5,000 units (1,000 mcg)
- Liquid for injection 15,000 units (3,000 mcg)

Mechanism of Action

Pharmacology

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 people. Prevention of Rh sensitization, in turn, prevents hemolytic disease of fetus and newborn in subsequent Rh _o (D) antigen–positive children.

Pharmacokinetics

Absorption

T _max is 2 h (IV) or 5 to 10 days (IM). C _max is 36 to 48 ng/mL (IV) or 18 to 19 ng/mL (IM).

Bioavailability is 69% (IM); 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).

Elimination

The t _½ is about 24 days (IV) or about 30 days (IM).

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).

Indications and Usage

At the time of spontaneous or induced abortion of up to 12 wk gestation provided: 1) the mother is Rh _o (D)-negative and not sensitized to Rh _o (D)-antigen, 2) the father is not known to be Rh _o (D)-negative, and 3) gestation is not more than 12 wk at termination.

Including the following (unless the father or baby are conclusively Rh-negative): pregnancy/delivery of an Rh-positive baby irrespective of the ABO groups of the mother and baby; abortion/threatened abortion at any stage of gestation; ectopic pregnancy; antepartum fetal-maternal hemorrhage (suspected or proven) resulting from antepartum hemorrhage (eg, placenta previa), amniocentesis, chorionic villus sampling, percutaneous umbilical blood sampling, other obstetrical manipulative procedure (eg, version) or abdominal trauma; transfusion of Rh-incompatible blood or blood products.

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).

Suppression of Rh isoimmunization in nonsensitized Rh _o (D)-negative women; 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). Criteria for an Rh-incompatible pregnancy requiring administration at 28 to 30 wk gestation and within 72 h include the following: mother must be Rh _o (D)-negative; father must be Rh _o (D)-negative or Rh _o (D)-unknown; baby must be Rh _o (D)-positive or Rh _o (D)-unknown; and mother must not be previously sensitized to the Rh _o (D) factor.

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.

Treatment of ITP must be given IV when an increase in platelet count occurs to prevent excessive hemorrhage in treating nonsplenectomized, Rh _o (D)-negative: 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 in nonsensitized Rh _o (D)-negative women 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. Criteria requiring administration at 29 wk gestation and within 72 h after delivery in a Rh _o (D)-negative mother include the following: 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 have been previously sensitized to Rh _o (D) factor.

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.

Contraindications

Hypersensitivity to thimerosal, any immune globulin, or any of the product"s components. Do not administer to an infant when used for suppression of Rh isoimmunization.

Any indication with continuation of pregnancy or beyond 12 wk gestation.

Dosage and Administration

IM 1 syringe of HyperRHO S/D Mini-Dose provides sufficient antibody to prevent Rh sensitization to Rh _o (D)-positive packed RBCs 2.5 mL or the equivalent (5 mL) of whole blood. This dose is sufficient to provide protection against maternal Rh sensitization for women undergoing spontaneous or induced abortion of up to 12 wk gestation. Administer within 3 h or as soon as possible following spontaneous or induced abortion. If prompt administration is not possible, give within 72 h after termination of pregnancy.

IM A single dose, approximately 50 mcg, is contained in each prefilled syringe. This dose suppresses the immune response to Rh-positive RBCs 2.5 mL. MICRhoGAM is indicated within 72 h after termination of pregnancy up to and including wk 12 of gestation. At or beyond wk 13 of gestation, administer RhoGAM instead of MICRhoGAM .

IM A single dose, approximately 300 mcg, is contained in each prefilled syringe. This is the usual dose for the indications associated with pregnancy unless there is clinical or laboratory evidence of a fetal-maternal hemorrhage in excess of 15 mL of Rh-positive RBCs. Administer RhoGAM within 72 h of known or suspected exposure to Rh-positive RBCs. If RhoGAM is administered for one of the indications listed below 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. Multiple doses of RhoGAM are required if fetal-maternal hemorrhage exceeds 15 mL, which is possible but unlikely prior to the third trimester of pregnancy, and is most likely at delivery. Patients known or suspected to be at increased risk of fetal-maternal hemorrhage should be tested by qualitative or quantitative methods. A single dose of RhoGAM will suppress the immune response after exposure to 15 mL or less of Rh-positive RBCs. Because laboratory methods used to determine the amount of exposure (volume of transfusion or fetal-maternal hemorrhage) to Rh-positive RBCs are imprecise, administration of more than 20 mcg of RhoGAM per mL of Rh-positive RBCs should be considered whenever a large fetal-maternal hemorrhage or RBC exposure is suspected or known.

Administer 300 mcg (if abortion or termination of pregnancy occurs up to and including 12 wk gestation, or less than 2.5 mL of Rh-incompatible RBCs are administered, a single dose of MICRhoGAM [approximately 50 mcg] may be used instead of RhoGAM ).

If newborn is Rh-positive, administer 300 mcg (additional doses of RhoGAM are indicated when the patient has been exposed to more than 15 mL of Rh-positive RBCs).

Administer 300 mcg for the following indications:

• prophylaxis at 26 to 28 wk gestation (if antepartum prophylaxis is indicated, it is essential that the mother receive a postpartum dose if the infant is Rh-positive)
• amniocentesis, chorionic villus sampling, and percutaneous umbilical blood sampling
• abdominal trauma or obstetrical manipulation
• ectopic pregnancy (if abortion or termination of pregnancy occurs up to and including 12 wk gestation, or less than 2.5 mL of Rh-incompatible RBCs are administered, a single dose of MICRhoGAM [approximately 50 mcg] may be used instead of RhoGAM ).

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 greater than 10 g/dL, redose between 50 and 60 mcg/kg. If the Hgb is less than 8 g/dL, administer with caution.

IM/IV Administer 300 mcg of Rh _o (D) at 28 to 30 wk gestation for routine antepartum prevention or postpartum prevention (within 72 h).

IM/IV Administer 300 mcg at 28 wk gestation. If administered early in the pregnancy, administration at 12-wk intervals is recommended. Administer a 120 mcg dose 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.

IM/IV Administer 300 mcg for obstetric complications or invasive procedures during pregnancy (see Indications).

IM/IV Administer a 120 mcg dose 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. Administration should be within 72 h after the event. Give a 300 mcg dose immediately after amniocentesis (before 34 wk gestation) or after chorionic villus sampling. Repeat this dose every 12 wk while pregnant. In case of threatened abortion, give as soon as possible.

IM/IV Administer 20 mcg of anti-D IgG per 2 mL of transfused Rh _o (D)-positive blood or per 1 mL of Rh _o (D)-positive erythrocyte concentrate.

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

Storage/Stability

Store at 35° to 46°F. Do not freeze. Protect Rhophylac from light.

Drug Interactions

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).

Adverse Reactions

Cardiovascular

Hypertension; hypotension; tachycardia; vasodilation.

CNS

Headache; asthenia; dizziness; hyperkinesia; malaise; somnolence.

Dermatologic

Pruritus; rash; sweating.

GI

Abdominal pain; diarrhea; nausea; vomiting.

Genitourinary

Hemoglobinuria.

Hematologic-Lymphatic

Anemia; DIC; hemoglobinemia; intravascular hemolysis.

Lab Tests

Bilirubin elevated; creatinine elevated; haptoglobin decreased; LDH increased.

Local

Induration; mild pain; redness; soreness; swelling.

Musculoskeletal

Arthralgia; back pain; myalgia.

Renal

Acute renal insufficiency.

Miscellaneous

Allergic or anaphylactic reactions; chills; cutaneous reactions; death; dyspnea; fever; pallor; shock; slight temperature elevation.

Precautions

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.

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.

IM administration

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

Infection

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

Rh isoimmunization suppression

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

Overdosage

Symptoms

Risk of hemolytic reaction.

Patient Information

• Explain name, dose, action, and potential adverse reactions of the drug.
• Obtain patient history, including drug history and any known allergies.
• 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.
• Advise women to notify health care provider if pregnant, planning to become pregnant, or breast-feeding.
• Caution patient to not take any prescription or OTC medications, herbal preparations, or dietary supplements unless advised by health care provider.
• Advise patients that follow-up visits may be necessary and to keep appointments.