Rhophylac (Rho(D) immune globulin)

Preparations of Rho(D) immune globulin for IM use only are commercially available in single-dose prefilled syringes containing a full dose (standard dose) of Rho(D) immune globulin (HyperRHO(R) S/D Full Dose, RhoGAM(R)) or in single-dose prefilled syringes containing a minidose of Rho(D) immune globulin (HyperRHO(R) S/D Mini-Dose, MICRhoGAM(R)). Each single-dose prefilled syringe containing a full dose of Rho(D) immune globulin contains enough anti-Rho(D) (approximately 300 mcg) to suppress the immunization potential of 15 mL of Rho(D)-positive packed red blood cells (RBCs). Each single-dose prefilled syringe of minidose Rho(D) immune globulin contains enough anti-Rho(D) to suppress the immunization potential of 2.5 mL of Rho(D)-positive packed RBCs or the equivalent (5 mL) of whole blood.

Single-dose vials of Rho(D) immune globulin for IV or IM administration (WinRho(R) SDF) containing 1500 units (300 mcg) contain enough anti-Rho(D) to suppress the immunization potential of 17 mL of Rho(D)-positive RBCs. Single-dose prefilled syringes of Rho(D) immune globulin for IV or IM administration (Rhophylac(R)) contain enough anti-Rho(D) (1500 units or 300 mcg) to suppress the immunization potential of at least 15 mL of Rho(D)-positive RBCs.

Rho(D) immune globulin is administered IV or IM. Certain preparations (i.e., HyperRHO(R) S/D Full Dose, HyperRHO(R) S/D Mini-Dose, MICRhoGAM(R), RhoGAM(R)) are for IM injection only and should not be administered IV. Other preparations (i.e., Rhophylac(R), WinRho(R) SDF) may be administered either IV or IM. For indications related to the suppression of Rh isoimmunization, Rho(D) immune globulin may be administered IV or IM; however, when used for the treatment of idiopathic thrombocytopenic purpura (ITP; also known as immune thrombocytopenic purpura), Rho(D) immune globulin must be administered by IV injection. Efficacy of Rho(D) immune globulin for suppression of Rh isoimmunization appears to be similar following IV or IM administration.

For suppression of Rh isoimmunization related to an Rh-incompatible pregnancy, Rho(D) immune globulin is administered to the mother and should not be administered to the infant. Prior to administration of Rho(D) immune globulin, appropriate laboratory tests should be performed to assess the Rh status of the woman and determine whether she was previously sensitized to the Rho(D) antigen. (See Precautions and Contraindications Related to Use for Suppression of Rh Isoimmunization under Cautions: Precautions and Contraindications.)

Solutions of Rho(D) immune globulin should be inspected visually for particulate matter and discoloration prior to administration. Some preparations (Rhophylac(R), WinRho(R) SDF) should be brought to room temperature prior to administration. Vials and prefilled syringes of Rho(D) immune globulin are for single use only and contain no preservatives; any unused solution should be discarded.

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Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.

Rho Immunoglobulin/Selected Live Viral Vaccines

SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.

MECHANISM OF ACTION: Immune globulin products may prevent the immune system from properly responding to the vaccine.(1-6)

CLINICAL EFFECTS: Administration of a live viral vaccine after immunoglobulins may impair the efficacy of the vaccine.(1-6) Administration of immunoglobulins within 2-4 weeks after a live viral vaccine impair the efficacy of the vaccine.(1-6)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: Administration of a live viral vaccine should be postponed for three months in patients who have received immunoglobulin therapy, including Rho immunoglobulin.(1-6) If a live viral vaccine is given within two to four weeks of rho immunoglobulin, then repeat vaccination three months after the completion of immunoglobulin should be considered.(2-4)

DISCUSSION: Administration of a live viral vaccine after immunoglobulins(1-6) or administration of immunoglobulins after a live vaccine(3) may impair the efficacy of the vaccine.

Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

Igg Antibodies And Derivatives/Efgartigimod-Alfa

SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

MECHANISM OF ACTION: The neonatal Fc receptor (FcRn) prevents catabolism and mediates recycling of IgG and albumin, which leads to their long persistence in the body.(1,2) Efgartigimod-alfa binds to FcRn and may decrease systemic exposure of other ligands of FcRn, like immunoglobulins and IgG-based antibodies.(3)

CLINICAL EFFECTS: The effectiveness of medicines that bind to FcRn may be decreased.(3)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: The manufacturer of efgartigimod-alfa states that efgartigimod-alfa should not be combined with long-term use of FcRn-binding medications. If the medication is essential for the patient, efgartigimod-alfa should be discontinued.(3)

DISCUSSION: Clinical drug interaction studies with efgartigimod-alfa have not been performed. Efgartigimod-alfa may decrease concentrations of compounds that bind to the human FcRn.(3)

Igg Antibodies And Derivatives/Nipocalimab-Aahu

SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

MECHANISM OF ACTION: The neonatal Fc receptor (FcRn) prevents catabolism and mediates recycling of IgG and albumin, which leads to their long persistence in the body.(1,2) Nipocalimab-aahu binds to FcRn and may decrease systemic exposure of other ligands of FcRn, like immunoglobulins and IgG-based antibodies.(3)

CLINICAL EFFECTS: The effectiveness of medicines that bind to FcRn may be decreased.(3)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: The manufacturer of nipocalimab-aahu states that nipocalimab-aahu should not be combined with long-term use of FcRn-binding medications. If the medication is essential for the patient, nipocalimab-aahu should be discontinued.(3)

DISCUSSION: Clinical drug interaction studies with nipocalimab-aahu have not been performed. Nipocalimab-aahu may decrease concentrations of compounds that bind to the human FcRn.(3)

Moderate Interaction: Assess the risk to the patient and take action as needed.

Igg Antibodies And Derivatives/Rozanolixizumab-Noli

SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.

MECHANISM OF ACTION: The neonatal Fc receptor (FcRn) prevents catabolism and mediates recycling of IgG and albumin, which leads to their long persistence in the body.(1,2) Rozanolixizumab-noli binds to FcRn and may decrease systemic exposure of other ligands of FcRn, like immunoglobulins and IgG-based antibodies.(3)

CLINICAL EFFECTS: The effectiveness of medications that bind to FcRn may be decreased.(3)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: The manufacturer of rozanolixizumab-noli states that concurrent use with medications that bind to the human neonatal Fc receptor (FcRn) should be closely monitored for reduced effectiveness of these medications. If long-term use of such medications is essential for the patient, consider discontinuing rozanolixizumab-noli and use alternative therapies.(3)

DISCUSSION: Clinical drug interaction studies with rozanolixizumab-noli have not been performed. Rozanolixizumab-noli may decrease concentrations of compounds that bind to the human FcRn.(3)

Rho Immunoglobulin/Rubella Vaccine

SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.

MECHANISM OF ACTION: Immune globulin products may prevent the immune system from properly responding to the vaccine.(1-6)

CLINICAL EFFECTS: Administration of live rubella vaccine after immunoglobulins may impair the efficacy of the vaccine.(1-6) Administration of immunoglobulins within 2-4 weeks after a live viral vaccine impair the efficacy of the vaccine.(1-6)

PREDISPOSING FACTORS: The amount of antigen-specific antibody present in the administered immunoglobulin product determines the duration of the interaction.(7)

PATIENT MANAGEMENT: Due to the importance of rubella immunity in women of child-bearing age, and the low dose of anti-Rho immunoglobulin administered, postpartum vaccination of rubella-susceptible women with rubella or MMR should not be delayed.(7) CDC recommendations state the low dose of anti-Rho globulin administered to postpartum women has not been demonstrated to reduce the response to the RA27/3 strain of rubella vaccine.(7) Vaccination should be performed immediately after delivery. If possible, test for immune response to rubella and measles three or more months after vaccination and repeat the vaccine if necessary.(6,7) Administration of live rubella vaccine should be postponed for 3 to 11 months in patients who have received other types of immunoglobulin therapy.(1-7) If live rubella vaccine is given and administration of an immune globulin becomes necessary within 14 days, vaccination should be repeated unless serologic testing indicates a protective antibody response.(7)

DISCUSSION: CDC Immunization Recommendations(7) provide discussions, charts, and further details regarding appropriate use and timing of vaccine therapy.

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• Autoimmune hemolytic anemia
• Disseminated intravascular coagulation
• Hemolysis
• IgA deficiency
• Intravascular hemolysis
• Transfusion related acute lung injury

• Acute renal failure
• Atherosclerotic cardiovascular disease
• Bed-ridden
• Cryoglobulinemia
• Dehydration
• Hypertriglyceridemia
• Increased risk of bleeding due to coagulation disorder
• Monoclonal gammopathy
• Severe anemia
• Thrombotic disorder

• Diabetes mellitus
• Kidney disease with reduction in glomerular filtration rate (GFr)
• Sepsis

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Less Frequent

• Hypotension
• Kidney disease with reduction in glomerular filtration rate (GFr)

Rare or Very Rare

• Acute renal failure
• Acute respiratory distress syndrome
• Anaphylaxis
• Anemia
• Bruising
• Disseminated intravascular coagulation
• Dyspnea
• Dysuria
• Edema
• Hematuria
• Hypertension
• Increased risk of bleeding
• Intravascular hemolysis
• Multiple organ failure
• Severe anemia
• Thromboembolic disorder

More Frequent

• Chills
• Dizziness
• General weakness
• Headache disorder

Less Frequent

• Acute abdominal pain
• Arthralgia
• Diarrhea
• Drowsy
• Fever
• Hyperhidrosis
• Hyperkinesis
• Injection site sequelae
• Myalgia
• Pallor
• Skin rash
• Vasodilation of blood vessels

Rare or Very Rare

• Anorexia
• Lower back pain
• Malaise
• Nausea
• Polydipsia
• Pruritus of skin
• Vomiting
• Weight gain

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Rho(D) immune globulin is used IM or IV to suppress the active antibody response to Rho(D) and formation of anti-Rho(D) antibodies in unsensitized, Rho(D)-negative women with an Rh-incompatible pregnancy. Rh incompatibility is assumed if the fetus/neonate is either Rho(D)-positive or Rho(D)-unknown or if the father is either Rho(D)-positive or Rho(D)-unknown. The American College of Obstetricians and Gynecologists (ACOG) and other experts recommend routine antenatal prophylaxis with Rho(D) immune globulin at approximately 28 weeks of gestation in all Rho(D)-negative women who have not been previously sensitized to the Rho(D) antigen, unless the father of the fetus is known to be Rho(D)-negative; the recommended timing of this dose is typically at 28 weeks of gestation, but may range from 26 to 30 weeks of gestation. Another dose of Rho(D) immune globulin should be administered within 72 hours after delivery if the neonate is Rho(D)-positive. If the Rho(D) type of an infant born to an Rho(D)-negative mother cannot be determined within this time period, the infant should be assumed to be Rho(D)-positive and a postpartum dose of Rho(D) immune globulin should be administered to the mother at 72 hours after delivery. If Rho(D) immune globulin is administered at any time during pregnancy because of suspected fetal-maternal hemorrhage (e.g., threatened abortion, amniocentesis, chorionic villus sampling, percutaneous umbilical blood sampling, abdominal trauma), a postpartum dose must still be administered to the mother following delivery of an Rho(D)-positive infant. In addition, if Rho(D) immune globulin is administered early in the pregnancy (before 26-28 weeks of gestation), additional antepartum doses should be administered (e.g., at 12-week intervals) to maintain an adequate level of passively acquired anti-Rho(D) antibody throughout the pregnancy.

Clinical studies have shown that administration of Rho(D) immune globulin to the mother within 72 hours after delivery of a full-term infant reduces the incidence of development of active antibody response and formation of anti-Rho(D) from 12-13% to 1-2%. The 1-2% failure rate probably is due to Rh isoimmunization occurring during the latter part of pregnancy or following delivery. The incidence of Rh isoimmunization can be further reduced to about 0.1-0.2% by administering a 2-dose regimen of Rho(D) immune globulin that involves administering an antepartum dose at 28 weeks of gestation in addition to the postpartum dose.

In a study evaluating use of Rho(D) immune globulin for suppression of Rh isoimmunization in unsensitized, Rho(D)-negative pregnant women in cases when the blood type of the father of the fetus was Rho(D)-positive or unknown, Rho(D) immune globulin doses of 600 units (120 mcg) or 1200 units (240 mcg) were given to the mother at 28 weeks of gestation or, alternatively, doses of 1200 units (240 mcg) were given at both 28 and 34 weeks of gestation. A postpartum dose of 600 units (120 mcg) was administered to any of these women who delivered an Rho(D)-positive infant. There was no evidence of Rh isoimmunization in women who received both the antepartum and postpartum doses of Rho(D) immune globulin and who were evaluated for Rh isoimmunization 6 months after delivery.

Animal reproduction studies have not been performed with Rho(D) immune globulin. Available evidence suggests that administration of Rho(D) immune globulin for the suppression of Rh isoimmunization during pregnancy does not have adverse effects on the fetus or future pregnancies and does not adversely affect the reproduction capacity of the mother. Rho(D) immune globulin has not been evaluated systematically in pregnant women with ITP; when treatment is indicated, therapy with corticosteroids and/or immune globulin IV (IGIV) generally is recommended. Infants born to women who received antepartum Rho(D) immune globulin may have a weakly positive direct antiglobulin (Coombs') test at birth.

Rhophylac(R) is used in nursing women for the suppression of Rh isoimmunization; no adverse effects are expected during breastfeeding. Rho(D) immune globulin has not been evaluated in nursing women with ITP. It is not known whether Rho(D) immune globulin is distributed into human milk; because many drugs are distributed into milk, caution is advised when Rho(D) immune globulin is administered to nursing women.

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