Hyperrho S-D

Drug overview for HYPERRHO S-D (rho(d) immune globulin):

Generic name: RHO(D) IMMUNE GLOBULIN
Drug class: Rho(D) Immune Globulins
Therapeutic class: Biologicals

Rho(D) immune globulin contains anti-Rho(D) antibody to the red blood cell antigen Rho(D) and is prepared from plasma of Rho(D)-negative donors immunized with Rho(D)-positive red blood cells.

Rho(D) immune globulin is used to suppress the active antibody response and formation of anti-Rho(D) antibodies (i.e., Rh isoimmunization) in Rho(D)-negative women who have been exposed to Rho(D)-positive fetal red blood cells (RBCs) as the result of pregnancy or other obstetric conditions; prevention of Rh isoimmunization decreases the likelihood of hemolytic disease of the newborn (erythroblastosis fetalis) occurring if the woman has a subsequent pregnancy with an Rho(D)-positive fetus. Rho(D) immune globulin also is used to suppress isoimmunization in Rho(D)-negative individuals transfused with Rho(D)-positive blood or blood components (e.g., RBCs, platelets, granulocytes). In addition, certain preparations of Rho(D) immune globulin (Rhophylac(R), WinRho(R) SDF) are used to increase platelet counts to prevent excessive hemorrhage in nonsplenectomized, Rho(D)-positive individuals with acute or chronic idiopathic thrombocytopenic purpura (ITP; also known as immune thrombocytopenic purpura) or ITP secondary to human immunodeficiency virus (HIV) infection.

Rho(D) immune globulin is not indicated as replacement therapy in individuals with immunoglobulin deficiency syndromes. Several preparations of Rho(D) immune globulin are commercially available; some preparations may be administered IM or IV (Rhophylac(R), WinRho(R) SDF), while others are labeled for IM use only (MICRhoGAM(R), RhoGAM(R), HyperRHO(R) S/D Full Dose, HyperRHO(R) S/D Mini-Dose). When used for the treatment of ITP, Rho(D) immune globulin must be administered IV. When used for suppression of Rh isoimmunization, Rho(D) immune globulin may be administered either IV or IM.

DRUG IMAGES

HYPERRHO S-D 1,500 UNIT SYRING

The following indications for HYPERRHO S-D (rho(d) immune globulin) have been approved by the FDA:

Indications:
Prevention of Rh isoimmunization after blood transfusion
Prevention of Rh isoimmunization at first-trimester pregnancy termination
Prevention of rhesus isoimmunization affecting pregnancy

Professional Synonyms:
Prophylaxis of Rh isoimmunization at first-trimester pregnancy termination
Rh hemolytic disease of the newborn prophylaxis
Rh isoimmunization prophylaxis after blood transfusion
Suppression of rhesus isoimmunization

The following dosing information is available for HYPERRHO S-D (rho(d) immune globulin):

Dosing
Administration
Dosing Information
Generic

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.

For suppression of Rh isoimmunization in an unsensitized, Rho(D)-negative woman following delivery of an Rho(D)-positive infant, the usual dosage of HyperRHO(R) S/D Full Dose and RhoGAM(R) is one prefilled syringe containing a full dose (1500 units or 300 mcg) of Rho(D) immune globulin. The dose should be administered by IM injection, preferably within 72 hours after delivery. If multiple doses are required, such as in the case of a large fetal-maternal hemorrhage, the doses may be given at the same time (at different sites) or at spaced intervals, provided the entire dose is administered within 72 hours.

For routine antepartum prophylaxis in an unsensitized, Rho(D)-negative woman, one single-dose prefilled syringe containing a full dose (1500 units or 300 mcg) of Rho(D) immune globulin (HyperRHO(R) S/D Full Dose, RhoGAM(R)) should be administered by IM injection at approximately 26-28 weeks of gestation; a second single-dose prefilled syringe containing a full dose of Rho(D) immune globulin should be administered within 72 hours after delivery if the neonate is Rho(D)-positive.

Whenever a large fetal-maternal hemorrhage occurs during delivery, the manufacturer of HyperRHO(R) states that the number of single-dose prefilled syringes containing HyperRHO(R) S/D Full Dose that are required can be determined by dividing the packed RBC volume of the fetal-maternal hemorrhage by 15 mL; if the calculated dose results in a fraction of a single-dose prefilled syringe, the next whole number of syringes should be administered. Because methods used to determine the extent of fetal-maternal hemorrhage are imprecise, the manufacturer of RhoGAM(R) recommends that a dose of RhoGAM(R) exceeding 100 units (20 mcg) per mL of Rho(D)-positive RBCs should be considered whenever a large fetal-maternal hemorrhage or RBC exposure is suspected or documented.

For suppression of Rh isoimmunization after spontaneous or induced abortion occurring up to and including 12 weeks of gestation, the usual dosage of HyperRho(R) S/D Mini-Dose and MICRhoGAM(R) is one single-dose prefilled syringe containing a minidose (250 units or 50 mcg) of Rho(D) immune globulin administered by IM injection as soon as possible, within 72 hours following termination of pregnancy. A full dose may be administered if the minidose preparation is not available.

For suppression of Rh isoimmunization after spontaneous or induced abortion occurring at 13 or more weeks of gestation, the usual dosage of HyperRHO(R) S/D Full Dose and RhoGAM(R) is one single-dose prefilled syringe containing a full dose (1500 units or 300 mcg) of Rho(D) immune globulin administered by IM injection as soon as possible, within 72 hours following termination of pregnancy.

The usual dosage of HyperRHO(R) S/D Full Dose or RhoGAM(R) for suppression of Rh isoimmunization following amniocentesis, percutaneous umbilical blood sampling, chorionic villus sampling, ectopic pregnancy, or other abdominal trauma or obstetric manipulation during pregnancy is one single-dose prefilled syringe containing a full dose (1500 units or 300 mcg) of Rho(D) immune globulin administered by IM injection within 72 hours of the event. Following threatened abortion (with continuation of pregnancy) at any stage of gestation, the manufacturer of HyperRHO(R) S/D Full Dose states that a full dose of Rho(D) immune globulin should be administered. The manufacturer of RhoGAM(R) states that a full dose of Rho(D) immune globulin should be administered if threatened abortion (with continuation of pregnancy) occurs after 12 weeks of gestation, but that a minidose (250 units or 50 mcg) may be given if the event occurs at or before 12 weeks of gestation; a full dose may be administered if the minidose preparation (MICRhoGAM(R)) is not available.

The number of single-dose prefilled syringes containing a full dose (1500 units or 300 mcg) of Rho(D) immune globulin (HyperRHO(R) S/D Full Dose) to be administered by IM injection is determined by dividing the volume of Rho(D)-positive packed RBCs transfused by 15 mL.

For transfusions of less than 2.5 mL of Rho(D)-positive RBCs, a minidose of Rho(D) immune globulin (MICRhoGAM(R)) containing 250 units (50 mcg) may be administered; however, a full dose of the drug (RhoGAM(R) 1500 units or 300 mcg) should be given following transfusions of 2.5-15 mL of Rho(D)-positive RBCs.

Additional doses should be administered if the patient has been exposed to more than 15 mL of Rho(D)-positive RBCs; in these situations, the manufacturer of RhoGAM(R) recommends administration of 100 units (20 mcg) of Rho(D) immune globulin per mL of RBC exposure.

If the calculated dose of Rho(D) immune globulin results in a fraction of a prefilled syringe, the next whole number of single-dose prefilled syringes should be administered. Rho(D) immune globulin should be administered within 72 hours after an incompatible transfusion, but preferably as soon as possible. If multiple syringes are required, the total dose may be given by IM injection at the same time (at different sites) or at spaced intervals, provided the entire dose is administered within 72 hours.

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.

No dosing information available.

No generic dosing information available.

The following drug interaction information is available for HYPERRHO S-D (rho(d) immune globulin):

Contraindicated
Severe
Moderate

There are 1 contraindications. These drug combinations generally should not be dispensed or administered to the same patient. A manufacturer label warning that indicates the contraindication warrants inclusion of a drug combination in this category, regardless of clinical evidence or lack of clinical evidence to support the contraindication.

Drug Interaction	Drug Names
Selected Live Viral Vaccines/Rho Immunoglobulin 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.	ADENOVIRUS TYPE 4, ADENOVIRUS TYPE 4 AND TYPE 7, ADENOVIRUS TYPE 7, DENGVAXIA, FLUMIST 2025-2026, FLUMIST HOME 2025-2026, ROTARIX, ROTATEQ, STAMARIL, VARIVAX VACCINE, YF-VAX

Drug Interaction

Drug Names

Selected Live Viral Vaccines/Rho Immunoglobulin

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.

ADENOVIRUS TYPE 4, ADENOVIRUS TYPE 4 AND TYPE 7, ADENOVIRUS TYPE 7, DENGVAXIA, FLUMIST 2025-2026, FLUMIST HOME 2025-2026, ROTARIX, ROTATEQ, STAMARIL, VARIVAX VACCINE, YF-VAX

There are 2 severe interactions. These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.

Drug Interaction	Drug Names
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)	VYVGART, VYVGART HYTRULO
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)	IMAAVY

Drug Interaction

Drug Names

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)

VYVGART, VYVGART HYTRULO

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)

IMAAVY

There are 2 moderate interactions. The clinician should assess the patient’s characteristics and take action as needed. Actions required for moderate interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration.

Drug Interaction	Drug Names
Rubella Vaccine/Rho Immunoglobulin 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.	M-M-R II VACCINE, PRIORIX, PROQUAD
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)	RYSTIGGO

Drug Interaction

Drug Names

Rubella Vaccine/Rho Immunoglobulin

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.

M-M-R II VACCINE, PRIORIX, PROQUAD

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)

RYSTIGGO

The following contraindication information is available for HYPERRHO S-D (rho(d) immune globulin):

Overview
Contraindicated
Severe
Moderate

Drug contraindication overview.

No enhanced Contraindications information available for this drug.

There are 6 contraindications. Absolute contraindication.

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

There are 10 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
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

There are 3 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

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

The following adverse reaction information is available for HYPERRHO S-D (rho(d) immune globulin):

Overview
Severe
Less Severe

Adverse reaction overview.

No enhanced Common Adverse Effects information available for this drug.

There are 18 severe adverse reactions.

More Frequent	Less Frequent
None.	Hypotension Kidney disease with reduction in glomerular filtration rate (GFr)

Rare/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

There are 24 less severe adverse reactions.

More Frequent	Less Frequent
Chills Dizziness General weakness Headache disorder	Acute abdominal pain Arthralgia Diarrhea Drowsy Fever Hyperhidrosis Hyperkinesis Injection site sequelae Myalgia Pallor Skin rash Vasodilation of blood vessels

Rare/Very Rare
Anorexia Lower back pain Malaise Nausea Polydipsia Pruritus of skin Vomiting Weight gain

The following precautions are available for HYPERRHO S-D (rho(d) immune globulin):

Pediatric
Pregnant
Lactation
Geriatric

No enhanced Pediatric Use information available for this drug.

Contraindicated

None

Severe Precaution

None

Management or Monitoring Precaution

None

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.

No enhanced Geriatric Use information available for this drug.

The following icd codes are available for HYPERRHO S-D (rho(d) immune globulin)'s list of indications:

Prevention of rhesus isoimmunization affecting pregnancy
O36.01	Maternal care for anti-D [rh] antibodies
O36.011	Maternal care for anti-D [rh] antibodies, first trimester
O36.0110	Maternal care for anti-D [rh] antibodies, first trimester, not applicable or unspecified
O36.0111	Maternal care for anti-D [rh] antibodies, first trimester, fetus 1
O36.0112	Maternal care for anti-D [rh] antibodies, first trimester, fetus 2
O36.0113	Maternal care for anti-D [rh] antibodies, first trimester, fetus 3
O36.0114	Maternal care for anti-D [rh] antibodies, first trimester, fetus 4
O36.0115	Maternal care for anti-D [rh] antibodies, first trimester, fetus 5
O36.0119	Maternal care for anti-D [rh] antibodies, first trimester, other fetus
O36.012	Maternal care for anti-D [rh] antibodies, second trimester
O36.0120	Maternal care for anti-D [rh] antibodies, second trimester, not applicable or unspecified
O36.0121	Maternal care for anti-D [rh] antibodies, second trimester, fetus 1
O36.0122	Maternal care for anti-D [rh] antibodies, second trimester, fetus 2
O36.0123	Maternal care for anti-D [rh] antibodies, second trimester, fetus 3
O36.0124	Maternal care for anti-D [rh] antibodies, second trimester, fetus 4
O36.0125	Maternal care for anti-D [rh] antibodies, second trimester, fetus 5
O36.0129	Maternal care for anti-D [rh] antibodies, second trimester, other fetus
O36.013	Maternal care for anti-D [rh] antibodies, third trimester
O36.0130	Maternal care for anti-D [rh] antibodies, third trimester, not applicable or unspecified
O36.0131	Maternal care for anti-D [rh] antibodies, third trimester, fetus 1
O36.0132	Maternal care for anti-D [rh] antibodies, third trimester, fetus 2
O36.0133	Maternal care for anti-D [rh] antibodies, third trimester, fetus 3
O36.0134	Maternal care for anti-D [rh] antibodies, third trimester, fetus 4
O36.0135	Maternal care for anti-D [rh] antibodies, third trimester, fetus 5
O36.0139	Maternal care for anti-D [rh] antibodies, third trimester, other fetus
O36.019	Maternal care for anti-D [rh] antibodies, unspecified trimester
O36.0191	Maternal care for anti-D [rh] antibodies, unspecified trimester, fetus 1
O36.0192	Maternal care for anti-D [rh] antibodies, unspecified trimester, fetus 2
O36.0193	Maternal care for anti-D [rh] antibodies, unspecified trimester, fetus 3
O36.0194	Maternal care for anti-D [rh] antibodies, unspecified trimester, fetus 4
O36.0195	Maternal care for anti-D [rh] antibodies, unspecified trimester, fetus 5
O36.0199	Maternal care for anti-D [rh] antibodies, unspecified trimester, other fetus