Treating With HyperRHO S/D1

HyperRHO S/D is an immune globulin with a high level of preformed antibodies against rhesus (Rh)-positive blood cells.

The injection of an RHo(D) immune globulin provides a passive immunity for rapid immune protection and an acute response in high-risk situations.

HyperRHO S/D destroys any Rh-positive blood cells that may have entered the mother's bloodstream and prevents the mother's immune system from producing Rh-positive antibodies, thus protecting the baby from developing hemolytic disease.

*BD UltraSafe Plus™ passive needle guard is a registered trademark of Becton, Dickinson and Company.

Trusted Dependability

  • Four-step virus removal and inactivation process
  • The only Rhₒ(D) immune globulin product with US Food and Drug Administration (FDA) labeling for capacity to remove pathogenic prions1-4
  • Not made with Mercury (thimerosal) or natural rubber latex1,5
  • BD UltraSafe Plus™ passive needle guard* to protect against needlestick injury
  • Grifols only uses plasma from qualified donors 
    • Each unit of plasma is extensively tested and subjected to careful controls to protect its quality through a multiphase production process
    • PediGri® provides additional information related to the quality and safety of Grifols plasma derivatives and can be accessed at www.pedigri.grifols.com

Provide Immediate and Effective Protection With HyperRHO S/D1,5,6

Immediate Protection1

Each single-dose syringe of HyperRHO S/D contains sufficient anti-Rho(D) to effectively suppress the immunizing potential of 15 mL of Rh-positive red blood cells.

Antepartum and postpartum administration of a single dose of HyperRHO S/D to susceptible Rh-negative women reduces the incidence of Rh isoimmunization to less than 0.1%.

 

Effective Protection1,5,6

HyperRHO S/D destroys Rh-positive cells in the mother's body, prevents the mother's immune system from producing Rh-positive antibodies, and protects the baby from contracting HDN.

Reliability5

Dosing consistent with the American College of Obstetricians and Gynecologists (ACOG) practice guidelines.

Convenience1,6

Low-volume, fully assembled, prefilled syringes

HyperRHO® S/D Full Dose (Rho[D] immune globulin [human]) is indicated for the prevention of Rh HDN and the prevention of isoimmunization in Rho(D)-negative individuals who have been transfused with Rho(D)-positive blood or blood components containing red blood cells.

HyperRHO® S/D Mini-Dose (Rho[D] immune globulin [human]) is recommended to prevent the isoimmunization of Rho(D)-negative women at the time of spontaneous or induced abortion of up to 12 weeks' gestation provided the following criteria are met:

  1. The mother must be Rho(D) negative and must not already be sensitized to the Rhₒ(D) antigen.
  2. The father is not known to be Rho(D) negative.
  3. Gestation is not more than 12 weeks at termination.

How Does HyperRHO S/D Full Dose Prevent HDN?1

Mother receives a HyperRHO S/D Full Dose injection during week 28 of the pregnancy, before Rh-positive antibodies have formed.

HyperRHO S/D Full Dose protects the mother and baby by preventing the development of Rh-positive antibodies.

Within 72 hours after the baby's delivery, the mother receives a second dose of HyperRHO S/D Full Dose if the baby is Rh positive.

Clinical Efficacy

A clinical study of 1579 women to assess the protection against sensitization to the Rh antigen found that 6 months after delivery, the efficacy of HyperRHO S/D was7:

  • 99.5% in women with an ABO-compatible pregnancy
  • 100% in other women

Administering HyperRHO S/D within 72 hours of birth to a full term, Rh-positive infant whose mother is Rh-negative reduces the rate of Rh sensitization from 12-13% to 1-2%1

Safety Is a Priority

Product Information

For more than 55 years, produced with an unwavering commitment to safety, HyperRHO S/D has been a reliable treatment choice for Rh-negative pregnant women.8

Manufacturing Process1,6

The HyperRHO S/D manufacturing process was investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the Creutzfeldt-Jakob disease (CJD) and variant CJD agents.

4-Step Purification Process

The HyperRHO S/D manufacturing process includes steps with the capacity to inactivate and remove viruses*

Cold ethanol fractionation

Virus removal by precipitation

Depth filtration

Virus removal

Solvent/detergent (S/D) treatment

Enveloped virus inactivation

Incubation of the final preparation in container for 21-28 days at 20 °C to 27 °C

Virus inactivation

*These steps contribute to the virus clearance capacity

HyperRHO S/D is made from human blood and may carry a risk of transmitting infectious agents, eg, viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

Traceability and Transparency of Information9

Grifols' manufacturing process has a comprehensive computer system called PediGri® that ensures full traceability from every donation.

  • Each plasma unit is coded and computer-traced from the start of the process until the units are transformed into a final product
  • Users can access the donation number and the viral screening conducted at the origin of the donation with the product lot number
    • Specific information is also available, including the total number of plasma units, the total volume of plasma, the certificate of analysis showing the plasma origin viral screening, and biochemical characteristics of the final product
  • Users can access the applicable product SPC/package insert for their country

For immediate, easy, and convenient access to all information on the origin and quality of Grifols' plasma derivatives, visit www.pedigri.grifols.com

Dosing Recommendations for HyperRHO S/D1,6

Postpartum prophylaxis—preferably within 72 hours of delivery

Indication

If volume of red blood cells that has entered the circulation is ≤15 mL
Dosage

1500 IU or 300 mcg IM

If large (>30 mL whole blood or 15 mL red blood cells) fetomaternal hemorrhage is suspected
Dosage

Fetal red blood cell count should be performed to determine dosage. See complete Prescribing Information

Indication Dosage

If volume of red blood cells that has entered the circulation is ≤15 mL

1500 IU or 300 mcg IM

If large (>30 mL whole blood or 15 mL red blood cells) fetomaternal hemorrhage is suspected

Fetal red blood cell count should be performed to determine dosage. See complete Prescribing Information

Antenatal prophylaxis

Indication

At approximately 28 weeks' gestation. Then, postpartum, preferably within 72 hours of delivery, if infant is Rh positive
Dosage

1500 IU or
300 mcg IM

Indication Dosage

At approximately 28 weeks' gestation. Then, postpartum, preferably within 72 hours of delivery, if infant is Rh positive

1500 IU or
300 mcg IM

Other obstetric conditions

Indication

Following threatened abortion at any stage of gestation with continuation of pregnancy*†
Dosage

1500 IU or 300 mcg IM

Following miscarriage, abortion, or termination of ectopic pregnancy at or beyond 13 weeks' gestation*†
Dosage

1500 IU or 300 mcg IM

If pregnancy is terminated up to 12 weeks’ gestation
Dosage

250 IU or 50 mcg IM Mini-Dose

Following amniocentesis at 15 to 18 weeks' gestation or during third trimester*†
Dosage

1500 IU or 300 mcg IM

Following abdominal trauma in second or third trimester*†
Dosage

1500 IU or 300 mcg IM

Transfusion
Dosage

For dosage calculation, see complete Prescribing Information

*If >15 mL of red blood cells are suspected due to fetomaternal hemorrhage, see "postpartum prophylaxis" above.
†If abdominal trauma, amniocentesis, or another adverse event required administration of HyperRHO S/D at 13 to 18 weeks' gestation, another 1500-IU dose should be given at 26 to 28 weeks' gestation.
IM, intramuscular.

*If >15 mL of red blood cells are suspected due to fetomaternal hemorrhage, see "postpartum prophylaxis" above.
†If abdominal trauma, amniocentesis, or another adverse event required administration of HyperRHO S/D at 13 to 18 weeks' gestation, another 1500-IU dose should be given at 26 to 28 weeks' gestation.
IM, intramuscular.
Indication Dosage

Following threatened abortion at any stage of gestation with continuation of pregnancy*†

1500 IU or 300 mcg IM

Following miscarriage, abortion, or termination of ectopic pregnancy at or beyond 13 weeks' gestation*†

1500 IU or 300 mcg IM

If pregnancy is terminated up to 12 weeks’ gestation

250 IU or 50 mcg IM Mini-Dose

Following amniocentesis at 15 to 18 weeks' gestation or during third trimester*†

1500 IU or 300 mcg IM

Following abdominal trauma in second or third trimester*†

1500 IU or 300 mcg IM

Transfusion

For dosage calculation, see complete Prescribing Information

Coding Information

Coding System

HCPCS (Healthcare Common Procedure Coding System) Codes*
Coding for HyperRHO S/D

J2790

Dosage

Injection, (Rho[D] immune globulin [human]), Full Dose, 300 mcg (1500 IU)

Coding for HyperRHO S/D

J2788

Dosage

Injection, (Rhₒ[D] immune globulin [human]), Mini-Dose 50 mcg (250 IU)

Administration Procedures CPT Code†
Coding for HyperRHO S/D

96372

Dosage

Therapeutic, prophylactic, or diagnostic injection (specify substance or drug); subcutaneous or intramuscular

ICD-10-CM‡
Coding for HyperRHO S/D

229.13

Dosage

Encounter for prophylactic Rhₒ(D) immune globulin

Coding for HyperRHO S/D

231.82

Dosage

Encounter for Rh incompatibility status

Coding for HyperRHO S/D

O43.011

Dosage

Fetomaternal placental transfusion syndrome, first trimester

Coding for HyperRHO S/D

O43.012

Dosage

Fetomaternal placental transfusion syndrome, second trimester

Coding for HyperRHO S/D

O43.013

Dosage

Fetomaternal placental transfusion syndrome, third trimester

Coding for HyperRHO S/D

O43.019

Dosage

Fetomaternal placental transfusion syndrome, unspecified trimester

Coding for HyperRHO S/D

O00.11

Dosage

Tubal pregnancy

Coding for HyperRHO S/D

O00.8

Dosage

Other ectopic pregnancy

Coding for HyperRHO S/D

O03.89

Dosage

Complete or unspecified spontaneous abortion with other complications

Coding for HyperRHO S/D

O03.9

Dosage

Complete or unspecified spontaneous abortion without complication

Coding for HyperRHO S/D

O20.0

Dosage

Threatened abortion

Coding for HyperRHO S/D

O36.0110

Dosage

Maternal care for anti-D [Rh] antibodies, first trimester, not applicable or unspecified

Coding for HyperRHO S/D

O36.0120

Dosage

Maternal care for anti-D [Rh] antibodies, second trimester, not applicable or unspecified

Coding for HyperRHO S/D

O36.0130

Dosage

Maternal care for anti-D [Rh] antibodies, third trimester, not applicable or unspecified

Coding for HyperRHO S/D

O36.0190

Dosage

Maternal care for anti-D [Rh] antibodies, unspecified trimester, not applicable or unspecified

Full Dose NDC§
Coding for HyperRHO S/D

13533-0631-02

Dosage

Full Dose single prefilled syringe 1500 IU IM (300 mcg)

Full Dose NDC§
Coding for HyperRHO S/D

13533-0631-11

Dosage

Full Dose prefilled syringe (10 pack) 1500 IU IM (300 mcg)

Mini-Dose NDC§
Coding for HyperRHO S/D

13533-0661-06

Dosage

Mini-Dose prefilled syringe (10 pack) 250 IU IM (50 mcg)

*Centers for Medicare and Medicaid Services (CMS). HCPCS file located at: http://www.cms.gov/Medicare/Coding/HCPCSReleaseCodeSets/Alpha-Numeric-HCPCS.html.
†Current Procedural Terminology (CPT) 5-digit codes, nomenclature, and other data are ®2019 American Medical Association (AMA).
‡Optum, ICD-10-CM for Hospitals and Payers, Volumes 1, 2, and 3, publisher of the official code set issued by the Department of Health and Human Services.
§For billing purposes, an 11-digit National Drug Code (NDC) is required.

The information is provided for informational purposes only and is subject to change. Providers are encouraged to contact their payers for specific information. Coding rules and guidelines are subject to payer discretion and should always be verified by the paying entity. Healthcare providers make the ultimate determination as to when to use a specific product, based on clinical appropriateness for a patient. This guide is not intended to provide specific guidance on how to use, code, bill, or charge for any product or service. Third-party payment for medical products and services is affected by numerous factors, and Grifols cannot make any representation or guarantee concerning reimbursement or coverage for any service or item.

*Centers for Medicare and Medicaid Services (CMS). HCPCS file located at: http://www.cms.gov/Medicare/Coding/HCPCSReleaseCodeSets/Alpha-Numeric-HCPCS.html.
†Current Procedural Terminology (CPT) 5-digit codes, nomenclature, and other data are ®2019 American Medical Association (AMA).
‡Optum, ICD-10-CM for Hospitals and Payers, Volumes 1, 2, and 3, publisher of the official code set issued by the Department of Health and Human Services.
§For billing purposes, an 11-digit National Drug Code (NDC) is required.

The information is provided for informational purposes only and is subject to change. Providers are encouraged to contact their payers for specific information. Coding rules and guidelines are subject to payer discretion and should always be verified by the paying entity. Healthcare providers make the ultimate determination as to when to use a specific product, based on clinical appropriateness for a patient. This guide is not intended to provide specific guidance on how to use, code, bill, or charge for any product or service. Third-party payment for medical products and services is affected by numerous factors, and Grifols cannot make any representation or guarantee concerning reimbursement or coverage for any service or item.
Coding System Coding for HyperRHO S/D Dosage

HCPCS (Healthcare Common Procedure Coding System) Codes*

J2790

Injection, (Rho[D] immune globulin [human]), Full Dose, 300 mcg (1500 IU)

J2788

Injection, (Rhₒ[D] immune globulin [human]), Mini-Dose 50 mcg (250 IU)

Administration Procedures CPT Code†

96372

Therapeutic, prophylactic, or diagnostic injection (specify substance or drug); subcutaneous or intramuscular

ICD-10-CM‡

229.13

Encounter for prophylactic Rhₒ(D) immune globulin

231.82

Encounter for Rh incompatibility status

O43.011

Fetomaternal placental transfusion syndrome, first trimester

O43.012

Fetomaternal placental transfusion syndrome, second trimester

O43.013

Fetomaternal placental transfusion syndrome, third trimester

O43.019

Fetomaternal placental transfusion syndrome, unspecified trimester

O00.11

Tubal pregnancy

O00.8

Other ectopic pregnancy

O03.89

Complete or unspecified spontaneous abortion with other complications

O03.9

Complete or unspecified spontaneous abortion without complication

O20.0

Threatened abortion

O36.0110

Maternal care for anti-D [Rh] antibodies, first trimester, not applicable or unspecified

O36.0120

Maternal care for anti-D [Rh] antibodies, second trimester, not applicable or unspecified

O36.0130

Maternal care for anti-D [Rh] antibodies, third trimester, not applicable or unspecified

O36.0190

Maternal care for anti-D [Rh] antibodies, unspecified trimester, not applicable or unspecified

Full Dose NDC§

13533-0631-02

Full Dose single prefilled syringe 1500 IU IM (300 mcg)

Full Dose NDC§

13533-0631-11

Full Dose prefilled syringe (10 pack) 1500 IU IM (300 mcg)

Mini-Dose NDC§

13533-0661-06

Mini-Dose prefilled syringe (10 pack) 250 IU IM (50 mcg)

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Important Safety Information for HyperRHO® S/D Mini-Dose (Rhₒ[D] immune globulin [human])

HyperRHO® S/D Mini-Dose (RhO[D] immune globulin [human]) is recommended to prevent the isoimmunization of RhO(D) negative women at the time of spontaneous or induced abortion of up to 12 weeks' gestation provided the following criteria are met:

  1. The mother must be RhO(D) negative and must not already be sensitized to the RhO(D) antigen.
  2. The father is not known to be RhO(D) negative.
  3. Gestation is not more than 12 weeks at termination.

HyperRHO S/D Mini-Dose is made from human plasma. Products made from human plasma may contain infectious agents, such as viruses, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent that can cause disease. There is also the possibility that unknown infectious agents may be present in such products.

NEVER ADMINISTER HYPERRHO S/D MINI-DOSE INTRAVENOUSLY. INJECT ONLY INTRAMUSCULARLY. ADMINISTER ONLY TO WOMEN POSTABORTION OR POSTMISCARRIAGE OF UP TO 12 WEEKS' GESTATION. NEVER ADMINISTER TO THE NEONATE.

HyperRHO S/D Mini-Dose should be given with caution to patients with a history of prior systemic allergic reactions following the administration of human immune globulin preparations.

The attending physician who wishes to administer HyperRHO S/D Mini-Dose to persons with isolated immunoglobulin A (IgA) deficiency must weigh the benefits of immunization against the potential risks of hypersensitivity reactions. Such persons have increased potential for developing antibodies to IgA and could have anaphylactic reactions to subsequent administration of blood products that contain IgA.

As with all preparations administered by the intramuscular route, bleeding complications may be encountered in patients with thrombocytopenia or other bleeding disorders.

Although systemic reactions to immunoglobulin preparations are rare, epinephrine should be available for treatment of acute anaphylactic symptoms.

Other antibodies in the HyperRHO S/D Mini-Dose preparation may interfere with the response to live vaccines such as measles, mumps, polio or rubella. Therefore, immunization with live vaccines should not be given within 3 months after HyperRHO S/D Mini-Dose administration.

Animal reproduction studies have not been conducted with HyperRHO S/D Mini-Dose. It is also not known whether HyperRHO S/D Mini-Dose can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. HyperRHO S/D Mini-Dose is not indicated for use during pregnancy and it should be administered only postabortion or postmiscarriage.

Safety and effectiveness in the pediatric population have not been established.

Reactions to HyperRHO S/D Mini-Dose are infrequent in RhO(D) negative individuals and consist primarily of slight soreness at the site of injection and slight temperature elevation. While sensitization to repeated injections of human globulin is extremely rare, it has occurred.

Please see full Prescribing Information for HyperRHO S/D Mini-Dose.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Important Safety Information for HyperRHO® S/D Full Dose (Rhₒ[D] immune globulin [human])  

HyperRHO® S/D Full Dose (RhO[D] immune globulin [human]) is indicated for prevention of Rh hemolytic disease of the newborn (HDN) and the prevention of isoimmunization in RhO(D) negative individuals who have been transfused with RhO(D) positive red blood cells.

HyperRHO S/D Full Dose is made from human plasma. Because this product is made from human plasma, it may carry a risk of transmitting infectious agents, such as viruses, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

Never administer HyperRHO S/D Full Dose intravenously. Inject only intramuscularly. Never administer to the neonate.

RhO(D) immune globulin (human) should be given with caution to patients with a history of prior systemic allergic reactions following the administration of human immunoglobulin preparations. Such persons have increased potential for developing antibodies to IgA and could have anaphylactic reactions to subsequent administration of blood products that contain IgA.

As with all preparations administered by the intramuscular route, bleeding complications may be encountered in patients with thrombocytopenia or other bleeding disorders.

A large fetomaternal hemorrhage late in pregnancy or following delivery may cause a weak mixed field positive DU test result. If there is any doubt about the mother's Rh type, she should be given RhO(D) immune globulin (human). A screening test to detect fetal red blood cells may be helpful in such cases.

If more than 15 mL of D-positive red blood cells are present in the mother's circulation, more than a single dose of HyperRHO S/D Full Dose is required. Failure to recognize this may result in the administration of an inadequate dose.

Although systemic reactions to human immunoglobulin preparations are rare, epinephrine should be available for treatment of acute anaphylactic symptoms.

Administration of live virus vaccines (eg, MMR) should be deferred for approximately 3 months after RhO(D) immune globulin (human) administration.

HyperRHO S/D Full Dose should be given in pregnant women only if clearly needed because animal reproduction studies have not been conducted.

Reactions to RhO(D) immune globulin (human) are infrequent in RhO(D)-negative individuals and consist primarily of slight soreness at the site of injection and slight temperature elevation. While sensitization to repeated injections of human immunoglobulin is extremely rare, it has occurred.

Elevated bilirubin levels have been reported in some individuals receiving multiple doses of RhO(D) immune globulin (human) following mismatched transfusions. This is believed to be due to a relatively rapid rate of foreign red cell destruction.

Please see full Prescribing Information for HyperRHO S/D Full Dose.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

 

References

  1. HyperRHO S/D Full Dose (Rho[D] immune globulin [human]) Prescribing Information. Grifols.
  2. Rhophylac. Prescribing information. CSL Behring; 2020.
  3. WinRho SDF. Prescribing information. Kamada Inc.; 2022.
  4. RhoGAM and MICRhoGAM Ultra-Filtered PLUS. Prescribing information. Kedrion Biopharma Inc.; 2022.
  5. ACOG Practice Bulletin No. 181: prevention of RhD alloimmunization. Obstet Gynecol. 2017;130(2):e57-e70.
  6. HyperRHO S/D Mini-Dose (Rho[D] immune globulin [human]) Prescribing Information. Grifols.
  7. Wurzel JF, Hansen LM, Evensen KL. Clinical experience with a new preparation of Rho(D) immune globulin (human). Obstet Gynecol. 1973;41(5):760-764.
  8. Watchko JF. Neonatal indirect hyperbilirubinemia and kernicterus In: Gleason CA, Devaskar SU, eds. Avery’s Diseases of the Newborn. 9th ed. Saunders; 2012:1123-1142.
  9. Data on file, Grifols.