Indications

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 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.

 

It is estimated that each year, nearly 1 million pregnancies are impacted by the potential of Rh sensitization, which may lead to HDN due to maternal-fetal Rho(D) blood type incompatibility. This occurs when the mother is Rh negative and the father is Rh positive, potentially creating an Rh-positive baby. It is crucial for the mother to receive immune globulin treatment in a timely manner because once she is sensitized, it can no longer help.1-3 


Development of HDN1


HDN Is Preventable With HyperRHO S/D1

It is estimated that each year, nearly 1 million pregnancies are impacted by the potential of Rh sensitization, which may lead to HDN due to maternal-fetal Rho(D) blood type incompatibility. This occurs when the mother is Rh negative and the father is Rh positive, potentially creating an Rh-positive baby. It is crucial for the mother to receive immune globulin treatment in a timely manner because once she is sensitized, it can no longer help.1-3 

Development of HDN1

Provide Effective, Immediate, and Adequate Protection With HyperRHO S/D4,5

Effective Protection

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.

Immediate Protection

An 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%.

Adequate Protection

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.

Product Information

For over 45 years, produced with an unwavering commitment to safety, HyperRHO S/D has been a reliable treatment choice for Rh-negative pregnant women.

SAFETY

  • 4-step virus removal and inactivation process
  • The only Rho(D) immune globulin product with FDA labeling for capacity to remove pathogenic prions
  • Mercury (thimerosal) free and latex free
  • UltraSafe® 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® is additional information related to the quality and safety of Grifols plasma derivatives and can be accessed at www.pedigri.grifols.com

Because HyperRHO S/D 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 that can cause disease. There is also the possibility that unknown infectious agents may be present in such products.

 

RELIABILITY

  • Dosing consistent with The American College of Obstetricians and Gynecologists practice guidelines6

CONVENIENCE

  • Low-volume fully assembled prefilled syringes
 

Coding Information7-9

This resource provides coding guidance for HyperRHO S/D; however, the treating physician is ultimately responsible for certifying the codes that best describe the patient's diagnosis and treatment. Government and other third-party payer coding requirements change periodically; therefore, please verify current coding requirements directly with the payer being billed. All codes listed in this guide are for informational purposes and are not an exhaustive list of possible codes. The CPT®, HCPCS, and ICD-10-CM diagnosis codes provided are based on American Medical Association (AMA) or Centers for Medicare & Medicaid Services (CMS) guidelines.


HCPCS (Healthcare Common Procedure Coding System)7


ICD-10-CM (International Classification of Diseases, 10th Revision, Clinical Modification) Diagnosis Codes8


CPT® Code (Current Procedural Terminology)9

This code is used to report services performed by the healthcare provider in a clinical setting. Include with drug codes. CPT is a registered trademark of the AMA.


HyperRHO S/D for Intramuscular Injection4,5


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.


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. American College of Obstetrics and Gynecologists (ACOG). The Rh factor: How it can affect your pregnancy. ACOG website. http://www.acog.org/Patients/FAQs/The-Rh-Factor-How-It-Can-Affect-Your-Pregnancy. Updated September 2013. Accessed August 2, 2017.
  2. Hirose TG, Mays DA. The safety of RhIG in the prevention of haemolytic disease of the newborn. J Obstet Gynaecol. 2007;27(6):545-547.
  3. Curtin SC, Abma JC, Kost K. 2010 pregnancy rates among U.S. women. National Center for Health Statistics website. https://www.cdc.gov/nchs/data/hestat/pregnancy/2010_pregnancy_rates.htm. Updated April 6, 2010. Accessed September 7, 2017.
  4. HyperRHO S/D Full Dose (RhO[D] immune globulin [human]) Prescribing Information. Grifols.
  5. HyperRHO S/D Mini-Dose (RhO[D] immune globulin [human]) Prescribing Information. Grifols.
  6. ACOG Practice Bulletin No.181: prevention of Rd D alloimmunization. Obstet Gynecol. 2017;130(2):e57-e70.
  7. U.S. Department of Health & Human Services, Centers for Medicare & Medicaid Services. HCPCS Release & Code Sets. 2017 HCPCS Alpha-Numeric Index. https://www.cms.gov/Medicare/Coding/HCPCSReleaseCodeSets/Downloads/2017-Alpha-Numeric-Index.pdf. Accessed August 31, 2017.
  8. Centers for Medicare & Medicaid Services. International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM). 2017 Code Tables and Index. https://www.cms.gov/Medicare/Coding/ICD10/2017-ICD-10-CM-and-GEMs.html. Accessed August 31, 2017.
  9. American Medical Association. CPT® Code/Relative Value Search. https://ocm.ama-assn.org/OCM/CPTRelativeValueSearch.do. Accessed August 31, 2017.