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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.

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Trusted Dependability

  • 4-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 prions
  • Mercury (thimerosal) and latex free1,3
  • 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

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

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Provide Immediate and Effective Protection With HyperRHO S/D1-3

Immediate 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.

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 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.

Reliability

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

Convenience

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 red blood cells.

 

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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.

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

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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 was4:

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

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The administration of HyperRHO S/D within 72 hours of a full-term delivery of an Rh-positive infant by an Rh-negative mother reduces the rate of Rh sensitization from 12%-13% to 1%-2%.1

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Safety Is a Priority

Product Information

For over 40 years, produced with an unwavering commitment to safety, HyperRHO S/D has been a reliable treatment choice for Rh-negative pregnant women.

Manufacturing Process1,2

The HyperRHO S/D manufacturing process is designed 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.

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.

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Traceability and Transparency of Information5

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

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

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Dosing Recommendations for HyperRHO S/D1,2

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Coding Information

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Download an informational guide about the Hypermunes portfolio. 

isi-hyperrho-mini-dose

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.


isi-hyperrho-full-dose

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.


Home references

References:

  1. HyperRHO S/D Full Dose (Rho[D] immune globulin [human]) Prescribing Information. Grifols.
  2. HyperRHO S/D Mini-Dose (Rho[D] immune globulin [human]) Prescribing Information. Grifols.
  3. ACOG Practice Bulletin No. 181: prevention of RhD alloimmunization. Obstet Gynecol. 2017;130(2):e57-e70.
  4. 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.
  5. Data on file, Grifols.