Compare Rh0(D) Immune Globulin (Human) Products (PDF)
The products discussed herein may only be dispensed with a prescription from a doctor or healthcare provider.
For Prevention of Rh Hemolytic Disease of the Newborn (HDN)
Each year approximately 540,000 pregnancies in the US are complicated by maternal-fetal Rh0 (D) blood type incompatibility. Although the risk to the first fetus is only slight, subsequent pregnancies carry progressively higher risk of life-threatening hemolytic disease of the fetus. Treatment with HyperRHO® S/D, Rh0(D) Immune Globulin (Human), can reduce the risk of hemolytic disease for present and future maternal-fetal Rh0(D) incompatible situations.
Recommended Use of HyperRHO® S/D
Indicated for the prevention of Rh hemolytic disease of the newborn by its administration to the Rh0(D) negative mother within 72 hours after birth of an Rh0(D) positive infant when the following criteria are met:
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The mother must be Rh0(D) negative and must not be already sensitized to the Rh0(D) factor
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Her child must be Rh0(D) positive and should have a negative direct antiglobulin test |
Not for neonatal administration.
For Intramuscular Administration Only
Needle guard can protect against post-injection needlesticks
Available on selected Hypermunes™ products.
Product Attributes
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Solvent/Detergent treatment for virus inactivation (See : Full Dose, Mini-Dose (PDF)
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Pre-filled syringes for single-use IM injection only
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Tamper-evident packaging
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Distinct dosing for women who are postpartum and those who miscarry before 13 weeks gestation |
Contraindications, side effects, and precautions
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Use caution in persons with a history of prior systemic allergic reaction to human immune globulin products or a history of IgA deficiency
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Administration of live virus vaccines (eg, MMR) should be deferred for approximately 3 months after Rh0(D) immune globulin (human) administration
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The most common side effects reported are slight soreness at the site of injection and slight temperature elevation |
Rh0(D) Blood Type Incompatibility Info
Hemolytic Disease of the Newborn (HDN)
HDN, also known as erythroblastosis fetalis or "blue baby syndrome," occurs when a pregnant woman's Rh blood type differs from her baby's. Rh refers to the presence or absences of the Rh antigen; blood is considered either Rh positive or Rh negative.
Rh incompatibility causes the woman's antibodies to attack and destroy the baby's red blood cells. In response to the attack on its red blood cells, the baby reacts by manufacturing a large number of red blood cells quickly. The baby's liver is unable to handle the increased work, and fluid begins to collect throughout the baby's body.
After delivery, the baby might experience severe newborn jaundice (yellowing of the body and skin) and a low red blood cell count (anemia).
Intravenous immune globulin can be used to treat an Rh-negative mother who gives birth to an Rh-positive infant.
HyperRHO® S/D — Important Safety Information
WARNINGS
HyperRHO® S/D is made from human plasma. Products made from human plasma may contain infectious agents, such as viruses that can cause disease.
PLEASE SEE WARNINGS, PRECAUTIONS, AND ADVERSE REACTIONS IN THE PRESCRIBING INFORMATION.
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NEVER ADMINISTER HyperRHO S/D FULL DOSE INTRAVENOUSLY. INJECT ONLY INTRAMUSCULARLY. NEVER ADMINISTER TO THE NEONATE.
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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.
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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.
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The attending physician who wishes to administer RhO(D) immune globulin (human) 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.
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As with all preparations administered by the intramuscular route, bleeding complications may be encountered in patients with thrombocytopenia or other bleeding disorders.
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PRECAUTIONS
HyperRHO® S/D FULL DOSE:
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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.
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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.
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HyperRHO® S/D FULL DOSE AND HyperRHO® S/D MINI DOSE :
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Although systemic reactions to human immunoglobulin preparations are rare, epinephrine should be available for treatment of acute anaphylactic symptoms.
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Administration of live virus vaccines (eg, MMR) should be deferred for approximately 3 months after RhO(D) immune globulin (human) administration.
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Should be given in pregnant women only if clearly needed because animal reproduction studies have not been conducted.
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Safety and efficacy in pediatric patients have not been established.
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ADVERSE REACTIONS
HyperRHO® S/D FULL DOSE:
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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.
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HyperRHO® S/D FULL DOSE AND HyperRHO® S/D MINI DOSE :
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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.
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While sensitization to repeated injections of human immunoglobulin is extremely rare, it has occurred.
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HyperRHO S/D is made from human plasma. As with all plasma-derived therapeutics, the potential to transmit infectious agents, such as viruses and theoretically, the Creutzfeldt-Jakob (CJD) agent that can cause disease, cannot be totally eliminated. There is also the possibility that unknown infectious agents may be present in such products.
To view Prescribing Information for HyperRHO S/D FULL DOSE, please visit http://www.talecris-pi.info/inserts/hyperrho-fd.pdf (PDF).
To view Prescribing Information for HyperRHO S/D MINI-DOSE, please visit http://www.talecris-pi.info/inserts/hyperrho-md.pdf (PDF).
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.
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