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HyperRHO® S/D [RhO(D) Immune Globulin (Human)]
for prevention of Rh hemolytic disease of the newborn (HDN)

HyperRHO S/D Full Dose and Mini-Dose 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. NEVER ADMINISTER HyperRHO S/D FULL DOSE INTRAVENOUSLY. INJECT ONLY INTRAMUSCULARLY. NEVER ADMINISTER TO THE NEONATE.

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.

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

PRECAUTIONS

HyperRHO S/D FULL DOSE AND HyperRHO S/D MINI-DOSE:

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.

HyperRHO S/D FULL 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.

Should be given in pregnant women only if clearly needed because animal reproduction studies have not been conducted.

Safety and efficacy in pediatric patients have not been established.

ADVERSE REACTIONS

HyperRHO S/D FULL DOSE:

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.

HyperRHO S/D FULL DOSE AND HyperRHO S/D MINI-DOSE:

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.

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.

For full Prescribing Information, click here.

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 and Mini-Dose 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. NEVER ADMINISTER HyperRHO S/D FULL DOSE INTRAVENOUSLY. INJECT ONLY INTRAMUSCULARLY. NEVER ADMINISTER TO THE NEONATE.

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.

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

PRECAUTIONS

HyperRHO S/D FULL DOSE AND HyperRHO S/D MINI-DOSE:

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.

HyperRHO S/D FULL 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.

Should be given in pregnant women only if clearly needed because animal reproduction studies have not been conducted.

Safety and efficacy in pediatric patients have not been established.

ADVERSE REACTIONS

HyperRHO S/D FULL DOSE:

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.

HyperRHO S/D FULL DOSE AND HyperRHO S/D MINI-DOSE:

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.

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.

For full Prescribing Information, click here.

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.