Treatment with
HyperRAB® S/D
Rabies Immune Globulin (Human)


Treatment with
HyperTET® S/D
Tetanus Immune Globulin (Human)


Treatment with
HyperRHO® S/D
RH0(D) Immune Globulin (Human)


Treatment with
HyperHEP® S/D
Hepatitis B Immune Globulin (Human)


Treatment with
GamaSTAN® S/D
Immune Globulin (Human)


If you're faced with an urgent immune situation, make sure you are protected with Hypermunes™—Hypermunes are specific immunoglobulins that provide rapid immune coverage in potentially life threatening situations1

Imminent Threat. Immediate Protection. Hypermunes™.

Active vs Passive Immunity

Active Immunity (Vaccine) is the stimulation of the immune system to produce antibodies. This immunity is usually life-long, but may take weeks to build efficacy. In times of urgency, when the need is immediate, passive immunity is required.1,2

Passive Immunity (Hyperimmune) is the transfer of antibody produced by one human or other animal to another. This protection is temporary. Passive immunity, provided by the Hypermunes product line, gives you the immediate protection that is needed when faced with potentially life-threatening situations.1,2

When faced with a potentially life-threatening situation, a vaccine alone may not be enough. Make sure you're protected. For more information on a specific Hypermune, click above.



HyperRAB S/D IMPORTANT SAFETY INFORMATION

Rabies vaccine and HyperRAB S/D should be given to all persons suspected of exposure to rabies with one exception: persons who have been previously immunized with rabies vaccine and have a confirmed adequate rabies antibody titer should receive only vaccine.

HyperRAB S/D (Rabies 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 HyperRAB S/D 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.

Soreness at the site of injection and mild temperature elevations may be observed at times. Sensitization to repeated injections has occurred occasionally in immunoglobulin-deficient patients. Angioneurotic edema, skin rash, nephrotic syndrome, and anaphylactic shock have rarely been reported after intramuscular injection so that a causal relationship between immunoglobulin and these reactions is not clear.

Administration of live virus vaccines (e.g., MMR) should be deferred for approximately 3 months after rabies immune globulin (human) administration.

HyperRAB S/D is made from human plasma. Product 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.

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.


HyperTET S/D IMPORTANT SAFETY INFORMATION

HyperTET S/D should be given with caution to patients with a history of prior systemic allergic reactions following the administration of human immunoglobulin preparations. In patients who have severe thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections, HyperTET S/D should be given only if the expected benefits outweigh the risks.

Slight soreness at the site of injection and slight temperature elevation may be noted at times. Sensitization to repeated injections of human immunoglobulin is extremely rare. In the course of routine injections of large numbers of persons with immunoglobulin, there have been a few isolated occurrences of angioneurotic edema, nephrotic syndrome, and anaphylactic shock after injection.

Administration of live virus vaccines (eg, MMR) should be deferred for approximately 3 months after Tetanus Immune Globulin (Human) administration.

HyperTET 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.

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.

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.


HyperHEP B S/D IMPORTANT SAFETY INFORMATION

HyperHEP B S/D should be given with caution to patients with a history of prior systemic allergic reactions following the administration of human immunoglobulin preparations. Epinephrine should be available.

In patients who have severe thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections, Hepatitis B Immune Globulin (Human) should be given only if the expected benefits outweigh the risks.

Local pain and tenderness at the injection site, urticaria, and angioedema may occur; anaphylactic reactions, although rare, have been reported following the injection of human immunoglobulin preparations.

Administration of live virus vaccines (eg, MMR) should be deferred for approximately 3 months after Hepatitis B Immune Globulin (Human) administration.

HyperHEP B 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.

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.


GamaSTAN S/D IMPORTANT SAFETY INFORMATION

GamaSTAN® S/D (immune globulin [human]) is indicated for prophylaxis of hepatitis A infection, prevention or modification of measles (rubeola), and passive immunization against varicella in immunosuppressed patients, and also possibly for prophylaxis of rubella in early pregnancy (for women who will not consider a therapeutic abortion).

The prophylactic value of GamaSTAN S/D is greatest when given before or soon after exposure to hepatitis A. GamaSTAN S/D is not indicated in persons with clinical manifestations of hepatitis A or in those exposed more than 2 weeks previously.

GamaSTAN S/D should be given to prevent or modify measles in a susceptible person exposed fewer than 6 days previously. A susceptible person is one who has not been vaccinated and has not had measles previously. GamaSTAN S/D and measles vaccine should not be given at the same time.

Thrombosis may occur with immune globulin products, including GamaSTAN S/D. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling central vascular catheters, hyperviscosity, and cardiovascular risk factors. Thrombosis may occur in the absence of known risk factors. For patients at risk of thrombosis, do not exceed the recommended dose of GamaSTAN S/D. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.

Do not give GamaSTAN S/D to persons with isolated immunoglobulin A (IgA) deficiency. Such persons have the potential for developing antibodies to IgA and could have anaphylactic reactions to subsequent administration of blood products that contain IgA.

Do not give GamaSTAN S/D to patients who have severe thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections.

Administer GamaSTAN S/D cautiously to patients with a history of prior systemic allergic reactions following the administration of human immunoglobulin preparations.

GamaSTAN S/D is made from human plasma. Because GamaSTAN S/D is made from human blood, it may carry a risk of transmitting infectious agents, eg, viruses, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent. No cases of transmission of viral diseases or CJD have ever been identified for GamaSTAN S/D.

Do not administer immune globulin (human) subcutaneously or intravenously because of the potential for serious reactions (eg, renal dysfunction/failure/hemolysis, transfusion-related acute lung injury (TRALI)]. Do not inject into a blood vessel.

Do not perform skin tests. In most patients the intradermal injection of concentrated gamma globulin solution with its buffers causes a localized area of inflammation, which can be misinterpreted as a positive allergic reaction. In actuality, this does not represent an allergy; rather, it is localized tissue irritation of a chemical nature. Misinterpretation of the results of such tests can lead the physician to withhold beneficial human immunoglobulin from a patient who is not actually allergic to this material. Although true allergic responses to human gamma globulin given in the prescribed intramuscular manner are rare, have epinephrine available for treatment of acute allergic symptoms, should they occur.

Passive transfer of antibodies may transiently impair the immune responses to live attenuated virus vaccines such as mumps, rubella, and varicella for up to 6 months, and for a year or more to measles (rubeola). Inform the immunizing physician of recent therapy with GamaSTAN S/D so that appropriate precautions can be taken. No interactions with other products are known.

Local pain and tenderness at the injection site, urticaria, and angioedema may occur. Anaphylactic reactions, although rare, have been reported following the injection of human immune globulin preparations. Anaphylaxis is more likely to occur if GamaSTAN S/D is given intravenously; therefore, GamaSTAN S/D must be administered only intramuscularly.

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. Baxter D. Active and passive immunity, vaccine types, excipients and licensing. Occupational Medicine. 2007;57:552-556.
  2. Centers for Disease Control and Prevention. Principles of vaccination. http://cdc.gov/vaccines/pubs/pinkbook/downloads/prinvac.pdf. Accessed September 17, 2009.