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Glossary

Anaphylaxis
Rapidly progressing, potentially life-threatening allergic reaction of the immune system to a substance, causing a release of histamines that can cause airway obstruction or shock

Anti-D
Immunoglobulins with antibody against the "D" or Rh(_O) blood group antigen

Autoimmune disease
A disease in which the body attacks one or more otherwise normal organ systems. More than 80 autoimmune diseases have been identified, affecting as many as 14 million Americans according to the National Institutes of Health (NIH).

Bilirubin
A bile with a reddish or red-yellow pigment, caused by a breakdown of hemoglobin

Disseminated intravascular coagulation (DIC)
A disorder in which proteins that control blood clotting are overactive, resulting in an excess of small blood clots not in response to injury, which depletes platelets and clotting factors, potentially causing severe bleeding.

Enveloped virus
A virus that has a covering, or envelope, over its outer shell, which is used to help the virus enter host cells

Extravascular
Located outside of the blood vessels

Hematologist
A doctor who specializes in blood and blood disorders

Hemolysis
Alteration or destruction of red blood cells, leading to release of hemoglobin into blood plasma

Idiopathic
Of unknown origin, such as a disease in which the cause is not known

Incidence
The rate of occurrence of new cases of a disease in a specific period of time

IVIG (intravenous immunoglobulin)
A sterile solution of concentrated antibodies extracted from human plasma, and administered intravenously

Oncologist
A doctor who specializes in the diagnosis and treatment of cancer

Plasma
The portion of blood that does not include red cells or platelets, but contains gamma globulin, albumin, clotting factors, and other proteins. Learn more about plasma therapies, collection, and CSL manufacturing.

Platelets
Small cells (less than 1/10,000 of a centimeter in diameter) circulating in the blood that stick to and spread on the walls of a damaged blood vessel to promote clotting

Prevalence
The total number of existing cases of a disease at a specific time

Purpura
A condition characterized by hemorrhages in the skin and mucous membranes that cause purplish bruises or patches.

Splenectomy
Surgical removal of the spleen, sometimes recommended as a treatment option because in ITP, the spleen is the location where red blood cells destroy platelets

Thrombocytopenia
A condition in which a person has an abnormally small number of platelets circulating in the blood

Important Safety Information

Rhophylac^®, Rh_o(D), Immune Globulin Intravenous (Human), is indicated for suppression of rhesus (Rh) isoimmunization in:

Pregnancy and obstetric conditions in non-sensitized, Rh_o(D)-negative women with an Rh-incompatible pregnancy, including routine antepartum and postpartum Rh prophylaxis and Rh prophylaxis in cases of obstetric complications, invasive procedures during pregnancy, or obstetric manipulative procedures.
Incompatible transfusions in Rh_o(D)-negative individuals transfused with blood components containing Rh_o(D)-positive red blood cells.

For suppression of Rh isoimmunization, Rhophylac can be administered IM or IV.

Rhophylac is indicated to raise platelet counts in Rh_o(D)-positive, non-splenectomized adult patients with chronic immune thrombocytopenic purpura (ITP). For the treatment of ITP, Rhophylac must be administered IV.

WARNING: INTRAVASCULAR HEMOLYSIS IN ITP
This warning does not apply to Rh₀(D)-negative patients treated for the suppression of Rh isoimmunization.
Intravascular hemolysis leading to death has been reported in Rh_o(D)-positive patients treated for immune thrombocytopenic purpura (ITP) with Rh_o(D) Immune Globulin Intravenous (Human) products. Intravascular hemolysis can lead to clinically compromising anemia and multi-system organ failure, including acute respiratory distress syndrome (ARDS). Serious complications, including severe anemia, acute renal insufficiency, renal failure, and disseminated intravascular coagulation (DIC), have also been reported. Closely monitor patients treated for ITP with Rhophylac in a healthcare setting for at least 8 hours after administration. See full prescribing information for complete boxed warning.

Rhophylac is contraindicated in individuals with known anaphylactic or severe systemic reaction to human immune globulin products. Rhophylac is contraindicated in IgA-deficient patients with antibodies to IgA and a history of hypersensitivity.

Allergic or hypersensitivity reactions may occur with Rhophylac; early signs of hypersensitivity include generalized urticaria, chest tightness, wheezing, hypotension, and anaphylaxis.

Rhophylac is derived from human plasma. The risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated.

Suppression of Rh Isoimmunization: For postpartum use following an Rh-incompatible pregnancy, Rhophylac should not be given to the newborn infant.

The most common adverse reactions in the suppression of Rh isoimmunization with Rhophylac are nausea, dizziness, headache, injection-site pain, and malaise.

Immune Thrombocytopenic Purpura: The most serious adverse reactions in patients receiving Rh_o(D) immune globulin have been observed in the treatment of ITP. ITP patients being treated with Rhophylac should be monitored for signs and symptoms of intravascular hemolysis, including back pain, shaking chills, fever, and hemoglobinuria. Potentially serious complications of intravascular hemolysis include clinically compromising anemia, acute renal insufficiency, and, very rarely, disseminated intravascular coagulation, and death.

The most common adverse reactions observed in the treatment of ITP are chills, pyrexia/increased body temperature, and headache. Mild extravascular hemolysis has also been observed. In patients with preexisting anemia, weigh the benefits of Rhophylac against the potential risk of increasing the severity of the anemia.

Immunoglobulin administration may transiently interfere with the immune response to live virus vaccines, such as measles, mumps and rubella

Please see full prescribing information.

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.