Rhophylac is made from human plasma collected from US donors
using a patented manufacturing process called ChromaPlus™ . This unique manufacturing
process not only helps reduce the risk of viral transmission, but also uses ion-exchange
chromatography, a crucial element in allowing both intramuscular
and intravenous administration by eliminating virtually all foreign aggregates from
the collected plasma.
Each syringe contains a minimum of 1500 IU (300 mcgs) of IgG antibodies to Rho(D)
in a 2 mL solution, sufficient to suppress the immune response to at least 15 mL
of Rh-positive RBCs. For Rh incompatible pregnancies, treatment consists of 2 doses delivered to the mother: first at 28 to 30 weeks' gestation
and again within 72 hours after delivery. For Rh-negative women who are pregnant, this protection is essential
in thwarting the development of hemolytic disease of the newborn (HDN).
Important Safety Information
Rhophylac®, Rho(D), Immune Globulin Intravenous (Human), is indicated for suppression of rhesus (Rh) isoimmunization in:
- Pregnancy and obstetric conditions in non-sensitized, Rho(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 Rho(D)-negative individuals transfused with blood components containing Rho(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 Rho(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 Rho(D)-positive patients treated for immune thrombocytopenic purpura (ITP) with Rho(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 Rho(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.