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About Rhophylac® for ITP

Rhophylac® is an anti-D immunoglobulin (anti-D), indicated to raise platelet counts in RhO(D)-positive, non-splenectomized adult patients with chronic Immune (Idiopathic) Thrombocytopenic Purpura (ITP). Rhophylac® has never been formulated with thimerosal (mercury), contains no latex, and is the only anti-D immunoglobulin made using CSL Behring’s patented ChromaPlus™ process. This unique manufacturing process minimizes the risk of viral transmission. Rhophylac® ITP therapy that counts

  • Rhophylac® is effective in raising platelet counts
  • Rhophylac® provides an Assurance of Safety characterized by a staunch focus on virus removal and inactivation using the ChromaPlus™ process
  • CSL Behring, the maker of Rhophylac®, has more than 100 years of experience in providing safe and effective plasma therapies
  • Rhophylac® offers pre-filled syringes containing a guaranteed 300-mcg dose and has the longest shelf-life of any anti-D immunoglobulin (3 years from date of manufacture)
WARNING: INTRAVASCULAR HEMOLYSIS IN ITP

This warning does not apply to Rho(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. Perform a dipstick urinalysis at baseline, 2 hours and 4 hours after administration, and prior to the end of the monitoring period. Alert patients to, and monitor them for, the signs and symptoms of intravascular hemolysis, including back pain, shaking chills, fever, and discolored urine or hematuria. Absence of these signs and/or symptoms within 8 hours does not indicate IVH cannot occur subsequently. If signs and/or symptoms of intravascular hemolysis are present or suspected after Rhophylac administration, perform post-treatment laboratory tests, including plasma hemoglobin, haptoglobin, LDH, and plasma bilirubin (direct and indirect).

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.