|Customer Services |Global Home |Contact Us |Site Map |US Web Sites |Register |Login

Rhophylac^®

Rh_o(D) Immune Globulin Intravenous (Human)

Rhophylac is indicated for:

Pregnancy and Obstetrical Conditions—(1) The suppression of Rh isoimmunization in nonsensitized Rh_o(D)-negative (D-negative) women. (2) Rhesus prophylaxis in cases of obstetric complications (eg, miscarriage, abortion, threatened abortion, ectopic pregnancy or hydatidiform mole, or transplacental hemorrhage resulting from antepartum hemorrhage). (3) Rhesus prophylaxis in cases of invasive procedures during pregnancy (eg, amniocentesis, chorionic biopsy), or obstetric manipulative procedures (eg, external version or abdominal trauma).

Incompatible Transfusions—Rhophylac is recommended for suppression of Rh isoimmunization in D-negative individuals transfused with Rh_o(D)-positive red blood cells or blood components containing Rh_o(D)-positive red blood cells.

Immune Thrombocytopenic Purpura (ITP) - Rhophylac is indicated to raise platelet counts in Rh_o(D)-positive, non-splenectomized adult patients with chronic Immune Thrombocytopenic Purpura (ITP).

See Important Safety Information below for boxed warning for use of Rhophylac in ITP.

Efficacy

      Pregnancy and Obstetrical Conditions, and Incompatible Transfusions

• Each syringe contains a minimum of 300 µg of RhIgG, ensuring that a dose of Rhophylac adequately suppresses the immune response to at least 15 mL of Rh-positive red blood cells.
• When given intravenously in clinical trials, Rhophylac began to work immediately and cleared an average of 99% of 15 mL Rh-positive blood cells within 12 hours.¹
• The efficacy of Rhophylac is supported by the results of two clinical trials in 466
  Rh_o(D)-negative pregnant women.
• In the clinical trials, no women developed antibodies to the Rh_o(D) antigen.
• The most common adverse reactions in the suppression of Rh isoimmunization are nausea, dizziness, headache, injection-site pain, and malaise.

      Immune Thrombocytopenic Purpura (ITP)

• The efficacy of Rhophylac in ITP is supported by an open-label, single-arm, multicenter study, of 98 Rh_o(D)-positive adult subjects with chronic ITP and a platelet count of 30 x 10⁹ /L or less who were treated with Rhophylac.
• The primary efficacy response rate (ITT population) demonstrated a clinically relevant response to treatment, i.e., the lower bound of the 95% CI was greater than the predefined response rate of 50%.
• The median time to platelet response was 3 days, and the median duration of platelet response was 22 days.
• An overall regression of hemorrhage was seen in 44 (88%, 95% CI: 76% to 94%) of the 50 subjects with bleeding at baseline.
• The most common adverse reactions were chills, pyrexia, headache, and mild hemolysis.
• For treatment of patients with ITP, Rhophylac must be administered IV.

Safety

• Rhophylac is manufactured from plasma collected at FDA licensed US plasma collection centers. In addition to the donors undergoing a rigorous screening process to reduce the risk of receiving donations containing blood-borne pathogens, each plasma donation used in the manufacture of Rhophylac is tested for the presence of HBV surface antigen (HBsAg), HIV-1/2, HCV antibodies, and tested by NAT for hepatitis A virus (HAV) and B19 virus (B19V).
• The manufacturing process for Rhophylac utilizes three complementary safety steps, which are designed to minimize the risk of virus transmission.
• The risk of transmission of infectious agents cannot be completely eliminated.

Purity

• Rhophylac has a high concentration of IgG.
• The IgA content is below the limit of detection of 5 µg/mL.
• Patients with selective IgA deficiency can develop antibodies to IgA and may develop severe hypersensitivity and anaphylactic reactions.
• Rhophylac is thimerosal (mercury)-free and latex-free.

Flexible delivery

• Rhophylac can be administered for IV or IM for the suppression of Rh isoimmunization. For ITP patients, it must be administered by IV.
• IM is convenient for either hospital or office administration.
• IV may be a more comfortable option for patients.

Convenience

• Rhophylac can be stored for 3 years from the date of manufacture at 36°F to 46°F (2°C to 8°C).
• Rhophylac comes in prefilled, ready-to-use syringes.
• Safety needles are primed for immediate IM or IV use. Click here for important information on the Rhophylac compatible needle-free system.

NDC Number	Product Description
44206-300-01	1-pack of Rhophylac 1500 IU (300 μg)
44206-300-10	10-pack of Rhophylac 1500 IU (300 μg)

Important Safety Information

Rhophylac^®, Rh₀(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: 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 Rh₀(D)-positive patients treated for immune thrombocytopenic purpura (ITP) with Rh₀(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.

Allergic or hypersensitivity reactions may occur with Rhophylac; early signs of hypersensitivity include generalized urticaria, chest tightness, wheezing, hypotension, and anaphylaxis. Individuals with selective IgA deficiency can develop antibodies to IgA and may develop severe hypersensitivity and anaphylactic reactions. For these individuals, weigh the expected benefits of treatment against the potential risks.

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 Rh₀(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.

Reference: 1. Miescher S, Spycher MO, Amstutz H, et al. A single recombinant anti-RhD IgG prevents RhD immunization: association of RhD-positive red blood cell clearance rate with polymorphisms in the FcγRIIA genes and FcγIIIA genes. Blood. 2004

CUSTOMER SUPPORT 1-800-683-1288 or Customer Services

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.

• Full Prescribing Information for Rhophylac^®