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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 (e.g., 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 (e.g., amniocentesis, chorionic biopsy), or obstetric manipulative procedures (e.g., 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).

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. Adverse reactions were usually mild and transient.
• In the clinical trials, no women developed antibodies to the Rh_o(D) antigen.

      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.
  

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.

Purity

• Rhophylac^® has a high concentration of IgG.
• The IgA content is below the limit of detection of 5 µg/mL.
• Rhophylac^® is thimerosal (mercury)-free and latex-free.

Flexible delivery

• IM is convenient for either hospital or office administration.
• IV* is ideal for hospital administration and may be a more comfortable option for patients.

Convenience

• Rhophylac^® comes in prefilled syringes with safety needles primed for immediate IM or IV* use.
• Rhophylac^® can be stored for 3 years from the date of manufacture at 36°F to 46°F (2°C to 8°C).

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^® is indicated for suppression of rhesus (Rh) isoimmunization in:

• Pregnancy and obstetric conditions in non-sensitized, Rh₀(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 Rh₀(D)-negative individuals transfused with blood components containing Rh₀(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 Rh₀(D)-positive, non-splenectomized adult patients with chronic immune thrombocytopenic purpura (ITP). For the treatment of ITP, Rhophylac^® must be administered IV.

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.

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

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Frequently Asked Questions for Rhophylac^®

To learn more about Rhophylac^® for HDN, please visit www.Rhophylac.com

To learn more about Rhophylac^® for ITP, please visit www.Rhophylac4ITP.com

• Full Prescribing Information for Rhophylac^®