Rhophylac®
Rho(D) Immune Globulin Intravenous (Human)
Rhophylac® is indicated for:
Pregnancy and Obstetrical Conditions—(1) The suppression of Rh
isoimmunization in nonsensitized Rho(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
Rho(D)-positive red blood cells or blood components containing
Rho(D)-positive red blood cells.
Immune Thrombocytopenic Purpura (ITP) - Rhophylac® is indicated to raise platelet counts in Rho(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
Rho(D)-negative pregnant women.
Adverse reactions were usually mild and transient.
- In the clinical trials, no women developed antibodies to the
Rho(D) antigen.
Immune Thrombocytopenic Purpura (ITP)
- The efficacy of Rhophylac in ITP is supported by an open-label, single-arm, multicenter study, of 98 Rho(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, 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 isommunization, 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.
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. As with all plasma-derived products, 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: 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.
In patients with preexisting anemia, weigh the benefits of Rhophylac® against the potential risk of increasing the severity of the anemia.
The most common adverse reactions in ITP treatment with Rhophylac® are chills, fever, increased bilirubin, and headache.
* When administered for ITP, Rhophylac must be given Intravenous
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
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
null 31 January 2008