Therapeutic Areas and Products
Allergy and Immunology
Our world-leading immunoglobulin (Ig) franchise is the cornerstone of the immunology therapeutic area. Our efforts in this area focus on bringing trusted products and technologies to serve patients with a range of rare and serious diseases, including Primary Immunodeficiencies (PID) and Hereditary Angioedema (HAE).
IndicationsSuppression 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
- Rh prophylaxis in obstetric complications or invasive procedures
- Incompatible transfusions in Rh0 (D)-negative individuals transfused with blood components containing Rh0 (D)-positive red blood cells (RBCs)
- Raising platelet counts in Rh0 (D)-positive, non-splenectomized adults with chronic ITP
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), acute renal insufficiency, renal failure, and disseminated intravascular coagulation (DIC).
- Monitor patients for signs and symptoms of intravascular hemolysis in a healthcare setting for at least 8 hours after administration.
See full prescribing information for complete boxed warning.
- History of anaphylactic or severe systemic reaction to human immune globulin products
- IgA deficient patients with antibodies against IgA and a history of hypersensitivity to Rhophylac or any of its components
- Do not administer Rhophylac to the newborn infant of the mother that received Rhophylac postpartum
DO NOT confuse micrograms (mcg) with International Units (IU) when calculating the dose of RHOPHYLAC. Miscalculations could result in a significant overdose or underdose of the product. Note that 1 mcg = 5 IU of RHOPHYLAC.
Suppression of Rh Isoimmunization
RHOPHYLAC should be administered by intravenous or intramuscular injection. If large doses (greater than 5 mL) are required and intramuscular injection is chosen, it is advisable to administer RHOPHYLAC in divided doses at different sites.
Ensure the site of administration will allow the injection to reach the muscle if RHOPHYLAC is administered intramuscularly. Consider intravenous administration if reaching the muscle is of concern. Do not administer RHOPHYLAC subcutaneously into the fatty tissue.
Refer to Table 1 (for dosing instructions in micrograms) and Table 2 (for dosing instructions in International Units) by indication.
Table 1: Dosing Guidelines based on Micrograms (mcg) for Suppression of Rh Isoimmunization
Table 2: Dosing Guidelines based on International Units (IU) for Suppression of Rh Isoimmunization
Treatment of ITP