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Rhophylac
Rho(d) Immune Globulin (human)
$150.00
300mcg/2ml · 1 vial
BrandBranded medicine· By Vetter Pharma
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FDA boxed warningIntravascular hemolysis in itp
This warning does not apply to Rh(D)-negative patients treated for the suppression of Rh isoimmunization.
Intravascular hemolysis leading to death has been reported in Rh(D)-positive patients treated for immune thrombocytopenic purpura (ITP) with Rh(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 treated for signs and symptoms of hemolysis 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 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).
Monitor patients for signs and symptoms of intravascular hemolysis in a healthcare setting for at least 8 hours after administration.
About Rhophylac
Overview
Rhophylac contains human Rho(D) immune globulin (anti-D), an antibody preparation made from donated human plasma. It is used to prevent Rh sensitization in Rh(D)-negative people who have not already become sensitized, during an Rh-incompatible pregnancy, after childbirth, or following a transfusion containing Rh(D)-positive red blood cells. It is also used to raise platelet counts in Rh(D)-positive adults with chronic immune thrombocytopenic purpura (ITP) who have not had their spleen removed. For prevention of Rh sensitization, its anti-D antibodies suppress the body's immune response to Rh(D)-positive red blood cells.
What it treats
- Prevention of Rh sensitization in Rh(D)-negative women who are not already sensitized and have an Rh-incompatible pregnancy, including before and after delivery and following obstetric complications or invasive procedures. - Prevention of Rh sensitization in Rh(D)-negative individuals after transfusion with blood components containing Rh(D)-positive red blood cells. - Raising platelet counts in Rh(D)-positive adults with chronic immune thrombocytopenic purpura (ITP) who have not had their spleen removed.
Safety information
Side effects
When Rhophylac is used to prevent Rh sensitisation, common side effects include nausea, dizziness, headache, pain at the injection site and feeling unwell. When used to treat ITP, common side effects include chills, fever or increased body temperature, and headache. Breakdown of red blood cells (hemolysis) has also been reported. Seek urgent medical attention for a severe allergic reaction, including anaphylaxis. Serious reactions reported during ITP treatment include breakdown of red blood cells within blood vessels, severe anemia, sudden kidney impairment and, very rarely, disseminated intravascular coagulation (a serious blood-clotting disorder) and death. Rhophylac may also worsen existing anemia during ITP treatment. Rhophylac carries a potential risk of transmitting viruses and, theoretically, the agent that causes Creutzfeldt-Jakob disease (CJD).
FDA boxed warning
Intravascular hemolysis in itp
This warning does not apply to Rh(D)-negative patients treated for the suppression of Rh isoimmunization.
Intravascular hemolysis leading to death has been reported in Rh(D)-positive patients treated for immune thrombocytopenic purpura (ITP) with Rh(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 treated for signs and symptoms of hemolysis 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 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).
Monitor patients for signs and symptoms of intravascular hemolysis in a healthcare setting for at least 8 hours after administration.
A boxed warning is the strongest warning the US Food and Drug Administration requires on a medicine label. Text is taken from the official label, with internal section references removed.
When to call your doctor
If symptoms are severe or getting worse quickly, seek emergency care rather than waiting.
Before taking this medicine
Rhophylac must not be given to anyone who has had an anaphylactic reaction or another severe, body-wide reaction to human immune globulin. It must also not be given to people with IgA deficiency who have antibodies against IgA and a history of hypersensitivity to Rhophylac or any of its components. It must not be given to the newborn infant of a mother who received Rhophylac after giving birth. Severe allergic reactions, including anaphylaxis, may occur. There is a potential risk of transmission of viruses and, theoretically, the agent that causes Creutzfeldt-Jakob disease (CJD). When used to treat ITP, Rhophylac can cause red blood cells to break down within blood vessels. Patients must be monitored for signs and symptoms, with laboratory tests to confirm suspected cases. It may also worsen pre-existing anemia in patients being treated for ITP.
Interactions
Rhophylac may temporarily interfere with the immune response to live virus vaccines, such as measles, mumps and rubella vaccines. Tell your doctor if you are planning to receive a live virus vaccine.
Using Rhophylac
Dosing
Dosing is set by your prescriber. Each health care professional may prescribe medication differently according to a patient's medical history and condition, so follow the directions on your prescription label and speak to your doctor or pharmacist before changing anything.
Storage
Store in the original carton below 25°C, protected from light, unless the pack states refrigeration. Do not freeze. Keep all medicines out of the sight and reach of children.
Clinical information on this page is summarised from the US FDA label RHOPHYLAC (HUMAN RHO(D) IMMUNE GLOBULIN) SOLUTION [CSL BEHRING AG] (DailyMed, retrieved 19 September 2026).
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