Rho(D) immune globulin

Pronunciation: roh-D im-MYOON GLOB-yoo-lin.

Generic name
Rho(D) immune globulin (human anti-D immunoglobulin)
Drug class
Plasma-derived biologic; passive (polyclonal antibody) immunising agent
Form
Solution for injection, prefilled syringe or single-dose vial, in multiple IU/microgram strengths depending on product and indication
Route
Intramuscular injection (Rh-sensitisation prophylaxis products) or intravenous injection (WinRho SDF, ITP treatment and, in the US/Canada, also usable for Rh-sensitisation prophylaxis)
Legal status
Prescription-only, administered by or under the supervision of a healthcare professional

Availability and supply rules vary by country

Trade names by country: United States · United Kingdom · Canada · Australia · New Zealand

Australia: Rhophylac (6), Rh(D) Immunoglobulin-VF (6) · Full directory

What Rho(D) immune globulin (human anti-D immunoglobulin) is and how it works

Rho(D) immune globulin is a biologic medicine made from human plasma, containing antibodies against the Rh(D) blood group antigen. Its best-known use is to prevent an Rh-negative person's immune system from reacting against Rh-positive blood cells encountered during pregnancy, delivery, miscarriage, or a blood transfusion -- a process called Rh sensitisation, which can otherwise cause serious hemolytic disease in a future Rh-positive baby. A separate, distinct product form given intravenously (WinRho SDF) is also used to raise platelet counts in certain people with immune thrombocytopenic purpura (ITP), a condition where the immune system destroys platelets. (1) (2)

This medicine is given by a healthcare professional, never self-administered, and the correct product, route, and dose depend heavily on why it is being given. If it is being given intravenously to treat ITP, it carries a genuine, serious risk of intravascular hemolysis (a sudden breakdown of red blood cells) that has caused deaths, and requires close monitoring for at least 8 hours afterward. The intramuscular products used to prevent Rh sensitisation in pregnancy do not carry this same boxed-warning-level risk, but still require monitoring for allergic reactions. Because it is made from human plasma, there is also a small, honestly disclosed risk of transmitting an infectious agent, greatly reduced by donor screening and manufacturing safety steps but not zero.

Mechanism of action: how Rho(D) immune globulin (human anti-D immunoglobulin) works

Rho(D) immune globulin is a purified IgG fraction containing anti-D antibodies. For Rh-sensitisation prophylaxis, exogenous anti-D antibody clears fetal Rh(D)-positive red cells from the maternal circulation before the mother's own immune system can mount a sensitising response. In ITP, the postulated mechanism is that anti-D coats the patient's own Rh(D)-positive red blood cells, and the reticuloendothelial system preferentially clears these antibody-coated red cells over antibody-coated platelets, sparing platelets from destruction -- an effect that is transient, not curative. (2) (5)

What Rho(D) immune globulin (human anti-D immunoglobulin) is used for

Prevention of Rh sensitisation in pregnancy and delivery

Given to Rh(D)-negative women who are not already sensitised, to prevent their immune system from making antibodies against Rh(D)-positive blood cells encountered through pregnancy or delivery -- typically once at around 26-28 to 28-30 weeks of pregnancy, and again within 72 hours after delivery if the baby is Rh-positive or the baby's Rh status is unknown. (1) (3)

Prevention of Rh sensitisation after miscarriage, termination, ectopic pregnancy, or prenatal procedures

Given after any event that could expose an Rh-negative woman's blood to Rh-positive fetal blood cells, including miscarriage, termination of pregnancy, ectopic pregnancy, amniocentesis, chorionic villus sampling, cordocentesis, or significant abdominal trauma in pregnancy -- ideally as soon as possible and within 72 hours of the event. (2) (7)

Prevention of Rh sensitisation after an incompatible blood transfusion

Given to Rh(D)-negative individuals who have received a transfusion of Rh(D)-positive red blood cells, at a dose calculated based on the volume of Rh-positive blood received. (1) (7)

Treatment of immune thrombocytopenic purpura (ITP) -- intravenous product only

The intravenous product (WinRho SDF) is used to raise platelet counts and help control bleeding in non-splenectomised, Rh(D)-positive children and adults with ITP, including ITP related to HIV infection. This effect is temporary, not curative, and some people need repeated maintenance doses. (2) (5)

Before taking Rho(D) immune globulin (human anti-D immunoglobulin)

Do not take / not appropriate for

  • This medicine must not be given to a person who is Rh(D)-positive (for the sensitisation-prevention use). (all countries) (1) (7)
  • Must not be given to a person already sensitised to the Rh(D) antigen (a positive antibody screen) -- it provides no benefit for the sensitisation-prevention use in this situation, though it is not harmful either. (all countries) (2) (7)
  • Must not be given to anyone with a known history of anaphylactic or severe systemic reaction to this product or other human immune globulin products. (all countries) (1) (2)
  • For the specific New Zealand-licensed intramuscular product, it must NOT be given intravenously because of the risk of anaphylactic reaction -- a genuine, product-specific route restriction. (New Zealand) (7)
  • For the intravenous ITP-treatment product (WinRho SDF), it must not be given to people who are Rh(D)-negative, who have had a splenectomy, whose ITP is secondary to leukemia, lymphoma, or an active viral infection, or who have autoimmune hemolytic anemia -- because of the heightened intravascular hemolysis risk in these situations. (United States, Canada) (2) (5)

Tell your clinician about

  • Your Rh blood type and, if relevant, the reason it is being checked (pregnancy, transfusion, ITP).
  • Any known IgA deficiency or history of allergic reactions to blood products or immune globulins.
  • For ITP treatment: any history of a blood cancer (leukemia or lymphoma), hepatitis C, Epstein-Barr virus infection, or autoimmune blood disorders, since these increase intravascular hemolysis risk.
  • Your age and any heart, kidney, or liver conditions, particularly if you are over 65 and being considered for the intravenous ITP-treatment product.
  • Whether you are pregnant, planning pregnancy, or breastfeeding, and your exact gestational age if pregnant.
  • Any other recent immune globulin or blood product treatment.
(2) (5)

How to take Rho(D) immune globulin (human anti-D immunoglobulin)

  • This medicine is always given by, or under the direct supervision of, a healthcare professional -- it is never self-administered.
  • The exact product, route (intramuscular or intravenous), dose, and timing depend on why it is being given, and are decided by your care team -- never adjust or request a change to this yourself.
  • You will be monitored for a period after each dose: typically at least 20 minutes for intramuscular Rh-sensitisation prophylaxis, or at least 8 hours with repeated urine testing if you are receiving the intravenous product for ITP treatment.
(1) (2)

Procedures and treatment changes

Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1) (2) (3) (4) (5) (6) (7)

Missed dose

Contact your care team immediately if you think a scheduled dose was missed or delayed, especially around a pregnancy-related sensitising event, since timing (ideally within 72 hours) affects how well it works -- do not attempt to arrange or give an extra dose yourself.

Overdose

Seek urgent medical attention if you believe an incorrect or excessive dose was given. An overdose can increase the risk of a severe hemolytic reaction; a mix-up between International Units (IU) and micrograms, or between pounds and kilograms of body weight, has been specifically identified as a real risk factor for dosing errors with this medicine. (5)

Side effects

Side effects and their urgency vary; report severe, persistent, or concerning symptoms.

Injection-site swelling, redness, or mild pain (intramuscular products).

What to notice: Injection-site swelling, redness, or mild pain (intramuscular products).

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Headache, chills, fever, weakness, nausea, muscle aches, or dizziness (intravenous product).

What to notice: Headache, chills, fever, weakness, nausea, muscle aches, or dizziness (intravenous product).

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (2)

Mild skin reactions.

What to notice: Mild skin reactions.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (3)

Serious warnings

Signs of intravascular hemolysis (applies to the intravenous ITP-treatment product) — boxed_warning

Symptoms: Back pain, fever, chills, or dark or discoloured urine, usually within a few hours of the intravenous dose.

Action: Seek emergency medical help immediately -- this can indicate intravascular hemolysis, a serious and potentially fatal breakdown of red blood cells. This is why close monitoring for at least 8 hours, with urine testing, is required after an intravenous dose for ITP treatment. (2) (5)

Signs of a serious allergic (anaphylactic) reaction — emergency

Symptoms: Swelling of the face, lips, tongue, or throat; difficulty breathing; widespread rash or hives; sudden drop in blood pressure.

Action: Seek emergency medical help immediately. This is why you are monitored for a period after every dose, even though anaphylaxis is rare. (7) (3)

Signs of a blood clot (thromboembolic event) — high caution

Symptoms: Sudden chest pain, shortness of breath, leg swelling or pain, or signs of a stroke.

Action: Seek emergency medical help immediately -- immune globulin treatment carries a general blood clot risk, particularly in people with pre-existing cardiovascular risk factors, prolonged immobility, or blood-thickness disorders. (5)

Interactions

  • This medicine contains maltose, which can cause falsely high blood glucose readings on certain point-of-care blood glucose testing systems -- tell any healthcare professional monitoring your blood sugar that you have received this medicine. (5)
  • Other recent immune globulin or blood product treatment should be disclosed to your care team, as it can affect dosing decisions and monitoring. (5)

Pregnancy, breastfeeding, kidney/liver function, age

Pregnancy

This medicine's main use is specifically to protect future pregnancies in Rh-negative women; use during pregnancy for its licensed prophylaxis indication is standard practice under specialist guidance. (1) (2) (3) (4) (5) (6) (7)

Breastfeeding

Discuss with your clinician; this is a standard part of routine postpartum Rh-prophylaxis care in breastfeeding women. (1) (2) (3) (4) (5) (6) (7)

Children

The intravenous product is used to treat ITP in children as well as adults, including children with ITP secondary to HIV infection, at the same weight-based dosing as adults, with the same monitoring requirements. (1) (2) (3) (4) (5) (6) (7)

Elderly

For the intravenous ITP-treatment product specifically, people over 65 with underlying heart, kidney, or liver conditions are at increased risk of serious complications if intravascular hemolysis occurs, and dosing at the lower end of the range is recommended with extra caution. (1) (2) (3) (4) (5) (6) (7)

Hepatic_impairment

Not specifically quantified for the intramuscular prophylaxis products in the sources reviewed; relevant as a risk factor for intravenous ITP-treatment complications (see elderly/special-risk note above). (1) (2) (3) (4) (5) (6) (7)

Renal_impairment

Not specifically quantified for the intramuscular prophylaxis products in the sources reviewed; relevant as a risk factor for intravenous ITP-treatment complications (see elderly/special-risk note above). (1) (2) (3) (4) (5) (6) (7)

Monitoring

Before starting

  • Confirmation of Rh(D) blood type and, where relevant, antibody sensitisation status
  • Review of IgA deficiency or prior immune globulin allergic reaction history
  • For ITP treatment: confirmation of non-splenectomised status and exclusion of contraindicated underlying causes

During treatment

  • At least 20 minutes of observation after intramuscular administration (at least 1 hour if inadvertent intravenous injection is suspected).
  • At least 8 hours of observation after intravenous administration for ITP treatment, with dipstick urinalysis performed at baseline, 2 hours, 4 hours, and before monitoring ends, to check for intravascular hemolysis.
  • Laboratory monitoring (hemoglobin, haptoglobin, LDH, bilirubin) if intravascular hemolysis is suspected.
(2) (5) (7)

Storage

Store as directed on the product label; this medicine contains no preservative in most licensed formulations and must be used promptly once a vial or syringe is opened. Storage and administration are handled by the healthcare facility, not the patient.

Professional information

Clinician-facing context only, sourced from the current US FDA labels for both product forms and the Canadian product monograph reviewed for this dossier; verify against the current full label and local product/route licensing before administering.

United States

Indication: Rh-sensitisation prophylaxis (RhoGAM, intramuscular)

Dose summary: 300 mcg (1500 IU) IM within 72 hours for most indications; 20 mcg per mL of Rh-positive RBC exposure for transfusion, rounded up to the next whole syringe.

Renal context: Not specifically quantified in the sources reviewed. (1)

United States / Canada

Indication: ITP treatment (WinRho SDF, intravenous only)

Dose summary: 250 IU/kg (50 mcg/kg) IV single injection over 3-5 minutes; individualised maintenance dosing for chronic ITP.

Renal context: Not specifically quantified in the sources reviewed; advanced age with cardiac/renal/hepatic co-morbidity is a documented risk factor for serious complications if intravascular hemolysis occurs. (2) (5)

Mechanism of action

Hepatic guidance

Not specifically quantified in the sources reviewed for this dossier.

Overdose note

No specific antidote; manage with supportive care and close monitoring for hemolysis and its complications. Dosing-unit confusion (IU vs. micrograms, or pounds vs. kilograms) is a specifically documented real-world error risk factor for overdose. (2) (5)

Frequently asked questions

Does Rho(D) immune globulin have a boxed warning?

It depends on the product and how it is given. The intravenous product used to treat ITP (WinRho SDF) carries a real FDA boxed warning for intravascular hemolysis, which has caused deaths in some patients. The intramuscular products used to prevent Rh sensitisation in pregnancy (such as RhoGAM) do not carry a boxed warning, though they still require monitoring for allergic reactions. (1) (2)

Is there a risk of catching an infection from this medicine?

Because it is made from human plasma, there is a small, honestly disclosed theoretical risk of transmitting an infectious agent, including viruses and, theoretically, the agent that causes Creutzfeldt-Jakob disease. This risk is substantially reduced by donor screening, viral testing, and manufacturing steps such as solvent/detergent treatment and filtration, but it cannot be completely eliminated. (2) (7)

Why do I need to be monitored after receiving this medicine?

You are monitored to catch any early signs of an allergic reaction or, for the intravenous ITP-treatment product, intravascular hemolysis. Monitoring is at least 20 minutes for intramuscular Rh-prophylaxis doses, and at least 8 hours with repeated urine testing for intravenous ITP-treatment doses, because hemolysis-related complications can develop within that window. (2) (7)

What is the mechanism of action of Rho(D) immune globulin (human anti-D immunoglobulin)?

Rho(D) immune globulin is a purified IgG fraction containing anti-D antibodies. For Rh-sensitisation prophylaxis, exogenous anti-D antibody clears fetal Rh(D)-positive red cells from the maternal circulation before the mother's own immune system can mount a sensitising response. In ITP, the postulated mechanism is that anti-D coats the patient's own Rh(D)-positive red blood cells, and the reticuloendothelial system preferentially clears these antibody-coated red cells over antibody-coated platelets, sparing platelets from destruction -- an effect that is transient, not curative. (2) (5)

What is the generic name of Rho(D) immune globulin?

The generic name is Rho(D) immune globulin (human anti-D immunoglobulin). (1) (2)

What class of drug is Rho(D) immune globulin (human anti-D immunoglobulin)?

Rho(D) immune globulin is classed as: Plasma-derived biologic; passive (polyclonal antibody) immunising agent. (1) (2)

References

  1. RhoGAM Ultra-Filtered PLUS [Rho(D) Immune Globulin (Human)] -- full prescribing informationU.S. Food and Drug Administration / DailyMed (NIH), full prescribing information, Kedrion Biopharma · United States · accessed 2026-07-30 · source 1
  2. WinRho SDF [Rho(D) Immune Globulin Intravenous (Human)] -- full prescribing informationU.S. Food and Drug Administration / DailyMed (NIH), full prescribing information, Kamada Ltd. / Aptevo BioTherapeutics · United States · accessed 2026-07-30 · source 2
  3. Rhophylac 300 micrograms/2 ml, solution for injection in pre-filled syringe -- Summary of Product Characteristicselectronic medicines compendium (emc), United Kingdom -- CSL Behring UK Limited · United Kingdom · accessed 2026-07-30 · source 3
  4. Human anti-D immunoglobulin -- list of nationally authorised products (PSUSA/00001614/201503)European Medicines Agency (EMA) -- PSUSA list of nationally authorised human anti-D immunoglobulin products · European Union · accessed 2026-07-30 · source 4
  5. WinRho SDF, Rho(D) Immune Globulin (Human) for Injection -- Product Monograph including Patient Medication InformationHealth Canada product monograph, Aptevo BioTherapeutics LLC (distributed in Canada by Emergent BioSolutions Canada Inc.) · Canada · accessed 2026-07-30 · source 5
  6. RHOPHYLAC 1500IU human anti-D immunoglobulin solution for injection syringe -- ARTG entry 153815 (plus related CSL Rh(D) Immunoglobulin-VF entries 76643, 61217)Therapeutic Goods Administration (TGA), Australia · Australia · accessed 2026-07-30 · source 6
  7. Rh(D) Immunoglobulin-VF 250 IU / 625 IU, solution for intramuscular injection -- New Zealand Data Sheet (NZ DS 16.00)Medsafe (New Zealand Medicines and Medical Devices Safety Authority) · New Zealand · accessed 2026-07-30 · source 7

Brand names by country

Single-ingredient Rho(D) immune globulin (human anti-D immunoglobulin) names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.

Priority countries

United States

  • RhoGAM (Ultra-Filtered PLUS) (1)FDA approved currently labeled intramuscular prophylaxis · 50 mcg (MICRhoGAM), 300 mcg (1500 IU) · Kedrion Biopharma Inc.
  • WinRho SDF (2)FDA approved currently labeled intravenous ITP and prophylaxis · 600 IU (120 mcg), 1500 IU (300 mcg), 2500 IU (500 mcg), 5000 IU (1000 mcg), 15000 IU (3000 mcg) · Kamada Ltd. / Aptevo BioTherapeutics

United Kingdom

  • Rhophylac (3)MHRA licensed emc smpc confirmed · 300 micrograms/2 mL (750 IU/mL) · CSL Behring UK Limited

Canada

  • WinRho SDF (5)Health Canada approved confirmed product monograph dated 2017-08-14 · 600 IU (120 mcg), 1500 IU (300 mcg), 2500 IU (500 mcg), 5000 IU (1000 mcg), 15000 IU (3000 mcg) · Aptevo BioTherapeutics LLC (distributed by Emergent BioSolutions Canada Inc.)

Australia

  • Rhophylac (6)TGA ARTG registered 2009-12-22 confirmed · 1500 IU (300 mcg)/2 mL · CSL Behring (Australia) Pty Ltd
  • Rh(D) Immunoglobulin-VF (6)TGA ARTG registered confirmed related entries · 250 IU, 625 IU · CSL

New Zealand

  • Rh(D) Immunoglobulin-VF (7)Medsafe data sheet confirmed NZ DS 16.00 · 250 IU, 625 IU · not specified in source
View brands in additional countries.

European Union

Rhophylac (and other national anti-D immunoglobulin brands) (4)