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Immunoglobulin (Rh Prophylaxis) Pregnancy: §4.6: 'This medicinal product is intended for use in pregnancy. No study drug-related adverse events were reported in children delivered of 432 women who received antepartum administration of Rhophylac 300 micrograms.' Breastfeeding: 'This medicinal product can be used during breastfeeding. Immunoglobulins are excreted in human milk. No study drug-related adverse events were reported in children delivered of 256 women who received postpartum administration of Rhophylac 300 micrograms, nor in children delivered of 139 women who received postpartum administration of Rhophylac 200 micrograms.' Fertility: no animal fertility studies have been conducted; clinical experience with human anti-D immunoglobulin suggests no harmful effects on fertility are to be expected.

Anti-D (Rh₀) Immunoglobulin

Brand names: Rhesonativ, RHOPHYLAC, Partobulin SDF

Anti-D (Rh₀) immunoglobulin is a human plasma-derived antibody preparation given to RhD-negative individuals to prevent sensitisation to the RhD antigen, principally in obstetric care to avert haemolytic disease of the fetus and newborn.

Adult dose

Dose: PREVENTION OF Rh(D) ISOIMMUNISATION IN Rh(D) NEGATIVE WOMEN (this page's primary indication) — RHOPHYLAC 300 micrograms / 2 ml ONLY. ANTEPARTUM PROPHYLAXIS, §4.2 verbatim: 'The recommended dose is a single dose of 300 micrograms (1500 IU) administered by intravenous or intramuscular injection. Planned antepartum prophylaxis: A single dose of 300 micrograms at 28 - 30 weeks of pregnancy. If the need for antepartum prophylaxis is identified in the period beyond 30 weeks of pregnancy, Rhophylac should not be withheld but administered as soon as possible. Antepartum prophylaxis following complications of pregnancy: A single dose of 300 micrograms should be administered as soon as possible and within 72 hours... If necessary, the dose may be repeated at 6 - 12 week intervals throughout the pregnancy.' POSTPARTUM PROPHYLAXIS: 'The recommended dose is a single dose of 300 micrograms (1500 IU), administered by intravenous or intramuscular injection. When administered intravenously, a minimum dose of 200 micrograms may be sufficient provided large foeto-maternal haemorrhage can be excluded... administered to the mother as soon as possible within 72 hours of delivery of a Rh(D) positive (D, D weak, D partial) infant... The postpartum dose must still be given even when antepartum prophylaxis has been administered.' LARGE FOETO-MATERNAL HAEMORRHAGE (>4 ml Rh(D) positive foetal blood): 300 micrograms (1500 IU) as a single dose PLUS an additional 10 micrograms (50 IU) per 0.5 ml Rh(D) positive foetal RBCs, or per 1 ml Rh(D) positive foetal blood, the extent having been measured by Kleihauer-Betke or flow cytometry. SCOPE: every figure here is Rhophylac 300 micrograms/2 ml's own. The other anti-D products named on this page (Rhesonativ, Partobulin SDF) are licensed at different unit doses and were NOT fetched — do not carry these numbers across to them. §4.2 itself adds: 'Consideration should also be given to dose and dose schedules for human anti-D immunoglobulin for intramuscular and intravenous use recommended in other official guidance.'
Route: Intravenous or intramuscular, by slow injection. §4.2 verbatim: 'As with all blood products, patients should be observed for at least 20 minutes following administration of Rhophylac. For intravenous or intramuscular use, to be administered by slow injection. If a large volume (>2 ml for children or >5 ml for adults) is required and intramuscular injection is chosen, it is recommended to administer this in divided doses at different sites. If intramuscular administration is contraindicated (bleeding disorders), Rhophylac should be administered intravenously.' Obesity: 'In patients with a body mass index (BMI) ≥30 intravenous administration should be considered.'
Frequency: A single dose per event, on the schedule above — 28-30 weeks for planned antepartum prophylaxis; within 72 hours of a complication of pregnancy; within 72 hours of delivery of a Rh(D) positive infant. Where more than 72 hours have elapsed the product should not be withheld but administered as soon as possible. Antepartum, the dose may be repeated at 6-12 week intervals through the pregnancy if necessary.
Source: UK SPC (eMC) for Rhophylac 300 micrograms / 2 ml, solution for injection in pre-filled syringe, §4.2 posology plus §4.3, §4.4, §4.6 and §4.8 (https://www.medicines.org.uk/emc/product/6791/smpc). The §4.2 POSOLOGY SECTION IS COMPLETE in this bundle (it runs through the summary table to the Obesity paragraph). Some sections of the product information we used were incomplete — check the full SPC. NO maxDose FIELD IS SET, DELIBERATELY: the SPC's 3000 microgram ceiling belongs to a DIFFERENT indication (incompatible transfusion, below) and must not be presented as a ceiling for Rh prophylaxis, for which the SPC states no numeric maximum — in large foeto-maternal haemorrhage the extra dose is calculated from the measured bleed volume. DOSE BASIS, §4.2 verbatim: 'The dose of anti-D immunoglobulin should be determined according to the level of exposure to Rh(D) positive red blood cells (RBCs) and based on the knowledge that 0.5 ml of packed Rh(D) positive RBCs or 1 ml of Rh(D) positive blood is neutralised by approximately 10 micrograms (50 IU) of anti-D immunoglobulin.' Also: 'The Rhophylac dose may need to be increased if the patient is exposed to >15 ml of Rh(D) positive foetal RBCs. In this case, follow the dosing guidelines for large foeto-maternal haemorrhage.' SEPARATE INDICATION WITH ITS OWN CEILING — INCOMPATIBLE TRANSFUSIONS OF RBCs IN Rh(D) NEGATIVE PATIENTS (do not apply these figures to Rh prophylaxis): '20 micrograms (100 IU) anti-D immunoglobulin per 2 ml of transfused Rh(D) positive blood or per 1 ml of Rh(D) positive RBC concentrate. The appropriate dose should be determined in consultation with a specialist in blood transfusion. Follow-up tests for Rh(D) positive RBCs should be done every 48 hours and further anti-D administered until all Rh(D) positive RBCs have cleared from the circulation. A maximum dose of 3000 micrograms (15,000 IU) is sufficient even if more than 300 ml of Rh(D) positive blood or 150 ml of Rh(D) positive erythrocyte concentrate was transfused. Due to possible risk of haemolysis, however, it is suggested to not exceed the dose of 3000 micrograms (15000 IU). Intravenous use is recommended as it will achieve adequate plasma levels immediately. If given by intramuscular injection the large volume should be administered over a period of several days.' NOTE ON SOURCES: providers.openfda is null; providers.who is a reference link only (WHO eEML entry 460, https://list.essentialmeds.org/medicines/460) with no extracted dosing, so no WHO figure has been used.

Paediatric dose

Route: Intravenous or intramuscular by slow injection — if a large volume (>2 ml for children) is required and the intramuscular route is chosen, give in divided doses at different sites
Frequency: Determined by the volume of Rh(D) positive blood or RBC concentrate transfused, in consultation with a specialist in blood transfusion; follow-up tests every 48 hours until all Rh(D) positive RBCs have cleared
NOT WEIGHT-BASED, so dosePerKg is null and the weight calculator is deliberately left unset. The ONLY paediatric statement in this SPC concerns INCOMPATIBLE TRANSFUSION, not this page's primary indication (Rh prophylaxis in pregnancy, which does not arise in children). §4.2 verbatim: 'Paediatric population. As the posology in case of incompatible transfusion depends on the volume of Rh(D) positive blood or RBC concentrate transfused, the recommended dose in children and adolescents (0-18 years) is not considered to be different to that of adults. However, the appropriate dose should be determined in consultation with a specialist in blood transfusion.' The adult volume-based figure it refers to is 20 micrograms (100 IU) per 2 ml of transfused Rh(D) positive blood or per 1 ml of Rh(D) positive RBC concentrate, up to a maximum of 3000 micrograms (15,000 IU). §4.4: in the case of postpartum use, anti-D immunoglobulin is intended for maternal administration and 'should not be given to the new-born infant'. Verify against a children's formulary and with transfusion medicine before use.

Dose adjustments

Renal

Not stated in the product information we used — check the full SPC.

Hepatic

Not stated in the product information we used — check the full SPC.

Dose independently re-sourced from UK Summary of Product Characteristics (SPC) via the eMC — clinician-reviewed. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Hypersensitivity to the active substance or to any of the excipients of Rhophylac listed in section 6.1
  • Hypersensitivity to human immunoglobulins
  • The intramuscular route is contraindicated in persons with severe thrombocytopenia or other disorders of haemostasis
  • NOT INTENDED FOR (§4.4, not a §4.3 contraindication): Rh(D) positive individuals, or individuals already immunised to the Rh(D) antigen
  • NOT FOR THE INFANT (§4.4): in postpartum use the product is intended for maternal administration and should not be given to the new-born infant

Side effects

  • Most serious: hypersensitivity or allergic reactions, which may in rare cases progress to a sudden fall in blood pressure and anaphylactic shock, even when the patient has tolerated previous administrations
  • Immune system disorders (rare): hypersensitivity, anaphylactic shock
  • Nervous system (uncommon): headache
  • Cardiac (rare): tachycardia. Vascular (rare): hypotension. Respiratory (rare): dyspnoea
  • Gastrointestinal (rare): nausea, vomiting
  • Skin (uncommon): skin reaction, erythema, pruritus
  • Musculoskeletal (rare): arthralgia
  • General (uncommon): pyrexia, malaise, chills. Injection site (rare): swelling, pain, erythema, induration, warmth, pruritus, rash — local pain and tenderness may be observed with intramuscular administration
  • Spontaneous reports of severe intravascular haemolysis, including fatal cases, when anti-D was administered intravenously to Rh(D) POSITIVE patients with primary immune thrombocytopenia (ITP) — exact frequency not known

Interactions

  • PARTIAL — §4.5 was not separately fetched and §4.4 was truncated at the source-fetch limit; verify the complete interaction section (in particular the standard immunoglobulin/live-vaccine interval, which does not appear in the fetched text)
  • §4.4: individuals deficient in IgA have the potential to develop IgA antibodies and may have anaphylactic reactions after administration of blood components containing IgA — the IgA concentration in Rhophylac is below the 5 micrograms/ml detection limit but trace amounts may be present
  • §4.4: Rhophylac contains less than 1 mmol sodium (23 mg) per syringe — essentially sodium-free

Monitoring

  • Observe the patient for at least 20 minutes after administration, as with all blood products (§4.2)
  • Quantify a suspected large foeto-maternal haemorrhage (>4 ml Rh(D) positive foetal blood, e.g. with foetal/neonatal anaemia or intrauterine foetal death) by a suitable method such as the Kleihauer-Betke acid elution test for foetal haemoglobin, or flow cytometry identifying Rh(D) positive RBCs, and give additional anti-D accordingly (§4.2)
  • Incompatible transfusion: follow-up tests for Rh(D) positive RBCs every 48 hours, with further anti-D until all Rh(D) positive RBCs have cleared from the circulation (§4.2)
  • Patients receiving very large doses after incompatible transfusion should be monitored clinically and by biological parameters because of the risk of haemolytic reaction (§4.4)
  • Inform patients of the early signs of hypersensitivity — hives, generalised urticaria, tightness of the chest, wheezing, hypotension and anaphylaxis — and discontinue immediately if they occur (§4.4)
  • BMI ≥30: intramuscular administration has been reported to carry an increased risk of lack of efficacy; consider the intravenous route (§4.4)

Clinical monograph

How it works

Passively administered anti-D antibody binds and promotes clearance of RhD-positive fetal red cells from the maternal circulation before the mother can mount her own immune response, preventing formation of anti-D antibodies.

Prescribing in practice

  • It must be given to non-sensitised RhD-negative women after any potential sensitising event and routinely in pregnancy; it is ineffective and not indicated once the woman has already formed her own anti-D antibodies, so confirm she is not already sensitised.
  • The size of a large feto-maternal haemorrhage should be quantified (e.g. by Kleihauer testing) after delivery or major sensitising events so that additional doses can be given if needed.
  • As a blood-derived product it should be given by the appropriate route promptly after the event and recorded carefully, with the usual precautions for anaphylaxis.

Monitoring

Confirm RhD status and antibody screen, and assess feto-maternal haemorrhage where indicated to ensure adequate cover.

Counselling the patient

  • This injection protects future pregnancies by stopping your immune system reacting to a baby's blood group.
  • It is given after events such as bleeding, certain procedures, miscarriage or delivery, as well as routinely during pregnancy.
  • Keep a record of when you received it and report any rash, swelling or breathing difficulty after the injection.

Evidence & guidelines

Routine antenatal and postnatal anti-D prophylaxis for RhD-negative women is recommended by NICE and UK transfusion guidelines.

Reference: NICE NG25 (Ectopic pregnancy and miscarriage: anti-D, 2021); BCSH Guideline on anti-D prophylaxis (2014 updated); RCOG Green-top Guideline No. 22 (Anti-D immunoglobulin); Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.

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