- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Single dose vial containing 250 iu human anti D immunoglobulin (Rho)
Single dose vial containing 500 iu human anti D immunoglobulin (Rho)
Single dose vial containing 1500 iu human anti D immunoglobulin (Rho)
Single dose vial containing 2500 iu human anti D immunoglobulin (Rho)
Prefilled syringe containing 300micrograms (1500 iu) human anti-D immunoglobulin in 2ml
1. Prevention of rhesus D antibody formation in rhesus-negative women of child bearing age to prevent haemolytic disease of the new born in any subsequent child born to the woman. Its use will typically be in the following cases:
(i) Non immunised Rh-negative women who give birth to a Rh-positive infant.
(ii) Prevention of ante-natal rhesus D immunisation in Rh-negative women.
(iii) Non-immunised Rh-negative women following any incidents during pregnancy that may lead to transplacental bleeding including abortion, miscarriage, threatened abortion, ectopic pregnancy, hydatiform mole, amniocentesis, chorionic biopsy, obstetric manipulative procedures.
2. Prevention of rhesus D immunisation in Rh-negative persons who have been given incompatible blood transfusions, or erythrocyte concentrates.
The manufacturers of different preparations recommend different doses and routes of administration. The manufacturer's literature should be consulted. The doses below are provided for guidance.
The Royal College of Obstetricians Guidelines may be found at www.rcog.org.uk
The National Institute for Clinical Excellence guidelines may be found at www.nice.org.uk
Some European countries use higher standard doses than those routinely used in the UK, but with no requirement for a routine Kleihauer test. The licensed doses for some products available for use in the UK reflect European practice. The recommended policy in the UK, alongside the smaller routine doses used is to obtain an anticoagulated blood sample as soon as possible after delivery (or other sensitising event) and to undertake a Kleihauer screening test to identify women with a large FMH (foeto-maternal haemorrhage) who need additional anti-D immunoglobulin.
Abortion, miscarriage or other sensitising event (e.g. amniocentesis)
Following every abortion or miscarriage where D (Rho) sensitisation may be expected before 20 weeks gestation, 250 iu per episode administered immediately or at the latest within 72 hours. The dose should be increased to 500 iu after 20 weeks gestation.
Some manufacturers recommend 1500 iu repeated, if necessary, at 6 - 12 week intervals throughout the pregnancy.
500 iu may be administered in weeks 28 and 34 of pregnancy and then within 72 hours of delivery if the baby is Rh(D) positive.
Other manufacturers recommend a single dose of 1500 iu at 28 to 30 weeks gestation.
500 iu administered immediately or at the latest within 72 hours.
Some manufacturers recommend doses of 1000 iu administered intravenously, or 1000 to 1500 iu administered intramuscularly.
The number of foetal red blood cells in the maternal circulation should be determined by a suitable method such as the Kleihauer test. If a foetal - maternal haemorrhage in excess of 4ml has occurred, then additional doses of anti-D should be administered as indicated.
125 iu per ml (some manufacturers recommend 50 iu) of transfused Rh(D) positive blood.
100 iu per ml of erythrocyte concentrate
250 iu per three adult doses of platelets.
Follow up tests should be done every 48 hours and further anti-D administered until all Rh(D) positive red blood cells have cleared from the circulation.
A maximum dose of 15,000 iu is sufficient in the case of larger incompatible transfusions independent of whether the transfusion volume is greater than 300 ml of Rh(D) positive blood.
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.
When more than 2 units of rhesus D positive blood have been transfused, an exchange transfusion should be considered.
Use in the elderly is usually limited to incompatible blood transfusions. In these cases there is no altered dosage (see adult dosage).
Use in children is usually limited to incompatible blood transfusions. In these cases there is no altered dosage (see adult dosage).
Additional Dosage Information
In August 2008 the National Institute of Clinical Excellence (NICE) recommended that all non-sensitised rhesus-negative pregnant women should be offered routine antenatal anti-D prophylaxis. Use of such routine prophylaxis should not be affected by previous anti-D prophylaxis for a sensitising event early in the same pregnancy. Similarly, post partum anti-D prophylaxis should not be affected by any previous antenatal anti-D prophylaxis.
Different brands may be licensed for different routes of administration. Follow the manufacturer's recommendations concerning intravenous, intramuscular or subcutaneous injection.
If large volumes are given by intramuscular injection (more than 5ml), they should be administered as divided doses at different sites.
The Royal College of Obstetricians recommend that intramuscular anti-D immunoglobulin is best given into the deltoid muscle as injections into the gluteal region often only reach the subcutaneous tissue and absorption may be delayed.
Severe thrombocytopenia, coagulation abnormalities: use of an appropriate product via the subcutaneous or intravenous route should be considered.
Rhesus (D) positive patients
Precautions and Warnings
Women who have a weak expression of the RhD blood group (Du) do not require prophylaxis.
May affect immune response to live virus vaccines if administered within 2 to 4 weeks of the live vaccine. Live virus vaccine should not be given for 3 months after treatment.
May interfere with blood typing and antibody testing.
The product may contain trace elements of immunoglobulin A. Patients who may develop antibodies to immunoglobulin A (e.g. IgA deficient individuals) are at increased risk of hypersensitivity reactions - the potential benefit must be weighed against the possible risk.
Monitor the patient for at least 20 minutes post injection.
Discontinue if allergic reactions occur. Inform patients of the early signs of hypersensitivity reactions (hives, generalised urticaria, tightness of the chest, wheezing, hypotension and anaphylaxis). If necessary, administer the standard emergency treatment for shock.
In the post partum period this product is intended for maternal use - do not administer to the neonate.
The risk of transmission of infective agents in products prepared from blood or plasma cannot be totally excluded.
It is important that each name and batch number of every administered dose be registered.
Divide large doses amongst various intramuscular injection sites to prevent local side effects.
Administer by the route recommended on the label only. Inappropriate administration may cause shock.
Pregnancy and Lactation
Anti D immunoglobulin is regularly used in pregnancy and no adverse effects have been seen in the children delivered.
Non-administration may lead to sensitisation of the mother and thus increase the risk of spontaneous abortion or haemolytic disease of the new born in subsequent pregnancies.
The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14-17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
There are no known harmful effects when this medicine is used by breastfeeding women.
Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1
Local pain (injection site)
Tenderness (injection site)
Swelling (injection site)
Erythema at injection site
Induration (injection site)
Sensation of warm and/or cold at injection site
Effects on Laboratory Tests
Following injection, the transitory rise of the various passively transferred antibodies in the patient's blood may result in misleading positive results in serological testing. The passive transmission of antibodies to erythrocyte antigens may interfere with some serological tests for red cell antibodies, e.g. the antiglobulin (Coombs' test), particularly in Rh(D) positive neonates whose mothers have received antepartum prophylaxis.
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
British National Formulary, 63rd Edition (2012) Pharmaceutical Press, London.
National Institute for Health and Clinical Excellence
Routine antenatal anti-D prophylaxis for women who are rhesus D negative
NICE technology appraisal guidance 156. Issued August 2008.
Royal College of Obstetricians and Gynaecologists
The Use of Anti-D Immunoglobulin for Rhesus D Prophylaxis - Green-top Guideline No. 22. Revised March 2011.
Summary of Product Characteristics: D-GAM solution for injection 250iu vials. Bio Products Laboratory. Revised August 2011
Summary of Product Characteristics: D-GAM solution for injection 500iu vials. Bio Products Laboratory. Revised August 2011
Summary of Product Characteristics: D-GAM solution for injection 1500 & 2500iu vials. Bio Products Laboratory. Revised August 2011
Summary of Product Characteristics: Rhophylac 300 (1500IU). CSL Behring UK Limited. Revised July 2011
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