Anti-D Immunoglobulins


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : IM Postnatal prophylaxis of RhD immunisation in RhD negative women In Rhesus (Rh)-negative mothers who have just delivered Rh(D)-positive infants: 500 IU (100 mcg) as soon as possible after delivery. Recommended dose range: 500-1,500 IU (100-300 mcg). If large FMH (>4 mL) is suspected, extent must be determined by suitable method (e.g. Kleihauer-Betke acid elution test or flow cytometry) and additional doses of 50 IU (10 mcg) per 0.5 mL foetal RBC may be administered. Routine antenatal prophylaxis of RhD immunisation in RhD negative women Recommended dose: 500 IU given at both 28 and 34 weeks of gestation. Alternatively, 1,500 IU as single dose may be given between 28-30 weeks of gestation. Recommended dose range: 250-1,650 IU (50-330 mcg). Antenatal prophylaxis of RhD immunisation following complications of pregnancy in RhD negative women Following any potential sensitising episode (e.g. stillbirth, abortion, amniocentesis) up to 20 weeks gestation: 250 IU as single dose to be given as soon as possible and within 72 hours. Following any potential sensitising episode (e.g. stillbirth, abortion, amniocentesis) after 20 weeks gestation: 500 IU as single dose to be given as soon as possible and within 72 hours. Doses may be repeated at 6- to 12-week intervals throughout pregnancy, if necessary. A test for the FMH size must be performed when administered after 20 weeks of gestation and additional doses may be administered as indicated. Suppression of Rh immunisation following incompatible transfusions In Rh(D)-negative individuals who undergone transfusions with Rh(D)-positive blood components: Recommended dose: 100 IU (20 mcg) per 2 mL of transfused Rh(D) positive blood or per 1 mL of RBC concentrate. Max: 15,000 units (3,000 mcg). Clinical evaluation is recommended to determine the dosage requirement. Dosages may vary depending on the preparation used (refer to detailed product guideline). IV Idiopathic thrombocytopenic purpura In Rh(D)-positive, non-splenectomised patients: Initial: 250 IU/kg (50 mcg/kg) as single dose or may be given in 2 divided doses on separate days. Maintenance dose: 125-300 IU/kg (25-60 mcg/kg) depending on clinical response. Patient with pre-existing anaemia (Hb <10 g/dL): Initial: 125-200 IU/kg (25-40 mcg/kg) as single dose or may be given in 2 divided doses on separate days.
Dosage Details
Intramuscular
Postnatal prophylaxis of RhD immunisation in RhD negative women
Adult: In Rhesus (Rh)-negative mothers who have just delivered Rh(D)-positive infants: 500 IU (100 mcg) as soon as possible after delivery. Recommended dose range: 500-1,500 IU (100-300 mcg). Testing of the amount of fetomaternal haemorrhage (FMH) must be performed when lower dose is administered. Postnatal dose should still be administered even when antenatal prophylaxis has been given and residual activity can be demonstrated in maternal serum. If large FMH (>4 mL) is suspected, extent must be determined by suitable method (e.g. Kleihauer-Betke acid elution test or flow cytometry) and additional doses of 50 IU (10 mcg) per 0.5 mL foetal RBC may be administered.

Intramuscular
Routine antenatal prophylaxis of RhD immunisation in RhD negative women
Adult: Recommended dose: 500 IU given at both 28 and 34 weeks of gestation. Alternatively, 1,500 IU as single dose may be given between 28-30 weeks of gestation. Recommended dose range: 250-1,650 IU (50-330 mcg). Dosage may vary depending on the preparation used (refer to detailed product guideline).

Intramuscular
Antenatal prophylaxis of RhD immunisation following complications of pregnancy in RhD negative women
Adult: Following any potential sensitising episode (e.g. stillbirth, abortion, amniocentesis) up to 20 weeks gestation: 250 IU as single dose to be given as soon as possible and within 72 hours. Following any potential sensitising episode (e.g. stillbirth, abortion, amniocentesis) after 20 weeks gestation: 500 IU as single dose to be given as soon as possible and within 72 hours. Doses may be repeated at 6- to 12-week intervals throughout pregnancy, if necessary. A test for the FMH size must be performed when administered after 20 weeks of gestation and additional doses may be administered as indicated. Doses may vary among countries, refer to specific product guideline.

Intramuscular
Suppression of RhD immunisation following incompatible transfusions
Adult: In Rh(D)-negative individuals who undergone transfusions with Rh(D)-positive blood components: Recommended dose: 100 IU (20 mcg) per 2 mL of transfused Rh(D) positive blood or per 1 mL of RBC concentrate. Max: 15,000 units (3,000 mcg). Clinical evaluation is recommended to determine the dosage requirement. Dosage may vary depending on the preparation used (refer to detailed product guideline).

Intravenous
Idiopathic thrombocytopenic purpura
Adult: In Rh(D)-positive, non-splenectomised patients: Initially, 250 IU/kg (50 mcg/kg) as single dose or may be given in 2 divided doses on separate days. Maintenance dose: 125-300 IU/kg (25-60 mcg/kg) depending on clinical response. Patient with pre-existing anaemia (Hb <10 g/dL): Initially, 125-200 IU/kg (25-40 mcg/kg) as single dose or may be given in 2 divided doses on separate days.
Contraindications
Hypersensitivity. Rh(D)-negative or splenectomised patient (in treatment of idiopathic thrombocytopenic purpura [ITP]); IgA deficiency with antibodies to IgA.
Special Precautions
Patient with autoimmune haemolytic anaemia, pre-existing or at risk of haemolysis (e.g. elevated reticulocyte count, positive direct antiglobulin test), bleeding disorders (e.g. thrombocytopenia), diabetes mellitus, volume depletion, sepsis, paraproteinaemia, known or suspected hyperviscosity, impaired cardiac output, prolonged immobilisation, indwelling central vascular catheters, multiple CV risk factors; history of atherosclerosis, venous or arterial thrombosis; hypertension. Not intended for Rh(D) positive individuals (except for the treatment of ITP) or individuals immunised for Rh(D) antigen; not indicated for replacement therapy in immune globulin deficiency syndromes. Renal impairment. Pregnancy and lactation.
Adverse Reactions
Significant: Severe hypersensitivity reactions, anaphylaxis, pulmonary oedema, thrombotic events (e.g. MI, stroke, DVT, pulmonary embolism), haemolytic reactions.
Cardiac disorders: Tachycardia.
Gastrointestinal disorders: Nausea, vomiting.
General disorders and administration site conditions: Fever, malaise, chills, inj site reaction (e.g. swelling, pain, erythema, induration, warmth, pruritus, rash).
Musculoskeletal and connective tissue disorders: Arthralgia, moderate low back pain.
Nervous system disorders: Headache, dizziness.
Vascular disorders: Hypotension, hypertension.
Potentially Fatal: Intravascular haemolysis (in patients treated for ITP) resulting to anaemia, acute renal failure, disseminated intravascular coagulation, acute respiratory distress syndrome.
IM/IV/Parenteral: C
MonitoringParameters
ITP treatment: Monitor CBC prior to and 1-3 days after treatment; differential and peripheral blood smear, direct antiglobulin test and antibody screen, and reticulocyte count before therapy; urinalysis prior to and 1-2 hours after treatment (or at baseline then after administration at 2 hours, 4 hours and prior to end of monitoring period); serum creatinine and BUN before and after therapy. Monitor plasma Hb, haptoglobin, lactate dehydrogenase and plasma bilirubin (direct and indirect) in patients suspected of intravascular haemolysis. Monitor for signs and symptoms of intravascular haemolysis (e.g. back pain, shaking, chills, fever, discoloured urine, haematuria); observe patient for 8 hours after administration. Other indications: Monitor for systemic reactions for 20 minutes following administration; signs and symptoms of haemolytic reaction. Observe blood pressure.
Drug Interactions
May impair the efficacy of live virus vaccines (e.g. measles, mumps, rubella, varicella).
Lab Interference
May cause false-positive result in serological testing; may affect results of blood-typing, antibody screening test and Coombs test.
Action
Description: Anti-D immunoglobulins suppresses the immune response and antibody formation by Rh-D-negative mothers to RhD-positive RBCs thus preventing isoimmunisation. Its mechanism in the treatment of idiopathic thrombocytopenic purpura (ITP) is not completely understood but it is postulated to be due to the formation of anti-D-coated RBC complexes which then bind to macrophage Fc receptors within the reticuloendothelial system (RES) resulting to blockade of the RES ability to clear antibody-coated cells, including the platelets. Therefore, sparing the platelets from destruction.
Synonym: Rho(D) immune globulin.
Duration: Treatment of ITP: 30 days (variable).
Pharmacokinetics:
Absorption: Slowly absorbed (IM).
Excretion: Half-life: Approx 3-4 weeks (IM).
Storage
Store between 2-8°C. Do not freeze. Protect from light.
ATC Classification
J06BB01 - anti-D (rh) immunoglobulin ; Belongs to the class of specific immunoglobulins. Used in passive immunizations.
References
Anon. Rh (D) Immune Globulin. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 03/08/2020.

Buckingham R (ed). Anti-D Immunoglobulins. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 03/08/2020.

D-Gam 250 micrograms/mL Solution for Injection (Bio Products Laboratory Ltd.). MHRA. https://products.mhra.gov.uk/. Accessed 03/08/2020.

Joint Formulary Committee. Anti-D (Rh) immunoglobulin. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 15/09/2020.

Rhesonativ 625 IU/mL, Solution for Injection (Octapharma AB). MIMS Malaysia. http://www.mims.com/malaysia. Accessed 03/08/2020.

WinRho Liquid (Aptevo BioTherapeutics LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 03/08/2020.

Disclaimer: This information is independently developed by MIMS based on Anti-D Immunoglobulins from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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