Anti-D (Rh) Immunoglobulin
Indications
Registered South African indications:
- Rhesus incompatibility
Cautions
Contraindications
- Hypersensitivity to the active ingredient or any of its excipients
- Rhesus positive individuals
Cautions
- Renal impairment
- Elderly
- Diabetes mellitus
- Volume depletion
- Cardiovascular disorders
- Atherosclerosis
- Risk factors for thrombosis
- IgA deficiency
- Sepsis
- Paraproteinaemia
- Anaemia
- Thrombocytopaenia
- Coagulation disorders
- Asplenia
- Children
Adult dosage
Forms avail. in SA and covered in this monograph: inj
Antenatal prophylaxis in rhesus negative women
- IM: 500 IU, given at 28 and/or 34 weeks gestation
Prophylaxis following potentially sensitising events in rhesus negative women
- amniocentesis
- antepartum haemorrhage
- abdominal trauma
- external cephalic version
- ectopic pregnancy
- chorionic villus sampling
- still birth
- foetal blood sampling
- abortions
- <20 weeks gestational age: IM: 250 IU, as a single dose
- >20 weeks gestational age: IM: 500 IU, as a single dose
Postnatal prophylaxis in rhesus negative women
- IM: 500 IU, to be given within 7 days of delivery
Transfusion of rhesus incompatible blood
- IM: 125 IU for each 1ml of red cells
Transfusion of rhesus positive platelets in rhesus negative women of child bearing age
- IM: 250 IU for each dose of platelets; Max: 500 IU
Administer within 72hrs of a sensitising event
Paediatric dosage
No information available
Special populations
Pregnancy
- Safe; no evidence of risk in studies
- Human anti-d immunoglobulin is used in pregnancy. No study drug-related adverse events were reported in children delivered of 432 women who received antepartum administration of human anti-d immunoglobulin 300 micrograms
Breastfeeding
- Compatible
- 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 human anti-d immunoglobulin 300 micrograms, nor in children delivered of 139 women who received postpartum administration of human anti-d immunoglobulin 200 micrograms
Renal Impairment
Hepatic Impairment
Elderly
Porphyria Information
Drugs in Sport
- Permitted - No warnings
Adverse reactions
Central Nervous System Disorders
- Headache
- Lightheadedness
Cardiovascular Disorders
- Hypotension
- Tachycardia
- Shock
- Flushing
Gastrointestinal Disorders
- Nausea and vomiting
Skin and Subcutaneous Disorders
- Injection site reactions
- Chills
- Allergic reactions
Interactions
- Measles, mumps and rubella vaccine
- Measles, mumps, rubella and varicella vaccine
- Live vaccines
- Varicella vaccine
Monitoring
None routine
Mechanism of action
Anti-D immunoglobulin prevents isoimmunization by suppressing the immune response and antibody formation by Rh(D)-negative individuals to Rh(D)-positive red blood cells. When administered within 72 hours of a full term delivery, the incidence of Rh isoimmunization decreases.
Dosage forms
- Injection
Formulation
Injection (per 2ml) 500 IU
- Rhesugam (National Bioproducts)
References
1. SAMF_12th Edition_Page 350 2. https://drive.google.com/drive/folders/0BxqKo-EBYgZDcEloNE5LeFctVjA (26/03/2012_NBP_Rhesugam_inj) 3. https://www.drugs.com/pregnancy/rho-d-immune-globulin.html 4. U2D: Anti-D immune globulin (Rho[D] immune globulin): Drug information; Uptodate; Downloaded online; 27 Jul 2018 https://www.uptodate.com/contents/rho-d-immune-globulin-drug-information?source=search_result&search=rhesugam&selectedTitle=1~2 5. SmPC: D-GAM, Human Anti-D Immunoglobulin 2,500 IU, solution for injection, Bio Products Laboratory Limited: Last update on eMC: Last updated on eMC: 02 Aug 2016; Downloaded online; 11 Nov 2018 https://www.medicines.org.uk/emc/product/8234/smpc 6. SmPC: Rhophylac 300 (1500 IU), CSL Behring UK Limited: Last updated on eMC: 23 Aug 2016; Downloaded online; 11 Nov 2018 https://www.medicines.org.uk/emc/product/6791/smpc#PRODUCTINFO 7. NAPOS The Drug Database for Acute Porphyria: Immunoglobulin anti-D; Accessed online 11 Nov 2018 http://www.drugs-porphyria.org/languages/UnitedKingdom/s3.php?atc_code=J06BB01&l=gbr 8. South African Institute for Drug-Free Sport: Rhesugam; Accessed online 11 Nov 2018 [http://www.drugfreesport.org.za/online-medication-check/]
Brands & products
1 product · cached snapshot- Rhesugam
INJInjection· 1 product
from R1020.40| Product | Strength | Pack | Applicant | Min price |
|---|---|---|---|---|
| Rhesugam IM | 500 iu/2ml | 2 | National Bioproducts Institute (NPC) | R1020.40 |
Medical aid coverage
data not yet integrated- Comprehensive Series—
- Executive Plan—
- KeyCare Series—
- Priority Series—
- Saver Series—
Formulary scraper pending — coverage tier, co-pay and authorisation requirements will appear here once data is ingested.
- BonClassic—
- BonComprehensive—
- BonEssential—
- BonFit Select—
- BonSave—
- BonStart—
Formulary scraper pending — coverage tier, co-pay and authorisation requirements will appear here once data is ingested.
- Beryl—
- Emerald—
- Onyx—
- Ruby—
- Sapphire—
- Tanzanite One—
Formulary scraper pending — coverage tier, co-pay and authorisation requirements will appear here once data is ingested.
- Aquarium Option—
- Efficiency Option—
- Marine Option—
Formulary scraper pending — coverage tier, co-pay and authorisation requirements will appear here once data is ingested.