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Anti-D (Rh) Immunoglobulin

AntibodyImmunoglobulin

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
Trade names (1)
  • Rhesugam

INJInjection· 1 product

from R1020.40
ProductStrengthPackApplicantMin price
Rhesugam IM500 iu/2ml2National Bioproducts Institute (NPC)R1020.40

Medical aid coverage

data not yet integrated
Discovery Health
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.

Bonitas Medical Fund
not yet integrated
  • BonClassic—
  • BonComprehensive—
  • BonEssential—
  • BonFit Select—
  • BonSave—
  • BonStart—

Formulary scraper pending — coverage tier, co-pay and authorisation requirements will appear here once data is ingested.

GEMS — Government Employees Medical Scheme
not yet integrated
  • Beryl—
  • Emerald—
  • Onyx—
  • Ruby—
  • Sapphire—
  • Tanzanite One—

Formulary scraper pending — coverage tier, co-pay and authorisation requirements will appear here once data is ingested.

POLMED — Police Medical Aid Scheme
not yet integrated
  • Aquarium Option—
  • Efficiency Option—
  • Marine Option—

Formulary scraper pending — coverage tier, co-pay and authorisation requirements will appear here once data is ingested.

NeoHealth® ID 14593 · updated 5/10/2024