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Rhophylac

Manufactured by CSL Behring
Sourced in Norway

Rhophylac is a sterile solution of anti-D immunoglobulin (human) for intramuscular injection. It is used to prevent Rh(D) sensitization in Rh(D)-negative individuals.

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2 protocols using rhophylac

1

Rhesus D Immunization Prevention in Norway

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All pregnant women are ABO/RhD typed and antibody screened at the first antenatal visit. For those who are RhD‐negative, fetal RHD genotyping and antibody screening are performed at GW 24. Anti‐D prophylaxis at GW 28 is recommended to non‐D‐immunized women when the fetus is predicted to be positive and when the result is inconclusive.1 Two different anti‐D Ig products are available in Norway: 1500 IU Rhophylac (CSL Behring GmbH, Germany) and 1250 IU Rhesonativ (Octapharma, Switzerland). Due to a misunderstanding the latter product was in use at AUH during the whole study period and until April 2020, whereas the recommended dose of 1500 IU anti‐D Ig was used from the start at OUH.2
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2

Characterization of IgG Subclass Composition

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The IgG preparations used in this study included Sandoglobulin, Privigen, Hizentra, Cytogam and Rhophylac (CSL Behring AG), Gamunex (Talecris Biotherapeutics) and Intratect (Biotest). Sandoglobulin and Privigen (IgG content ≥98%) contained ≤2% and ≤0.01% IgA, respectively, and only traces of IgM, IgD, and IgE (as reported by CSL Behring). The IgG subclass composition of Sandoglobulin was analyzed by nephelometry (Quest Diagnostics) and contained principally IgG1 (61%) and IgG2 (32%), with small quantities of IgG3 (5%) and IgG4 (2%). Privigen contained 66% IgG1, 29% IgG2, 3% IgG3, and 3% IgG4 (as reported by CSL Behring). To remove the stabilizing sucrose component of Sandoglobulin, dialysis was performed as previously described (62 (link)). Further information on the immunoglobulin preparations is provided in table S2.
A control IgG preparation (IgG control mix) was made by mixing 2 monoclonal human myeloma proteins, IgG1λ (67%) and IgG2κ (33%), purchased from Sigma-Aldrich. This process resulted in a κ/λ ratio of 0.5, which is well within the range found in normal serum (0.26–1.65). Anti-human IgG monoclonal antibody (clone HP-6043-Biot), recognizing all IgG subtypes, and Streptavidin-Alexa633 were purchased from Invitrogen (Invitrogen, Life Technologies).
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