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Rho (d) immune globulin Pregnancy and Breastfeeding Warnings

Brand names: Anti-D (RHO) Immunoglobulin, BayRHo-D, BayRHo-D Full Dose, BayRHo-D Mini-Dose, D-Gam Anti-D, Gamulin Rh, HypRho-D Mini-Dose, HyperRHO S/D Full Dose, HyperRHO S/D Mini-Dose, Liberim D, MICRhoGAM, MicRhoGAM Ultra-Filtered Plus, Mini-Gamulin Rh, Partobulin SDF, RhoGAM, RhoGAM Ultra-Filtered Plus, Rhophylac, WinRho SDF

Medically reviewed by Drugs.com. Last updated on Jul 31, 2023.

Rho (d) immune globulin Pregnancy Warnings

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.

AU TGA pregnancy category: Not formally assigned to a pregnancy category.
US FDA pregnancy category: C

Comments: Some formulations are not approved for use during pregnancy. The manufacturer product information should be consulted.

Animal studies have not been conducted. Available evidence does not suggest harm to the fetus or future pregnancies when given to Rho(D) negative women during pregnancy. There are no controlled data in human pregnancy.

US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

See references

Rho (d) immune globulin Breastfeeding Warnings

This drug should be used only if clearly needed.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments: No undesirable effects are expected on nursing infants

See references

References for pregnancy information

  1. Product Information. WinRho SDF (RHo (D) immune globulin). Apothecon Inc. 2022.
  2. Product Information. BayRHo-D (RHo (D) immune globulin). Bayer.
  3. Product Information. Rhophylac (RHo (D) immune globulin). Apothecon Inc. 2022.
  4. Product Information. HyperRHO S/D Full Dose (RHo (D) immune globulin). Talecris Biotherapeutics. 2022.
  5. Cerner Multum, Inc. UK Summary of Product Characteristics.
  6. TGA. Therapeutic Goods Administration. Australian Drug Evaluation Committee. Prescribing medicines in pregnancy: an Australian categorisation of risk of drug use in pregancy. http://www.tga.gov.au/docs/pdf/medpreg.pdf 2007.
  7. Cerner Multum, Inc. Australian Product Information.
  8. Product Information. RhoGAM Ultra-Filtered Plus (RHo (D) immune globulin). Kedrion Biopharma Inc. 2022.

References for breastfeeding information

  1. Product Information. WinRho SDF (RHo (D) immune globulin). Apothecon Inc. 2022.
  2. Product Information. BayRHo-D (RHo (D) immune globulin). Bayer.
  3. Product Information. Rhophylac (RHo (D) immune globulin). Apothecon Inc. 2022.
  4. Product Information. HyperRHO S/D Full Dose (RHo (D) immune globulin). Talecris Biotherapeutics. 2022.
  5. Cerner Multum, Inc. UK Summary of Product Characteristics.
  6. Cerner Multum, Inc. Australian Product Information.
  7. Product Information. RhoGAM Ultra-Filtered Plus (RHo (D) immune globulin). Kedrion Biopharma Inc. 2022.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.