Ibalizumab-uiyk (Trogarzo, IBA)

Entry and Attachment Inhibitors

Animal studies

Carcinogenicity
Carcinogenicity and mutagenicity studies of IBA have not been conducted.¹

Reproduction/Fertility
Reproductive toxicology studies of IBA have not been conducted.¹

Teratogenicity/Adverse Pregnancy Outcomes
Early embryonic development and embryo-fetal development studies with IBA have not been conducted.

Placental and Breast Milk Passage
No data are available on placental or breast milk passage of IBA in animals.

Human Studies in Pregnancy

Pharmacokinetics
No pharmacokinetic studies of IBA in pregnant women have been reported.

Placental and Breast Milk Passage
No data are available on placental or breast milk passage of IBA in humans. However, since monoclonal antibodies are transported across the placenta during pregnancy, IBA has the potential to be transmitted from the mother to the developing fetus. Human immunoglobulin G is also present in human milk, although published data indicate that antibodies in breast milk do not enter the neonatal or infant circulation system in substantial amounts.¹

Teratogenicity/Adverse Pregnancy Outcomes
There are currently no data on the risk of birth defects in infants born to women who received IBA during pregnancy.

Excerpt from Table 8

Excerpt from Table 8
Generic Name (Abbreviation) Trade Name	Formulation	Dosing Recommendations^a	Use in Pregnancy
Ibalizumab (IBA) Trogarzo	IBA (Trogarzo): Solution for IV infusion is available in single-dose vials	Standard Adult Dose: IBA 2,000-mg loading dose, followed by IBA 800-mg maintenance doses administered every 2 weeks Pregnancy PKs in Pregnancy: No PK studies in human pregnancy. Dosing in Pregnancy: Insufficient data to make dosing recommendations.	No data available, but placental transfer of IBA, a monoclonal antibody, is possible. Insufficient data to assess for teratogenicity in humans.
^a Individual ARV drug doses may need to be adjusted in patients with renal or hepatic insufficiency (for details, see the Adult and Adolescent Antiretroviral Guidelines, Appendix B, Table 10). Key: ARV = antiretroviral; IBA = ibalizumab; IV = intravenous; PK = pharmacokinetic

References

Ibalizumab (Trogarzo) [package insert]. Food and Drug Administration. 2018. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761065lbl.pdf.

Entry and Attachment Inhibitors