Ibalizumab

The Basics

What is Ibalizumab?

Used to manage multidrug-resistant HIV-1 infection

Brand names for Ibalizumab

N/A

How Ibalizumab is classified

Antibodies – Monoclonal, Anti-HIV Agents, Antiviral Agents, Anti-Retroviral Agents

Ibalizumab During Pregnancy

Ibalizumab pregnancy category

Category N/ANote that the FDA has deprecated the use of pregnancy categories, so for some medications, this information isn’t available. We still think it’s useful to list historical info, however, given what a common proxy this has been in the past.

What we know about taking Ibalizumab while pregnant

N/A

Taking Ibalizumab While Breastfeeding

What are recommendations for lactation if you're taking Ibalizumab?

No information is available on the clinical use of ibilizumab during breastfeeding. Because ibilizumab is a large protein molecule with a molecular weight of 150,000, the amount in milk is likely to be very low and absorption is unlikely because it is probably destroyed in the infant’s gastrointestinal tract. Until more data become available, ibilizumab-uiyk should be used with caution during breastfeeding, especially while nursing a newborn or preterm infant. The manufacturer recommends avoiding breastfeeding while taking ibilizumab. In the United States and other developed countries, HIV-infected mothers should generally not breastfeed their infants. In countries in which no acceptable, feasible, sustainable and safe replacement feeding is available, World Health Organization guidelines recommend that all women with an HIV infection who are pregnant or breastfeeding should be maintained on antiretroviral therapy for at least the duration of risk for mother-to-child transmission. Mothers should exclusively breastfeed their infants for the first 6 months of life; breastfeeding with complementary feeding should continue through at least 12 months of life up to 24 months of life.[1] The first choice regimen for nursing mothers is tenofovir, efavirenz and either lamivudine or emtricitabine. If these drugs are unavailable, alternative regimens include: 1) zidovudine, lamivudine and efavirenz; 2) zidovudine, lamivudine and nevirapine; or 3) tenofovir, nevirapine and either lamivudine or emtricitabine. Exclusively breastfed infants should also receive 6 weeks of prophylaxis with nevirapine.[2][3] Ibilizumab is a human immunoglobulin G4 (IgG4) antibody. Holder pasteurization (62.5 degrees C for 30 minutes) decreases the concentration of endogenous immunoglobulin G by up to 79%.[4][5] A study of 67 colostrum samples that underwent Holder pasteurization found that IgG amounts decreased by 34 to 40%. Specific IgG subclasses decreased by different amounts, with Holder pasteurization having little effect on IgG4 activity.[6] None of the studies measured IgG activity.

Maternal / infant drug levels

No information is available on the clinical use of ibilizumab during breastfeeding. Because ibilizumab is a large protein molecule with a molecular weight of 150,000, the amount in milk is likely to be very low and absorption is unlikely because it is probably destroyed in the infant’s gastrointestinal tract. Until more data become available, ibilizumab-uiyk should be used with caution during breastfeeding, especially while nursing a newborn or preterm infant. The manufacturer recommends avoiding breastfeeding while taking ibilizumab. In the United States and other developed countries, HIV-infected mothers should generally not breastfeed their infants. In countries in which no acceptable, feasible, sustainable and safe replacement feeding is available, World Health Organization guidelines recommend that all women with an HIV infection who are pregnant or breastfeeding should be maintained on antiretroviral therapy for at least the duration of risk for mother-to-child transmission. Mothers should exclusively breastfeed their infants for the first 6 months of life; breastfeeding with complementary feeding should continue through at least 12 months of life up to 24 months of life.[1] The first choice regimen for nursing mothers is tenofovir, efavirenz and either lamivudine or emtricitabine. If these drugs are unavailable, alternative regimens include: 1) zidovudine, lamivudine and efavirenz; 2) zidovudine, lamivudine and nevirapine; or 3) tenofovir, nevirapine and either lamivudine or emtricitabine. Exclusively breastfed infants should also receive 6 weeks of prophylaxis with nevirapine.[2][3] Ibilizumab is a human immunoglobulin G4 (IgG4) antibody. Holder pasteurization (62.5 degrees C for 30 minutes) decreases the concentration of endogenous immunoglobulin G by up to 79%.[4][5] A study of 67 colostrum samples that underwent Holder pasteurization found that IgG amounts decreased by 34 to 40%. Specific IgG subclasses decreased by different amounts, with Holder pasteurization having little effect on IgG4 activity.[6] None of the studies measured IgG activity.

Possible effects of Ibalizumab on milk supply

Relevant published information was not found as of the revision date.

Possible alternatives to Ibalizumab

None listed