Obinutuzumab

The Basics

What is Obinutuzumab?

Used to treat certain types of blood cancer.

Brand names for Obinutuzumab

Gazyva

How Obinutuzumab is classified

Antibodies – Monoclonal, Antineoplastic Agents

Obinutuzumab During Pregnancy

Obinutuzumab 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 Obinutuzumab while pregnant

Based on findings from animal studies and its mechanism of action, GAZYVA can cause fetal B-cell depletion [see CLINICAL PHARMACOLOGY]. There are no data with GAZYVA use in pregnant women to inform a drug-associated risk. Monoclonal antibodies are transferred across the placenta. In animal reproduction studies, weekly intravenous administration of obinutuzumab to pregnant cynomolgus monkeys from day 20 of pregnancy until parturition which includes the period of organogenesis at doses with exposures up to 2.4 times the exposure at the clinical dose of 1,000 mg monthly produced opportunistic infections and immune complex mediated hypersensitivity reactions. No embryo-toxic or teratogenic effects were observed in the monkeys (see Data). Advise pregnant women of the potential risk to the fetus. The background risk of major birth defects and miscarriage for the indicated population is unknown; however, the estimated background risk in the U.S. general population of major birth defects is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies.

Taking Obinutuzumab While Breastfeeding

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

No information is available on the clinical use of obinutuzumab during breastfeeding. Because obinutuzumab is a large protein molecule with a molecular weight of about 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, obinutuzumab should be used with caution during breastfeeding, especially while nursing a newborn or preterm infant.[1] The manufacturer recommends that breastfeeding be discontinued during obinutuzumab therapy.

Maternal / infant drug levels

No information is available on the clinical use of obinutuzumab during breastfeeding. Because obinutuzumab is a large protein molecule with a molecular weight of about 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, obinutuzumab should be used with caution during breastfeeding, especially while nursing a newborn or preterm infant.[1] The manufacturer recommends that breastfeeding be discontinued during obinutuzumab therapy.

Possible effects of Obinutuzumab on milk supply

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

Possible alternatives to Obinutuzumab

None listed