Necitumumab

The Basics

What is Necitumumab?

A recombinant human IgG1 monoclonal antibody used as an antineoplastic.

Brand names for Necitumumab

Portrazza

How Necitumumab is classified

Antibodies – Monoclonal, Antineoplastic Agents

Necitumumab During Pregnancy

Necitumumab 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 Necitumumab while pregnant

Based on animal data and its mechanism of action, PORTRAZZA can cause fetal harm when administered to a pregnant woman [see CLINICAL PHARMACOLOGY]. Disruption or depletion of EGFR in animal models results in impairment of embryo-fetal development including effects on placental, lung, cardiac, skin, and neural development. The absence of EGFR signaling has resulted in embryolethality as well as post-natal death in animals (see Data). No animal reproduction studies have been conducted with necitumumab. There are no available data for PORTRAZZA exposure in pregnant women. Advise pregnant women of the potential risk to a fetus, and the risk to postnatal development. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

Taking Necitumumab While Breastfeeding

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

No information is available on the clinical use of necitumumab during breastfeeding. Because necitumumab is a large protein molecule with a molecular weight of 145,000, 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. However, the manufacturer recommends that women receiving necitumumab should not breastfeed during therapy or for 3 months following the final dose. Necitumumab is a human immunoglobulin G1 (IgG1) kappa antibody. Holder pasteurization (62.5 degrees C for 30 minutes) decreases the concentration of endogenous immunoglobulin G by up to 79%.[1][2] 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 IgG1 activity decreasing by about 37%.[3] None of the studies measured IgG activity.

Maternal / infant drug levels

No information is available on the clinical use of necitumumab during breastfeeding. Because necitumumab is a large protein molecule with a molecular weight of 145,000, 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. However, the manufacturer recommends that women receiving necitumumab should not breastfeed during therapy or for 3 months following the final dose. Necitumumab is a human immunoglobulin G1 (IgG1) kappa antibody. Holder pasteurization (62.5 degrees C for 30 minutes) decreases the concentration of endogenous immunoglobulin G by up to 79%.[1][2] 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 IgG1 activity decreasing by about 37%.[3] None of the studies measured IgG activity.

Possible effects of Necitumumab on milk supply

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

Possible alternatives to Necitumumab

None listed