Belatacept

The Basics

What is Belatacept?

It can prevent the body from rejecting a transplanted kidney.

Brand names for Belatacept

Nulojix

How Belatacept is classified

Immunosuppressive Agents

Belatacept During Pregnancy

Belatacept pregnancy category

Category CNote 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 Belatacept while pregnant

NULOJIX should not be used in pregnancy unless the potential benefit to the mother outweighs the potential risk to the fetus. There are no studies of NULOJIX treatment in pregnant women. Belatacept is known to cross the placenta of animals. Belatacept was not teratogenic in pregnant rats and rabbits at doses approximately 16 and 19 times greater than the exposure associated with the maximum recommended human dose (MRHD) of 10 mg per kg administered over the first month of treatment, based on area under the concentration-time curve (AUC). Belatacept administered to female rats daily during gestation and throughout the lactation period was associated with maternal toxicity (infections) in a small percentage of dams at doses of ‚â•20 mg per kg (‚â•3 times the MRHD exposure based on AUC) resulting in increased pup mortality (up to 100% pup mortality in some dams). In pups that survived, there were no abnormalities or malformations at doses up to 200 mg per kg (19 times the MRHD exposure). In vitro data indicate that belatacept has lower binding affinity to CD80/CD86 and lower potency in rodents than in humans. Although the rat toxicity studies with belatacept were done at pharmacologically saturating doses, the in vivo difference in potency between rats and humans is unknown. Therefore, the relevance of the rat toxicities to humans and the significance of the magnitude of the relative exposures (rats: humans) are unknown. Abatacept, a fusion protein that differs from belatacept by 2 amino acids, binds to the same ligands (CD80/CD86) and blocks T-cell costimulation like belatacept, but is more active than belatacept in rodents. Therefore, toxicities identified with abatacept in rodents, including infections and autoimmunity, may be predictive of adverse effects in humans treated with belatacept [see Nonclinical Toxicology]. Autoimmunity was observed in one rat offspring exposed to abatacept in utero and/ or during lactation and in juvenile rats after treatment with abatacept. However, the clinical relevance of autoimmunity in rats to patients or a fetus exposed in utero is unknown [see Nonclinical Toxicology]. Pregnancy Registry To monitor maternal-fetal outcomes of pregnant women who have received NULOJIX or whose partners have received NULOJIX, healthcare providers are strongly encouraged to register pregnant patients in the National Transplant Pregnancy Registry (NTPR) by calling 1-877-955-6877.

Taking Belatacept While Breastfeeding

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

No information is available on the use of belatacept during breastfeeding. The manufacturer recommends avoiding nursing if belatacept is given. Because the drug’s half-life is 8 to 10 days, it may be more than a month after a dose before the drug is absent from breastmilk.

Maternal / infant drug levels

No information is available on the use of belatacept during breastfeeding. The manufacturer recommends avoiding nursing if belatacept is given. Because the drug’s half-life is 8 to 10 days, it may be more than a month after a dose before the drug is absent from breastmilk.

Possible effects of Belatacept on milk supply

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

Possible alternatives to Belatacept

Azathioprine, Cyclosporine, Tacrolimus.