Abatacept

The Basics

What is Abatacept?

Used to treat rheumatoid arthritis.

Brand names for Abatacept

Orencia

How Abatacept is classified

Antirheumatic Agents

Abatacept During Pregnancy

Abatacept 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 Abatacept while pregnant

There are no adequate and well-controlled studies of ORENCIA use in pregnant women., Abatacept has been shown to cross the placenta in animals, and in animal reproduction studies, alterations in immune function occurred. ORENCIA should be used during pregnancy only if the, potential benefit to the mother justifies the potential risk to the fetus., Abatacept was not teratogenic when administered to pregnant mice at doses up to 300 mg/kg and, in pregnant rats and rabbits at doses up to 200 mg/kg daily representing approximately 29 times, the exposure associated with the maximum recommended human dose (MRHD) of 10 mg/kg, based on AUC (area under the time-concentration curve)., Abatacept administered to female rats every three days during early gestation and throughout the, lactation period, produced no adverse effects in offspring at doses up to 45 mg/kg, representing 3, times the exposure associated with the MRHD of 10 mg/kg based on AUC. However, at, 200 mg/kg, 11 times the MRHD exposure, alterations in immune function were observed, consisting of a 9-fold increase in T-cell dependent antibody response in female pups and thyroid, inflammation in one female pup. It is not known whether these findings indicate a risk for, development of autoimmune diseases in humans exposed in utero to abatacept. However,, exposure to abatacept in the juvenile rat, which may be more representative of the fetal immune, system state in the human, resulted in immune system abnormalities including inflammation of, the thyroid and pancreas [see Nonclinical Toxicology (13.2)]. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ORENCIA during pregnancy. Healthcare professionals are encouraged to register patients and pregnant women are encouraged to enroll themselves by calling 1-877-311-8972. Risk Summary The data with ORENCIA use in pregnant women are insufficient to inform on drug-associated risk. In reproductive toxicology studies in rats and rabbits, no fetal malformations were observed with intravenous administration of ORENCIA during organogenesis at doses that produced exposures approximately 29 times the exposure at the maximum recommended human dose (MRHD) of 10 mg/kg/month on an AUC basis. However, in a pre-and postnatal development study in rats, ORENCIA altered immune function in female rats at 11 times the MRHD on an AUC basis. Data Human Data There are no adequate and well-controlled studies of ORENCIA use in pregnant women. The data with ORENCIA use in pregnant women are insufficient to inform on drug-associated risk. Animal Data Intravenous administration of abatacept during organogenesis to mice (10, 55, or 300 mg/kg/day), rats (10, 45, or 200 mg/kg/day), and rabbits (10, 45, or 200 mg/kg every 3 days) produced exposures in rats and rabbits that were approximately 29 times the MRHD on an AUC basis (at maternal doses of 200 mg/kg/day in rats and rabbits), and no embryotoxicity or fetal malformations were observed in any species. In a study of pre-and postnatal development in rats (10, 45, or 200 mg/kg every 3 days from gestation day 6 through lactation day 21), alterations in immune function in female offspring, consisting of a 9-fold increase in T-cell-dependent antibody response relative to controls on postnatal day (PND) 56 and thyroiditis in a single female pup on PND 112, occurred at approximately 11 times the MRHD on an AUC basis (at a maternal dose of 200 mg/kg). No adverse effects were observed at approximately 3 times the MRHD (a maternal dose of 45 mg/kg). It is not known if immunologic perturbations in rats are relevant indicators of a risk for development of autoimmune diseases in humans exposed in utero to abatacept. Exposure to abatacept in the juvenile rat, which may be more representative of the fetal immune system state in the human, resulted in immune system abnormalities including inflammation of the thyroid and pancreas [see Nonclinical Toxicology].

Taking Abatacept While Breastfeeding

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

No information is available on the use of abatacept during breastfeeding. Abatacept is a large genetically engineered fusion protein that interferes with T-cell activation. It has a molecular weight of 92,000. Only small amounts would be expected to enter breastmilk. If abatacept is required by the mother, it is not a reason to discontinue breastfeeding.[1] However, an alternate drug may be preferred, especially while nursing a newborn or preterm infant.

Maternal / infant drug levels

No information is available on the use of abatacept during breastfeeding. Abatacept is a large genetically engineered fusion protein that interferes with T-cell activation. It has a molecular weight of 92,000. Only small amounts would be expected to enter breastmilk. If abatacept is required by the mother, it is not a reason to discontinue breastfeeding.[1] However, an alternate drug may be preferred, especially while nursing a newborn or preterm infant.

Possible effects of Abatacept on milk supply

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

Possible alternatives to Abatacept

(Rheumatoid Arthritis) Auranofin, Gold Sodium Thiomalate, Hydroxychloroquine, Infliximab, Methotrexate, Penicillamine, Sulfasalazine.