Combination with TNF blockers including infliximab is not recommended due to increased risk of serious infections with no added clinical benefit.
Source: NLP:infliximab
Brand names: Orencia
Selective T Cell Costimulation Modulator
Route: Intravenous, Subcutaneous
Contraindications
4 CONTRAINDICATIONS None. None. (4)
Pregnancy & Breastfeeding
8.1 Pregnancy Risk Summary The data with ORENCIA use in pregnant women are insufficient to inform on drug-associated risk. However, there are clinical considerations for administering live vaccines to infants who were exposed to ORENCIA while in utero (see Clinical Considerations) . 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. Clinical Considerations Infants and Administration of Live Vaccines It is unknown if abatacept can cross the placenta into the fetus when a woman is treated with ORENCIA during pregnancy. Abatacept is an immunomodulatory agent. It is unknown if the immune response of an infant who was exposed in utero to abatacept and subsequently administered a live vaccine is impacted. Risks and benefits should be considered prior to vaccinating such infants [see Warnings and Precautions (5.4) ] . 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 fun
15 interactions on record
Combination with TNF blockers including infliximab is not recommended due to increased risk of serious infections with no added clinical benefit.
Source: NLP:infliximab
Combination with abatacept is not recommended due to increased risk of serious infections with no added clinical benefit seen in clinical studies of TNF blockers.
Source: NLP:infliximab-dyyb
Increased risk of serious infection when combined with TNF blockers; not recommended in RA patients.
Source: NLP:adalimumab
Increased risk of serious infection with no added benefit. Concomitant use not recommended in patients with RA.
Source: NLP:adalimumab-aaty
Increased risk of serious infection when combined with adalimumab-adaz. Use not recommended in patients with RA due to no added benefit.
Source: NLP:adalimumab-adaz
Increased risk of serious infection when combined with adalimumab-adbm. Concomitant use not recommended in patients with RA.
Source: NLP:adalimumab-adbm
Increased risk of serious infection when combined with TNF blockers. Use not recommended in patients with RA due to no added benefit.
Source: NLP:adalimumab-afzb
Increased risk of serious infection when combined with YUSIMRY; concomitant use not recommended in RA patients.
Source: NLP:adalimumab-aqvh
Increased risk of serious infection when combined with AMJEVITA (adalimumab-atto). Concomitant use not recommended in RA patients.
Source: NLP:adalimumab-atto
Increased risk of serious infection when combined with HADLIMA; not recommended for RA patients.
Source: NLP:adalimumab-bwwd
Increased risk of serious infection when combined with adalimumab-ryvk. Not recommended in patients with RA.
Source: NLP:adalimumab-ryvk
Increased risk of serious infections when used in combination with TNF-blocking agents. Combination therapy not recommended.
Source: NLP:certolizumab pegol
Concomitant administration associated with increased risk of serious infections and no significant additional efficacy. Concurrent therapy not recommended.
Source: NLP:abatacept
Insufficient experience to assess safety and efficacy when administered concurrently. Use not recommended.
Source: NLP:abatacept
Insufficient experience to assess safety and efficacy when administered concurrently with other biologic therapy. Use not recommended.
Source: NLP:abatacept