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Abatacept

Intravenous
Subcutaneous
Class
T-cell costimulation inhibitors
Subclass
CTLA-4 / IgG1 Fc fusion protein
Substance name
Abatacept
Brand names
Orencia®
Common formulations
Powder for parenteral solution
Dosage and administration
Adults patients
Psoriatic arthritis • Active
Weight < 60 kg
•
Start at: 500 mg IV q2 weeks for 2 doses
•
Maintenance: 500 mg IV q4 weeks
Rheumatoid arthritis • Moderate-to-severe, active
Weight < 60 kg
•
Start at: 500 mg IV q2 weeks for 2 doses
•
Maintenance: 500 mg IV q4 weeks
Indications for use
Labeled indications
Adults
•
Treatment of psoriatic arthritis (active)
•
Treatment of rheumatoid arthritis (moderate-to-severe, active)
•
Prevention of acute GvHD (for hematopoietic stem-cell transplantation from a matched or 1 allele-mismatched unrelated donor)
Safety risks
Contraindications
Hypersensitivity to abatacept or any of its components
Live vaccines administration during or within 3 months after discontinuation of therapy
•
Prior to initiating therapy, be sure to update vaccination to reflect current immunization guidelines
Concomitant use of TNF (TNF) antagonists, other biologic rheumatoid arthritis therapy, other biologic psoriatic arthritis therapy, or JAK (JAK) inhibitors
Warnings and precautions
Acute exacerbations of COPD, cough, dyspnea, rhonchi
•
Use caution in patients with COPD.
Reactivation of HBV infection
•
Use caution in patients with a positive hepatitis B screen. Screen for viral hepatitis prior to starting treatment with Abatacept.
Reactivation of tuberculosis
•
Use caution in patients with positive tuberculosis test. Screen for latent TB and if positive treat with standard medical practice prior to starting treatment with Abatacept.
Severe bacterial infection
•
Use caution in patients with a history of recurrent infections, underlying immunosuppression, concomitant immunosuppressive therapy or conditions that may predispose to infections.
Skin cancer, lung cancer, lymphoma
•
Use caution in patients with risk factors for malignancies. periodic skin examinations are recommended.
Specific populations
Renal impairment
eGFR 20-50 mL/min/1.73 m²
•
Use acceptable. No dose adjustment required.
eGFR 10-20 mL/min/1.73 m²
•
Use with caution. Monitor for infections and malignancy.
eGFR < 10 mL/min/1.73 m²
•
Use with caution. Monitor for infections and malignancy.
Renal replacement therapy
Continuous renal replacement
•
Use with caution. Dose as in eGFR 10-20 mL/min/1.73 m².
Intermittent hemodialysis
•
Use with caution. Dose as in eGFR < 10 mL/min/1.73 m².
Peritoneal dialysis
•
Use with caution. Dose as in eGFR < 10 mL/min/1.73 m².
Hepatic impairment
Any severity
•
No guidance available.
Pregnancy and breastfeeding
Pregnancy
All trimesters • Australia Category: C
•
Avoid use. Evidence of fetal harm in animals. Data with abatacept use during human pregnancy are insufficient to inform a drug-associated risk. It is unknown if abatacept can cross the placenta into the fetus when a woman is treated with abatacept during pregnancy.
Breastfeeding
Consider alternative agents that may be safer.
•
Mothers who are receiving abatacept may continue breastfeeding. Some professional guidelines considered the drug to be acceptable during breastfeeding. However, an alternate drug may be preferred, especially while nursing a newborn or preterm infant.
Unknown drug levels in breastfed infants.
No overt adverse effects reported in breastfed infants.
Adverse reactions
Very common > 10%
•
Bronchitis, influenza virus infection, nasopharyngitis, headache, nausea, upper respiratory tract infections
Common 1-10%
•
Herpes simplex virus infection, hypertension, pneumonia, back pain, cough, dizziness, limb pain, skin rash, rhinitis, urinary tract infections
Uncommon < 1%
•
Acute lymphoblastic leukemia, anaphylaxis, drug hypersensitivity reaction, hypotension, lung cancer, malignant lymphoma, skin flushing, rhonchi, urticaria, varicella zoster virus infection, wheezing, dyspnea
Interactions
Drug(s)
Check Interactions
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