Abatacept (Orencia):20 Injection/Infusion
Drug class: selective T cell costimulation modulator, DMARD, immunomodulator
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Explore This IssueApril 2019
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Warnings & Precautions
- Concomitant use with a TNF blocker can increase the risk of (serious) infections. Discontinue abatacept if a serious infection occurs.
- Anaphylaxis or anaphylactoid reactions can occur after the first infusion and can be life threatening. Appropriate medical support should be immediately available in the event of a reaction. Post-marketing experience notes at least one case of fatal anaphylaxis following the first abatacept infusion. Following an anaphylactic or other serious allergic reaction, abatacept administration should be stopped immediately, with appropriate therapy instituted. Abatacept should be permanently discontinued.
- Patients with a history of recurrent infections or underlying conditions predisposing them to infections may experience more infections.
- Screen for latent TB prior to initiating therapy. Patients testing positive should be treated prior to initiating abatacept.
- Live vaccines should not be given concurrently or within three months of abatacept discontinuation.
- Based on its mechanism of action, abatacept may blunt the effectiveness of some immunizations.
- Chronic obstructive pulmonary disease (COPD) patients may develop more frequent adverse respiratory events.
Commentary: The FDA approved abatacept based on the results of two randomized, controlled trials that involved nearly 600 adults with long-standing PsA. The most common adverse reactions (≥10%) are headache, upper respiratory tract infection, nasopharyngitis and nausea.
Ustekinumab (Stelara):21 Injection
Drug class: monoclonal antibody, interleukin (IL-12/23) inhibitor
Warnings & Precautions
- Serious infections have occurred. Do not start ustekinumab during any clinically important active infection. If a serious infection or clinically significant infection develops, consider discontinuing ustekinumab until the infection resolves.
- Theoretical infection risk—Serious infections from mycobacteria, salmonella and Bacillus Calmette-Guerin (BCG) vaccinations have occurred in patients genetically deficient in IL-12/23. Diagnostic tests for these infections should be considered as dictated by clinical circumstances.
- Evaluate patients for TB prior to initiating treatment with ustekinumab. Initiate treatment of latent TB before administering ustekinumab.
- Ustekinumab may increase malignancy risk. The safety of using ustekinumab in patients with a history of, or a known, malignancy has not been evaluated.
- Anaphylaxis or other clinically significant hypersensitivity reactions may occur.
- Reversible posterior leukoencephalopathy syndrome (RPLS) has been reported in one case. If suspected, treat promptly and discontinue ustekinumab.
- Cases of noninfectious, interstitial pneumonia, eosinophilic pneumonia and cryptogenic organizing pneumonia have been reported during post-
marketing ustekinumab use. If diagnosis is confirmed, discontinue ustekinumab and initiate appropriate treatment.
Commentary: The FDA based its approval on two randomized, controlled trials of more than 900 patients. The study participants had at least five tender and swollen joints and high levels of C-reactive protein (a measure of inflammation), and were not responding to current therapies. The most common adverse reactions (≥3%) are arthralgia and nausea.