Apremilast (Otezla):7 Tablets
Drug class: DMARD, phosphodieasterase 4 (PDE4) inhibitor
Warnings & Precautions
- Depression: Individuals should be alerted to watch for the emergence or worsening of depression, suicidal thoughts or other mood changes. If these changes occur, they should contact their physician. Carefully weigh the risks and benefits of apremilast treatment in patients with a history of depression and/or suicidal thoughts or behavior.
- Weight decrease: Weight should be regularly monitored. If unexplained or clinically significant weight loss occurs, consider discontinuing apremilast.
- Drug interactions: Using apremilast with strong cytochrome P450 (CYP 450) enzyme inducers (e.g., rifampin, phenobarbital, carbamazepine, phenytoin) is not recommended due to potential loss of efficacy.
Commentary: The safety and effectiveness of apremilast was evaluated in three clinical trials involving 1,493 patients with active PsA. In the trials, study participants were randomly assigned placebo or 20 or 30 mg apremilast twice daily. Patients were able to continue with DMARDs, low-dose corticosteroids or NSAIDs during the trial. The primary endpoint was ACR 20 response at Week 16. Apremilast plus DMARDs compared with placebo plus DMARDs was associated with greater improvement in signs and symptoms of PsA. Evidence of greater improvement in physical function was also apparent with apremilast (30 mg twice daily) compared with placebo. The most common adverse reactions (≥5%) are diarrhea, nausea and headache.| ← Previous | | | Next → | Single Page