The oral anticoagulant apixaban (Elquis) has received an additional indication from the Food and Drug Administration (FDA) for deep vein thrombosis (DVT) prophylaxis in patients who have undergone hip or knee replacement surgery.1 This oral Factor Xa inhibitor is dosed twice daily and requires no routine laboratory (coagulation) testing. To gain approval, more than 11,000 patients were evaluated in comparison to enoxaparin use. The FDA is also reviewing data on apixaban for treating DVT and pulmonary embolism (PE), as well as to reduce the DVT and PE risk. These decisions are expected by August 2014.
Apremilast 30 mg tablets (Otezla) have been FDA approved for treating adult patients with active psoriatic arthritis.2 Apremilast is an oral phosphodiesterase 4 (PDE4) inhibitor specific for cyclic adenosine monophosphate, and it’s the first oral treatment approved by the FDA for psoriatic arthritis. Patients should be monitored for significant weight loss and the development of depression, which may necessitate medication discontinuation. When apremilast is given concomitantly with strong cytochrome P450 (CYP450) inducers, such as phenytoin, carbamazepine, phenobarbital or rifampin, loss of efficacy may occur due to metabolism of the agent. Therefore, it’s not recommended to co-administer strong CYP450 inducers with apremilast. Adverse reactions that occurred in clinical trials more commonly than with placebos included diarrhea, vomiting, upper respiratory infection, nasopharyngitis, headache and upper abdominal pain. The FDA is reviewing apremilast data for treating psoriasis, with a decision expected by September 2014.3
Hyaluronic acid (HA) injection (Monovisc) has been FDA approved as the first single-injection HA product from a non-animal source.4 It is approved to improve joint mobility and pain in patients with osteoarthritis (OA) of the knee.
Methotrexate (Otrexup) for subcutaneous injection, mentioned in the January issue of this column, is now available as a single-dose disposable auto-injector pen for once-weekly administration.5 The product was approved in October 2013 for treating patients with severe, active rheumatoid arthritis (RA) who have not adequately responded to full-dose nonsteroidal antiinflammatory agents. Additional approvals are to treat children with active polyarticular juvenile idiopathic arthritis and to control symptoms of severe recalcitrant, disabling psoriasis in adults who have not adequately responded to other therapies. Otrexup is available as a 0.4 mL injection, in the following strengths: 10 mg, 15 mg, 20 mg and 25 mg.
The generic of Avelox 400 mg tablets, moxifloxacin, is now available.6
Oxycodone hydrochloride/acetaminophen (Xartemis XR) extended-release tablets have been approved by the FDA for managing acute pain severe enough to require opioid therapy and for patients who have had an inadequate response to other therapies or who have not tolerated other therapies.7 This proprietary formulation of oxycodone and acetaminophen includes both immediate- and extended-release components, which are formulated to provide a quick onset of pain relief in less than one hour and to also allow for twice-daily dosing. The current product labeling does not include abuse-deterrent language; however, the manufacturer is working closely with the FDA to develop more data to characterize abuse-deterrence features of the formulation. The manufacturer is also conducting additional studies and will provide this data when it is available.