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Weekly Drug News Round-Up: September 28, 2016

Amjevita, A Humira Biosimilar, Wins FDA Approval

A fourth biosimilar has now been approved in the U.S. Read More…

Amgen’s Amjevita (adalimumab-atto) is the first adalimumab (Humira) biosimilar approved by the FDA and is used for the treatment of seven inflammatory diseases, including rheumatoid arthritis, psoriatic arthritis, and plaque psoriasis. Amjevita is an anti-TNF-α monoclonal antibody that has the same amino acid sequence as adalimumab. However, Amjevita is not approved as an interchangeable product, meaning the pharmacist needs approval from the prescribing doctor to substitute Amjevita for Humira if not specified on the prescription. Common side effects include infections and injection site reactions. Amjevita will be commercially available in a prefilled syringe or autoinjector.

Stelara Clears FDA for Treatment of Crohn's Disease

After Stelara induction dosing, maintenance doses are given every 8 weeks for patients with Crohn’s disease Read More...

The FDA has cleared Janssen Biotech’s Stelara (ustekinumab), the first biologic interleukin (IL)-12/23 inhibitor for Crohn’s disease. Specifically, Stelara is used in adults who failed or could not tolerate immunomodulators or corticosteroids but never failed treatment with a tumor necrosis factor (TNF) blocker; or who failed or could not tolerate one or more TNF blockers. Stelara was previously approved to treat moderate to severe plaque psoriasis and active psoriatic arthritis. In clinical studies, between 34 and 56 percent of patients experienced relief from their Crohn's disease symptoms in just six weeks after receiving the one-time intravenous (IV) induction dose of Stelara, and the majority of these went on to remission.

Ilaris Gains Three New Uses for Periodic Fever Syndromes

Ilaris is an interleukin-1β blocker that lowers the inflammatory response in the body Read More…

This week, the FDA approved Novartis’ Ilaris (canakinumab) for treatment of three rare but serious autoimmune diseases in adults and children: Tumor Necrosis Factor Receptor Associated Periodic Syndrome (TRAPS); Hyperimmunoglobulin D Syndrome (HIDS)/Mevalonate Kinase Deficiency (MKD); and Familial Mediterranean Fever (FMF). These diseases are marked by periodic attacks of fever and inflammation, as well as severe muscle pain. For these new indications, Ilaris is given as a weight-based subcutaneous injection every 4 weeks. The most common side effects were injection site reactions and the common cold; Ilaris is also linked with an increased risk of serious infection.

FDA Approves Lomaira for Weight Reduction

Drugs such as phentermine are only meant as a weight-loss adjunct for short-term use Read More…

This past week, the FDA approved Lomaira (phentermine) an appetite suppressant for weight reduction in adults with an initial body mass index (BMI) of at least 30 (obese) or 27 (overweight). Patients must also have at least one weight-related risk factor such as high blood pressure, diabetes, or high cholesterol. Lomaira is an 8 mg, scored tablet which can be taken in a lower dose up to three times a day before meals. While a 5% to 10% weight loss can produce beneficial effects, patients and doctors should consider the possible side effects of phentermine, such as serious heart risks, insomnia and constipation.

Joint Effort: A Provider's Guide To Orthopedic Pain Options

As a health care provider, what safer options besides opioids do you have for your patient’s joint pain? Read More...

Orthopedic pain can be multifactorial, and treatment may require several therapies to combine synergistic mechanisms. Opioids for long-term pain relief are becoming less of an option due to addiction, overdose and illegal diversion, and authorities are clamping down on their prescribing. So what non-controlled medications can a doctor use to ease a patient’s bone pain? Besides NSAIDs, acetaminophen, and muscle relaxants, other options might include antidepressants, anticonvulsants, topical anti-inflammatories and hyaluronic acid derivatives. In this slideshow developed especially for health care providers, review unique pharmacotherapy options, novel treatment tips, and news on recent opioid guidance.