Products and Services - December 2015

New Drugs

The following are recent approvals announced by the US Food and Drug Administration (FDA):

• Narcan, the first FDA-approved nasal spray version of naloxone hydrochloride, can be used in adults or children, does not require assembly, and delivers a consistent, measured dose when used as directed. Using this spray in patients who are opioid-dependent may lead to severe opioid withdrawal, including body aches, diarrhea, tachycardia, fever, runny nose, sneezing, piloerection, sweating, nausea or vomiting, and restlessness or irritability.
• Genvoya (a combination tablet with elvitegravir, cobicistat, emtricitabine, and tenofovir ala­fenamide) has been approved as a complete regimen for human immunodeficiency virus-1 infection in adults and pediatric patients aged ≥12 years. Nausea was the most commonly reported side effect associated with the drug. Adverse events included new or worsening kidney problems, decreased bone mineral density, fat redistribution, and immune reconstitution syndrome.
• Adynovate, Antihemophilic Factor (Recombinant), PEGylated has been approved for adults and adolescents aged ≥12 years with hemophilia A. This drug can be used as needed to treat, control, and reduce the frequency of bleeding episodes.
• Tagrisso (osimertinib) has been approved for patients with advanced non−small-cell lung cancer whose tumors have T790M epidermal growth factor receptor (EGFR) mutation, and whose disease worsened after treatment with other EGFR-blocking therapy. The most common side effects reported with the use of this drug included diarrhea, and skin and nail conditions (eg, rash and infection or redness around the fingernails). Adverse events included inflammation of the lungs, and injury to the heart; this drug may also cause harm to developing fetuses.
• Cotellic (cobimetinib) has been approved by the FDA in combination with vemurafenib to treat patients with advanced melanoma that has metastasized or is unresectable, and that has BRAF V600E or V600K mutation. The most common side effects associated with the drug included diarrhea, photosensitivity, nausea, fever, and vomiting.
• Darzalex (daratumumab) was approved for patients with multiple myeloma who have received ≥3 previous treatments. It is the first monoclonal antibody approved to treat this type of cancer. Daratumumab injection is given as an infusion, and works by helping certain cells in the immune system attack cancer cells. The most common side effects associated with this drug were infusion-related reactions, and included fatigue, nausea, back pain, fever, and cough.
• Ninlaro (ixazomib) has been approved in combination with 2 other therapies (Revlimid [lenalidomide] and dexamethasone) to treat people with multiple myeloma who have received ≥1 prior therapies. Ninlaro is a proteasome inhibitor that blocks enzymes from multiple myeloma cells, obstructing their ability to grow. Common side effects associated with the drug are diarrhea, constipation, thrombocytopenia, peripheral neuropathy, nausea, peripheral edema, vomiting, and back pain.

1. US Food and Drug Administration. Press announcements. www.fda.gov/NewsEvents/News room/PressAnnouncements. Updated November 23, 2015. Accessed November 23, 2015.