New products for pharmacists 11-10-2014

New Rx, New drugs

October saw simultaneous FDA approval of pirfenidone (Esbriet; InterMune) in 267-mg capsules and nintedanib (Ofev; Boehringer Ingelheim) in 150-mg capsules to treat idiopathic pulmonary fibrosis (IPF). Progressive lung scarring caused by IPF results in shortness of breath and severe coughing disruptive of normal living. According to FDA, treatments to date have included oxygen therapy, pulmonary rehabilitation, and lung transplant, making Esbriet and Ofev significant new treatment options. Both products will cost more than $90,000 per year, and will manage, not cure, the disease, requiring lifelong adherence. (www.esbriet.com;www.ofev.com) (Esbriet image courtesy of Intermune) (Ofev image courtesy of Boehringer Ingelheim

Eisai has announced FDA approval of the fixed combination of netupitant 300 mg/palonosetron 0.5 mg (Akynzeo) for the prevention of acute and delayed nausea and vomiting associated with chemotherapy treatment. There are no contraindications. Patients have reported some hypersensitivity reactions, including anaphylaxis, and adverse reactions have included headache, asthenia, dyspepsia, fatigue, constipation and erythema. Patients with severe hepatic or renalimpairment should not use this product. (www.akynzeo.com) (Akynzeo; image courtesy of Eisai)

FDA has approved ledipasvir 90 mg/sofosbuvir 400 mg (Harvoni; Gilead Sciences), the first combination tablet for the treatment of chronic hepatitis C genotype 1 infection. The interferon- and ribavirin-free once-a-day therapy is expected to simplify treatment regimens. Three phase 3 trials demonstrated sustained virological response rates (no sign of virus six months after treatment) above 90%. Sofosbuvir, branded Sovaldi, is priced at $1,000/pill. The price tag for one tablet of Harvoni is $1,125; 24 weeks of treatment will run $189,000. Gilead Sciences is offering a patient-assistance program for patients who lack insurance coverage; for information, paste “Support Path for Sovaldi and Harvoni” into your browser. Harvoni is the third drug treating chronic HCV infection to win FDA approval in the past year. Simeprevir (Olysio) was approved in November 2013 and sofosbuvir in December 2013. (www.harvoni.com)

Teva has announced that its beclomethasone dipropionate HFA with dose counter (Qvar), approved in May, is now commercially available throughout the United States. The inhaled corticosteroid is approved for twice-daily use in the ongoing treatment of asthma as a preventative therapy for patients five years of age and older. This product does not replace inhalers for quick relief of sudden symptoms. (www.qvar.com) (Qvar; image courtesy of Teva)

New generics 

Camber Pharmaceuticals has launched raloxifene hydrochloride, USP 60-mg tablets, generic for Eli Lilly’s Evista, used to treat and prevent osteoporosis in postmenopausal women. (www.camberpharma.com) (raloxifene HCl; image courtesy of Camber Pharma) 

Dr. Reddy’s has announced the launch of levalbuterol inhalation solution, a bronchodilator for treatment of bronchospasm in people with reversible obstructive airway disease. The product is a generic version of Sunovion’s Xopenex. (www.drreddys.com)

Heritage Pharmaceuticals has launched rizatriptan benzoate IR, generically equivalent to Merck’s Maxalt, in 5-mg and 10-mg strengths, to treat migraine headaches. (www.heritagepharma.com) (RIzatriptan benzoate; image courtesy of Heritage Pharmaceuticals)

OTC

The eb5 brand of anti-aging skin-care products, created by a pharmacist 60 years ago using a blend of vitamins A, B, and E, and botanticals, has launched a new formulation that is hypoallergenic, non-GMO, vegan, and paraben-, gluten-, and fragrance-free. Find products at Walmart, Ulta, select Walgreens and CVS stores, and many independent drugstores and retail chains. (www.eb5.com)  (eb5 facial treatment; image courtesy of eb5)

Arctic Ease, which makes the only iceless cold and compression-therapy wrap, has launched a wrap specifically for small joints such as wrists, ankles, and elbows. All wraps provide cool relief from pain and swelling for up to three hours, can be reused up to five times, and need no refrigeration. These products retail at CVS and the Vitamin Shoppe, as well as online. (www.arcticeasewrap.com) (Arctic Ease Instant Cold Wrap image courtesy of Arctic Ease)

A new product now available is the Pill Terminator, a bottled compound that destroys prescription medications, syrups, capsules, or suspensions when water is added and the bottle is shaken. Each single-use bottle can dispose of up to 300 pills. Order this product from Amazon or the manufacturer’s website. (http://pillterminator.com) (Pill Terminator image courtesy of Pill Terminator)