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Alternative Medicines Corner Advising on this article: Nicole M. Maisch February 1, 2016 Melatonin supplementation may improve outcomes in children with atopic dermatitis Key Point Results of a small study suggest that children with atopic dermatitis who are given melatonin at bedtime have improvements in disease severity and sleep-onset latency. Source URL: http://www.aphadruginfoline.com/alternative-medicines-corner/melatonin-supplementation-may-improve-outcomes-chil dren-atopic page 3 / 9
New Drug Approvals Generic Name (Trade Name Company) Uses/Notes February 1, 2016 Elbasvir and grazoprevir (Zepatier Merck & Co.) FDA approves new combination oral treatment for chronic HCV genotypes 1 and 4 FDA has approved elbasvir and grazoprevir with or without ribavirin for the treatment of chronic hepatitis C virus (HCV) genotypes 1 and 4 infections in adult patients. Safety and efficacy of elbasvir and grazoprevir with or without ribavirin were evaluated in clinical trials of 1,373 participants with chronic HCV genotype 1 or 4 infections with and without cirrhosis. The participants received the combination drug with or without ribavirin once daily for 12 or 16 weeks. The studies were designed to measure whether a participant s HCV was no longer detected in the blood 12 weeks after finishing treatment (sustained virologic response [SVR]), suggesting a participant s infection had been cured. The overall SVR rates ranged from 94% to 97% in participants infected with genotype 1 and from 97% to 100% in participants infected with genotype 4 across trials for the approved treatment regimens. To maximize SVR rates for patients, the product label provides recommendations on length of treatment with or without ribavirin specifically tailored to the characteristics of the patient and his or her virus. Health professionals should screen genotype 1a infected patients for certain viral genetic variations before starting treatment with elbasvir and grazoprevir to determine dosage regimen and duration. The most common adverse effects of elbasvir and grazoprevir without ribavirin were fatigue, headache, and nausea. The most common adverse effects with ribavirin were anemia and headache. The product carries a warning alerting patients and health care providers that elevations of liver enzymes to greater than five times the upper limit of normal occurred in approximately 1% of clinical trial participants, generally at or after treatment week 8. Liver-related blood tests should be performed before starting therapy and at certain times during treatment. The agent should not be given to patients with moderate or severe liver impairment. page 4 / 9
Source URL: http://www.aphadruginfoline.com/new-drug-approvals/fda-approves-new-combination-oral-treatment-chronic-hcv-genot ypes-1-and-4 page 5 / 9
Supplemental Approvals Generic Name (Trade Name Company) Uses/Notes February 1, 2016 Prefilled insulin pen (Humulin R U-500 KwikPen Eli Lilly) FDA approves first U-500 insulin pen device FDA has approved the first prefilled pen device containing concentrated U-500 strength insulin for patients with diabetes who require more than 200 units per day. The product is designed as a more convenient alternative to the current U-500 vial, which requires use of either a syringe designed for U-100 strength insulin or a volumetric (tuberculin) syringe, both of which require dose conversions. Each KwikPen holds 1,500 units of insulin (3 ml, with each ml containing 500 units), the amount contained in five U-100 insulin pens. However, it is the same size as other Eli Lilly KwikPens and dials in five-unit increments. Humulin R U-500 exhibits both basal and prandial properties, allowing it to be used as insulin monotherapy. This effect has been attributed to the high concentration of the preparation. As with other insulins, Humulin R U-500 is contraindicated during hypoglycemic episodes and in patients hypersensitive to Humulin R U-500 or any of its additives or components. Eli Lilly, the manufacturer, offers a savings card program for eligible commercially insured patients to pay as little as $25 per prescription for up to 12 redemptions over a 12-month period. Source URL: http://www.aphadruginfoline.com/supplemental-approvals/fda-approves-first-u-500-insulin-pen-device page 6 / 9
Supplemental Approvals Generic Name (Trade Name Company) Uses/Notes February 2, 2016 Methylphenidate extended-release tablets (Adzenys XR-ODT Neos Therapeutics) First orally disintegrating tablet for ADHD is approved FDA has approved a methylphenidate extended-release orally disintegrating tablet (ODT) for the treatment of ADHD in children aged 6 years and older. Approval was based on data demonstrating that the drug is the bioequivalent of a previously approved mixed amphetamine salts extended-release capsule (Adderall XR Shire), one of the most commonly prescribed medications for the treatment of ADHD. The product will be available in six dosage strengths, equivalent to the Adderall XR dosage strengths, thus allowing health care providers to individualize the dose. Source URL: http://www.aphadruginfoline.com/supplemental-approvals/first-orally-disintegrating-tablet-adhd-approved page 7 / 9
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