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Weekly Drug News Round-Up: August 9, 2017

Mavyret Cleared as First 8 Week Hepatitis C Treatment for All Genotypes

Standard treatment length for HCV was previously 12 weeks or more Read More...

The  U.S. Food and Drug Administration (FDA) has approved AbbVie's Mavyret (glecaprevir and pibrentasvir), the first 8 week treatment for all chronic hepatitis C virus (HCV) genotypes (1-6) in adult patients without cirrhosis (liver disease) without previous treatments. Glecaprevir inhibits NS3/4A protease and pibrentasvir inhibits NS5A.  More specifically, Mavyret is approved for two patient populations: either chronic HCV genotype 1, 2, 3, 4, 5 or 6 infection without cirrhosis and with compensated cirrhosis (Child-Pugh A), or adult patients with HCV genotype 1 infection, previously treated with an HCV NS5A inhibitor or an NS3/4A protease inhibitor, but not both. Studies demonstrated that 92 to 100 percent of patients had no virus detected in the blood 12 weeks after finishing treatment, suggesting a cure. The most commonly reported adverse reactions (> 10%) are headache and fatigue.

Vyxeos Cleared to Treat Advanced Types of Acute Myeloid Leukemia

The NCI estimates that roughly 21,380 people will be diagnosed with AML this year Read More...

Acute myeloid leukemia (AML) is a rapidly progressive cancer of the bone marrow. In response, the FDA has cleared Vyxeos (cytarabine and daunorubicin liposome injection) from Jazz Pharmaceuticals, a fixed-combination of chemotherapy drugs daunorubicin and cytarabine. Vyxeos is used in high-risk forms of newly-diagnosed therapy-related AML (t-AML) or AML with myelodysplasia-related changes (AML-MRC), both with low survival expectancy. In studies, patients who received Vyxeos lived longer than patients who received separate treatments of daunorubicin and cytarabine (median overall survival 9.56 months vs. 5.95 months). Common side effects include bleeding, fever, low white blood-cell count, rash, tissue swelling and nausea.

CaroSpir: The First Oral Suspension Form of Spironolactone

CaroSpir will be introduced early in the fourth quarter of 2017 Read More...

The FDA has approved CMP Pharma’s CaroSpir (spironolactone oral suspension, 25 mg/5mL), the first approved oral liquid form of the potassium-sparing diuretic spironolactone. CaroSpir comes an oral suspension used for the treatment of heart failure, management of edema, and for use as an add-on therapy in the treatment of hypertension. CaroSpir oral suspension, 25 mg/5 mL, is not therapeutically equivalent to the tablet form of spironolactone and dosing instructions should be closely followed. Do not use CaroSpir in patients with the following conditions: hyperkalemia, Addison’s disease, and patients taking eplerenone (Inspra).

Liletta Intrauterine Device Use Extended to Four Years

Liletta is an IUD that can be used whether you have had children or not Read More...

The FDA has approved the supplemental application to extend the duration of use of Liletta (levonorgestrel-releasing intrauterine system) 52 mg for the prevention of pregnancy for up to four years. Liletta, initially approved in February 2015, is a hormone-releasing system placed in a woman’s uterus to prevent pregnancy. In studies of 1,751 U.S. women receiving Liletta, the IUD contraceptive was more than 99 percent effective in preventing pregnancy, regardless of age, race, body mass index (BMI) or parity (whether or not the woman had given birth to at least one child).

FDA MedWatch: Stop Use of PharmaTech’s Liquid Drug Products

Patients with concerns should contact their healthcare professional Read More...

FDA is advising providers and patients not to use any liquid product made by PharmaTech LLC, Davie, Florida, due to Burkholderia cepacia contamination and the potential for severe patient infection. Rugby Laboratories, Livonia, Michigan, announced a voluntary recall on August 3, 2017, of two such products - Diocto Liquid and Diocto Syrup - both oral liquid docusate products often used as a stool softener and manufactured by PharmaTech. However, other companies besides Rugby may be distributing these liquids. In 2016, the FDA made a similar advisory based on CDC findings. Products are not labeled with “PharmaTech”, so facilities should check with their supplier, especially with liquid docusate products, to determine if the origin was PharmaTech.

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