Rx Product News (December 2014)
Marketed by: Genzyme Corporation
Indication: The FDA has approved Cerdelga (eliglustat), a glucosylceramide synthase inhibitor, for longterm treatment of adult patients with Gaucher disease type 1 who are CYP2D6 extensive metabolizers (EMs), intermediate metabolizers (IMs), or poor metabolizers (PMs), as detected by an FDA-cleared test. For CYP2D6 EMs or IMs, the dosage is 84 mg orally twice daily. For CYP2D6 PMs, the dosage is 84 mg orally once daily. Patients should swallow capsules whole and should not consume grapefruit or grapefruit juice.
Dosage Form: Capsules: 84 mg
For More Information: www.cerdelga.com
Marketed by: KERYX Biopharmaceuticals, Inc
Indication: The FDA has approved Auryxia (ferric citrate), a phosphate binder, for the control of serum phosphorus levels in patients with chronic kidney disease on dialysis. The starting dose is 2 tablets orally 3 times per day with meals. The dose should be adjusted by 1 to 2 tablets as needed to maintain serum phosphorus at target levels, up to a maximum of 12 tablets daily. The dose can be titrated at 1-week or longer intervals.
Dosage Form: Tablets: 210 mg of ferric iron, equivalent to 1 g of ferric citrate
For More Information: www.auryxia.com
OFEVMarketed by: Boehringer Ingelheim Pharmaceuticals, Inc
Indication: The FDA has approved Ofev (nintedanib), a kinase inhibitor, for the treatment of idiopathic pulmonary fibrosis. The recommended dosage is 150 mg twice daily, approximately 12 hours apart, with food. For management of adverse reactions, the dose can be temporarily reduced to 100 mg, or treatment can be interrupted or discontinued.
Dosage Form: Capsules: 100 and 150 mg
For More Information: www.ofev.com
HARVONIMarketed by: Gilead Sciences, Inc
Indication: The FDA has approved Harvoni—a fixed-dose combination of ledipasvir (a hepatitis C virus [HCV] NS5A inhibitor) and sofosbuvir (an HCV nucleotide analog NS5B polymerase inhibitor)—for the treatment of chronic hepatitis C genotype 1 infection in adults. The recommended dosage is 1 tablet orally once daily, with or without food.
Dosage Form: Tablets: 90 mg of ledipasvir, and 400 mg of sofosbuvir
For More Information: www.harvoni.com