Since January 2015, the FDA has approved more than a dozen drugs indicated for primary care diseases. Here, a quick slide update on 10 of them.
Viberzi (eluxadoline) is a mu-opioid receptor agonist indicated for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults. The recommended dosage in adults is 100 mg twice daily taken with food and 75 mg twice daily taken with food in patients who do not have a gallbladder, are unable to tolerate the 100-mg dose, are receiving concomitant OATP1B1 inhibitors, have mild or moderate hepatic impairment. Approved 5/27/15; Manufacturer: Actavis plc. Prescribing Information, here.
Stiolto Respimat is a combination of tiotropium, an anticholinergic and olodaterol, a LABA, indicated for long-term, once-daily maintenance treatment of airflow obstruction in patients with COPD. Stiolto Respimat is NOT indicated to treat acute deterioration of COPD and NOT indicated to treat asthma. Two inhalations of Stiolto Respimat once-daily at the same time of day. Approved 5/21/15. Manufacturer: Boehringer Ingelheim Pharmaceuticals, Inc. Prescribing Information, here.
Breo Ellipta is a combination of fluticasone furoate, an inhaled corticosteroid (ICS), and vilanterol, a long-acting beta2-adrenergic agonist, indicated for long-term, once-daily, maintenance treatment of airflow obstruction and reducing exacerbations in patients with COPD. NEW INDICATION: Once-daily treatment of asthma in patients aged 18 years and older. Not indicated for relief of acute bronchospasm. Maintenance treatment of COPD: 1 inhalation of Breo Ellipta 100/25 once daily. Asthma: 1 inhalation of Breo Ellipta 100/25 or Breo Ellipta 200/25 once daily. New Indication Approved 4/30/15. Manufacturer: GlaxoSmithKline plc,Prescribing Information, here.
Tuzistra XR (codeine polistirex and chlorpheniramine polistirex) is an extended-release opiate agonist antitussive and histamine-1 (H1) receptor antagonist combination indicated for the relief of cough and symptoms associated with upper respiratory tract allergies or the common cold. Tuzistra XR is not indicated for patients under 18 years of age. Dosage in persons 18 years and older: 10 mL every 12 hours. Not to exceed 2 doses (20 mL) in 24 hours. For oral use only, with or without food. Approved 4/30/15. Manufacturer: Vernalis plc and Tris Pharma Inc.Prescribing Information, here.
ProAir RespiClick (albuterol sulfate) is a breath-actuated, dry-powder, short-acting beta-agonist inhaler indicated for treatment or prevention of bronchospasm in patients 12 years and older with reversible obstructive airway disease and for prevention of exercise-induced bronchospasm in patients 12 years and older. Dosage for treatment or prevention of bronchospasm in adults and adolescents aged 12 and older: 2 inhalations every 4 to 6 hours; in some patients, 1 inhalation every 4 hours may be sufficient. Dosage for prevention of exercise-induced bronchospasm in adults and adolescents aged 12 and over: 2 inhalations 15 to 30 minutes before exercise. Approved 3/31/15. Manufacturer: Teva Pharmaceutical Industries Ltd.Prescribing Information, here.
Quadracel (Diphtheria and Tetanus Toxoids and Acellular Pertussis Absorbed and Inactivated Poliovirus; DTaP-IPV) is a vaccine for active immunization against diphtheria, tetanus, pertussis, and poliomyelitis. A single dose of Quadracel is approved for use in children 4 through 6 years of age as a fifth dose in the diphtheria, tetanus, pertussis vaccination (DTaP) series, and as a fourth or fifth dose in the inactivated poliovirus vaccination (IPV) series, in children who have received 4 doses of Pentacel and/or Daptacel vaccine. Quadracel is given in a single intramuscular injection of 0.5 mL. Approved 3/24/15. Manufacturer: Sanofi Pasteur.Prescribing Information, here.
Toujeo (insulin glargine [rDNA origin] Injection U300 is a once-daily, long-acting basal insulin used to improve glycemic control in adults with type 1 and type 2 diabetes. Toujeo is not recommended for treating diabetic ketoacidosis. Individualize dose based on type of diabetes, metabolic needs, blood glucose monitoring results and glycemic control goal. Administer subcutaneously once daily at any time during the day, at the same time every day. Approved 2/25/15. Manufacturer: sanofi-aventis U.S. LLC Prescribing Information, here.
Bexsero (meningococcal group B vaccine) is a vaccine indicated for active immunization to prevent invasive disease caused by Neisseria meningitides serogroup B and approved for use in individuals 10 through 25 years of age. Bexsero is administered in 2 doses (0.5 mL each) at least 1 month apart.Approved 1/23/15. Manufacturer: Novartis Vaccines and Diagnostics Inc. Prescribing Information, here.
Zohydro ER (hydrocodone bitartrate) Extended-Release Capsules, CII, with BeadTekâ¢ Zohydro ER is an opioid agonist indicated for the management of pain severe enough to require daily, around-the-clock, longâterm opioid treatment and for which alternative treatment options are inadequate. NEW FORMULATION BeadTekâ¢ is a formulation technology designed to provide abuse-deterrent properties without changing the release properties of hydrocodone when Zohydro ER is used as intended. New Formulation Approved 1/30/15. Manufacturer: Pernix Therapeutics, LLC. Prescribing Information, here.
Glyxambi (empagliflozin and linagliptin) is a sodium-glucose co-transporter 2 (SGLT2) inhibitor and dipeptidyl peptidase-4 (DPP-4) inhibitor combination product indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both empagliflozin and linagliptin is appropriate. Glyxambi is not for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis; it has not been studied in patients with a history of pancreatitis. The recommended dose of Glyxambi is 10 mg empagliflozin/5 mg linagliptin once daily taken in the morning, with or without food. Dose may be increased to 25 mg empagliflozin/5 mg linagliptin once daily. Assess renal function (eGFR) before initiating Glyxambi. Manufacturer: Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company. Prescribing Information, here.
Since January 2015, the FDA has approved more than a dozen medications indicated for primary care diseases. In the slides above, a brief look at 10 of the newest approvals, starting with the most recent.