New Products

PORTRAZZA

  • 2/14/2016
  • Lilly, Eli and Company
  • Necitumumab 800mg/50mL; solution for IV infusion after dilution; preservative-free.
  • In combination with gemcitabine and cisplatin, for first-line treatment of metastatic squamous non-small cell lung cancer (NSCLC). Limitations of use: not for treatment of non-squamous NSCLC.
UTIBRON NEOHALER

UTIBRON NEOHALER

  • 2/7/2016
  • Novartis Pharmaceuticals Corp
  • Indacaterol 27.5mcg, glycopyrrolate 15.6mcg; per capsule; dry powder for oral inhalation for use with Neohaler device; contains lactose.
  • Long-term maintenance treatment of airflow obstruction in COPD, including chronic bronchitis and/or emphysema. Limitations of use: not for the relief of acute bronchospasm or for the treatment of asthma.
EMPLICITI

EMPLICITI

  • 1/31/2016
  • BristolMyers Squibb
  • Elotuzumab 300mg, 400mg; per vial; lyophilized powder for IV infusion after reconstitution; preservative-free.
  • In combination with lenalidomide and dexamethasone, for the treatment of patients with multiple myeloma who have received 1–3 prior therapies.
BELBUCA

BELBUCA

  • 1/24/2016
  • Endo Pharmaceuticals
  • Buprenorphine 75mcg, 150mcg, 300mcg, 450mcg, 600mcg, 750mcg, 900mcg; buccal films; peppermint flavor.
  • Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Limitations of use: reserve for use in patients for whom alternative treatment options are ineffective, not tolerated, or inadequate to provide sufficient management of pain. Not indicated as an as-needed (prn) analgesic.
DARZALEX

DARZALEX

  • 1/17/2016
  • Janssen Biotech, Inc.
  • Daratumumab 100mg/5mL, 400mg/20mL; per vial; soln for IV infusion after dilution; contains mannitol; preservative-free.
  • Treatment of multiple myeloma in patients who have received ≥3 prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent.
NUCALA

NUCALA

  • 1/10/2016
  • GlaxoSmithKline
  • Mepolizumab 100mg; per vial; lyophilized pwd for SC inj after reconstitution; preservative-free.
  • As add-on maintenance treatment of severe asthma in patients ≥12yrs old, and with an eosinophilic phenotype. Limitations of use: not for treating other eosinophilic conditions. Not for relief of acute bronchospasm or status asthmaticus.
GENVOYA

GENVOYA

  • 12/27/2015
  • Gilead Sciences, Inc.
  • Elvitegravir 150mg, cobicistat 150mg, emtricitabine 200mg, tenofovir alafenamide (AF) 10mg; tablets.
  • As a complete regimen for the treatment of HIV-1 infection in patients who are antiretroviral treatment-naïve or to replace current antiretroviral (ARV) regimen in virologically-suppressed patients on a stable ARV regimen for ≥6 months with no history of treatment failure and no known substitutions associated with resistance to any components of Genvoya.
COTELLIC

COTELLIC

  • 12/20/2015
  • Genentech, Inc.
  • Cobimetinib 20mg; tablets.
  • In combination with vemurafenib for the treatment of unresectable or metastatic melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test. Limitation of use: not for treatment of wild-type BRAF melanoma.

VIBERZI

  • 12/13/2015
  • Allergan
  • Eluxadoline 75mg, 100mg; tablets.
  • Treatment of irritable bowel syndrome with diarrhea (IBS-D).

TRESIBA

  • 12/6/2015
  • Novo Nordisk
  • Insulin degludec 100 Units/mL, 200 Units/mL; soln for SC inj; contains zinc, m-cresol.
  • To improve glycemic control in adults with type 1 or type 2 diabetes mellitus. Limitations of use: not for treating diabetic ketoacidosis.

LONSURF

  • 11/29/2015
  • Taiho Oncology, Inc.
  • Trifluridine, tipiracil; 15mg/6.14mg, 20mg/8.19mg; tablets.
  • Treatment of metastatic colorectal cancer in patients previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy.

VARUBI

  • 11/22/2015
  • Tesaro Inc.
  • Rolapitant 90mg; tablets.
  • In combination with other antiemetic agents in adults for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy.
STRENSIQ

STRENSIQ

  • 11/15/2015
  • Alexion Pharmaceuticals, Inc.
  • Asfotase alfa 18mg/0.45mL, 28mg/0.7mL, 40mg/mL, 80mg/0.8mL; soln for SC inj; preservative-free.
  • Treatment of perinatal/infantile- and juvenile-onset hypophosphatasia (HPP).
COLCIGEL

COLCIGEL

  • 11/8/2015
  • Gensco Laboratories
  • Colchicinum 4X; per gram; 0.25mL per each pump depression; transdermal gel.
  • Treatment and prophylaxis of acute gout flares.

ARISTADA

  • 10/30/2015
  • Alkermes
  • Aripiprazole lauroxil extended-release injectable suspension 441mg/1.6mL, 662mg/2.4mL, 882mg/3.2mL; for IM inj.
  • Schizophrenia.
ODOMZO

ODOMZO

  • 10/25/2015
  • Novartis Pharmaceuticals Corp
  • Sonidegib 200mg; capsules.
  • Treatment of adults with locally advanced basal cell carcinoma (BCC) that has recurred following surgery or radiation therapy, or those who are not candidates for surgery or radiation therapy.
ADDYI

ADDYI

  • 10/18/2015
  • Sprout Pharmaceuticals
  • Flibanserin 100mg; tablets.
  • Acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women and is not due to a coexisting medical or psychiatric condition, problems within the relationship, or adverse effect of a medication or other drug substance. Limitations of use: not for HSDD in postmenopausal women or men. Not for sexual performance enhancement.
SYNJARDY

SYNJARDY

  • 10/11/2015
  • Boehringer Ingelheim and Lilly
  • Empagliflozin, metformin HCl; 5mg/500mg, 12.5mg/500mg, 5mg/1000mg, 12.5mg/1000mg; tablets.
  • Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes who are not adequately controlled on metformin or empagliflozin regimen, or who are already being treated with both. Limitations of use: not for treating type 1 diabetes or diabetic ketoacidosis.
KEVEYIS

KEVEYIS

  • 10/4/2015
  • Taro Pharmaceuticals
  • Dichlorphenamide 50mg; scored tabs.
  • Primary hyperkalemic or hypokalemic periodic paralysis and related variants.
REPATHA

REPATHA

  • 9/27/2015
  • Amgen, Inc.
  • Evolocumab 140mg/mL; soln for SC inj; preservative-free.
  • Adjunct to diet and maximally tolerated statin therapy, in adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (CVD) requiring additional lowering of LDL-C. Adjunct to diet and other LDL-lowering therapies, in patients with homozygous familial hypercholesterolemia (HoFH) requiring additional lowering of LDL-C. Limitations of use: effect on cardiovascular morbidity and mortality has not been determined.

New Drug Product Slideshows

Genvoya

As a complete regimen for the treatment of HIV-1 infection in patients who are antiretroviral treatment-naïve or to replace current antiretroviral (ARV) regimen in virologically-suppressed patients on a stable ARV regimen for ≥6 months with no history of treatment failure and no known substitutions associated with resistance to any components of Genvoya.

Viberzi

New Drug Product: TRESIBA

This slideshow reviews drug information for TRESIBA (insulin degludec). <a href="http://www.empr.com/tresiba/drugproduct/397/">Click here</a> for the complete TRESIBA new product monograph<br><br> <b>For a downloadable PDF of this slideshow, <a href="http://www.empr.com/downloadmedia/45272">click here</a>.</b>

Lonsurf

Treatment of metastatic colorectal cancer in patients previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy.

Varubi

In combination with other antiemetic agents in adults for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy.

Strensiq

Treatment of perinatal/infantile- and juvenile-onset hypophosphatasia (HPP).

Colcigel

Treatment and prophylaxis of acute gout flares.

Aristada

Indications: Schizophrenia.