New Therapeutic Agents Marketed in 2016: Part 2

Activity Preview

In the first part of this two-part series, 8 new therapeutic agents marketed in 2016 were reviewed (Pharmacy Today, September 2016).  In this second and concluding part of the series, 8 additional new therapeutic agents marketed in 2016 are covered:  lixisenatide, lifitegrast, eteplirsen, nusinersen, sugammadex, obeticholic acid, defibrotide, and obiltoxaximab.  The authors review indications, mechanisms of action, and information on dosage and administration for these new agents, as well as their most important pharmacokinetic properties, adverse events, and other risks and precautions.  Where possible, they compare the new agents with older drugs marketed for the same indications, and identify the advantages and disadvantages of the new drugs.  

Lixisenatide is the fifth glucagon-like peptide-1 receptor agonist to be marketed and is administered subcutaneously as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus.  Lifitegrast is the first drug to be approved for the treatment of both the signs and symptoms of dry eye disease, and has a unique mechanism of action.  Muscular dystrophy and spinal muscular atrophy are rare genetic diseases for which effective treatments have not been available.  Eteplirsen and nusinersen are antisense oligonucleotides that are the first drugs to be approved, for the treatment of patients with Duchenne muscular dystrophy and spinal muscular atrophy, respectively.  Sugammadex is a muscle relaxant reversal agent that is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adult patients undergoing surgery.  Obeticholic acid is the second agent to be approved for the treatment of patients with primary biliary cholangitis (PBC), and is used in combination with ursodeoxycholic acid (UDCA) for the treatment of adult patients with an inadequate response to UDCA, or as monotherapy in adults who are unable to tolerate UDCA.  Defibrotide is the first drug to be approved for use in certain patients with blood or bone marrow cancers who have experienced hepatic veno-occlusive disease with renal or pulmonary dysfunction following hematopoietic stem cell transplantation.  Obiltoxaximab has properties that are similar to those of raxibacumab, and is indicated for the treatment of patients with inhalational anthrax in combination with appropriate antibacterial drugs, and for prophylaxis of inhalational anthrax when alternative therapies are not available or are not appropriate.  In addition, summary information is provided for four new antineoplastic drugs – venetoclax, rucaparib, atezolizumab, and olaratumab.

NOTE: If you have not yet enrolled in Part 1, you can access New Therapeutic Agents Marketed in 2016: Part 1 in APhA's Library.  If you have completed Part 1, but would like to review, please access through your My Training page.

Learning Objectives

After participating in this activity, the participant will be able to:

  1. Identify the new therapeutic agents that are considered and explain their appropriate use.
  2. Identify the indications and mechanisms of action of the new therapeutic agents.
  3. Identify the most important adverse events and other risks of the new therapeutic agents.
  4. State the route of administration for each new drug and the most important considerations regarding dosage and administration.
  5. Compare the new therapeutic agents with older medications to which they are most similar in properties and/or use, and identify the most important advantages and disadvantages for the new drugs.

Activity type: Knowledge-based
Target Audience
: Pharmacists and Technicians
Learning level: 1

Accreditation Information

The American Pharmacists Association is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  This activity is approved for 2.0 contact hour of CPE credit (0.20 CEUs). The ACPE Universal Activity Numbers for this activity are 0202-0000-17-133-H01-P and 0202-0000-17-133-H01-T.

To obtain 2.0 contact hours of continuing pharmacy education credit (0.2 CEUs) for completing "New Therapeutic Agents Marketed in 2016: Part 2" complete the CPE assessment with a passing grade of 70% or better, evaluation questions, and CLAIM your credit. Please visit CPE Monitor for your transcript of CPE.

APhA continuing pharmacy education policy provides you with two opportunities to successfully complete this continuing pharmacy education assessment. Please note that the questions may not appear in the same order as printed, and you will not be permitted to submit the assessment a third time. The current policy of the APhA Education Department is not to release the correct answers to any of our CPE tests. This policy is intended to maintain the integrity of the CPE activity and the assessment. 

Initial release date: March 1, 2017
Expiration date: March 1, 2020 - NO CREDIT GRANTED AFTER THIS DATE

Development

"New Therapeutic Agents Marketed in 2016: Part 2" is a home-study continuing education activity for pharmacists developed by the American Pharmacists Association.

Author

Daniel A. Hussar, PhD, FAPhA
Remington Professor of Pharmacy
University of the Sciences College of Pharmacy
Philadelphia, PA 

Advisory Board

Mark S. Johnson, PharmD, BCPS
Professor and Vice Chair of Pharmacy Practice
Director of Postgraduate Education
Shenandoah University
Winchester, VA

Disclosures

Daniel A. Hussar, PhD, FAPhA declares no conflicts of interest, real or apparent, and no financial interests in any company, product, or service mentioned in this program, including grants, employment, gifts, stock holdings, and honoraria.

Mark S. Johnson, PharmD, BCPS, declares that he and his spouse hold stock in Merck & Co.

APhA’s editorial staff declare no conflicts of interest or financial interests in any product or service mentioned in this activity, including grants, employment, gifts, stock holdings, and honoraria.. For complete staff disclosures please see the APhA Accreditation Information section at www.pharmacist.com/apha-disclosures.

Fee

There is no fee associated with this activity for members of the American Pharmacists Association. There is a $25 fee for nonmembers.

System Requirements

Computer and Internet access is required to complete this activity.  Please visit our website to view the Technology System Requirements to have a positive learning experience.

Credit Information

Activity Number Credit Amount Accreditation Period
ACPE# 0202-0000-17-133-H01-P 0.2 CEUs March 01, 2017 - March 01, 2020
ACPE# 0202-0000-17-133-H01-T 0.2 CEUs March 01, 2017 - March 01, 2020