PPA News


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Posted by: Matthew Helms on Apr 29, 2021

 

We thank you, our members, for the highest record attendance ever at the Annual Meeting last week. PPA has continued to evolve and grow during this unprecedented year and that is due to all of you. You continued to provide clinical care and produce academic work, thereby supporting  the mission of PPA to promote the health and wellbeing of children through your efforts. As a testament to some of those achievements, the Pediatric Pharmacy Association is pleased to announce the following awards given during the 30th Annual PPA Meeting last week.

Richard A Helms Award of Excellence in Pediatric Pharmacy Practice

David Hoff, PharmD
System Clinical Pharmacy Manager, Children’s Minnesota, Minneapolis, MN

Fellows of the Pediatric Pharmacy Association (FPPA)

Bob Hansen, PharmD, BCPS, BCPPS, FPPA.
Children’s Hospital at St. Francis, Tulsa, OK
Tara Higgins, PharmD, BCPPS, FPPA.
UF Health Shands Children's Hospital, Gainesville, FL
Amy Holmes, PharmD, BCPPS, FPPA.
Wake Forest Baptist Medical Center, Winston-Salem, NC
Amy Mitchell Van-Steele, PharmD, BCPPS, FPPA.
Albany Medical Center, Albany, NY

Best Practice Award

Seerat Kapoor, William Mabry, Dhyana Naik, and Kelly Bobo. 
Le Bonheur Children's Hospital, Memphis, TN.
Integration of the key potentially inappropriate drugs in pediatrics (KIDs list) with formulary management and clinical decision support in a freestanding children’s hospital

Outstanding Original Paper

Selina Lim
KK Women’s and Children’s Hospital, Singapore.
Comparison of vancomycin trough-based and 24-hour area under the curve over minimum inhibitory concentration (AUC/MIC)-based therapeutic drug monitoring in pediatric patients

Christensen Memorial New Investigator Award

Emma Wysocki, PharmD
Nationwide Children's Hospital, Columbus, OH.
When there is no trough: Continuous infusion vancomycin utilization at a free-standing children’s hospital

Student Investigator Award

Abigail Benfield, PharmD candidate
UNC Eshelman School of Pharmacy, Chapel Hill, NC.
Management of suspected central-line associated bloodstream infections (CLABSI) in pediatric hematology/oncology and bone marrow transplant patients admitted to UNC Children's Hospital

John Dice Memorial Student Scholarship

Kennedy Freeman, PharmD candidate
University of South Carolina
Chelsea Vallejos, PharmD candidate
University of Colorado

PPA Presidential Citation

Norm Fenn, PharmD, Penn State Health, for his outstanding service as Chair of the Education Committee

Spirit of PPA Award

Lauren Henretty, for her outstanding contributions as PPA Manager of Education during the COVID-19 pandemic

Inaugural Jeffrey Low Service to PPA Award

Jeffrey Low, PharmD, BCPPS, FPPA
Pediatric Clinical Pharmacist Lead, Children’s Hospital Dartmouth, Lebanon, NH

Neonatal Pharmacy Small Grants

James Fly, PharmD
Le Bonheur Children’s Hospital/ University of Tennessee, Memphis, TN
Project: Comparing Outcomes Between Antibiotic Regimens for Necrotizing Enterocolitis

Seerat Kapoor, PharmD
Le Bonheur Children’s Hospital/ University of Tennessee, Memphis, TN
Project: Comparison of fungal infection rates among patients receiving histamime2 receptor antagonist or proton pump inhibitors in the NICU- A multicenter database analysis

Pediatric Pharmacy Small Grant

Emma Lynne Wysocki, PharmD
Nationwide Children’s Hospital, Columbus, OH
Project: Population pharmacokinetics of high dose extended interval amikacin in critically ill children


Congratulations to all of the award recipients! 

Sincerely,
PPA Board of Directors
PPA Membership Committee
PPA Advocacy Committee
PPA Research Committee
PPA Education Committee


 

 

Posted by: Matthew Helms on Apr 25, 2021

 

David Hoff, PharmD, BCPPS, FCCP, FPPA has been named recipient of the 2021 Richard A. Helms Award of Excellence in Pediatric Pharmacy Practice.

Dr. David Hoff is a pharmacy Clinical Leader, site Residency Program Director and member of the Professional Staff at Children's Minnesota. He is a Board Certified Pediatric Pharmacy Specialist and holds clinical faculty appointments at the University of Minnesota and Drake University. He has been a pediatric pharmacy practitioner, leader and teacher for over 28 years since graduating from the University of Minnesota.

David is a past President and member of the Board of Directors of the Pediatric Pharmacy Association and is a past President of the Minnesota College of Clinical Pharmacy. He holds membership and has been honored as a Fellow of both the American College of Clinical Pharmacy and the Pediatric Pharmacy Association. He is also an affiliate member of the American Academy of Pediatrics.

David has served as the manager of the Children's Minnesota Medication Safety Value Stream and is a former member of the Children's Minnesota Board Quality Committee. He has served as a consultant in pediatric pharmacy to the pharmaceutical industry, Children's HeartLink and to the Ministry of Health, Kingdom of Saudi Arabia.

In 2008, David was the recipient of the Health Care Hero Award by Twin Cities Business magazine. He has published book chapters, original research and abstracts and presented lectures locally, nationally and internationally on a number of pediatric drug topics.

He is a member of the international editorial board of the Journal of Pediatric Pharmacology and Therapeutics and serves as a peer reviewer for articles in pediatric pharmacotherapy submitted to a number of other scientific journals. David's main areas of professional interest are pediatric and neonatal critical care and medication safety.

Most recently, Dr. Hoff was awarded the PPA Presidential CItation for his work on the important article, Key Potentially Inappropriate Drugs in Pediatrics: The KIDs List, published in the Journal of Pediatric Pharmacology and Therapeutics. 

Dr. Hoff presented the Helms Award Lecture entitled, "A Journey Through Clinical Pharmacy Leadership" on Friday, April 23, 2021 during the 30th Annual PPA Meeting!

 

 

Posted by: Matthew Helms on Apr 24, 2021

PPA is pleased to announce the results of the 2021 Board election. The new members will join Kristin Klein (President), Shannon Manzi (Immediate Past President), Cathy Poon (Treasurer), Chad Knoderer (Director), Lizbeth Hansen (Director), Petrea Cober (Director), and Jeremy Stultz (Director) on the Board. 

PPA thanks Hanna Phan (President), Kelly Matson (Director), and Eloise Woodruff (Director) for their three years of service on the Executive Committee and Board, respectively. 

“I have always been excited to be a member of PPA! From my first day as a member, PPA has provided a unique opportunity for a specialized group of practitioners to come together to network, learn and collaborate! It has been exciting to be a part of the growth of PPA and it is exciting to think about where our members will take us in the future!” -Michael Chicella, PharmD, BCPPS, FPPA

Mike Chicella is the Clinical Manager for the Department of Pharmacy, and he is the pharmacist for the Pediatric Intensive Care Unit at Children’s Hospital of The King’s Daughters (CHKD) in Norfolk, Virginia. He graduated from the University of North Carolina in 1991 with his Bachelor of Science in Pharmacy. After working at Duke University Children’s Hospital, Mike returned to Campbell University where he earned his Doctor of Pharmacy degree. After graduation, he completed a residency at Le Bonheur/ University of Tennessee. Mike was then on faculty at Auburn University School of Pharmacy before moving to CHKD in 2003. Mike has published a number of book chapters and peer-reviewed manuscripts. He has also had numerous presentations at national meetings. Mike is extensively involved in the education of both students and residents during their rotations at CHKD. He is an Assistant Professor in the Department of Pediatrics at Eastern Virginia Medical School. Additionally, he serves as the Residency Program Director at CHKD. To date he has trained more than twenty five residents. With regard to his involvement in PPA, Mike has been both a member and the chair of the research committee. He has served two terms on the Board of Directors. One term from 2011-2014, and the second term as Board of Directors Secretary from 2018-2021. Additionally, he is currently the critical care section chair for the board preparation and recertification course. Mike also oversees the John B. Dice Memorial Scholarship at PPA. In 2016 Mike was named a Fellow of PPA.

“I am very honored and appreciative for the PPA members to show their trust and support and elect me Treasurer-Elect.  For the next three years, I  plan to work closely with the Board of Directors and Executive Director to try to assure continued financial success and stewardship of the organization’s valued resources." - Brian Gardner, PharmD

Brian Gardner is the Pediatric Team Clinical Coordinator and primary pharmacist for the Pediatric Intensive Care Unit at Kentucky Children’s Hospital in Lexington, Kentucky. He was a graduate of the inaugural all PharmD class from the University of Kentucky and completed a pharmacy practice residency at the University of Louisville. Over the course of a decade, he was fortunately given the opportunity to specialize in pediatric pharmacy practice at Mayo Eugenio Litta Children’s Hospital, begin precepting students and residents, help start a PGY-1 residency program, and serve as the residency program director for two years prior to returning to his alma mater. In 2015, he succeeded Dr. Robert Kuhn and became the second University of Kentucky PGY-2 Pediatric Pharmacy Residency Program Director, and has graduated ten residents to date. Brian is an Adjunct Assistant Professor at the University of Kentucky College of Pharmacy and co-advisor of the PediaKATS, PPA student organization.  His research and publications encompass such topics as pediatric pharmacokinetics, pediatric critical care, antimicrobials, and medication reconciliation. He has been a proud member of PPA since 2003, core member of the PPA Finance Committee since 2016, two-time winner of the PPA Best Practice Award, co-planner for the 2019 PPA Fall Conference, member of the local Midwest Pediatric Pharmacy Association Group, and active recruiter of numerous PPA members through the years.  

“I am extremely honored to be able to serve PPA members as an executive committee. I hope to help PPA grow and move forward as we hopefully enter the post-pandemic world.” - Tara Higgins, PharmD, FPPA

Tara is a clinical specialist in pediatric hematology/oncology/BMT at UF Health Shands Children’s Hospital. She serves as residency program director of PGY2 pediatric pharmacy residency. In addition, Tara serves as clinical assistant professor at the University of Florida College of Pharmacy. She received her Doctor of Pharmacy from the University of Rhode Island. Tara completed her PGY1 pharmacy practice residency at Massachusetts General Hospital and a PGY2 pediatric pharmacy residency at the University of Kentucky Chandler Medical Center. Tara’s previous leadership experience includes Pediatric Pharmacy Association (PPA) membership council chair, PPA recertification and board prep hematology/oncology section lead, PPA hematology/oncology SIG chair and elected member of board of directors 2017-2020. 

"Honored, humbled, grateful. I am excited to serve the people and PPA for the next three years in this incredible role!" - Norm Fenn, PharmD, BCPS

Norm Fenn is a Clinical Pharmacist at the Penn State Children’s Hospital in Hershey, PA, and holds an adjunct faculty role with the UT Tyler Fisch College of Pharmacy. He completed his PharmD degree with Honors from the University of Colorado Skaggs School of Pharmacy & Pharmaceutical Sciences in 2014. He subsequently completed a PGY-1 residency at Children’s National Medical Center in 2015 and continued as a clinical pharmacist the following year. He then completed a two-year Academia & Ambulatory Care Fellowship at the Purdue University College of Pharmacy (2016-18) prior to a clinical assistant professor appointment in pediatrics at UT FCOP (2018-21). Dr. Fenn has served as the Webinar co-Chair (2018-20) and Education Committee Chair (2020-21) within the Education Committee in PPA, in addition to being an active member in the Academia Special Interest Group and Research Committee. He has volunteered as a moderator, poster judge, content reviewer, and JPPT reviewer, and has presented at the PPA Annual Meeting and Fall Conference. He is active in other pharmacy organizations including the American Society of Health-System Pharmacists and the American Academy of Colleges of Pharmacy. He enjoys sharing his unbridled enthusiasm for pediatric pharmacotherapy with his students and colleagues alike, and spends his limited spare time with his growing family.


“I am honored to serve PPA on the Board of Directors and give back to the organization that has given me so much over the past 20 years…friends, mentors, mentees, leadership and research opportunities, professional growth, advocacy for children and our profession and especially many fun memories. As Dave Matthews says, “it’s not where but who you’re with that really matters” and I’m so happy to be on this journey with all of you as we plan the future of PPA!” Kalen Manasco, PharmD, BCPPS, FPPA

Kalen B. Manasco, Pharm.D., BCPS, BCPPS, FCCP, FPPA is a Clinical Professor and Division Head at the University of Florida College of Pharmacy and Clinical Pharmacy Specialist at UF Health Shands Children’s Hospital in Gainesville, Florida. She obtained a B.S. degree in microbiology from the University of Georgia in 1993 and a Pharm.D. degree from University of Georgia College of Pharmacy in 2001. Following graduation, she completed a pharmacy practice residency at Shands Hospital at the University of Florida and a pediatric specialty residency at Medical University of South Carolina. From 2003-2007, she served as Clinical Assistant Professor in the Department of Clinical and Administrative Sciences at Mercer University College of Pharmacy and Health Sciences. From 2007-March 2017, Dr. Manasco served as a Clinical Associate Professor in the Department of Clinical and Administrative Pharmacy at the University of Georgia College of Pharmacy, Augusta campus where she also served as the PGY2 pediatric pharmacy residency director for the Augusta University Medical Center/University of Georgia College of Pharmacy residency program. She maintains an active practice site in pediatric critical care and pediatric cystic fibrosis at UF Health Shands Hospital where she precepts students, PGY1 and PGY2 residents. Dr. Manasco is an active member of PPA, ACCP, ASHP, and AACP. She also serves as the faculty advisor for the PPA student chapter (Pediagators) at the University of Florida College of Pharmacy. Her research interests include pediatric infectious disease, pediatric cystic fibrosis, and increasing education and awareness among pharmacists and pharmacy students regarding the appropriate use of medications in pediatric patients.

 

Posted by: Matthew Helms on Mar 4, 2021

The U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for bamlanivimab and etesevimab administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age or older weighing at least 40 kilograms [about 88 pounds]) who test positive for SARS-CoV-2 and who are at high risk for progressing to severe COVID-19. The authorized use includes treatment for those who are 65 years of age or older or who have certain chronic medical conditions. The authorized dosage is bamlanivimab 700 mg and etesevimab 1400 mg administered together. Under this EUA, bamlanivimab and etesevimab must be diluted and administered together as a single intravenous infusion as soon as possible after positive viral test for SARS-CoV-2 and within 10 days of symptom onset.

Bamlanivimab and etesevimab are not authorized for use in patients who are hospitalized due to COVID-19, who require oxygen therapy due to COVID-19, or who require an increase in baseline oxygen flow rate due to COVID-19 in those on chronic oxygen therapy due to underlying non-COVID-19 related comorbidity. Treatment with bamlanivimab and etesevimab has not been studied in patients hospitalized due to COVID-19. Monoclonal antibodies, such as bamlanivimab and etesevimab, may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high flow oxygen or mechanical ventilation. Additional information regarding Limitations of Authorized Use can be found in the Fact Sheet for Health Care Providers linked below.

Serious hypersensitivity reactions, including anaphylaxis, have been observed with administration of bamlanivimab with and without etesevimab. Infusion-related reactions have been observed with administration of bamlanivimab and etesevimab together. These reactions may be severe or life threatening, warranting slowing or stopping the infusion and administering appropriate medications and/or supportive care. Additional information regarding these reactions can be found in the Fact Sheet for Health Care Providers linked below.

Mechanism of Action (MOA) and Pharmacokinetics (PK)

MOA: Bamlanivimab and etesevimab are monoclonal antibodies that are specifically directed against the spike protein of SARS-CoV-2, designed to block the virus’ attachment and entry into human cells. Bamlanivimab and etesevimab bind to different but overlapping sites on the spike protein of the virus. Using both antibodies together is expected to reduce the risk of viral resistance.

General PK: PK of bamlanivimab and etesevimab are linear and dose-proportional between 700 mg and 7000 mg following a single IV administration. There were no differences in PK of bamlanivimab between severe/moderate participants who were hospitalized and mild/moderate ambulatory participants. There were no differences in PK of etesevimab between mild/moderate ambulatory participants and healthy participants. There is no change in PK of bamlanivimab or etesevimab administered alone or together suggesting there is no interaction between the two antibodies.

Mean (90% CI) bamlanivimab Cmax was 196 µg/mL (102 to 378 µg/mL) following approximately 1 hr 700 mg IV infusion. Mean (90% CI) etesevimab Cmax is estimated to be 504 µg/mL (262 to 974 µg/mL) following approximately 1 hr 1400 mg IV infusion.

Distribution: Bamlanivimab mean volume of distribution (Vd) was 2.87 L and 2.71 L for the central and peripheral compartments, respectively; the between subject variability (%CV) was 23.2%. Etesevimab mean Vd was 2.38 L and 1.98 L for the central and peripheral compartments, respectively; %CV was 27.8%.

Elimination: Bamlanivimab and etesevimab are expected to be degraded into small peptides and component amino acids via catabolic pathways in the same manner as endogenous IgG antibodies. Bamlanivimab clearance (CL) was 0.27 L/hr (22.3%) and the mean apparent terminal elimination half-life was 17.6 days (15.8%). Etesevimab CL was 0.128 L/hr (33.8%) and the mean apparent terminal elimination half-life was 25.1 days (29.2%).

Use in Specific Populations

The PK profiles of bamlanivimab and etesevimab were not affected by age, sex, race, body weight (over
the body weight range of 41 kg to 173 kg), or disease severity. Renal impairment is not expected to impact the PK of bamlanivimab and etesevimab. There is no significant difference in PK of bamlanivimab or etesevimab in patients with mild hepatic impairment compared to patients with normal hepatic function. Bamlanivimab and etesevimab have not been studied in patients with moderate or severe hepatic impairment.

Pediatric Population
The safety and effectiveness of bamlanivimab and etesevimab administered together are being assessed in adolescent patients in ongoing clinical trials. The recommended dosing regimen is expected to result in comparable serum exposures of bamlanivimab and etesevimab in patients 12 years of age and older and weighing at least 40 kg as observed in adults, based on a PK modeling approach which accounted for effect of body weight changes associated with age on clearance and volume of distribution.

Efficacy and Safety

The issuance of an EUA is different than an FDA approval. In determining whether to issue an EUA, the FDA evaluates the totality of available scientific evidence and carefully balances any known or potential risks with any known or potential benefits of the product for use during an emergency. Based on the FDA’s review of the totality of the scientific evidence available, the agency has determined that it is reasonable to believe that bamlanivimab and etesevimab administered together may be effective in treating certain patients with mild or moderate COVID-19. When used to treat COVID-19 for the authorized population, the known and potential benefits of these antibodies outweigh the known and potential risks.

Efficacy and Rationale for Authorized Dose
In a clinical trial of patients with COVID-19 at high risk for disease progression, a single intravenous infusion of bamlanivimab 2800 mg and etesevimab 2800 mg administered together significantly reduced COVID-19-related hospitalization and death during 29 days of follow-up compared to placebo. The safety and effectiveness of this investigational therapy for use in the treatment of COVID-19 continue to be evaluated. Detailed information on the clinical trials and supporting data for this EUA can be found in the Fact Sheet for Health Care Providers linked below.

The authorized dosage of 700 mg bamlanivimab and 1400 mg etesevimab administered together is based on analyses of available preclinical, clinical, and virologic data, as well as PK and pharmacodynamic modeling, which, in totality, support that the authorized dosage is expected to have a similar clinical and virologic effect to 2800 mg bamlanivimab and 2800 mg etesevimab administered together.

Safety
The most common adverse events in the clinical trial were nausea, dizziness, and rash. These
events each occurred in 1% of subjects treated with bamlanivimab and etesevimab and in 1% of placebo subjects. Across ongoing, blinded clinical trials, a case of anaphylaxis and other cases of serious infusion-related reactions were reported with infusion of bamlanivimab with and without etesevimab. The infusions were stopped. All reactions required treatment, one required epinephrine. All events resolved. Information regarding other immediate hypersensitivity events (e.g., flushing, infusion-related reactions, pruritis, rash) can be found in the Fact Sheet for Health Care Providers linked below.

Additional adverse events associated with bamlanivimab and etesevimab, some of which may be serious, may become apparent with more widespread use.


Additional Information

The Fact Sheet for Health Care Providers provides essential information about using bamlanivimab and etesevimab administered together in treating COVID-19 as authorized and is available at https://go.usa.gov/xs8ch. A fact sheet for patients, parents, and caregivers is available at https://go.usa.gov/xs8xC and contains information for understanding the potential risks and potential benefits of taking bamlanivimab and etesevimab, including side effects.

The EUA authority allows FDA to help strengthen the nation’s public health protections against chemical, biological, radiological, and nuclear threats by facilitating the availability and use of medical countermeasures needed during public health emergencies. For additional information on the EUA authority and EUAs for COVID-19, please visit https://go.usa.gov/xs8x4.

________________________________________
The Office of Clinical Pharmacology (OCP) is pleased to offer the e-mail subscription service Clinical Pharmacology Corner. This is a free service from FDA to provide occasional updates from OCP regarding newly approved therapies, new regulatory and scholarly publications, upcoming events and other items of interest. Subscribe today at https://public.govdelivery.com/accounts/USFDA/subscriber/topics and select Clinical Pharmacology Corner under Drugs.

We always welcome your thoughts regarding the format, content, and utility of this communication. Comments may be sent via email to ocp@fda.hhs.gov.

This communication was prepared by the Office of Clinical Pharmacology, Office of Translational Sciences, CDER, FDA.
 

Posted by: Gilbert Burckart on Dec 8, 2020

On November 25, 2020, the U.S. Food and Drug Administration (FDA) approved DANYELZA (naxitamab-gqgk) for use in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF) for the treatment of pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

The approved recommended dosage of DANYELZA is 3 mg/kg/day (up to 150 mg/day), administered as an intravenous infusion after dilution on Days 1, 3, and 5 of each treatment cycle (first infusion over 60 minutes and subsequent infusions over 30-60 minutes as tolerated). Treatment cycles are repeated every 4 weeks until complete response or partial response, followed by 5 additional cycles every 4 weeks. Subsequent cycles may be repeated every 8 weeks. Discontinue DANYELZA and GM-CSF for disease progression or unacceptable toxicity. Administer GM-CSF subcutaneously prior to and during each treatment cycle as recommended.

WARNING:

  • Serious Infusion-Related Reactions: DANYELZA can cause serious infusion reactions, including cardiac arrest, anaphylaxis, hypotension, bronchospasm, and stridor. Premedicate prior to each DANYELZA infusion as recommended. Reduce the rate, interrupt infusion, or permanently discontinue DANYELZA based on severity.
  • Neurotoxicity: DANYELZA can cause severe neurotoxicity, including severe neuropathic pain, transverse myelitis, and reversible posterior leukoencephalopathy syndrome (RPLS). Premedicate to treat neuropathic pain as recommended. Permanently discontinue DANYELZA based on the adverse reaction and severity.

DANYELZA is contraindicated in patients with a history of severe hypersensitivity reaction to naxitamab-gqgk. Reactions have included anaphylaxis. Additional information regarding dosage and administration as well as warnings and precautions about serious infusion-related reactions, neurotoxicity, hypertension, and embryo-fetal toxicity can be found in the full prescribing information linked below.

Mechanism of Action (MOA) and Pharmacokinetics (PK)

MOA: Naxitamab-gqgk is a GD2-binding monoclonal antibody.

General PK: The geometric mean (CV%) maximum plasma concentration (Cmax) of naxitamab-gqgk was 57.4 μg/mL (49%) following DANYELZA 3 mg/kg intravenous infusion over 30 minutes.

Elimination: The mean terminal half-life of naxitamab-gqgk was 8.2 days.

Metabolism: Naxitamab-gqgk is expected to be metabolized into small peptides by catabolic pathways.

Immunogenicity: In a clinical trial, 2 of 24 (8%) patients tested positive for anti-drug antibodies (ADA) after treatment with DANYELZA. In another clinical trial, 27 of 117 patients (23%) tested positive for ADA after treatment with DANYELZA by an assay that was not fully validated; therefore, the incidence of ADA may not be reliable.

Use in Specific Populations

Population pharmacokinetic analyses suggest that age (range: 1 to 34 years), sex, and race have no clinically important effect on the clearance of naxitamab-gqgk. The naxitamab-gqgk systemic exposure (AUC) at 150 mg/day (450 mg per cycle) for patients with body weight over 50 kg is not expected to differ clinically from that of the naxitamab-gqgk exposures at 3 mg/kg/day (9 mg/kg per cycle) for patients with body weight of 30 to 50 kg.

Efficacy and Safety

The efficacy of DANYELZA in combination with GM-CSF was evaluated in two open-label, single arm trials in patients with high-risk neuroblastoma with refractory or relapsed disease in the bone or bone marrow. Additional information regarding the efficacy trials can be found in the full prescribing information linked below.

The most common adverse reactions (≥25%) are infusion-related reaction, pain, tachycardia, vomiting, cough, nausea, diarrhea, decreased appetite, hypertension, fatigue, erythema multiforme, peripheral neuropathy, urticaria, pyrexia, headache, injection site reaction, edema, anxiety, localized edema, and irritability. The most common Grade 3 or 4 laboratory abnormalities (≥5%) are decreased lymphocytes, decreased neutrophils, decreased hemoglobin, decreased platelet count, decreased potassium, increased alanine aminotransferase, decreased glucose, decreased calcium, decreased albumin, decreased sodium, and decreased phosphate.


Full prescribing information is available at https://go.usa.gov/x76wd.

Visit Drugs@FDA at http://go.usa.gov/cMsjT for prescribing and patient information, approval letters, reviews and other information for FDA-approved drug products, which are often available shortly following approval.

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System by completing a form online at https://www.fda.gov/safety/medwatch/default.htm, by faxing (1-800-FDA-0178), or by mailing the postage-paid address form provided online, or by telephone (1-800-FDA-1088).

The Office of Clinical Pharmacology (OCP) is pleased to offer the e-mail subscription service Clinical Pharmacology Corner. This is a free service from FDA to provide occasional updates from OCP regarding newly approved therapies, new regulatory and scholarly publications, upcoming events and other items of interest. Subscribe today at https://updates.fda.gov/subscriptionmanagement (note: this link does not work with Internet Explorer) and select Clinical Pharmacology Corner under Drugs.

We always welcome your thoughts regarding the format, content, and utility of this communication. Comments may be sent via email to ocp@fda.hhs.gov.

This communication was prepared by Office of Clinical Pharmacology, Office of Translational Sciences, CDER, FDA (and sent to PPA members by the Pediatric Pharmacy Association).

Posted by: Matthew Helms on Nov 6, 2020

 

The Research Committee is accepting grant applications in the areas of neonatal and pediatric research. 

NEONATAL PHARMACY SMALL RESEARCH GRANT 

The Neonatal Pharmacy Resident/Fellow Research Grant supports research in neonatal medication use conducted by pharmacy residents (e.g., PGY-1, PGY-2 pediatric pharmacy resident) and fellows. The primary purpose of the research award is to improve safe and effective use of medications in neonates. Research projects can comprise a wide range of medication-use topics, including but not limited to: technology, safety, and/or pharmacotherapy. A secondary goal of the program is to develop and strengthen the skills of pharmacy residents and fellows by fostering development of mentoring relationships with more experienced senior investigators.

The $2,000.00 grant(s) provide funding for specific neonatal research related to medication use and are not intended for long-term support of research programs.

The application deadline is December 20, 2020

For more information and to apply, please direct your browser to: https://www.ppag.org/?pg=NeonatalSmallGrant


PEDIATRIC PHARMACY SMALL RESEARCH GRANT - NEW PROGRAM

The Pediatric Pharmacy Resident/Fellow Research Grant supports research in pediatric medication use conducted by pharmacy residents (e.g., PGY-1, PGY-2 pediatric pharmacy resident) and fellows. The primary purpose of the research award is to improve safe and effective use of medications in pediatric patients. Research projects can comprise a wide range of medication-use topics, including but not limited to: technology, safety, and/or pharmacotherapy. A secondary goal of the program is to develop and strengthen the skills of pharmacy residents and fellows by fostering development of mentoring relationships with more experienced senior investigators.

The $2,000.00 grant(s) provide funding for specific pediatric research related to medication use and are not intended for long-term support of research programs.

The application deadline is December 20, 2020

For more information and to apply, please direct your browser to: https://www.ppag.org/?pg=PediatricSmallGrant

Posted by: Shannon Manzi & Matthew Helms on Nov 3, 2020

The 30th Annual PPA Meeting is going virtual (AGAIN!).  Although we will miss being in beautiful Norfolk, VA in the Spring of 2021, we hope to get there soon! The dates of the Annual Meeting will be moving to Wednesday, April 21 to Sunday, April 25, 2021 to be consistent with our traditional Annual Meeting schedule.

The Board of Directors based this decision on many factors. First and foremost, the health and wellbeing of our members and attendees will always be at the forefront of our decision making process. Secondly, we are aware of departmental travel and budget restrictions that many of you face in the wake of the pandemic. PPA has successfully hosted two virtual conferences, and we are confident we will be able to once again provide an excellent continuing education opportunity and meeting experience for our members.

Regardless of the delivery method, we are committed to providing CE and BCPPS recertification sessions in the areas of infectious disease and pediatric intensive care. We will also be conducting a virtual poster session and residency presentations, which have been very well rated during our previous virtual conferences. And like the Fall Conference, we will be adding round table discussions, committee meetings, and social events to the agenda!

Registration information will be posted on the PPA website soon.

We have also re-opened the Call for Education Proposals. You now have until Friday, November 6, 2020 to submit your proposal. Click here.

Thank you for your ongoing support of and contributions to your PPA. Although these are challenging times, we continue to be enthusiastic about our virtual conferences. We look forward to “seeing” you there.

Posted by: Matthew Helms on Oct 26, 2020

On October 22, 2020, the U.S. Food and Drug Administration (FDA) approved VEKLURY (remdesivir) for adults and pediatric patients (12 years of age and older and weighing at least 40 kg) for the treatment of coronavirus disease 2019 (COVID-19) requiring hospitalization. VEKLURY should only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care. Perform renal and hepatic laboratory testing and assess prothrombin time in all patients before initiating VEKLURY and during treatment as clinically appropriate.

The approved recommended dosage of VEKLURY in adults and pediatric patients 12 years of age and older and weighing at least 40 kg is a single loading dose of VEKLURY 200 mg on Day 1 followed by once-daily maintenance doses of VEKLURY 100 mg from Day 2 infused over 30 to 120 minutes. For patients not requiring invasive mechanical ventilation and/or extracorporeal membrane oxygenation (ECMO), the recommended total treatment duration is 5 days. If a patient does not demonstrate clinical improvement, treatment may be extended for up to 5 additional days for a total treatment duration of up to 10 days. For patients requiring invasive mechanical ventilation and/or ECMO, the recommended total treatment duration is 10 days.

Additional information regarding dosage and administration as well as warnings and precautions about hypersensitivity including infusion-related and anaphylactic reactions, increased risk of transaminase elevations, and risk of reduced antiviral activity when coadministered with chloroquine phosphate or hydroxychloroquine sulfate can be found in the full prescribing information linked below.

Mechanism of Action (MOA) and Pharmacokinetics (PK)

MOA: Remdesivir is an antiviral drug with activity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

PK: The PK properties of remdesivir and metabolites are provided in Table 1. The multiple dose PK parameters of remdesivir and metabolites in healthy adults are provided in Table 2.

 

 

 

 

 

 

 

 

 


 

 

 

 

 

 

Use in Specific PopulationsDrug Interactions

Concomitant use of VEKLURY with chloroquine phosphate or hydroxychloroquine sulfate is not recommended due to antagonism observed in cell culture. Drug-drug interaction trials of VEKLURY and other concomitant medications have not been conducted in humans.

Pharmacokinetic differences based on sex, race, or age on the exposures of remdesivir have not been evaluated.

Renal Impairment: The pharmacokinetics of VEKLURY have not been evaluated in patients with renal impairment. Determine eGFR in all patients before starting VEKLURY and monitor while receiving VEKLURY as clinically appropriate. VEKLURY is not recommended in patients with eGFR less than 30 mL per minute because the excipient betadex sulfobutyl ether sodium is renally cleared and accumulates in patients with decreased renal function. Patients with eGFR greater than or equal to 30 mL per minute have received VEKLURY for treatment of COVID-19 with no dose adjustment of VEKLURY.

Hepatic Impairment: The pharmacokinetics of VEKLURY have not been evaluated in patients with hepatic impairment. Perform hepatic laboratory testing in all patients before starting VEKLURY and while receiving VEKLURY as clinically appropriate.

Pediatric Patients: The pharmacokinetics of VEKLURY in pediatric patients have not been evaluated. Using modeling and simulation, the recommended dosing regimen is expected to result in comparable steady-state plasma exposures of remdesivir and metabolites in patients 12 years of age and older and weighing at least 40 kg as observed in healthy adults.

Efficacy and Safety

Subjects with Mild/Moderate and Severe COVID-19: Efficacy of VEKLURY was demonstrated in a randomized, double-blind, placebo-controlled clinical trial of hospitalized adult subjects with confirmed SARS-CoV-2 infection and mild, moderate, or severe COVID-19 compared treatment with VEKLURY for 10 days with placebo. The primary clinical endpoint was time to recovery within 29 days after randomization.

Pediatrics: The safety and effectiveness of VEKLURY for the treatment of COVID-19 have been established in pediatric patients 12 years and older and weighing at least 40 kg. Use in this age group is based on extrapolation of pediatric efficacy from adequate and well-controlled studies in adults. Clinical trials of VEKLURY included 30 adult subjects weighing 40-50 kg. The safety in this weight group was comparable to adult subjects weighing greater than 50 kg. Thirty-nine pediatric patients 12 years and older and weighing at least 40 kg received VEKLURY in a compassionate use program; the available clinical data from these patients are limited. The safety and effectiveness of VEKLURY have not been established in pediatric patients younger than 12 years of age or weighing less than 40 kg.

Additional information regarding the efficacy trials can be found in the full prescribing information linked below.

The most common adverse reactions (incidence greater than or equal to 5%, all grades) observed with treatment with VEKLURY are nausea, ALT increased, and AST increased.


Full prescribing information is available at https://go.usa.gov/x7YVW.

Visit Drugs@FDA at http://go.usa.gov/cMsjT for prescribing and patient information, approval letters, reviews and other information for FDA-approved drug products, which are often available shortly following approval.

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System by completing a form online at https://www.fda.gov/safety/medwatch/default.htm, by faxing (1-800-FDA-0178), or by mailing the postage-paid address form provided online, or by telephone (1-800-FDA-1088).

The Office of Clinical Pharmacology (OCP) is pleased to offer the e-mail subscription service Clinical Pharmacology Corner. This is a free service from FDA to provide occasional updates from OCP regarding newly approved therapies, new regulatory and scholarly publications, upcoming events and other items of interest. Subscribe today at https://updates.fda.gov/subscriptionmanagement (note: this link does not work with Internet Explorer) and select Clinical Pharmacology Corner under Drugs.

We always welcome your thoughts regarding the format, content, and utility of this communication. Comments may be sent via email to ocp@fda.hhs.gov.

This communication was prepared by Office of Clinical Pharmacology, Office of Translational Sciences, CDER, FDA.

Posted by: Matthew Helms on Oct 7, 2020

This communication was prepared by Office of Clinical Pharmacology, Office of Translational Sciences, CDER, FDA.

On September 29, 2020, the U.S. Food and Drug Administration (FDA) approved efficacy supplements for SIMPONI ARIA for patients 2 years of age and older for the treatment of active psoriatic arthritis (PsA) or active polyarticular juvenile idiopathic arthritis (pJIA). In addition to the treatment of children ages 2 years and older with active pJIA or active PsA, SIMPONI ARIA is approved for the treatment of adults with moderately to severely active rheumatoid arthritis (RA) in combination with methotrexate, active PsA, or active ankylosing spondylitis (AS).

The approved recommended dosage of SIMPONI ARIA is:

  • Adult patients with Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis: 2 mg/kg intravenous infusion over 30 minutes at weeks 0 and 4, and every 8 weeks thereafter.
  • Pediatric patients with polyarticular Juvenile Idiopathic Arthritis and Psoriatic Arthritis: 80 mg/m2 intravenous infusion over 30 minutes at weeks 0 and 4, and every 8 weeks thereafter.

Serious infections leading to hospitalization or death including tuberculosis (TB), bacterial sepsis, invasive fungal (such as histoplasmosis), and other opportunistic infections have occurred in patients receiving SIMPONI ARIA. Discontinue SIMPONI ARIA if a patient develops a serious infection or sepsis. Perform test for latent TB; if positive, start treatment for TB prior to starting SIMPONI ARIA. Monitor all patients for active TB during treatment, even if initial latent TB test is negative. Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, of which SIMPONI ARIA is a member.

Additional information regarding dosage and administration as well as warnings and precautions about serious infection, invasive fungal infections, hepatitis B reactivation, malignancies, congestive heart failure, demyelinating disorders, autoimmunity, use with anakinra or abatacept, switching between biological disease modifying antirheumatic drugs, hematologic cytopenias, vaccinations/therapeutic infectious agents, or hypersensitivity reactions can be found in the full prescribing information linked below.

Mechanism of Action (MOA), Pharmacokinetics (PK), and Pharmacodynamics (PD)

MOA: Golimumab is a human monoclonal antibody that binds to both the soluble and transmembrane bioactive forms of human TNFα.

General PK: Golimumab exhibited approximately dose-proportional pharmacokinetics in patients with RA over the dose range of 0.1 to 10.0 mg/kg (0.05 to 5 times the approved recommended adult dosage) following a single intravenous dose.

Absorption: Following a single intravenous administration of 2 mg/kg SIMPONI ARIA, a mean Cmax of 44.4 ± 11.3 mcg/mL was observed in patients with RA. Data directly comparing 2 mg/kg intravenous administration and 50 mg subcutaneous administration are not available.

Distribution: Following a single intravenous administration of 2 mg/kg SIMPONI ARIA, the mean volume of distribution was estimated to be 115 ± 19 mL/kg in healthy subjects, and 151 ± 61 mL/kg in patients with RA. The volume of distribution of golimumab may indicate that golimumab is distributed primarily in the circulatory system with limited extravascular distribution.

Elimination: Following a single intravenous administration of 2 mg/kg SIMPONI ARIA, the systemic clearance of golimumab was estimated to be 6.9 ± 2.0 mL/day/kg in healthy subjects and 7.6 ± 2.0 mL/day/kg in patients with RA. The mean terminal half-life was estimated to be 12 ± 3 days in healthy subjects and the mean terminal half-life in RA patients was 14 ± 4 days.

PD: Following treatment with SIMPONI ARIA in patients with RA, decreases from baseline were observed in tissue inhibitor of metalloproteinase-1 (TIMP-1), matrix metalloproteinase-1 (MMP-1), matrix metalloproteinase-3 (MMP-3), resistin, interleukin-6 (IL-6), macrophage inflammatory protein-1 (MIP-1b), vascular endothelial growth factor (VEGF), serum amyloid A (SAA), S100A12, and high sensitivity C-Reactive protein (hsCRP). Conversely, increases from baseline were observed in tartrate-resistant acid phosphatase (TRAP-5b). The clinical relevance of this information is not known.

Immunogenicity: Antibodies to golimumab were detected in 13 (3%) golimumab-treated patients following IV administration of SIMPONI ARIA in combination with MTX through Week 24 of Trial RA, of which all were neutralizing antibodies. Through approximately 6 months, the incidence of antibodies to golimumab for RA, PsA, AS, and pJIA was 21%, 19%, 19% and 31%, respectively. Where tested, approximately one-third to one-half were neutralizing. Patients with RA, PsA, AS and pJIA who developed antibodies to golimumab generally had lower trough steady-state serum concentrations of golimumab. The immune response effect on golimumab clearance in patients with JIA with active polyarthritis was comparable to adults with RA.

Drug Interactions

Methotrexate: SIMPONI ARIA should be used with MTX for the treatment of RA. Following IV administration, concomitant administration of methotrexate decreases the clearance of SIMPONI ARIA by approximately 9% based on population pharmacokinetics (PK) analysis. In addition, concomitant administration of methotrexate decreases the SIMPONI ARIA clearance by reducing the development of antibodies to golimumab.

Biologic Products for RA, PsA, AS, and pJIA: An increased risk of serious infections has been seen in clinical RA studies of other TNF-blockers used in combination with anakinra or abatacept, with no added benefit; therefore, use of SIMPONI ARIA with other biologic products, including abatacept or anakinra, is not recommended. A higher rate of serious infections has also been observed in RA patients treated with rituximab who received subsequent treatment with a TNF-blocker. The concomitant use of SIMPONI ARIA with biologics approved to treat RA, PsA, AS, and pJIA is not recommended because of the possibility of an increased risk of infection.

Live Vaccines/Therapeutic Infectious Agents: Live vaccines should not be given concurrently with SIMPONI ARIA. Therapeutic infectious agents should not be given concurrently with SIMPONI ARIA. Infants born to women treated with SIMPONI ARIA during their pregnancy may be at increased risk of infection for up to 6 months. Administration of live vaccines to infants exposed to SIMPONI ARIA in utero is not recommended for 6 months following the mother’s last SIMPONI ARIA infusion during pregnancy.

Cytochrome P450 Substrates: The formation of CYP450 enzymes may be suppressed by increased levels of cytokines (e.g., TNFα) during chronic inflammation. Therefore, it is expected that for a molecule that antagonizes cytokine activity, such as golimumab, the formation of CYP450 enzymes could be normalized. Upon initiation or discontinuation of SIMPONI ARIA in patients being treated with CYP450 substrates with a narrow therapeutic index, monitoring of the effect (e.g., warfarin) or drug concentration (e.g., cyclosporine or theophylline) is recommended and the individual dose of the drug product may be adjusted as needed.

Use in Specific Populations

No formal study of the effect of renal or hepatic impairment on the PK of golimumab was conducted.

Body Weight: Following intravenous administration, patients with higher body weight tended to have slightly higher serum golimumab concentrations than patients with lower body weights when golimumab was administered on a mg/kg (body weight) basis. However, based on population PK analysis, there were no clinically relevant differences in golimumab exposure following intravenous administration of 2 mg/kg SIMPONI ARIA in adult patients across a range of different body weights. Consistent with the intravenous data in adult patients with RA, population pharmacokinetic analyses for intravenous SIMPONI ARIA in pJIA revealed that there were no clinically relevant differences in golimumab exposure following intravenous administration of 80 mg/m2 SIMPONI ARIA in pediatric patients across a range of age and different body weights. The immune response effect on golimumab clearance in patients with JIA with active polyarthritis was comparable to adults with RA.

Pediatrics: When 80 mg/m2 SIMPONI ARIA was administered intravenously to patients with JIA with active polyarthritis at weeks 0, 4 and every 8 weeks thereafter, serum concentrations reached steady-state by Week 12. With concomitant use of MTX, treatment with 80 mg/m2 SIMPONI ARIA resulted in a mean steady-state trough serum golimumab concentration of approximately 0.5 ± 0.4 mcg/mL and a mean steady-state AUC of 425 ± 125 mcg∙day/mL in patients with JIA with active polyarthritis. Overall, the observed steady-state golimumab trough concentrations in patients with JIA with active polyarthritis were within the range of those observed for adult RA and PsA after administration of SIMPONI ARIA.

Efficacy and Safety

Psoriatic Arthritis: The efficacy of SIMPONI ARIA in pediatric patients with PsA is based on the pharmacokinetic exposure and extrapolation of the established efficacy of SIMPONI ARIA in adult PsA patients. The efficacy and safety of SIMPONI ARIA were evaluated in a multicenter, randomized, double-blind, placebo-controlled trial in 480 patients ≥ 18 years of age with active psoriatic arthritis despite NSAID or DMARD therapy. Previous treatment with a biologic was not allowed. The primary endpoint was the percentage of patients achieving an American College of Rheumatology (ACR) 20 response at Week 14.

Polyarticular Juvenile Idiopathic Arthritis: The efficacy of SIMPONI ARIA in pediatric patients with pJIA is based on the pharmacokinetic exposure and extrapolation of the established efficacy of SIMPONI ARIA in RA patients. Efficacy of SIMPONI ARIA was also assessed in a multicenter, open-label, single-arm study in 127 children (2 to < 18 years of age) with JIA with active polyarthritis despite treatment with MTX for at least 2 months. Efficacy was assessed as supportive endpoints through Week 52. Additional information regarding the efficacy trials can be found in the full prescribing information linked below.

Rheumatoid Arthritis: The efficacy and safety of SIMPONI ARIA were evaluated in one multicenter, randomized, double-blind, controlled trial in 592 patients ≥ 18 years of age with moderately to severely active RA despite concurrent MTX therapy and had not previously been treated with a biologic TNF-blocker. The primary endpoint in Trial RA was the percentage of patients achieving an ACR 20 response at Week 14.

Ankylosing Spondylitis: The efficacy and safety of SIMPONI ARIA were evaluated in a multicenter, randomized, double-blind, placebo-controlled trial in 208 patients ≥ 18 years of age with active ankylosing spondylitis (AS) and inadequate response or intolerance to NSAIDs. The primary endpoint was the percentage of patients achieving an Assessment in Ankylosing Spondylitis (ASAS) 20 response at Week 16.

Additional information regarding the efficacy trials can be found in the full prescribing information linked below.

The most common adverse reactions (incidence ≥ 3%) are: upper respiratory tract infection, alanine aminotransferase increased, viral infection, aspartate aminotransferase increased, neutrophil count decreased, bronchitis, hypertension, and rash.


Full prescribing information is available at https://go.usa.gov/xG6Zf.

Visit Drugs@FDA at http://go.usa.gov/cMsjT for prescribing and patient information, approval letters, reviews and other information for FDA-approved drug products, which are often available shortly following approval.

A non-comprehensive list of examples of clinical substrates, inhibitors and inducers for metabolic and transporter system related interactions may be found at https://go.usa.gov/xXY9C.

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System by completing a form online at https://www.fda.gov/safety/medwatch/default.htm, by faxing (1-800-FDA-0178), or by mailing the postage-paid address form provided online, or by telephone (1-800-FDA-1088).

The Office of Clinical Pharmacology (OCP) is pleased to offer the e-mail subscription service Clinical Pharmacology Corner. This is a free service from FDA to provide occasional updates from OCP regarding newly approved therapies, new regulatory and scholarly publications, upcoming events and other items of interest. Subscribe today at https://updates.fda.gov/subscriptionmanagement (note: this link does not work with Internet Explorer) and select Clinical Pharmacology Corner under Drugs.

 

We always welcome your thoughts regarding the format, content, and utility of this communication. Comments may be sent via email to ocp@fda.hhs.gov.

This communication was prepared by Office of Clinical Pharmacology, Office of Translational Sciences, CDER, FDA.

Posted by: Shannon Manzi & Matthew Helms on Sep 24, 2020

Hot off the press!  We are happy to share the Pharmacists as Childhood Immunizers Talking Point document created by our Advocacy Committee.  It is important to use our expertise to help support our colleagues who are less comfortable with pediatric care, especially when it comes to vaccinating children.  Education will be a key component in ensuring the gains we are making moving our profession forward will be sustained. 

Please see the document here


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