Please enjoy a brief update of recent FDA Approvals.

1. A MONTHLY
DOSE OF EDUCATION
Brian Pelletier, PharmD, BCGP, FASCP
CEO, A Dose of Education, LLC
June 2017

2. FDA Approval
• Baxdela® (delafloxacin) – approved 6/19/2017
• Fluoroquinolone indicated in adults for the treatment of acute bacterial
skin and skin structure infections (ABSSSI) caused by designated
susceptible bacteria
• Formulation / Administration
• Administered by injection or orally:
• 300 mg by intravenous infusion over 60 minutes, every 12 hours, or
• 450 mg tablet orally every 12 hours
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208610s000,208611s000lbl.pdf#page=24

3. Baxdela® (delafloxacin)
• Dose adjustment in renal impairment:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208610s000,208611s000lbl.pdf#page=24

4. FDA Approval
• Cotempla XR-ODT® (methylphenidate extended-release orally
disintegrating tablets) [CII]
• Indicated for the treatment of Attention Deficit Hyperactivity Disorder
(ADHD) in pediatric patients 6 to 17 years of age
• Has not been studied for use in patients over the age of 65 years
• Formulation/Administration:
• XR-ODT tablets available in 8.6 mg, 17.3 mg and 25.9 mg
• Recommended starting dose for pediatric patients 6 to 17 years of age is
17.3 mg given orally once daily in the morning. Dosage may be increased
weekly in increments of 8.6 mg to 17.3 mg per day. Daily dosage above
51.8 mg is not recommended
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205489s000lbl.pdf#page=21

5. FDA Approval
• Bevyxxa® (betrixaban)
• A factor Xa (FXa) inhibitor indicated for the prophylaxis of venous
thromboembolism (VTE) in adult patients hospitalized for an acute
medical illness who are at risk for thromboembolic complications due to
moderate or severe restricted mobility and other risk factors for VTE.
• Formulations/Dosing
• Capsules 80mg and 40mg
• Initial single dose of 160 mg, followed by 80 mg once daily, taken at the
same time each day with food
• The recommended duration of treatment is 35 to 42 days
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208383s000lbl.pdf#page=20

6. Bevyxxa® (betrixaban)
• Dosing in Renal Impairment
• For patients with CrCl ≥ 15 to < 30 mL/min (severe renal impairment), the
recommended dose is an initial single dose of 80 mg followed by 40 mg
once daily
• Using Cockcroft-Gault and actual body weight
• Duration of treatment remains 35 to 42 days
• Dosing with P-gp Inhibitors
• When receiving or starting concomitant P-gp inhibitors the
recommended dose is an initial single dose of 80 mg followed by 40 mg
once daily
• Examples of P-gp inhibitors include but are not limited to, amiodarone,
azithromycin, verapamil, ketoconazole
• Duration of treatment remains 35 to 42 days
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208383s000lbl.pdf#page=20

7. Thank you!