A brief review of FDA Approvals for September 2017

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

2. FDA Approval
• Solosec® (secnidazole) – approved 9/12/2017
• A nitroimidazole antimicrobial indicated for the treatment of bacterial
vaginosis in adult women
• Formulation / Administration:
• Available as oral granules – 2 g secnidazole
• Administer a single 2-gram packet of granules once orally, without regard
to the timing of meals
• Sprinkle entire contents of packet onto applesauce, yogurt or pudding
and consume all of the mixture within 30 minutes without chewing or
crunching the granules. A glass of water may be taken after the
administration of SOLOSEC to aid in swallowing
• SOLOSEC is not intended to be dissolved in any liquid
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209363s000lbl.pdf

3. Solosec® (secnidazole)
• Warnings/Precautions:
• The use of secnidazole may result in vulvo-vaginal candidiasis
• Use in the absence of proven or strongly suspected bacterial infection or
a prophylactic indication is unlikely to provide benefit to the patient and
increases the risk of the development of drug-resistant bacteria
• Breastfeeding is not recommended during treatment and for 96 hours
after administration
• Drug Interactions:
• No clinically significant interactions; can be used with oral contraceptives
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209363s000lbl.pdf

4. FDA Approval
• Trelegy Ellipta® (fluticasone furoate, umeclidinium, vilanterol)
• Approved 9/18/2017, a new combination of fluticasone furoate, an
inhaled corticosteroid (ICS); umeclidinium, an anticholinergic; and
vilanterol, a long-acting beta2-adrenergic agonist (LABA)
• Indicated for the long-term, once-daily, maintenance treatment of
patients with chronic obstructive pulmonary disease (COPD), including
chronic bronchitis and/or emphysema
• Appropriate for patients who are on a fixed-dose combination of
fluticasone furoate and vilanterol for airflow obstruction and reducing
exacerbations in whom additional treatment of airflow obstruction is
desired or for patients who are already receiving umeclidinium and a
fixed-dose combination of fluticasone furoate and vilanterol.
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209482s000lbl.pdf

5. Trelegy Ellipta® (fluticasone furoate, umeclidinium,
vilanterol)
• Formulation / Administration:
• For oral inhalation only
• One (1) inhalation once daily
• Inhalation Powder: Inhaler containing 2 foil blister strips of powder
formulation for oral inhalation. One strip contains fluticasone furoate 100
mcg per blister and the other contains umeclidinium/vilanterol 62.5
mcg/25 mcg per blister
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209482s000lbl.pdf

6. Trelegy Ellipta® (fluticasone furoate,
umeclidinium, vilanterol)
• Warnings / Precautions:
• Black box warning: Long-acting beta2-adrenergic agonists (LABA), such as vilanterol,
increase the risk of asthma-related death. A placebo-controlled trial with another
LABA (salmeterol) showed an increase in asthma-related deaths. This finding with
salmeterol is considered a class effect of all LABA
• Monoamine oxidase inhibitors and tricyclic antidepressants: Use with extreme
caution. May potentiate effect of vilanterol on vascular system
• Beta-blockers: Use with caution. May block bronchodilatory effects of beta-agonists
and produce severe bronchospasm
• Diuretics: Use with caution. Electrocardiographic changes and/or hypokalemia
associated with non–potassium-sparing diuretics may worsen with concomitant beta-
agonists
• Anticholinergics: May interact additively with concomitantly used anticholinergic
medications. Avoid administration with other anticholinergic-containing drugs
• Avoiding anticholinergic drugs may be difficult; use with caution
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209482s000lbl.pdf

7. Trelegy Ellipta® (fluticasone furoate,
umeclidinium, vilanterol)
• Drug Interactions:
• Strong cytochrome P450 3A4 inhibitors (e.g., ketoconazole): Use with
caution. May cause systemic corticosteroid and cardiovascular effects.
• Hepatic Impairment:
• Fluticasone furoate systemic exposure may increase in patients with
moderate or severe impairment. Monitor for systemic corticosteroid
effects.
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209482s000lbl.pdf

8. Other September FDA Approvals
• Aliqopa® (copanlisib) – approved 9/14/2017
• Indicated to treat adults with relapsed follicular lymphoma1
• Verzenio® (abemaciclib) – approved 9/28/2017
• Indicated to treat certain advanced or metastatic breast cancers2
• XHance® (fluticasone propionate) – approved 9/18/2017
• New formulation: Indicated for the treatment of nasal polyps in patients
18 years of age or older3
1. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209936s000lbl.pdf
2. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208716s000lbl.pdf
3. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209022s000lbl.pdf

9. Thank you!