APMA News - May/June 2020 - 10

BRIEF SUMMARY OF PRESCRIBING INFORMATION
This Brief Summary does not include all the information needed to use
JUBLIA safely and effectively. See full prescribing information for JUBLIA.

JUBLIA®(efinaconazole) topical solution, 10%
For topical use
Initial U.S. Approval: 2014
INDICATIONS AND USAGE
JUBLIA (efinaconazole) topical solution, 10% is an azole antifungal indicated
for the topical treatment of onychomycosis of the toenail(s) due to Trichophyton
rubrum and Trichophyton mentagrophytes.
DOSAGE AND ADMINISTRATION
Apply JUBLIA to affected toenails once daily for 48 weeks, using the integrated
flow-through brush applicator. When applying JUBLIA, ensure the toenail, the
toenail folds, toenail bed, hyponychium, and the undersurface of the toenail plate,
are completely covered.
JUBLIA is for topical use only and not for oral, ophthalmic, or intravaginal use.

Subcutaneous doses of 1, 5, and 10 mg/kg/day efinaconazole were administered
during the period of organogenesis (gestational days 6-19) to pregnant female
rabbits. In the presence of maternal toxicity, there was no embryofetal toxicity or
malformations at 10 mg/kg/day (154 times the MRHD based on AUC comparisons).
In a pre- and post-natal development study in rats, subcutaneous doses of
1, 5 and 25 mg/kg/day efinaconazole were administered from the beginning of
organogenesis (gestation day 6) through the end of lactation (lactation day 20).
In the presence of maternal toxicity, embryofetal toxicity (increased prenatal pup
mortality, reduced live litter sizes and increased postnatal pup mortality) was
noted at 25 mg/kg/day. No embryofetal toxicity was noted at 5 mg/kg/day (17
times the MRHD based on AUC comparisons). No effects on postnatal development
were noted at 25 mg/kg/day (89 times the MRHD based on AUC comparisons).
Nursing Mothers
It is not known whether efinaconazole is excreted in human milk. After repeated
subcutaneous administration, efinaconazole was detected in milk of nursing rats.
Because many drugs are excreted in human milk, caution should be exercised
when JUBLIA is administered to nursing women.
Pediatric Use
Safety and effectiveness of JUBLIA in pediatric subjects have not been established.

CONTRAINDICATIONS

Geriatric Use

None.

Of the total number of subjects in clinical trials of JUBLIA, 11.3% were 65
and over, while none were 75 and over. No overall differences in safety and
effectiveness were observed between these subjects and younger subjects, and
other reported clinical experience has not identified differences in responses
between the elderly and the younger subjects, but greater sensitivity of some
older individuals cannot be ruled out.

ADVERSE REACTIONS
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse
reaction rates observed in the clinical trials of a drug cannot be directly compared
to rates in the clinical trials of another drug and may not reflect the rates observed
in practice.
In two clinical trials, 1227 subjects were treated with JUBLIA, 1161 for at least
24 weeks and 780 for 48 weeks. Adverse reactions reported within 48 weeks of
treatment and in at least 1% of subjects treated with JUBLIA and those reported
in subjects treated with the vehicle are presented in Table 1.
Table 1: Adverse Reactions Reported by at Least 1% of Subjects Treated
for up to 48 Weeks
Adverse Event, n (%)

JUBLIA
N = 1227

Vehicle
N = 413

Ingrown toenail

28 (2.3%)

3 (0.7%)

Application site dermatitis

27 (2.2%)

1 (0.2%)

Application site vesicles

20 (1.6%)

0 (0.0%)

Application site pain

13 (1.1%)

1 (0.2%)

NONCLINICAL TOXICOLOGY
Carcinogenesis, Mutagenesis, Impairment of Fertility
A 2-year dermal carcinogenicity study in mice was conducted with daily topical
administration of 3%, 10% and 30% efinaconazole solution. Severe irritation was
noted at the treatment site in all dose groups, which was attributed to the vehicle
and confounded the interpretation of skin effects by efinaconazole. The high dose
group was terminated at week 34 due to severe skin reactions. No drug-related
neoplasms were noted at doses up to 10% efinaconazole solution (248 times the
MRHD based on AUC comparisons).
Efinaconazole revealed no evidence of mutagenic or clastogenic potential based
on the results of two in vitro genotoxicity tests (Ames assay and Chinese hamster
lung cell chromosome aberration assay) and one in vivo genotoxicity test (mouse
peripheral reticulocyte micronucleus assay).
No effects on fertility were observed in male and female rats that were
administered subcutaneous doses up to 25 mg/kg/day efinaconazole (279 times
the MRHD based on AUC comparisons) prior to and during early pregnancy.
Efinaconazole delayed the estrous cycle in females at 25 mg/kg/day but not at 5
mg/kg/day (56 times MRHD based on AUC comparisons).
PATIENT COUNSELING INFORMATION

DRUG INTERACTIONS
In vitro studies have shown that JUBLIA, at therapeutic concentrations, neither
inhibits nor induces cytochrome P450 (CYP450) enzymes.
USE IN SPECIFIC POPULATIONS
Pregnancy
Pregnancy Category C
There are no adequate and well-controlled studies with JUBLIA in pregnant
women. JUBLIA should be used during pregnancy only if the potential benefit
justifies the potential risk to the fetus.
Systemic embryofetal development studies were conducted in rats and
rabbits. Subcutaneous doses of 2, 10 and 50 mg/kg/day efinaconazole were
administered during the period of organogenesis (gestational days 6-16) to
pregnant female rats. In the presence of maternal toxicity, embryofetal toxicity
(increased embryofetal deaths, decreased number of live fetuses, and placental
effects) was noted at 50 mg/kg/day [559 times the Maximum Recommended
Human Dose (MRHD) based on Area Under the Curve (AUC) comparisons]. No
embryofetal toxicity was noted at 10 mg/kg/day (112 times the MRHD based
on AUC comparisons). No malformations were observed at 50 mg/kg/day
(559 times the MRHD based on AUC comparisons).

See FDA-Approved Patient Labeling (Patient Information).
Manufactured for:
Bausch Health Americas, Inc. Bridgewater, NJ 08807 USA
Manufactured by:
Bausch Health Companies Inc. Laval, Quebec H7L 4A8, Canada
JUBLIA is a trademark of Bausch Health Companies Inc. or its affiliates.
© 2019 Bausch Health Companies Inc. or its affiliates
U.S. Patents 8,039,494; 7,214,506
Based on 9462903

Rev 9/2016

JUB.0070.USA.19



APMA News - May/June 2020

Table of Contents for the Digital Edition of APMA News - May/June 2020

Contents
APMA News - May/June 2020 - Cover1
APMA News - May/June 2020 - Cover2
APMA News - May/June 2020 - 3
APMA News - May/June 2020 - 4
APMA News - May/June 2020 - 5
APMA News - May/June 2020 - 6
APMA News - May/June 2020 - 7
APMA News - May/June 2020 - Contents
APMA News - May/June 2020 - 9
APMA News - May/June 2020 - 10
APMA News - May/June 2020 - 11
APMA News - May/June 2020 - 12
APMA News - May/June 2020 - 13
APMA News - May/June 2020 - 14
APMA News - May/June 2020 - 15
APMA News - May/June 2020 - 16
APMA News - May/June 2020 - 17
APMA News - May/June 2020 - 18
APMA News - May/June 2020 - 19
APMA News - May/June 2020 - 20
APMA News - May/June 2020 - 21
APMA News - May/June 2020 - 22
APMA News - May/June 2020 - 23
APMA News - May/June 2020 - 24
APMA News - May/June 2020 - 25
APMA News - May/June 2020 - 26
APMA News - May/June 2020 - 27
APMA News - May/June 2020 - 28
APMA News - May/June 2020 - 29
APMA News - May/June 2020 - 30
APMA News - May/June 2020 - 31
APMA News - May/June 2020 - 32
APMA News - May/June 2020 - 33
APMA News - May/June 2020 - 34
APMA News - May/June 2020 - 35
APMA News - May/June 2020 - 36
APMA News - May/June 2020 - 37
APMA News - May/June 2020 - 38
APMA News - May/June 2020 - 39
APMA News - May/June 2020 - 40
APMA News - May/June 2020 - 41
APMA News - May/June 2020 - 42
APMA News - May/June 2020 - 43
APMA News - May/June 2020 - 44
APMA News - May/June 2020 - 45
APMA News - May/June 2020 - 46
APMA News - May/June 2020 - 47
APMA News - May/June 2020 - 48
APMA News - May/June 2020 - 49
APMA News - May/June 2020 - 50
APMA News - May/June 2020 - Cover3
APMA News - May/June 2020 - Cover4
APMA News - May/June 2020 - A1
APMA News - May/June 2020 - A2
APMA News - May/June 2020 - A3
APMA News - May/June 2020 - A4
https://www.nxtbook.com/nxtbooks/apma/news_20240506
https://www.nxtbook.com/nxtbooks/apma/news_20240304
https://www.nxtbook.com/nxtbooks/apma/news_20240102
https://www.nxtbook.com/nxtbooks/apma/news_20231112
https://www.nxtbook.com/nxtbooks/apma/news_20230910
https://www.nxtbook.com/nxtbooks/apma/news_20230708
https://www.nxtbook.com/nxtbooks/apma/news_20230506
https://www.nxtbook.com/nxtbooks/apma/news_20230304
https://www.nxtbook.com/nxtbooks/apma/news_20230102
https://www.nxtbook.com/nxtbooks/apma/news_20221112
https://www.nxtbook.com/nxtbooks/apma/news_20220910
https://www.nxtbook.com/nxtbooks/apma/news_20220708
https://www.nxtbook.com/nxtbooks/apma/news_20220506
https://www.nxtbook.com/nxtbooks/apma/news_20220304
https://www.nxtbook.com/nxtbooks/apma/news_20220102
https://www.nxtbook.com/nxtbooks/apma/news_20211112
https://www.nxtbook.com/nxtbooks/apma/news_20210910
https://www.nxtbook.com/nxtbooks/apma/news_20210708
https://www.nxtbook.com/nxtbooks/apma/news_20210506
https://www.nxtbook.com/nxtbooks/apma/news_20210304
https://www.nxtbook.com/nxtbooks/apma/news_20210102
https://www.nxtbook.com/nxtbooks/apma/news_20201112
https://www.nxtbook.com/nxtbooks/apma/news_20200910
https://www.nxtbook.com/nxtbooks/apma/news_20200708
https://www.nxtbook.com/nxtbooks/apma/news_20200506
https://www.nxtbook.com/nxtbooks/apma/news_20200304
https://www.nxtbook.com/nxtbooks/apma/news_20200102
https://www.nxtbook.com/nxtbooks/apma/news_20191112
https://www.nxtbook.com/nxtbooks/apma/news_20190910
https://www.nxtbook.com/nxtbooks/apma/news_20190708
https://www.nxtbook.com/nxtbooks/apma/news_20190506
https://www.nxtbook.com/nxtbooks/apma/news_20190304
https://www.nxtbook.com/nxtbooks/apma/news_20190102
https://www.nxtbook.com/nxtbooks/apma/news_20181112
https://www.nxtbook.com/nxtbooks/apma/news_20180910
https://www.nxtbook.com/nxtbooks/apma/news_20180708
https://www.nxtbook.com/nxtbooks/apma/news_20180506
https://www.nxtbook.com/nxtbooks/apma/news_20180304
https://www.nxtbook.com/nxtbooks/apma/news_20180102
https://www.nxtbook.com/nxtbooks/apma/news_20171112
https://www.nxtbook.com/nxtbooks/apma/news_20170910
https://www.nxtbook.com/nxtbooks/apma/news_20170708
https://www.nxtbook.com/nxtbooks/apma/news_20170506
https://www.nxtbook.com/nxtbooks/apma/news_20170304
https://www.nxtbook.com/nxtbooks/apma/news_20170102
https://www.nxtbook.com/nxtbooks/apma/news_20161112
https://www.nxtbook.com/nxtbooks/apma/news_20160910
https://www.nxtbook.com/nxtbooks/apma/news_20160708
https://www.nxtbook.com/nxtbooks/apma/news_20160506
https://www.nxtbook.com/nxtbooks/apma/news_20160304
https://www.nxtbook.com/nxtbooks/apma/news_20160102
https://www.nxtbook.com/nxtbooks/apma/news_20151112
https://www.nxtbook.com/nxtbooks/apma/news_20150910
https://www.nxtbook.com/nxtbooks/apma/news_20150708
https://www.nxtbook.com/nxtbooks/apma/news_201506
https://www.nxtbook.com/nxtbooks/apma/news_201505
https://www.nxtbook.com/nxtbooks/apma/news_201504
https://www.nxtbook.com/nxtbooks/apma/news_201503
https://www.nxtbook.com/nxtbooks/apma/news_201502
https://www.nxtbook.com/nxtbooks/apma/news_201501
https://www.nxtbook.com/nxtbooks/apma/news_20141112
https://www.nxtbook.com/nxtbooks/apma/news_201410
https://www.nxtbook.com/nxtbooks/apma/news_201409
https://www.nxtbook.com/nxtbooks/apma/news_20140708
https://www.nxtbook.com/nxtbooks/apma/news_201406
https://www.nxtbook.com/nxtbooks/apma/news_201405
https://www.nxtbook.com/nxtbooks/apma/news_201404
https://www.nxtbook.com/nxtbooks/apma/news_201403
https://www.nxtbook.com/nxtbooks/apma/news_201402
https://www.nxtbook.com/nxtbooks/apma/news_201401
https://www.nxtbook.com/nxtbooks/apma/news_201311
https://www.nxtbook.com/nxtbooks/apma/news_201310
https://www.nxtbook.com/nxtbooks/apma/news_201309
https://www.nxtbook.com/nxtbooks/apma/news_201308
https://www.nxtbook.com/nxtbooks/apma/news_201306
https://www.nxtbook.com/nxtbooks/apma/news_201305
https://www.nxtbook.com/nxtbooks/apma/news_201304
https://www.nxtbook.com/nxtbooks/apma/news_201303
https://www.nxtbook.com/nxtbooks/apma/news_201302
https://www.nxtbook.com/nxtbooks/apma/news_201301
https://www.nxtbook.com/nxtbooks/apma/news_201211
https://www.nxtbook.com/nxtbooks/apma/news_201210
https://www.nxtbook.com/nxtbooks/apma/news_201209
https://www.nxtbook.com/nxtbooks/apma/news_20120708
https://www.nxtbook.com/nxtbooks/apma/news_201206
https://www.nxtbook.com/nxtbooks/apma/news_201205
https://www.nxtbook.com/nxtbooks/apma/news_201204
https://www.nxtbook.com/nxtbooks/apma/news_201203
https://www.nxtbook.com/nxtbooks/apma/news_201202
https://www.nxtbook.com/nxtbooks/apma/news_201201
https://www.nxtbook.com/nxtbooks/apma/news_201111
https://www.nxtbook.com/nxtbooks/apma/news_201110
https://www.nxtbook.com/nxtbooks/apma/news_201109
https://www.nxtbook.com/nxtbooks/apma/news_201107
https://www.nxtbook.com/nxtbooks/apma/news_201106
https://www.nxtbook.com/nxtbooks/apma/news_201105
https://www.nxtbook.com/nxtbooks/apma/news_201104
https://www.nxtbook.com/nxtbooks/apma/news_201103
https://www.nxtbook.com/nxtbooks/apma/news_201102
https://www.nxtbookmedia.com