atric Use
Four hundred and four (404) patients ≥ 65 years old received PROTOPIC Ointment in phase 3 studies. The adverse event profile for these patients was consistent with that for other adult patients.
ADVERSE REACTIONS
No phototoxicity and no photoallergenicity were detected in clinical studies with 12 and 216 normal volunteers, respectively. One out of 198 normal volunteers showed evidence of sensitization in a contact sensitization study.
In three 12 week randomized vehicle-controlled studies and four safety studies, 655 and 9,163 patients respectively, were treated with PROTOPIC Ointment. The duration of follow-up for adult and pediatric patients in the safety studies is tabulated below.
Duration of Follow-up in Four Open-label Safety Studies
Time on Study Adult Pediatrics Total
< 1 year 4682 4481 9163
≥ 1 year 1185 1349 2534
≥ 2 years 200 275 475
≥ 3 years 118 182 300
The following table depicts the adjusted incidence of adverse events pooled across the 3 identically designed 12-week controlled studies for patients in vehicle, PROTOPIC Ointment 0.03%, and PROTOPIC Ointment 0.1% treatment groups. The table also depicts the unadjusted incidence of adverse events in four safety studies, regardless of relationship to study drug.
Incidence of Treatment Emergent Adverse Events
*
May be reasonably associated with the use of this drug product
†
Generally “warts”.
‡
All the herpes zoster cases in the pediatric 12-week study and the majority of cases in the open-label pediatric studies were reported as chicken pox.
12-Week, Randomized, Double-Blind, Phase 3 Studies
12-Week Adjusted Incidence Rate (%)
Open-Label Studies
(up to 3 years)
0.1% and 0.03%
Tacrolimus Ointment
Incidence Rate (%)
Adult
Pediatric Adult Pediatric Total
Vehicle
(n=212)
%
0.03% Tacrolimus Ointment
(n=210)
%
0.1% Tacrolimus Ointment
(n=209)
%
Vehicle
(n=116)
%
0.03%
Tacrolimus
Ointment
(n=118)
% (n=4682)% (n=4481)%
(n=9163)
%
Skin Burning* 26 46 58 29 43 28 20 24
Pruritus* 37 46 46 27 41 25 19 22
Flu-like symptoms* 19 23 31 25 28 22 34 28
Allergic Reaction 8 12 6 8 4 9 13 11
Skin Erythema 20 25 28 13 12 12 7 9
Headache* 11 20 19 8 5 13 9 11
Skin Infection 11 12 5 14 10 9 16 12
Fever 4 4 1 13 21 2 14 8
Infection 1 1 2 9 7 6 10 8
Cough Increased 2 1 1 14 18 3 10 6
Asthma 4 6 4 6 6 4 13 8
Herpes Simplex 4 4 4 2 0 4 3 3
Eczema Herpeticum 0 1 1 0 2 0 0 0
Pharyngitis 3 3 4 11 6 4
