TREAT ME LIKE ME…
Tolerability Typical of MPH Products
Commonly reported treatment-emergent Adverse Events with a 9-hour wear time
AEs ≥ 5% Dose Titration Phase |
AEs ≥ 2% Dose Maintenance Phase |
||
| AEs reported in Study 201 | Daytrana (n = 93) |
Daytrana (n = 80) |
Placebo (n = 80) |
| Decreased Appetite | 19.4
% |
— |
— |
| Headache | 10.8
% |
3.8
% |
3.8
% |
| Anorexia | 9.7
% |
2.5
% |
0
% |
| Insomnia | 9.7
% |
— |
— |
| Upper Abdominal Pain | 8.6
% |
— |
— |
| Irritability | 5.4
% |
— |
— |
| Pyrexia | 6.5
% |
— |
— |
| Upper Respiratory Tract Infection | 6.5
% |
0
% |
3.8
% |
| Cough | 5.4
% |
— |
— |
| Vomiting | 5.4
% |
— |
— |
| Initial Insomnia | 5.4
% |
— |
— |
| Nausea | — |
3.8
% |
0
% |
| Pharyngolaryngeal Pain | — |
2.5
% |
1.3
% |
| Allergic Rhinitis | — |
2.5
% |
0
% |
| Lymphadenopathy | — |
2.5
% |
0
% |
| Increased Blood Pressure | — |
2.5
% |
0
% |
| Rash | — |
1.3
% |
2.5
% |
| Nasopharyngitis | — |
1.3
% |
2.5
% |
Dash (–) indicates AEs did not meet reporting
thresholds (AEs ≥ 5% or AEs ≥ 2%).
- AEs were generally mild to moderate in a 7-week placebo-controlled laboratory classroom study, when the patch was worn for 9 hours3,10
- Daytrana may be removed earlier than 9 hours to help manage potential side effects, giving patients and parents added treatment flexibility11
NEW DATA: Clear Expectations for Transdermal Therapy
A phase III, multicenter, open-label, flexible-dose study was conducted
to evaluate the long-term safety of Daytrana in children aged 6-12 years
with
ADHD (N = 327).
12-month open-label study: mean skin evaluation scores11
- During this 12-month safety study, mean skin effects scores were generally low across visits11
- Mild redness of skin was commonly reported at the patch site11
- 22 out of 326 (6.7% of safety population) subjects discontinued Daytrana due to skin effects, the majority of which were described as "irritation" at patch application site11
- Most AEs were transient and mild to moderate in severity11
Considerations for Transdermal Treatment
- Erythema is not by itself an indication of allergic contact dermatitis (ACD).1 If erythema does not improve within 48 hours of patch removal or extends beyond patch application site, treatment should be discontinued as this may be evidence of ACD.1 Patients with suspected ACD should be referred for evaluation and initialized on oral MPH under close medical supervision.1
- The potential exists that some patients who develop ACD as a result of treatment with Daytrana may not be able to take MPH in any form1
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