Methylphenidate (Page 4 of 13)

5.8 Contact Sensitization

In an open-label study of 305 subjects conducted to characterize dermal reactions in children with ADHD treated with methylphenidate transdermal system using a 9-hour wear time, one subject (0.3%) was confirmed by transdermal system testing to be sensitized to methylphenidate (allergic contact dermatitis). This subject experienced erythema and edema at methylphenidate transdermal system application sites with concurrent urticarial lesions on the abdomen and legs resulting in treatment discontinuation. This subject was not transitioned to oral methylphenidate.

Use of methylphenidate transdermal system may lead to contact sensitization. Methylphenidate transdermal system should be discontinued if contact sensitization is suspected. Erythema is commonly seen with use of methylphenidate transdermal system and is not by itself an indication of sensitization. However, contact sensitization should be suspected if erythema is accompanied by evidence of a more intense local reaction (edema, papules, vesicles) that does not significantly improve within 48 hours or spreads beyond the transdermal system site. Confirmation of a diagnosis of contact sensitization (allergic contact dermatitis) may require further diagnostic testing.

Patients sensitized from use of methylphenidate transdermal system, as evidenced by development of an allergic contact dermatitis, may develop systemic sensitization or other systemic reactions if methylphenidate-containing products are taken via other routes, e.g., orally. Manifestations of systemic sensitization may include a flare-up of previous dermatitis or of prior positive transdermal system-test sites, or generalized skin eruptions in previously unaffected skin. Other systemic reactions may include headache, fever, malaise, arthralgia, diarrhea, or vomiting. No cases of systemic sensitization have been observed in clinical trials of methylphenidate transdermal system.

Patients who develop contact sensitization to methylphenidate transdermal system and require oral treatment with methylphenidate should be initiated on oral medication under close medical supervision. It is possible that some patients sensitized to methylphenidate by exposure to methylphenidate transdermal system may not be able to take methylphenidate in any form.

5.9 Visual Disturbance

Difficulties with accommodation and blurring of vision have been reported with stimulant treatment.

5.10 Patients Using External Heat

Patients should be advised to avoid exposing the methylphenidate transdermal system application site to direct external heat sources, such as hair dryers, heating pads, electric blankets, heated water beds, etc., while wearing the transdermal system. When heat is applied to methylphenidate transdermal system after transdermal system application, both the rate and extent of absorption are significantly increased. The temperature-dependent increase in methylphenidate absorption can be greater than 2-fold [see Clinical Pharmacology (12.3)]. This increased absorption can be clinically significant and can result in overdose of methylphenidate [see Overdosage (10)].

5.11 Hematologic Monitoring

Periodic CBC, differential, and platelet counts are advised during prolonged therapy.

6 ADVERSE REACTIONS

Detailed information on serious and adverse reactions of particular importance is provided in the Boxed Warning and Warnings and Precautions (5) sections:

Drug dependence [see Boxed Warning]
Hypersensitivity to Methylphenidate [see Contraindications (4.1)]
Marked anxiety, tension, or agitation [see Contraindications (4.2)]
Glaucoma [see Contraindications (4.3)]
Tics or a family history of Tourette’s syndrome [see Contraindications (4.4)]
Monoamine Oxidase Inhibitors [see Contraindications (4.5) and Drug Interactions (7.1)]
Serious Cardiovascular Events [see Warnings and Precautions (5.1)]
Increase in Blood Pressure [see Warnings and Precautions (5.1)]
Psychiatric Adverse Events [see Warnings and Precautions (5.2)]
Seizures [see Warnings and Precautions (5.3)]
Priapism [see Warnings and Precautions (5.4)]
Peripheral Vasculopathy [see Warnings and Precautions (5.5)]
Long-Term Suppression of Growth [see Warnings and Precautions (5.6)]
Chemical Leukoderma [see Warnings and Precautions (5.7)]
Contact Sensitization [see Warnings and Precautions (5.8)]
Visual Disturbance [see Warnings and Precautions (5.9)]
External Heat [see Warnings and Precautions (5.10)]
Hematologic Monitoring [see Warnings and Precautions (5.11)]

The most commonly reported (frequency ≥ 5% and twice the rate of placebo) adverse reactions in a controlled trial in children aged 6-12 included appetite decreased, insomnia, nausea, vomiting, weight decreased, tic, affect lability, and anorexia. The most commonly reported (frequency ≥ 5% and twice the rate of placebo) adverse reactions in a controlled trial in adolescents aged 13-17 were appetite decreased, nausea, insomnia, weight decreased, dizziness, abdominal pain, and anorexia [see Adverse Reactions (6.1)].

The most common (≥ 2% of subjects) adverse reaction associated with discontinuations in double-blind clinical trials in children or adolescents was application site reactions [see Adverse Reactions (6.1)].

The overall methylphenidate transdermal system development program included exposure to methylphenidate transdermal system in a total of 2,152 participants in clinical trials, including 1,529 children aged 6-12, 223 adolescents aged 13-17, and 400 adults. The 1,752 child and adolescent subjects aged 6-17 years were evaluated in 10 controlled clinical studies, 7 open-label clinical studies, and 5 clinical pharmacology studies. In a combined studies pool of children using methylphenidate transdermal system with a wear time of 9 hours, 212 subjects were exposed for ≥ 6 months and 115 were exposed for ≥ 1 year; 85 adolescents have been exposed for ≥ 6 months. Most patients studied were exposed to methylphenidate transdermal system sizes of 12.5 cm², 18.75 cm², 25 cm², or 37.5 cm², with a wear time of 9 hours.

In the data presented below, the adverse reactions reported during exposure were obtained primarily by general inquiry at each visit, and were recorded by the clinical investigators using terminology of their own choosing. Consequently, it is not possible to provide a meaningful estimate of the proportion of individuals experiencing adverse reactions without first grouping similar types of events into a smaller number of standardized event categories.

Throughout this section adverse reactions reported are events that were considered to be reasonably associated with the use of methylphenidate transdermal system based on comprehensive assessment of the available adverse event information. A causal association for methylphenidate transdermal system often cannot be reliably established in individual cases. Further, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in clinical trials of another drug and may not reflect the rates observed in clinical practice.

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