5 minutes). 90% of the pruritus events had a duration between 3 minutes and 10 hours (median 20 minutes). (see ADVERSE REACTIONS).
Bacterial and Viral Skin Infections
Before commencing treatment with PROTOPIC Ointment, cutaneous bacterial or viral infections at treatment sites should be resolved. Studies have not eva luated the safety and efficacy of PROTOPIC Ointment in the treatment of clinically infected atopic dermatitis.
While patients with atopic dermatitis are predisposed to superficial skin infections including eczema herpeticum (Kaposi’s varicelliform eruption), treatment with PROTOPIC Ointment may be independently associated with an increased risk of varicella zoster virus infection (chicken pox or shingles), herpes simplex virus infection, or eczema herpeticum.
Patients with Lymphadenopathy
In clinical studies, 112/13494 (0.8%) cases of lymphadenopathy were reported and were usually related to infections (particularly of the skin) and noted to resolve upon appropriate antibiotic therapy. Of these 112 cases, the majority had either a clear etiology or were known to resolve. Transplant patients receiving immunosuppressive regimens (e.g., systemic tacrolimus) are at increased risk for developing lymphoma; therefore, patients who receive PROTOPIC Ointment and who develop lymphadenopathy should have the etiology of their lymphadenopathy investigated. In the absence of a clear etiology for the lymphadenopathy, or in the presence of acute infectious mononucleosis, PROTOPIC Ointment should be discontinued. Patients who develop lymphadenopathy should be monitored to ensure that the lymphadenopathy resolves.
Sun Exposure
During the course of treatment, patients should minimize or avoid natural or artificial sunlight exposure, even while PROTOPIC is not on the skin. It is not known whether PROTOPIC Ointment interferes with skin response to ultraviolet damage.
Immunocompromised Patients
The safety and efficacy of PROTOPIC Ointment in immunocompromised patients have not been studied.
Renal Insufficiency
Rare post-marketing cases of acute renal failure have been reported in patients treated with PROTOPIC Ointment. Systemic absorption is more likely to occur in patients with epidermal barrier defects especially when PROTOPIC is applied to large body surface areas. Caution should also be exercised in patients predisposed to renal impairment.
Information for Patients
(See Medication Guide)
Patients using PROTOPIC Ointment should receive and understand the information in the Medication Guide. Please refer to the Medication Guide for providing instruction and information to the patient.
What is the most important information patients should know about PROTOPIC Ointment?
The safety of using PROTOPIC Ointment for a long period of time is not known. A very small number of people who have used PROTOPIC Ointment have had cancer (for example, skin or lymphoma). However, a link with PROTOPIC Ointment has not been shown. Because of this concern, instruct patients:
Do not use PROTOPIC Ointment continuously for a long time.
Use PROTOPIC Ointment only on areas of skin that have eczema.
Do not use PROTOPIC Ointment on a child under 2 years old.
PROTOPIC Ointment comes in two strengths:
Only PROTOPIC Ointment 0.03% is for use on children aged 2 to 15 years.
Either PROTOPIC Ointment 0.03% or 0.1% can be used by adults and children 16 years and older.
Advise patients to talk to their presc |
