Protopic® Ointment, both 0.03% and 0.1% for adults, and only 0.03% for children aged 2 to 15 years, is indicated as second-line therapy for the short-term and non-continuous chronic treatment of moderate to severe atopic dermatitis in non-immunocompromised adults and children who have failed to respond adequately to other topical prescription treatments for atopic dermatitis, or when those treatments are not advisable.
Protopic® Ointment is contraindicated in patients with a history of hypersensitivity to tacrolimus or any other component of the ointment.
Long-term Safety of Topical Calcineurin Inhibitors Has Not Been Established
Although a causal relationship has not been established, rare cases of malignancy (e.g., skin and lymphoma) have been reported in patients treated with topical calcineurin inhibitors, including Protopic® Ointment.
- Continuous long-term use of topical calcineurin inhibitors, including Protopic® Ointment, in any age group should be avoided, and application limited to areas of involvement with atopic dermatitis.
- Protopic® Ointment is not indicated for use in children less than 2 years of age. Only 0.03% Protopic® Ointment is indicated for use in children 2-15 years of age.
Prolonged systemic use of calcineurin inhibitors for sustained immunosuppression in animal studies and transplant patients following systemic administration has been associated with an increased risk of infections, lymphomas, and skin malignancies. These risks are associated with the intensity and duration of immunosuppression.
Based on the information above and the mechanism of action, there is a concern about potential risk with the use of topical calcineurin inhibitors, including Protopic® Ointment. While a causal relationship has not been established, rare cases of skin malignancy and lymphoma have been reported in patients treated with topical calcineurin inhibitors, including Protopic® Ointment. Therefore:
- Protopic® Ointment should not be used in immunocompromised adults and children.
- If signs and symptoms of atopic dermatitis do not improve within 6 weeks, patients should be re-examined by their healthcare provider and their diagnosis be confirmed (see PRECAUTIONS: General).
- The safety of Protopic® Ointment has not been established beyond one year of non-continuous use.
The use of Protopic® Ointment should be avoided on pre-malignant and malignant skin conditions. Some malignant skin conditions, such as cutaneous T-cell lymphoma (CTCL), may mimic atopic dermatitis.
The use of tacrolimus ointment is not recommended in patients having skin conditions with a skin barrier defect where there is the potential for increased systemic absorption of tacrolimus, including but not limited to, Netherton’s syndrome, lamellar ichthyosis, generalized erythroderma or cutaneous Graft Versus Host Disease. Oral application is also not recommended. Post-marketing cases of increased tacrolimus blood level have been reported in these conditions.
The use of Protopic® Ointment may cause local symptoms such as skin burning (burning sensation, stinging, soreness) or pruritus. Localized symptoms are most common during the first few days of Protopic® Ointment application and typically improve as the lesions of atopic dermatitis resolve. With Protopic® Ointment 0.1%, 90% of the skin burning events had a duration between 2 minutes and 3 hours (median 15 minutes). 90% of the pruritus events had a duration between 3 minutes and 10 hours (median 20 minutes) (see ADVERSE REACTIONS).
Before commencing treatment with Protopic® Ointment, cutaneous bacterial or viral infections at treatment sites should be resolved. Studies have not evaluated 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.
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.
During the course of treatment, patients should minimize or avoid natural or artificial sunlight exposure, even while Protopic® Ointment is not on the skin. It is not known whether Protopic® Ointment interferes with skin response to ultraviolet damage.
The safety and efficacy of Protopic® Ointment in immunocompromised patients have not been studied.
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® Ointment is applied to large body surface areas. Caution should also be exercised in patients predisposed to renal impairment.
(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 prescriber for more information.
How should Protopic® Ointment be used?
Advise patients to:
- Use Protopic® Ointment exactly as prescribed.
- Use Protopic® Ointment only on areas of skin that have eczema.
- Use Protopic® Ointment for short periods, and if needed, treatment may be repeated with breaks in between.
- Stop Protopic® Ointment when the signs and symptoms of eczema, such as itching, rash, and redness go away, or as directed.
- Follow their doctor’s advice if symptoms of eczema return after treatment with Protopic® Ointment.
- Call their doctor if:
- Their symptoms get worse with Protopic® Ointment.
- They get an infection on their skin.
- Their symptoms do not improve after 6 weeks of treatment. Sometimes other skin diseases can look like eczema.
To apply Protopic® Ointment:
- Wash their hands before applying Protopic® Ointment.
- Apply a thin layer of Protopic® Ointment twice daily to the areas of skin affected by eczema.
- Use the smallest amount of Protopic® Ointment needed to control the signs and symptoms of eczema.
- If they are a caregiver applying Protopic® Ointment to a patient, or if they are a patient who is not treating their hands, wash their hands with soap and water after applying Protopic® Ointment. This should remove any ointment left on the hands.
- Do not bathe, shower, or swim right after applying Protopic® Ointment. This could wash off the ointment.
- Moisturizers can be used with Protopic® Ointment. Make sure they check with their doctor first about the products that are right for them. Because the skin of patients with eczema can be very dry, it is important to keep up good skin care practices. If they use moisturizers, apply them after Protopic® Ointment.
What should patients avoid while using Protopic® Ointment?
- Do not use ultraviolet light therapy, sun lamps, or tanning beds during treatment with Protopic® Ointment.
- Limit sun exposure during treatment with Protopic® Ointment even when the medicine is not on their skin. If patients need to be outdoors after applying Protopic® Ointment, wear loose fitting clothing that protects the treated area from the sun. Doctors should advise what other types of protection from the sun patients should use.
- Do not cover the skin being treated with bandages, dressings or wraps. Patients can wear normal clothing.
- Avoid getting Protopic® Ointment in the eyes or mouth. Do not swallow Protopic® Ointment. Patients should call their doctor if they swallow Protopic® Ointment.
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