TACROLIM 0.1%

DOSAGE AND ADMINISTRATION

TACROLIM 0.1% should be initiated by physicians experienced in diagnosing and treating atopic dermatitis.

Method of application: 

Apply a thin layer to the affected or commonly affected areas of skin with atopic dermatitis. It can be applied to any part of the body, including the face, neck, and folds, except for the mucous membranes. Do not occlude the treated skin area as this method has not been studied in patients.

Dose:

Treatment of flares 

Tacrolimus can be used short-term and intermittently long-term. Continuous long-term treatment should be avoided. Treatment with tacrolimus should start at the first signs and symptoms of the disease. Each affected skin area should be treated until the lesions are cleared, almost cleared, or only mildly affected. After this, patients are suitable for maintenance treatment (see below). Upon the first signs of recurrence, treatment should be restarted.

Adults and adolescents (≥ 16 years): 

Treatment should begin with TACROLIM 0.1% twice daily and continued until the lesions are cleared. If symptoms recur, treatment should resume with TACROLIM 0.1% twice daily. Efforts should be made to reduce the frequency of application or switch to a lower strength preparation (TACROLIM 0.03%) if the clinical condition allows. 

Improvement is usually seen within 1 week of treatment. If no signs of improvement are seen after 2 weeks, other treatment options should be considered.

Elderly: 

No specific studies have been conducted in elderly patients. However, available clinical experience has shown no need for dose adjustment in these patients.

Children: 

Children aged 2 – 16 years should use TACROLIM 0.03% only. TACROLIM 0.1% should not be used in children under 2 years of age due to insufficient data.

Maintenance treatment 

Patients responding to 6 weeks of treatment with tacrolimus ointment twice daily (clear, almost clear, or mildly affected) are suitable for maintenance treatment.

Adults and adolescents (≥ 16 years): 

TACROLIM 0.1% ointment should be applied once daily, twice weekly (e.g., Monday and Thursday) to areas of skin commonly affected by atopic dermatitis to prevent the progression to flares. Between applications, there should be 2 – 3 days without treatment.

 After 12 months of treatment, the physician should review the patient's condition and decide whether to continue maintenance treatment, as no safety data are available for maintenance treatment beyond 12 months. 

If signs of flares occur, treatment should resume twice daily (see Treatment of flares above).

Elderly: 

No specific studies have been conducted in these patients (see Treatment of flares above).

Children:

 Children aged 2 years and older should use TACROLIM 0.03% ointment. 

TACROLIM 0.1% is not recommended for use in children under 2 years of age unless sufficient data is available

CONTRAINDICATIONS

Hypersensitivity to tacrolimus, macrolides in general, or any of the excipients of the medication.

WARNINGS AND PRECAUTIONS

Minimize exposure of the skin to sunlight and avoid the use of UV light from tanning beds, or UVB or UVA treatments with psoralens (PUVA) during treatment with tacrolimus. Physicians should advise patients on appropriate sun protection measures, such as reducing time in the sun, using sunscreen products, and covering skin with suitable clothing.

Do not apply the ointment to lesions considered potentially malignant or pre-malignant.

Any changes in the skin's appearance differing from previous eczema should be evaluated by a physician.

The use of tacrolimus ointment is not recommended in patients with Netherton's syndrome, lamellar ichthyosis, erythroderma, or graft-versus-host disease. In these conditions, the skin's barrier function is compromised, increasing tacrolimus absorption. Oral tacrolimus is also not recommended in these cases. Post-marketing reports have indicated increased tacrolimus blood levels in such patients.

Care should be taken when using tacrolimus over large body areas for prolonged periods, especially in children. Patients (particularly children) should be regularly evaluated for response and need for continued treatment. After 12 months, evaluation should include discontinuation of tacrolimus in children.

The long-term effects of topical immunosuppression (potential for infections or malignant skin conditions) are unknown.

Tacrolimus is a calcineurin inhibitor. In transplant patients, long-term systemic use of calcineurin inhibitors has been associated with an increased risk of lymphomas and malignant skin diseases. Cases of malignancies, including cutaneous T-cell lymphoma, other lymphomas, and skin cancers, have been reported in patients using tacrolimus ointment. 

Avoid use in immunocompromised patients.

Systemic tacrolimus levels are not significant in patients with atopic dermatitis treated with topical tacrolimus.

Lymphadenopathy has been rarely reported (0.8%) in clinical trials, mostly associated with infections (skin, respiratory, dental) and usually resolving with appropriate antibiotic therapy. Transplant patients on immunosuppressive therapy (systemic tacrolimus) are at risk for lymphomas. Patients on tacrolimus ointment with lymphadenopathy should be monitored to ensure resolution. Before starting treatment, lymphadenopathy should be evaluated. Persistent lymphadenopathy should be investigated, and in the absence of a clear etiology or presence of acute infectious mononucleosis, discontinuation of tacrolimus should be considered.

The safety and efficacy of tacrolimus ointment in patients with clinically infected atopic dermatitis have not been evaluated. Skin infections at treatment sites should be cleared before starting tacrolimus. Atopic dermatitis patients are prone to superficial skin infections. Tacrolimus treatment carries a risk of folliculitis and herpes virus infections (e.g., eczema herpeticum, herpes simplex [cold sores], Kaposi's varicelliform eruption). In such cases, the benefit-risk ratio of tacrolimus treatment should be carefully evaluated.

Moisturizers should not be applied to treatment areas within 2 hours of applying tacrolimus. Concurrent use with other topical preparations has not been evaluated. There is no experience with concurrent use with systemic immunosuppressants and steroids.

Avoid contact with eyes and mucous membranes. If contact occurs, wipe and rinse thoroughly with water.

Occlusive dressings should not be used. Hand washing is advised after application if hands are not the treatment area.

Although tacrolimus is largely metabolized in the liver and systemic levels are low when used topically, caution should be exercised in patients with hepatic insufficiency.

Excipients Caution

TACROLIM 0.1% contains butylated hydroxyanisole (BHA) and butylated hydroxytoluene (BHT): which may cause local skin reactions (e.g., contact dermatitis) or irritation to the eyes and mucous membranes.

Use During Pregnancy and Lactation

Pregnancy:

There are no adequate data on the use of tacrolimus ointment in pregnant women. Animal studies have shown reproductive toxicity with systemic tacrolimus. The potential risk to humans is unknown.

TACROLIM 0.1% should not be used during pregnancy unless clearly necessary.

Lactation:

Tacrolimus is excreted into breast milk after systemic administration. Although systemic exposure from topical use is low, breastfeeding is not recommended during treatment.

Fertility:

No data are available.

Effects on Ability to Drive and Use Machines

TACROLIM 0.1% does not affect or has negligible influence on the ability to drive and use machines

Shelf Life

36 months from the date of manufacture. Do not use more than 6 months after first opening.

Storage Conditions

Store in a dry place below 30°C, protected from light.

Aluminum tube. Box containing 1 tube x 10 g with a package insert.