The safety of tacrolimus ointment under occlusion, which may promote systemic exposure, has not been evaluated. No phototoxicity and no photoallergenicity were detected in clinical studies with 12 and 216 normal volunteers, respectively. Accidental oral ingestion of Tacrolimus ointment may lead to adverse effects associated with systemic administration of Tacrolimus. In general as treatment continued, systemic exposure declined as the skin returned to normal.

These risks are associated with the intensity and duration of immunosuppression. 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 tacrolimus ointment. Experimental evidence suggests that tacrolimus binds to an intracellular protein, FKBP-12.

In the 80-week mouse study and in the 104-week rat study no relationship of tumor incidence to tacrolimus dosage was found at daily doses up to 3 mg/kg [9X the Maximum Recommended Human Dose (MRHD) based on AUC comparisons] and 5 mg/kg (3X the MRHD based on AUC comparisons), respectively.A 104-week dermal carcinogenicity study was performed in mice with Tacrolimus Ointment (0.03% - 3%), equivalent to tacrolimus doses of 1.1-118 mg/kg/day or 3.3-354 mg/m In a 52-week photocarcinogenicity study, the median time to onset of skin tumor formation was decreased in hairless mice following chronic topical dosing with concurrent exposure to UV radiation (40 weeks of treatment followed by 12 weeks of observation) with Tacrolimus Ointment at ≥0.1% tacrolimus.Reproductive toxicology studies were not performed with topical tacrolimus. At baseline, 58% of the patients had severe disease and the mean body surface area (BSA) affected was 46%. Your FSA Administrator might provide you with an FSA Debit Card to use toward FSA eligible expenses.

Tacrolimus, given orally at 1.0 mg/kg (0.12X MRHD based on body surface area [BSA]) to male and female rats, prior to and during mating, as well as to dams during gestation and lactation, was associated with embryolethality and with adverse effects on female reproduction. The use of tacrolimus ointment should be avoided on pre-malignant and malignant skin conditions.

Because of the potential for serious adverse reactions in nursing infants from tacrolimus, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.Only the lower concentration, 0.03%, of Tacrolimus Ointment is recommended for use as a The long-term safety and effects of Tacrolimus Ointment on the developing immune system are unknown (see boxed Four studies were conducted involving a total of about 4,400 patients 2-15 years of age: one 12-week randomized vehicle-controlled study and three open-label safety studies of one to three years duration. Individual has failure, contraindication or intolerance to . In clinical studies with periodic blood sampling, a similar distribution of tacrolimus blood levels was also observed in adult patients, with 90% (1253/1391) of patients having a blood concentration less than 2 ng/mL.

The success rate for tacrolimus 0.03% ointment was lower in patients with severe atopic dermatitis at baseline (20%), in patients with extensive (75-100%) body surface area involvement (5%), and in black patients (16%).In the clinical study involving children 2-15 years of age with moderate to severe atopic dermatitis, the 0.1% ointment appeared to provide no added benefit over the 0.03% ointment. Formal topical drug interaction studies with tacrolimus ointment have not been conducted. Only the lower concentration, 0.03%, of tacrolimus ointment is recommended for use as a The most common adverse events from these studies associated with tacrolimus ointment application in pediatric patients were skin burning and pruritus (see Four hundred and four (404) patients ≥ 65 years old received tacrolimus ointment in phase 3 studies. The minimum amount required to control symptoms should be used and application limited to areas affected with atopic dermatitis.Treatment should be discontinued following resolution of signs and symptoms of atopic dermatitis (e.g., pruritus, rash, erythema).

Tacrolimus ointment is for external use only and should not be used in the eyes or ingested.

Topical tacrolimus is The concern for increased risk of malignancies is based principally on case reports of malignancies (including lymphoma and skin cancer) in children and adults receiving topical tacrolimus or pimecrolimus; the increased risk of lymphoma and skin cancer associated with prolonged systemic therapy with calcineurin inhibitors (e.g., cyclosporine, tacrolimus) in transplant patients; animal studies indicating dose-related increases in the risk of lymphoma and other malignancies (particularly of the skin) with tacrolimus and other calcineurin inhibitors, possibly secondary to immunosuppressive effects of the drug; and the known pharmacologic effects of these immunosuppressants. Caution should also be exercised in patients predisposed to renal impairment.