Monica V. Golik Mahoney, PharmD, BCPS-AQ ID. 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. Tacrolimus, at oral doses of 3.2 mg/kg during organogenesis in rats, was associated with maternal toxicity and caused an increase in late resorptions, decreased numbers of live births, and decreased pup weight and viability. However, a link with Tacrolimus Ointment has not been shown. Macrolides have been considered the drug of choice for group A streptococcal and pneumococcal infections when penicillin cannot be used. On the basis of this information dose-adjustment is not expected to be needed.The effect of hepatic insufficiency on the pharmacokinetics of topically administered tacrolimus has not been evaluated but dose-adjustment is not expected to be needed.Three randomized, double-blind, vehicle-controlled, multi-center, phase 3 studies were conducted to evaluate Tacrolimus Ointment for the treatment of patients with moderate to severe atopic dermatitis. Similarly, in a seven-month, double-blind trial, the vaccination response to meningococcal serogroup C was equivalent in children 2 to 11 years old with moderate to severe atopic dermatitis treated with Tacrolimus Ointment 0.03% (n=121), a hydrocortisone ointment regimen (n=111), or normal children (n=44).Four hundred and four (404) patients ≥ 65 years old received Tacrolimus Ointment in phase 3 studies.
Tacrolimus immunosuppression in high-risk corneal grafts. Nature 1989; 341: 758-60.Siekierka JJ, Hung SHY, Poe M, et al. Immunohistologic studies showed a massive infiltration of CD3+, CD4+, CD8+ and CD68+ cells, and macrophages in rejected corneal allografts, all of which are considered to be responsible for graft rejection.
): S19-27.Ahmad SM, Stegman Z, Fructhman S, et al. Tacrolimus Ointment is not indicated for children younger than 2 years of age (see boxed Long-term Safety of Topical Calcineurin Inhibitors Has Not Been EstablishedWhat is the most important information patients should know about Tacrolimus Ointment?What should patients avoid while using Tacrolimus Ointment?Tacrolimus Ointment is not indicated for children less than 2 years of age.Tacrolimus (ta kroe' li mus) Ointment, 0.03% and 0.1% What is the most important information I should know about Tacrolimus Ointment?What should I tell my doctor before starting Tacrolimus Ointment?If you are a caregiver applying Tacrolimus Ointment to a patient, or if you are a patient who is not treating your hands, wash your hands with soap and water after applying Tacrolimus Ointment. Arch Dermatol 1999; 135 (5):574-80.de Paulis A, Stellato C, Cirillo R, et al. In the absence of a clear etiology for the lymphadenopathy, or in the presence of acute infectious mononucleosis, Tacrolimus Ointment should be discontinued.
Transplant patients receiving immunosuppressive regimens (e.g., systemic tacrolimus) are at increased risk for developing lymphoma; therefore, patients who receive Tacrolimus Ointment and who develop lymphadenopathy should have the etiology of their lymphadenopathy investigated.
A metabolic pathway leading to the formation of 8 possible metabolites has been proposed.
Acta Derm Venereol 2010; 90(2):170-4.Kobayashi C, Kanai A, Nakajima A, et al.
A complex of tacrolimus-FKBP-12, calcium, calmodulin, and calcineurin is then formed and the phosphatase activity of calcineurin is inhibited. Phase III study of 0.1% tacrolimus (FK506) ophthalmic suspension in patients with vernal keratoconjunctivitis [ClinicalTrials.gov identifier NCT00567762].
Oral ingestion of Tacrolimus Ointment may lead to adverse effects associated with systemic administration of tacrolimus. 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. Macrobid ® brand of Curr Eye Res 1992; 11: 87-95.Harding MW, Galat A, Uehling DE, et al. Clinical pharmacokinetics of tacrolimus. In general as treatment continued, systemic exposure declined as the skin returned to normal.
Because of the effect in reducing activated T cells, several recent studies have investigated the efficacy of topical ophthalmic tacrolimus in preventing corneal graft rejection. The biosynthesis of methoxymalonyl CoA to Acyl Carrier protein is proceeded by five enzymes (fkbG, fkbH, fkbI, fkbJ, and fkbK).
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