Tacrolimus

Pharmacologic Category

Calcineurin Inhibitor; Immunosuppressant Agent; Topical Skin Product

Dosing: Adult

Atopic dermatitis (moderate-to-severe): Topical:

Treatment: Apply thin layer of 0.03% or 0.1% ointment to affected area twice daily; rub in gently and completely. Discontinue use when symptoms have cleared. If no improvement within 6 weeks, patients should be re-examined to confirm diagnosis.

Maintenance therapy (off-label use): Apply one application (thin layer of 0.03% or 0.1% ointment) to areas usually affected twice daily twice a week (Schneider 2012).

Oral lichen planus (off-label use): Topical: Apply thin layer of 0.1% ointment to affected area up to 4 times daily; the treatment period in clinical trials ranged from 4 to 6 weeks (Corrocher 2008; Laeijendecker 2006; Radfar 2008).

Psoriasis (off-label use): Topical: Apply thin layer of 0.03% ointment twice daily; the treatment period in clinical trials was 6 weeks (Liao 2007).

Pyoderma gangrenosum (off-label use): Topical: Apply thin layer of 0.1% or 0.3% ointment to affected area once daily (Ghislain 2004; Lyon 2001); the treatment period in one clinical trial (0.3% ointment) was up to 10 weeks (Lyon 2001).

Vitiligo (off-label use): Topical: Apply thin layer of 0.1% ointment to affected area twice daily; may require several months for adequate response; the treatment period in clinical trials ranged from 10 weeks to 18 months (Majid 2010; Radakovic 2009; Taieb 2013).

* See Dosage and Administration in AHFS Essentials for additional information.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Renal Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Pediatric

Moderate to severe atopic dermatitis: Note: Discontinue use when symptoms have cleared. If no improvement occurs within 6 weeks, patients should be reexamined to confirm diagnosis. Topical:

Ointment 0.03%: Children ≥2 years and Adolescents: Apply a thin layer to affected area twice daily; rub in gently and completely

Ointment 0.1%: Adolescents ≥16 years: Apply a thin layer of 0.1% ointment to affected area twice daily; rub in gently and completely

Dosing: Renal Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Use: Labeled Indications

Moderate to severe atopic dermatitis: Treatment of moderate to severe atopic dermatitis in immunocompetent patients not responsive to conventional therapy or when conventional therapy is not appropriate

* See Uses in AHFS Essentials for additional information.

Use: Off-Label: Adult

Atopic dermatitis (maintenance therapy)Level of Evidence [G]

Guidelines support use of topical calcineurin inhibitors, including tacrolimus, as maintenance to prevent flares and extend flare free intervals in patients with moderate to severe atopic dermatitis who responded to initial therapy Ref.

Oral lichen planusLevel of Evidence [B]

Data from controlled trials demonstrate that tacrolimus ointment is effective in improving clinical symptoms of oral lichen planus and may be considered an alternative therapy for patients who do not respond to topical steroids. Additional data may be necessary to further define the role of tacrolimus in this condition. Access Full Off-Label Monograph

PsoriasisLevel of Evidence [C, G]

Data from controlled trials suggest that topical tacrolimus may be an effective treatment for psoriasis in areas of thinner skin, such as the face, or in the treatment of intertriginous psoriasis Ref.

American Academy of Dermatology and National Psoriasis Foundation guidelines state that topical tacrolimus is a treatment option for intertriginous or facial psoriasis Ref. Access Full Off-Label Monograph

Pyoderma gangrenosumLevel of Evidence [C]

Results of a noncontrolled study and several case reports/case series suggest that topical tacrolimus may be beneficial in the treatment of pyoderma gangrenosum Ref.

RosaceaLevel of Evidence [C]

Topical tacrolimus for the management of rosacea has been studied in noncontrolled trials demonstrating variable results Ref. Access Full Off-Label Monograph

VitiligoLevel of Evidence [C, G]

Data from a meta-analysis and randomized controlled trials suggest that tacrolimus may be effective in the management of vitiligo Ref.

European Dermatology Forum consensus guidelines support the use of topical calcineurin inhibitors as first-line therapy for patients with vitiligo; use should be limited to the head and neck regions Ref. Access Full Off-Label Monograph

Level of Evidence Definitions

Level of Evidence Scale

Clinical Practice Guidelines

Atopic Dermatitis:

Journal of Allergy Clinical Immunology, Atopic Dermatitis: A Practice Parameter Update 2012, February 2013

Psoriasis:

American Academy of Dermatology, Guidelines of Care for the Management of Psoriasis and Psoriatic Arthritis; Sec. 3, Management and Treatment of Psoriasis with Topical Therapies, April 2009

Administration: Topical

Wash hands before and after application. Use the smallest amount of ointment needed to control the signs and symptoms of atopic dermatitis. Do not use with occlusive dressings. Do not bathe, shower, or swim right after application. Limit sun exposure during the treatment period. Burning at the application site is most common in first few days; improves as atopic dermatitis improves. Limit application to involved areas. Continue as long as signs and symptoms persist; discontinue if resolution occurs; re-evaluate if symptoms persist >6 weeks.

Administration: Pediatric

For external use only; avoid exposure to eyes or mouth. Wash hands before and after application. Use the smallest amount of ointment needed to control the signs and symptoms of atopic dermatitis. Do not cover with occlusive dressings. Do not bathe, shower, or swim right after application. Moisturizers can be applied after application. Limit sun exposure during the treatment period. Burning at the application site is most common in first few days; improves as atopic dermatitis improves.

Hazardous Drugs Handling Considerations

Hazardous agent (NIOSH 2016 [group 2]).

Use appropriate precautions for receiving, handling, administration, and disposal. Gloves (single) should be worn during receiving, unpacking, and placing in storage.

NIOSH recommends double gloving, a protective gown, and (if liquid that could splash) eye/face protection for administration of a topical product; if there is potential for inhalation, respiratory protection is recommended (NIOSH 2016). Assess risk to determine appropriate containment strategy (USP-NF 2017).

Storage/Stability

Store at room temperature of 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).

Medication Patient Education with HCAHPS Considerations

What is this drug used for?

• It is used to treat eczema.

• It may be given to you for other reasons. Talk with the doctor.

Frequently reported side effects of this drug

• Flu-like symptoms

• Itching

• Burning

• Stinging

• Skin tingling

• Temperature sensitivity

• Headache

• Cough

• Stuffy nose

• Acne

• Hair bumps

• Nausea

Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:

• Kidney problems like unable to pass urine, blood in the urine, change in amount of urine passed, or weight gain.

• Ear pain

• Severe skin irritation

• Skin infection

• Skin growths

• Swollen glands

• Muscle pain

• Signs of a significant reaction like wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Medication Safety Issues

Sound-alike/look-alike issues:

High alert medication:

Medication Guide and/or Vaccine Information Statement (VIS)

An FDA-approved patient medication guide, which is available with the product information and at http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088996.pdf, must be dispensed with this medication.

Contraindications

Hypersensitivity to tacrolimus or any component of the formulation

Warnings/Precautions

Concerns related to adverse events:

• Malignancy: [US Boxed Warning]: Topical calcineurin inhibitors have been associated with rare cases of malignancy (including skin and lymphoma); therefore, it should be limited to short-term and intermittent treatment using the minimum amount necessary for the control of symptoms and only on involved areas. Avoid use on malignant or premalignant skin conditions (eg cutaneous T-cell lymphoma). Limit sun and ultraviolet light exposure; use appropriate sun protection.

• Infection: Do not apply to areas of active bacterial or viral infection; infections at the treatment site should be cleared prior to therapy. Patients with atopic dermatitis are predisposed to skin infections, and tacrolimus therapy has been associated with risk of developing eczema herpeticum, varicella zoster, and herpes simplex.

• Lymphadenopathy: May be associated with development of lymphadenopathy; possible infectious causes should be investigated. Discontinue use in patients with unknown cause of lymphadenopathy or acute infectious mononucleosis.

• Renal failure: Acute renal failure has been observed (rarely) with topical use.

Disease related concerns:

• Immunosuppression: Should not be used in immunocompromised patients. Safety and efficacy have not been evaluated.

• Skin diseases with altered absorption: Not recommended for use in patients with skin disease which may increase systemic absorption (eg, Netherton's syndrome).

Special populations:

• Pediatric: [US Boxed Warning] Use in children <2 years of age is not recommended, only the 0.03% ointment should be used in children ages 2-15.

Other warnings/precautions:

• Appropriate use: Topical calcineurin agents are considered second-line therapies in the treatment of atopic dermatitis/eczema, and should be limited to use in patients who have failed treatment with other therapies. Safety not established in patients with generalized erythroderma. If atopic dermatitis is not improved in <6 weeks, re-evaluate to confirm diagnosis. Safety of intermittent use for >1 year has not been established, particularly since the effect on immune system development is unknown.

* See Cautions in AHFS Essentials for additional information.

Pregnancy Considerations

Tacrolimus(Topical) crosses the human placenta and is measurable in the cord blood, amniotic fluid, and newborn serum following systemic use. Refer to the Tacrolimus (Systemic) monograph for additional information.

Breast-Feeding Considerations

Tacrolimus is excreted into breast milk following systemic administration. Refer to the Tacrolimus (Systemic) monograph for additional information.

Briggs' Drugs in Pregnancy & Lactation

• Tacrolimus

Adverse Reactions

As reported in children and adults, unless otherwise noted. Frequency not always defined.

Cardiovascular: Peripheral edema (adults 3% to 4%), hypertension (adults 1%)

Central nervous system: Headache (adults 19% to 20%), tingling of skin (2% to 8%), hyperesthesia (adults 3% to 7%), insomnia (adults 4%), paresthesia (adults 3%), depression (adults 2%), pain (1% to 2%)

Dermatologic: Burning sensation of skin (43% to 58%), pruritus (41% to 46%), erythema (25% to 28%), skin infection (adults 12%), acne vulgaris (adults 4% to 7%), urticaria (adults 3% to 6%), folliculitis (2% to 6%), skin rash (adults 2% to 5%), dermatological disease (children 4%), vesiculobullous dermatitis (children 4%), contact dermatitis (3% to 4%), pustular rash (adults 2% to 4%), contact eczema herpeticum (children 2%), fungal dermatitis (adults 1% to 2%), sunburn (adults 1% to 2%), alopecia (adults 1%), xeroderma (children 1%)

Gastrointestinal: Diarrhea (3% to 5%), dyspepsia (adults 1% to 4%), abdominal pain (children 3%), gastroenteritis (adults 2%), vomiting (adults 1%), nausea (children 1%)

Genitourinary: Dysmenorrhea (adults 4%), urinary tract infection (adults 1%)

Hematologic & oncologic: Lymphadenopathy (children 3%), malignant lymphoma, malignant neoplasm of skin

Hypersensitivity: Hypersensitivity reaction (adults 6% to 12%)

Infection: Herpes zoster (1% to 5%), varicella zoster infection (1% to 5%), infection (adults 1% to 2%)

Neuromuscular & skeletal: Myalgia (adults 2% to 3%), weakness (adults 2% to 3%), arthralgia (adults 1% to 3%), back pain (adults 2%)

Ocular: Conjunctivitis (adults 2%)

Otic: Otitis media (children 12%), otalgia (children 1%)

Respiratory: Flu-like symptoms (23% to 31%), increased cough (children 18%), asthma (adults 6%), rhinitis (children 6%), pharyngitis (adults 4%), sinusitis (adults 2% to 4%), bronchitis (adults 2%), pneumonia (adults 1%)

Miscellaneous: Fever (children 21%), allergic reaction (4% to 12%), alcohol intolerance (adults 3% to 7%), accidental injury (6%), cyst (adults 1% to 3%)

<1%, postmarketing, and/or case reports (Limited to important or life-threatening): Abnormality in thinking, abscess, acne rosacea, acute renal failure, aggravated tooth caries, anaphylactoid reaction, anemia, anorexia, anxiety, application site edema, arthritis, arthropathy, basal cell carcinoma, benign neoplasm (breast), blepharitis, bone disease, bursitis, candidiasis, cataract, chest pain, chills, colitis, conjunctival edema, constipation, cutaneous candidiasis, cystitis, dehydration, dermal ulcer, diaphoresis, dizziness, dry nose, dysgeusia, dyspnea, ear disease, ecchymoses, edema, epistaxis, eye pain, furunculosis, gastritis, gastrointestinal disease, heart valve disease, hernia, hyperbilirubinemia, hypercholesterolemia, hypertonia, hypothyroidism, impetigo (bullous), laryngitis, leukoderma, malaise, malignant lymphoma, malignant melanoma, migraine, muscle cramps, nail disease, neck pain, neoplasm (benign), oral candidiasis, oral mucosa ulcer, osteoarthritis, osteomyelitis, otitis externa, pulmonary disease, rectal disease, renal insufficiency, seborrhea, seizure, septicemia, skin carcinoma, skin discoloration, skin hypertrophy, skin photosensitivity, squamous cell carcinoma, stomatitis, syncope, tachycardia, tendon disease, unintended pregnancy, vaginitis, vasodilation, vertigo, visual disturbance, vulvovaginal candidiasis, xerophthalmia, xerostomia

* See Cautions in AHFS Essentials for additional information.

Metabolism/Transport Effects

Substrate of CYP3A4 (minor), P-glycoprotein/ABCB1; Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential

Drug Interactions Open Interactions

Alcohol (Ethyl): Tacrolimus (Topical) may enhance the dermatologic adverse effect of Alcohol (Ethyl). Risk C: Monitor therapy

Antifungal Agents (Azole Derivatives, Systemic): May decrease the metabolism of Tacrolimus (Topical). Applicable Isavuconazonium considerations are addressed in separate monographs. Exceptions: Isavuconazonium Sulfate. Risk C: Monitor therapy

Calcium Channel Blockers (Nondihydropyridine): May decrease the metabolism of Tacrolimus (Topical). Exceptions: Bepridil. Risk C: Monitor therapy

CycloSPORINE (Systemic): Tacrolimus (Topical) may enhance the nephrotoxic effect of CycloSPORINE (Systemic). CycloSPORINE (Systemic) may enhance the nephrotoxic effect of Tacrolimus (Topical). Tacrolimus (Topical) may increase the serum concentration of CycloSPORINE (Systemic). CycloSPORINE (Systemic) may increase the serum concentration of Tacrolimus (Topical). Risk X: Avoid combination

Danazol: May increase the serum concentration of Tacrolimus (Topical). Risk C: Monitor therapy

Grapefruit Juice: May decrease the metabolism of Tacrolimus (Topical). Risk C: Monitor therapy

Immunosuppressants: Tacrolimus (Topical) may enhance the adverse/toxic effect of Immunosuppressants. Exceptions: Cytarabine (Liposomal). Risk X: Avoid combination

Macrolide Antibiotics: May increase the serum concentration of Tacrolimus (Topical). Exceptions: Fidaxomicin; Roxithromycin; Spiramycin. Risk C: Monitor therapy

Ombitasvir, Paritaprevir, and Ritonavir: May increase the serum concentration of Tacrolimus (Topical). Risk C: Monitor therapy

Ombitasvir, Paritaprevir, Ritonavir, and Dasabuvir: May increase the serum concentration of Tacrolimus (Topical). Risk C: Monitor therapy

Protease Inhibitors: May decrease the metabolism of Tacrolimus (Topical). Risk C: Monitor therapy

Serotonin Reuptake Inhibitor/Antagonists: May decrease the metabolism of Tacrolimus (Topical). Exceptions: TraZODone. Risk C: Monitor therapy

Sirolimus: Tacrolimus (Topical) may enhance the adverse/toxic effect of Sirolimus. Sirolimus may enhance the adverse/toxic effect of Tacrolimus (Topical). Risk X: Avoid combination

Temsirolimus: Tacrolimus (Topical) may enhance the adverse/toxic effect of Temsirolimus. Temsirolimus may enhance the adverse/toxic effect of Tacrolimus (Topical). Risk X: Avoid combination

Gene Testing May Be Considered

• CYP3A5 - Tacrolimus

Genes of Interest

• Cytochrome P450 2C19
• P-Glycoprotein

Advanced Practitioners Physical Assessment/Monitoring

Monitor for signs of opportunistic infection.

Nursing Physical Assessment/Monitoring

Monitor for signs of opportunistic infection.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Ointment, External:

Protopic: 0.03% (30 g, 60 g, 100 g); 0.1% (30 g, 60 g, 100 g)

Generic: 0.03% (30 g, 60 g, 100 g); 0.1% (30 g, 60 g, 100 g)

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Ointment, External:

Protopic: 0.03% (30 g, 60 g, 100 g); 0.1% (30 g, 60 g, 100 g)

Anatomic Therapeutic Chemical (ATC) Classification

• D11AH01

Generic Available (US)

Yes

Pricing: US

Ointment (Protopic External)

0.03% (per gram): $11.26

0.1% (per gram): $11.26

Ointment (Tacrolimus External)

0.03% (per gram): $8.68 - $9.65

0.1% (per gram): $8.68 - $9.65

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Mechanism of Action

Suppresses cellular immunity (inhibits T-lymphocyte activation), by binding to an intracellular protein, FKBP-12 and complexes with calcineurin dependent proteins to inhibit calcineurin phosphatase activity

Pharmacodynamics/Kinetics

Absorption: Minimally absorbed; serum concentrations range from undetectable to 20 ng/mL (~2 ng/mL in majority of adult patients studied)

Bioavailability: ~0.5%

Dental Use

Treatment of severe ulcerative or vesicobullous lesions (usually in consult with patient's physician)

* See Uses in AHFS Essentials for additional information.

Local Anesthetic/Vasoconstrictor Precautions

No information available to require special precautions

Effects on Dental Treatment

No significant effects or complications reported

Effects on Bleeding

No information available to require special precautions

Related Information

• Safe Handling of Hazardous Drugs

FDA Approval Date

December 08, 2000

References

<800> Hazardous Drugs—Handling in Healthcare Settings. United States Pharmacopeia and National Formulary (USP 40-NF 35). Rockville, MD: United States Pharmacopeia Convention; 2017:83-102.

Bamford JT, Elliott BA, Haller IV. Tacrolimus effect on rosacea. J Am Acad Dermatol. 2004;50(1):107-108.[PubMed 14699377]

Corrocher G, Di Lorenzo G, Martinelli N, et al. Comparative effect of tacrolimus 0.1% ointment and clobetasol 0.05% ointment in patients with oral lichen planus. J Clin Periodontol. 2008;35(3):244-249.[PubMed 18269664]

Darsow U, Wollenberg A, Simon D, et al, "ETFAD/EADV Eczema Task Force 2009 Position Paper on Diagnosis and Treatment of Atopic Dermatitis," J Eur Acad Dermatol Venereol, 2010, 24(3):317-28.[PubMed 19732254]

Ehst BD and Warshaw EM, “Alcohol-Induced Application Site Erythema After Topical Immunomodulator Use and Its Inhibition by Aspirin,” Arch Dermatol, 2004, 140(8):1014-5.[PubMed 15313828]

Garg G, Thami GP. Clinical efficacy of tacrolimus in rosacea. J Eur Acad Dermatol Venereol. 2009;23(2):239-240.[PubMed 18498336]

Ghislain PD, De Decker I, Lachapelle JM. Efficacy and systemic absorption of topical tacrolimus used in pyoderma gangrenosum. Br J Dermatol. 2004;150(5):1052-1053.[PubMed 15149540]

Kalb RE, Bagel J, Korman NJ, et al; National Psoriasis Foundation. Treatment of intertriginous psoriasis: from the Medical Board of the National Psoriasis Foundation. J Am Acad Dermatol. 2009;60(1):120-124.[PubMed 19103363]

Laeijendecker R, Tank B, Dekker SK, Neumann HA. A comparison of treatment of oral lichen planus with topical tacrolimus and triamcinolone acetonide ointment. Acta Derm Venereol. 2006;86(3):227-229.[PubMed 16710580]

Lebwohl M, Freeman AK, Chapman MS, Feldman SR, Hartle JE, Henning A; Tacrolimus Ointment Study Group. Tacrolimus ointment is effective for facial and intertriginous psoriasis. J Am Acad Dermatol. 2004;51(5):723-730.[PubMed 15523350]

Lee JH, Kwon HS, Jung HM, et al. Treatment outcomes of topical calcineurin inhibitor therapy for patients with vitiligo: a systematic review and meta-analysis. JAMA Dermatol. 2019;155(8):929-938. doi: 10.1001/jamadermatol.2019.0696.[PubMed 31141108]

Liao YH, Chiu HC, Tseng YS, Tsai TF. Comparison of cutaneous tolerance and efficacy of calcitriol 3 microg g (-1) ointment and tacrolimus 0.3 mg g (-1) ointment in chronic plaque psoriasis involving facial or genitofemoral areas: a double-blind, randomized controlled trial. Br J Dermatol. 2007;157(5):1005-1012.[PubMed 17935517]

Lubbe J and Milingou M, “Images in Clinical Medicine. Tacrolimus Ointment, Alcohol, and Facial Flushing,” N Engl J Med, 2004, 351(26):2740.[PubMed 15616208]

Lyon CC, Stapleton M, Smith AJ, et al. Topical tacrolimus in the management of peristomal pyoderma gangrenosum. J Dermatolog Treat. 2001;12(1):13-17.[PubMed 12171681]

Majid I. Does topical tacrolimus ointment enhance the efficacy of narrowband ultraviolet B therapy in vitiligo? A left-right comparison study. Photodermatol Photoimmunol Photomed. 2010;26(5):230-234.[PubMed 20831696]

Menter A, Korman NJ, Elmets CA, et al, "Guidelines of Care for the Management of Psoriasis and Psoriatic Arthritis: Section 3. Guidelines of Care for the Management and Treatment of Psoriasis With Topical Therapies," J Am Acad Dermatol, 2009, 60(4):643-59.[PubMed 19217694]

Nordal EJ, Guleng GE, Rönnevig JR. Treatment of vitiligo with narrowband-UVB (TL01) combined with tacrolimus ointment (0.1%) vs. placebo ointment, a randomized right/left double-blind comparative study. J Eur Acad Dermatol Venereol. 2011;25(12):1440-1443.[PubMed 21466589]

Protopic (tacrolimus) [prescribing information]. Madison, NJ: LEO Pharma Inc.; February 2019.

Radakovic S, Breier-Maly J, Konschitzky R, et al. Response of vitiligo to once- vs. twice-daily topical tacrolimus: a controlled prospective, randomized, observer-blinded trial. J Eur Acad Dermatol Venereol. 2009;23(8):951-953.[PubMed 19496898]

Radfar L, Wild RC, Suresh L. A comparative treatment study of topical tacrolimus and clobetasol in oral lichen planus. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2008;105(2):187-193.[PubMed 18230389]

Schachner LA, Lamerson C, Sheehan MP, et al, "Tacrolimus Ointment 0.03% is Safe and Effective for the Treatment of Mild to Moderate Atopic Dermatitis in Pediatric Patients: Results From a Randomized, Double-Blind, Vehicle-Controlled Study," Pediatrics, 2005, 116(3):e334-42.[PubMed 16140675]

Schneider L, Tilles S, Lio P, et al. Atopic dermatitis: a practice parameter update 2012. J Allergy Clin Immunol. 2013;131(2):295-299.e1-27. doi: 10.1016/j.jaci.2012.12.672.[PubMed 23374261]

Stinco G, Piccirillo F, Forcione M, Valent F, Patrone P. An open randomized study to compare narrow band UVB, topical pimecrolimus and topical tacrolimus in the treatment of vitiligo. Eur J Dermatol. 2009;19(6):588-593.[PubMed 19651562]

Taieb A, Alomar A, Böhm M, et al; Vitiligo European Task Force (VETF); European Academy of Dermatology and Venereology (EADV); Union Européenne des Médecins Spécialistes (UEMS). Guidelines for the management of vitiligo: the European Dermatology Forum consensus. Br J Dermatol. 2013;168(1):5-19.[PubMed 22860621]

US Department of Health and Human Services; Centers for Disease Control and Prevention; National Institute for Occupational Safety and Health. NIOSH list of antineoplastic and other hazardous drugs in healthcare settings 2016. http://www.cdc.gov/niosh/topics/antineoplastic/pdf/hazardous-drugs-list_2016-161.pdf. Updated September 2016. Accessed October 5, 2016.

Brand Names: International

Cromus (CO, CR, DO, GT, HN, NI, PA, SV); Effac (TW); Limus (BD); Mustopic Oint (IN); Protopec (JO); Protopic (AE, AR, AT, BB, BE, BH, BR, CH, CL, CO, CY, CZ, DE, DK, EC, EE, ES, FI, FR, GB, GR, HK, HR, ID, IE, IL, IT, KR, KW, LT, LU, LV, MT, MY, NL, NO, PE, PH, PL, PT, QA, RO, RU, SA, SE, SG, SI, SK, TH, TR, TW, UA, UY, VE, VN); Protopis (IS); Protopy (AT, BE, CH, CZ, DE, DK, EE, FI, FR, GB, GR, IE, IT, MT, NL, PL, PT, RU, SE, SK, TR); Remus (BD, LK); Rocimus (LK, PH); Tacrol (BD, PK); Tacroz (LK, PH); Tacroz Forte (PH); Talimus (LK); Talymus (JP); Vitilimus (BD)

Last Updated 4/8/20