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Protopic ® (tacrolimus) Ointment. Fujisawa Healthcare, Inc. February 15, 2005. Amy Paller, MD Professor & Chair, Dermatology Professor of Pediatrics Feinberg School of Medicine Northwestern University. M. Joyce Rico, MD Senior Medical Director Fujisawa Healthcare, Inc.

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Protopic ® (tacrolimus) Ointment

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protopic tacrolimus ointment

Protopic® (tacrolimus) Ointment

Fujisawa Healthcare, Inc.

February 15, 2005

Amy Paller, MD

Professor & Chair, Dermatology

Professor of Pediatrics

Feinberg School of Medicine

Northwestern University

M. Joyce Rico, MD

Senior Medical Director

Fujisawa Healthcare, Inc

atopic dermatitis
Atopic Dermatitis
  • Intensely itchy, painful relapsing inflammatory skin disease
  • Affects up to 20% of school age children
  • Serious impact on quality of life
    • Lack of sleep
    • Function at school, work
    • Social impairment
atopic dermatitis3
Atopic Dermatitis
  • Higher rate of infections
    • Bacteria, herpes
  • Higher risk of asthma
  • Cutaneous T cell lymphoma (CTCL) is often misdiagnosed as atopic dermatitis
need for treatment options
Need For Treatment Options
  • Protopic and Elidel are the only non-steroidal topical options for AD treatment
  • Treatment options vary with different patient populations
    • Not every drug/treatment works for all patients
    • Some treatments may be contraindicated or not well tolerated
treatment options in ad
Treatment Options in AD

Mild Moderate Severe

Topical Steroids



Oral Steroids

Light treatment

Cyclosporine, mycophenolate

topical calcineurin inhibitors
Topical Calcineurin Inhibitors
  • Protopic and Elidel:
    • Differ in vehicle and indicated patient population
      • Protopic: moderate-severe AD
      • Elidel: mild-moderate AD
    • Similar safety profile in the same patient populations
  • Important therapeutic option
  • Protopic is an important and effective treatment alternative for patients with moderate to severe AD
  • There is no evidence of systemic immune suppression or increased risk of malignancies
protopic safety and efficacy
Protopic Safety and Efficacy
  • Protopic is an important, safe and effective therapeutic option for patients with moderate-severe AD
    • Treatment options are limited
  • In extensive clinical trials (>19,000 patients treated, 7600 pediatric patients):
    • No increased risk of systemic infection
    • No increased risk of malignancy
    • No impairment of systemic immune response
minimal systemic exposure
Minimal Systemic Exposure
  • Minimal absorption after topical application of Protopic
    • Most patients have blood levels < 0.5 ng/mL
    • Absolute bioavailability is approximately 0.5%
  • No systemic accumulation
    • When detected, blood levels are transient
  • Because there is minimal systemic absorption, the likelihood of systemic infection or malignancy is remote.
ods post marketing analysis
ODS Post-marketing Analysis
  • Serious adverse events in patients <2 years
    • 10 reports
    • All except septicemia are in current labeling
  • Malignancy related reports
    • Globally, there have been 19 post-marketing malignancy related adverse events
    • A causal relationship has not been established
malignancy risk evaluation
Malignancy Risk Evaluation
  • Malignancies identified from transplant experience
    • Lymphoma (Post-transplant lymphoproliferative disease)
    • Non-Melanoma Skin Cancer (NMSC)
  • Malignancy rates in general US population:
    • Lymphoma 22 / 100,000 (SEER)
    • NMSC 533/100,000 (PHS)
  • Malignancies reported in 1.7M Protopic treated US patients
    • Lymphoma 11 ( including 6 CTCL)
    • NMSC 16
  • There are no lymphomas or NMSC in patients <16 years

There is no increased rate of malignancy for patients treated with Protopic compared with the expected rates in the population.

labeling considerations
Labeling Considerations
  • Protopic labeling contains appropriate precautions
  • Evidence does not indicate immune suppression or an increased risk of associated diseases
  • If changes to current labeling for this class are recommended:
    • Information should reflect current scientific knowledge
    • Information should balance risks and benefits
  • AD is a serious, life-altering disease; treatment options are important
  • Topical calcineurin inhibitors are safe and effective treatments
    • Extensive clinical and post-marketing experience
    • No increased risk of systemic infection or malignancy
  • Fujisawa is committed to the safety of patients and appropriate communication with patients, parents and healthcare providers.
external consultants
External Consultants
  • Samuel Cohen, MD, PhD

U of Nebraska Medical Center, Dept of Pathology & Microbiology

  • Michael Green, MD, MPH

U of Pittsburgh, Dept of Pediatrics

  • Peter Heald, MD

Yale University, Dept of Dermatology

  • Annette Stemhagen, DrPH, FISPE

Covance Periapproval Services, Epidemiologist