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Atopic Dermatitis

Introduction DUPIXENT ® (dupilumab) injection
EUCRISA™ (crisaborole) ointment pimecrolimus (Elidel ®)
tacrolimus (Protopic ®) --®
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Intro top of page

Incidence and Prevalence of Atopic Dermatitis
[More than 15 million people in the U.S. have symptoms of atopic dermatitis.]

Atopic dermatitis is very common. It affects males and females and accounts for 10 to 20 percent of all visits to dermatologists (doctors who specialize in the care and treatment of skin diseases). Although atopic dermatitis may occur at any age, it most often begins in infancy and childhood. Scientists estimate that 65 percent of patients develop symptoms in the first year of life, and 90 percent develop symptoms before the age of 5. Onset after age 30 is less common and is often due to exposure of the skin to harsh or wet conditions. Atopic dermatitis is a common cause of workplace disability. People who live in cities and in dry climates appear more likely to develop this condition.


Although it is difficult to identify exactly how many people are affected by atopic dermatitis, an estimated 20 percent of infants and young children experience symptoms of the disease.

Source / Read more: http://www.niams.nih.gov/Health_Info/Atopic_Dermatitis/default.asp

Other agents to be added during next update.....

DUPIXENT ® (dupilumab) injection  top of page


Drug UPDATES:  DUPIXENT ® (dupilumab) injection
[Drug information  /  PDF]     REVIEW PACKAGE INSERT FOR POSSIBLE UPDATES
PACKAGE INSERT -Dosing:  Click (+) next to Dosage and Administration section (drug info link)

Initial U.S. Approval:  2017

Mechanism of Action:
Dupilumab is a human monoclonal IgG4 antibody that inhibits interleukin-4 (IL-4) and interleukin-13 (IL-13) signaling by specifically binding to the IL-4Rα subunit shared by the IL-4 and IL-13 receptor complexes. Dupilumab inhibits IL-4 signaling via the Type I receptor and both IL-4 and IL-13 signaling through the Type II receptor.

Blocking IL-4Rα with dupilumab inhibits IL-4 and IL-13 cytokine-induced responses, including the release of proinflammatory cytokines, chemokines and IgE.

INDICATIONS AND USAGE:
DUPIXENT is an interleukin-4 receptor alpha antagonist indicated for the treatment of adult patients with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. DUPIXENT can be used with or without topical corticosteroids.

DOSAGE AND ADMINISTRATION: PDF
2.1 Dosage
DUPIXENT is administered by subcutaneous injection.

The recommended dose of DUPIXENT for adult patients is an initial dose of 600 mg (two 300 mg injections), followed by 300 mg given every other week.

DUPIXENT can be used with or without topical corticosteroids. Topical calcineurin inhibitors may be used, but should be reserved for problem areas only, such as the face, neck, intertriginous and genital areas.

If a dose is missed, instruct the patient to administer the injection within 7 days from the missed dose and then resume the patient's original schedule. If the missed dose is not administered within 7 days, instruct the patient to wait until the next dose on the original schedule.

2.2 Important Administration Instructions
DUPIXENT is intended for use under the guidance of a healthcare provider. A patient may self-inject DUPIXENT after training in subcutaneous injection technique using the pre-filled syringe. Provide proper training to patients and/or caregivers on the preparation and administration of DUPIXENT prior to use according to the "Instructions for Use".

For the initial 600 mg dose, administer each of the two DUPIXENT 300 mg injections at different injection sites.

Administer subcutaneous injection into the thigh or abdomen, except for the 2 inches (5 cm) around the navel. The upper arm can also be used if a caregiver administers the injection.

Rotate the injection site with each injection. DO NOT inject DUPIXENT into skin that is tender, damaged, bruised, or scarred.

The DUPIXENT "Instructions for Use" contains more detailed instructions on the preparation and administration of DUPIXENT [see INSTRUCTIONS FOR USE].

2.3 Preparation for Use of DUPIXENT Pre-filled Syringe With Needle Shield
Before injection, remove DUPIXENT pre-filled syringe from the refrigerator and allow DUPIXENT to reach room temperature (45 minutes) without removing the needle cap.

Inspect DUPIXENT visually for particulate matter and discoloration prior to administration. DUPIXENT is a clear to slightly opalescent, colorless to pale yellow solution. Do not use if the liquid contains visible particulate matter, is discolored or cloudy (other than clear to slightly opalescent, colorless to pale yellow). DUPIXENT does not contain preservatives; therefore, discard any unused product remaining in the pre-filled syringe.

HOW SUPPLIED:
Injection: 300 mg/2 mL solution in a single-dose pre-filled syringe with needle shield


EUCRISA™ (crisaborole) ointment, 2%, for topical use  top of page



Drug UPDATES:  EUCRISA™ (crisaborole) ointment, 2%, for topical use
[Drug information  /  PDF]    REVIEW PACKAGE INSERT FOR POSSIBLE UPDATES
PACKAGE INSERT -Dosing:  Click (+) next to Dosage and Administration section (drug info link)

Initial U.S. Approval:  2016

Mechanism of Action:
Crisaborole is a phosphodiesterase 4 (PDE-4) inhibitor. PDE-4 inhibition results in increased intracellular cyclic adenosine monophosphate (cAMP) levels. The specific mechanism(s) by which crisaborole exerts its therapeutic action for the treatment of atopic dermatitis is not well defined.

INDICATIONS AND USAGE:
EUCRISA is a phosphodiesterase 4 inhibitor indicated for topical treatment of mild to moderate atopic dermatitis in patients 2 years of age and older.

WARNINGS AND PRECAUTIONS
Hypersensitivity reactions: If signs and symptoms of hypersensitivity occur, discontinue EUCRISA immediately and initiate appropriate therapy.

DOSAGE AND ADMINISTRATION:
Apply a thin layer twice daily to affected areas.
For topical use only
Not for ophthalmic, oral, or intravaginal use.

HOW SUPPLIED:
EUCRISA is a white to off-white ointment containing 2% crisaborole and is supplied in 60 g and 100 g laminate tubes.




pimecrolimus  (Elidel ®):  top of page

Mechanism of Action/Pharmacodynamics
The mechanism of action of pimecrolimus in atopic dermatitis is not known. While the following have been observed, the clinical significance of these observations in atopic dermatitis is not known. It has been demonstrated that pimecrolimus binds with high affinity to macrophilin-12 (FKBP-12) and inhibits the calcium-dependent phosphatase, calcineurin. As a consequence, it inhibits T cell activation by blocking the transcription of early cytokines. In particular, pimecrolimus inhibits at nanomolar concentrations Interleukin-2 and interferon gamma (Th1-type) and Interleukin-4 and Interleukin-10 (Th2-type) cytokine synthesis in human T cells. In addition, pimecrolimus prevents the release of inflammatory cytokines and mediators from mast cells in vitro after stimulation by antigen/IgE.


INDICATIONS:
ELIDEL® (pimecrolimus) Cream 1% is indicated as second-line therapy for the short- term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non- immunocompromised adults and children 2 years of age and older, who have failed to respond adequately to other topical prescription treatments, or when those treatments are not advisable.

ELIDEL Cream is not indicated for use in children less than 2 years of age


DOSAGE AND ADMINISTRATION
The patient or care giver should apply a thin layer of ELIDEL® (pimecrolimus) Cream 1% to the affected skin twice daily. The patient or caregiver should stop using when signs and symptoms (e.g., itch, rash and redness) resolve and should be instructed on what actions to take if symptoms recur.

If signs and symptoms persist beyond 6 weeks, patients should be re-examined by their health care provider to confirm the diagnosis of atopic dermatitis.

Continuous long-term use of ELIDEL Cream should be avoided, and application should be limited to areas of involvement with atopic dermatitis.

The safety of ELIDEL Cream under occlusion, which may promote systemic exposure, has not been evaluated. ELIDEL Cream should not be used with occlusive dressings.

SUPPLIED:
Cream, topical: 1% (30 g, 60 g, 100 g)

tacrolimus (Protopic ®): top of page

Mechanism of Action
Tacrolimus prolongs the survival of the host and transplanted graft in animal transplant models of liver, kidney, heart, bone marrow, small bowel and pancreas, lung and trachea, skin, cornea, and limb.

In animals, tacrolimus has been demonstrated to suppress some humoral immunity and, to a greater extent, cell-mediated reactions such as allograft rejection, delayed type hypersensitivity, collagen-induced arthritis, experimental allergic encephalomyelitis, and graft versus host disease.

Tacrolimus inhibits T-lymphocyte activation, although the exact mechanism of action is not known. Experimental evidence suggests that tacrolimus binds to an intracellular protein, FKBP-12. A complex of tacrolimus-FKBP-12, calcium, calmodulin, and calcineurin is then formed and the phosphatase activity of calcineurin inhibited. This effect may prevent the dephosphorylation and translocation of nuclear factor of activated T-cells (NF-AT), a nuclear component thought to initiate gene transcription for the formation of lymphokines (such as interleukin-2, gamma interferon). The net result is the inhibition of T-lymphocyte activation (i.e., immunosuppression).


INDICATIONS:
PROTOPIC Ointment, both 0.03% and 0.1% for adults, and only 0.03% for children aged 2 to 15 years, is indicated as second-line therapyfor the short-term and non-continuous chronic treatment of moderate to severe atopic dermatitis in non-immunocompromised adults and children who have failed to respond adequately to other topical prescription treatments for atopic dermatitis, or when those treatments are not advisable.

PROTOPIC Ointment is not indicated for children younger than 2 years of age

DOSAGE AND ADMINISTRATION
Adult
PROTOPIC Ointment 0.03% and 0.1%

Apply a thin layer of PROTOPIC (tacrolimus) Ointment to the affected skin twice daily. The minimum amount should be rubbed in gently and completely to control signs and symptoms of atopic dermatitis. Stop using when signs and symptoms of atopic dermatitis resolve.

If signs and symptoms (e.g. itch, rash, and redness) do not improve within 6 weeks, patients should be re-examined by their healthcare provider to confirm the diagnosis of atopic dermatitis.

Continuous long-term use of topical calcineurin inhibitors, including PROTOPIC Ointment should be avoided, and application should be limited to areas of involvement with atopic dermatitis. The safety of PROTOPIC Ointment under occlusion, which may promote systemic exposure, has not been evaluated. PROTOPIC Ointment should not be used with occlusive dressings.


PEDIATRIC - FOR CHILDREN 2-15 YEARS
PROTOPIC Ointment 0.03%

Apply a thin layer of PROTOPIC (tacrolimus) Ointment, 0.03% to the affected skin twice daily. The minimum amount should be rubbed in gently and completely to control signs and symptoms of atopic dermatitis. Stop using when signs and symptoms of atopic dermatitis resolve.

If signs and symptoms (e.g. itch, rash, and redness) do not improve within 6 weeks, patients should be re-examined by their healthcare provider to confirm the diagnosis of atopic dermatitis.

Continuous long-term use of topical calcineurin inhibitors, including PROTOPIC Ointment should be avoided, and application should be limited to areas of involvement with atopic dermatitis.

The safety of PROTOPIC Ointment under occlusion, which may promote systemic exposure, has not been evaluated. PROTOPIC Ointment should not be used with occlusive dressings.

Supplied: Ointment (0.03% and 0.1% for adults, and only 0.03% for children aged 2 to 15 years).
 

Reference(s)

National Institutes of Health, U.S. National Library of Medicine, DailyMed Database.
Provides access to the latest drug monographs submitted to the Food and Drug Administration (FDA). Please review the latest applicable package insert for additional information and possible updates.  A local search option of this data can be found here.

Disclaimer

Listed dosages are for - Adult patients ONLY. PLEASE READ THE DISCLAIMER CAREFULLY BEFORE ACCESSING OR USING THIS SITE. BY ACCESSING OR USING THIS SITE, YOU AGREE TO BE BOUND BY THE TERMS AND CONDITIONS SET FORTH IN THE DISCLAIMER. GlobalRPH does not directly or indirectly practice medicine or provide medical services and therefore assumes no liability whatsoever of any kind for the information and data accessed through the Service or for any diagnosis or treatment made in reliance thereon.

David F. McAuley, Pharm.D., R.Ph.  GlobalRPh Inc.
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