PROTOPIC (Tacrolimus)

What is this medication?

PROTOPIC (Tacrolimus)
Calcineurin Inhibitor, Immunosuppressant

PROTOPIC (Tacrolimus) is officially indicated for the treatment of atopic dermatitis.

ALERT: WARNING

Malignancy: 
Although a causal relationship has not been established, rare cases of malignancy (ie, skin cancer and lymphoma) have been reported in patients treated with topical calcineurin inhibitors, including tacrolimus ointment. Avoid continuous long-term use of topical calcineurin inhibitors, including tacrolimus ointment, in any age group, and limit application to areas of involvement with atopic dermatitis.

Pediatrics: Tacrolimus ointment is not indicated for use in children younger than 2 years of age. Only tacrolimus 0.03% ointment is indicated for use in children 2 to 15 years of age.

How does this medication work? 

PROTOPIC (Tacrolimus) 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.

How should I take this medication? 

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

How to Use Topical Tacrolimus, Protopic:  Apply a thin layer to the affected area twice daily.  Do not cover the areas with an occlusive dressing.  A local sensation of burning and redness is very commonly experienced during the first days to week when using Tacrolimus, Protopic.  Stop using when symptoms resolve and/or re-evaluate if symptoms still persist beyond 6 weeks. 

What should I watch for while using this medication? 

Higher risk of developing eczema herpeticum, varicella zoster, and herpes simplex

Associated with the development of lymphadenopathy, malignancy, skin papilloma

Do not use in immunocompromised patients

What if I miss a dose?

If you miss a dose of medication, try to take it as soon as possible. However, if it is almost time for your next dose, take only that scheduled dose. Do not take double or extra doses.

How should I store this medication?

Keep out of the reach of children at all times. Store at room temperature, 59 to 86° F (15 to 30° C). Protect from light, heat, and moisture. Keep the tube tightly closed. Properly dispose of any unused medication after the expiration date.

What are the possible side effects of using this medication?

The most common adverse reactions when using Tacrolimus, Protopic are associated with the central nervous system and the skin, specifically at the sites of application:

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.

Note this is not a complete list of side effects for PROTOPIC (Tacrolimus), only common ones.