Pimecrolimus

Name: Pimecrolimus

What are the side effects of pimecrolimus?

The most common side effects of pimecrolimus are:

  • reactions at the site of application,
  • burning,
  • itching, and
  • redness.

Other important side effects include:

  • sore throat,
  • stuffy nose,
  • headache,
  • cough,
  • respiratory tract and
  • viral infections.

Skin cancer and lymphoma have rarely occurred during treatment with pimecrolimus. Therefore, pimecrolimus should not be used for long-term treatment and should only be applied to affected areas.

What else should I know about pimecrolimus?

What preparations of pimecrolimus are available?

Cream, 1%

How should I keep pimecrolimus stored?

Pimecrolimus should be stored at room temperature, 15 C - 30 C (59 F - 86 F).

Pimecrolimus and Pregnancy

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Pimecrolimus falls into category C. In animal studies, pimecrolimus did not cause any problems when it was applied topically on the skin of pregnant animals. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

 

Pimecrolimus and Lactation

It is not known if pimecrolimus crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using pimecrolimus.

 

Pimecrolimus Overdose

If you use too much pimecrolimus, contact your local Poison Control Center or seek emergency medical attention right away.

Uses for Pimecrolimus

Atopic Dermatitis

Second-line therapy for short-term treatment and noncontinuous chronic treatment of mild to moderate atopic dermatitis (eczema) in immunocompetent adults and children ≥2 years of age who are unable to tolerate or have not responded to first-line therapies (e.g., corticosteroids) or for whom first-line therapies are inadvisable.3 5 6 12 a c (See Carcinogenicity under Cautions.)

Not indicated for use in children <2 years of age.a c

Pimecrolimus Dosage and Administration

Administration

Topical Administration

Apply topically to the skin as a 1% cream.1 For external use only; do not use in the eyes or ingest.1

Apply in thin layers to affected areas of skin.a

Use minimum amount required to control symptoms;12 limit application to areas affected with atopic dermatitis.a (See Carcinogenicity under Cautions.)

Do not use occlusive dressings or wrappings.1

Dosage

Pediatric Patients

Atopic Dermatitis Topical

Children ≥2 years of age: Apply to affected areas twice daily.1

Treatment effects usually evident within 15 days; erythema and infiltration or papulation generally reduced within 8 days.1 3 4 Discontinue treatment following resolution of signs and symptoms (e.g., pruritus, rash, erythema).a If manifestations persist beyond 6 weeks, reexamine patient and confirm diagnosis.a

Adults

Atopic Dermatitis Topical

Apply to affected areas twice daily.1

Treatment effects usually evident within 15 days; erythema and infiltration or papulation generally reduced within 8 days.1 3 4 Discontinue treatment following resolution of signs and symptoms (e.g., pruritus, rash, erythema).a If manifestations persist beyond 6 weeks, reexamine patient and confirm diagnosis.a

Prescribing Limits

Pediatric Patients

Atopic Dermatitis Topical

For short-term and intermittent use only; avoid continuous long-term use.12 a Safety of noncontinuous use for >1 year not established.12 a c (See Carcinogenicity under Cautions.)

Adults

Atopic Dermatitis Topical

For short-term and intermittent use only; avoid continuous long-term use.12 a Safety of noncontinuous use for >1 year not established.12 a c (See Carcinogenicity under Cautions.)

Actions

  • Exact mechanism(s) of immunosuppressive action in the treatment of atopic dermatitis not known; appears to involve inhibition of T cell activation.1 3 7

  • Not genotoxic and does not interact directly with DNA; however, may impair local immunosurveillance.14

  • In vitro studies indicate pimecrolimus prevents release of inflammatory mediators from mast cells.1 3 7 11

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
  • Signs of skin infection like oozing, heat, swelling, redness, or pain.
  • Swollen gland.
  • Warts.
  • Cold sores.
  • Very bad burning or burning that does not go away.
  • Very bad irritation where this medicine is used.
  • Skin ulcers.
  • A skin lump or growth.
  • Change in color or size of a mole.

Dosing Adult

Atopic dermatitis (mild to moderate): Topical: Apply thin layer to affected area twice daily. Note: Limit application to involved areas. Discontinue use when symptoms have resolved; re-evaluate if symptoms persist >6 weeks.

Oral lichen planus (off-label use): Topical: Apply twice daily for 1 month (Passeron 2007; Swift 2005; Volz 2008)

Psoriasis (off-label use): Topical: Apply twice daily (Gribetz 2004; Menter 2009)

Vitiligo (off-label use): Topical: Apply twice daily for 6 months. Treatment beyond 12 months may be useful; long-term safety has not been established. (Esfandiarpour 2009; Stinco 2009; Taieb 2013)

Drug Interactions

CYP3A4 Inhibitors (Moderate): May decrease the metabolism of Pimecrolimus. Monitor therapy

CYP3A4 Inhibitors (Strong): May decrease the metabolism of Pimecrolimus. Monitor therapy

Immunosuppressants: Pimecrolimus may enhance the adverse/toxic effect of Immunosuppressants. Exceptions: Cytarabine (Liposomal). Avoid combination

In Summary

Commonly reported side effects of pimecrolimus topical include: application site reaction and localized burning. Other side effects include: local irritation and local pruritus. See below for a comprehensive list of adverse effects.

Renal Dose Adjustments

Data not available

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