Elidel (Pimecrolimus) is a calcineurin inhibitor for topical application. It inhibits the activation of T-cells in the epidermis of the skin when applied topically.

Elidel (Pimecrolimus) Uses:

• Atopic dermatitis:
  • It is recommended as a second-line therapy for the short-term continuous treatment or long-term non-continuous treatment of mild to moderate atopic dermatitis in non-immuno-compromised patients older than 2 years of age who have not responded to other topical treatments or when other treatments are not possible.
• Use: Off-Label: Adult
  • Oral lichen planus
  • Vitiligo
  • Intertriginous and facial psoriasis

Other calcineurin inhibitors include: Tacrolimus, sirolimus, temsirolimus, and everolimus

Elidel (Pimecrolimus) Dose in  Adults

Elidel (Pimecrolimus) Dose in the treatment of mild to moderate Atopic dermatitis:

• Apply a small coating twice a day to the afflicted region.
• Just apply the medication to the afflicted regions.
• As soon as the symptoms disappear, stop the medication.
• If no progress is shown after six weeks of therapy, reassess and reevaluate the patient.

Elidel (Pimecrolimus) Dose in the treatment of oral lichen planus (off-label):

• Apply over the affected area twice daily for one month.

Elidel (Pimecrolimus) Dose in the treatment of Psoriasis (off-label):

• Apply twice daily over the affected area.

Elidel (Pimecrolimus) Dose in the treatment of Vitiligo (off-label):

• Apply for six months, twice each day.
• Although a 12-month course of therapy could be beneficial, the drug's long-term safety has not been shown.

Elidel (Pimecrolimus) Dose in Childrens

Elidel (Pimecrolimus) Dose in the treatment of mild to moderate atopic dermatitis:

• Children over 2 years and Adolescents:
  • Apply topically twice a day in a thin coating over the afflicted region.
  • Ensure that you only apply to the impacted region.
  • If after six weeks of therapy there is still no sign of change, re-evaluate and re-assess the patient.
  • When the symptoms go away, stop.

Pregnancy Risk Factor C

• The topical application of topical creams did not cause adverse reactions in animal reproduction studies.

Pimecrolimus use during breastfeeding:

• It is unknown if the drug will be excreted into breastmilk.
• Manufacturers recommend that you stop breastfeeding, or that you use the drug. This is based on the risk and benefits of drug-exposure to your infant.

Elidel (Pimecrolimus) dose in kidney disease:

The manufacturer has not recommended any adjustments in the dose in patients with renal disease.   

Elidel (Pimecrolimus) dose in liver impairment:

The manufacturer has not recommended any adjustments in the dose in patients with liver disease.   

Common Side Effects of Elidel (Pimecrolimus):

• Central Nervous System:
  • Headache
  • Fever
• Infection:
  • Influenza
• Local:
  • Local Burning
  • Application Site Reaction
• Respiratory:
  • Nasopharyngitis
  • Upper Respiratory Tract Infection
  • Cough
  • Bronchitis

Less Common Side Effects Of Elidel (Pimecrolimus):

• Dermatologic:
  • Acne Vulgaris
  • Herpes Simplex Dermatitis
  • Folliculitis
  • Skin Infection
  • Impetigo
  • Warts
  • Molluscum Contagiosum
  • Urticaria
• Gastrointestinal:
  • Constipation
  • Abdominal Pain
  • Diarrhea
  • Gastroenteritis
  • Vomiting
  • Toothache
  • Nausea
• Infection:
  • Staphylococcal Infection
  • Varicella
  • Viral Infection
  • Herpes Simplex Infection
  • Bacterial Infection
• Genitourinary:
  • Dysmenorrhea
• Hypersensitivity:
  • Hypersensitivity
• Local:
  • Local Irritation
  • Local Pruritus
  • Localized Erythema
• Neuromuscular & Skeletal:
  • Arthralgia
  • Back Pain
• Otic:
  • Otic Infection
  • Otitis Media
• Ocular:
  • Conjunctivitis
  • Eye Infection
• Respiratory:
  • Sore Throat
  • Pharyngitis
  • Tonsillitis
  • Asthma
  • Asthma Aggravated
  • Streptococcal Pharyngitis
  • Nasal Congestion
  • Sinusitis
  • Epistaxis
  • Dyspnea
  • Flu-Like Symptoms
  • Pneumonia
  • Rhinitis
  • Rhinorrhea
  • Viral Upper Respiratory Tract Infection
  • Wheezing
• Miscellaneous:
  • Laceration

Contraindications to Elidel (Pimecrolimus):

Allergy or sensitivity to pimecrolimus, any component of the formulation

Warnings and precautions

• Infection
  • Patients with atopic dermatology are at greater risk for skin infections. Pimecrolimus, which can also be used to treat atopic dermatitis, may increase the likelihood of skin infections like varicella-zoster and eczema.
  • Treat the local infection first before beginning medication.
  • Do not apply the medication to locations where there are active viral and bacterial illnesses.
• Local symptoms
  • In the first few days, local symptoms like burning, pruritus and stinging can be resolved by self-treatment. These symptoms may resolve as the lesions heal.
• Lymphadenopathy:
  • It could be linked to lymphadenopathy. If lymphadenopathy is suspected, it is important to investigate infectious causes immediately.
  • Patients with infectious mononucleosis and patients suffering from lymphadenopathy may have to stop receiving treatment.
• Malignancy: [US Boxed Warning]
  • Patients with premalignant or malignant skin conditions, such as cutaneous T cell lymphoma, should not be given pimecrolimus or other calcineurin inhibitors.
  • Rare cases of skin cancers and lymphomas have been linked to its use.
• Skin papilloma
  • Pimecrolimus treatment may lead to the worsening or development of skin papilloma.
  • If the condition is getting worse or the papillomas are not responding to standard treatment, discontinue the treatment.
• Atopic dermatitis:
  • If clinical improvement does not occur within six weeks after treatment, discontinue the use of the product.
• Erythroderma
  • Pimecrolimus safety has not been proven safe in patients with generalized acne. Avoid using it.
• Systemic absorption may be increased by skin diseases
  • It should not be used by anyone who has Netherton's syndrome or any other skin problems.

Pimecrolimus: Drug Interaction

Monitor:

• Monitor the response to therapy.
• Re-evaluate if no improvement is noted within six weeks of the treatment.   

How to administer Elidel (Pimecrolimus)?

• Wash hands before and after applying for the medicine.
• A thin layer should be applied to the affected skin.
• Apply only to the area affected. Avoid applying occlusive dressings.
• Treatment with pimecrolimus may cause a burning sensation initially that improves when the condition starts to settle.
• If the symptoms persist beyond six weeks, re-evaluate the patient.
• Moisturizers may be applied over the area.

Oral lichen planus:

• To the oral mucosa that is impacted, use pimecrolimus.
• In order to prevent the medication from being diluted by saliva, cover it with a thin layer of gauze.
• After applying the medication, wait at least 30 minutes before eating, chewing, or drinking anything.

Mechanism of action of Elidel (Pimecrolimus):

• Pimecrolimus blocks the activation of T-cells in epidermis by inhibiting transcription of T-cell activating proinflammatory cytokine gene genes like IL-2, IL-4 and IL-10. It inhibits calcineurin binding to intracellular protein FKBP-12.
• This blocks the transcription of cytokines, and inhibits T cell activation.
• When stimulated with antigens/ IgE, it also stops the release of inflammatory mediators from mast cells.

The beginning of action:

• For significant improvements to be seen, it takes around eight days.

Absorption:

• It is very absorbent when applied topically.
• The drug was administered to treat atopic dermatitis and the blood concentration was not more than 2 ng/ml, despite the fact that the drug had a body surface area of 13-62 percent.
• Because of the large body surface area and high body mass, blood concentrations can be higher in pediatric patients.

Protein binding:

• The majority of the drug's 99.5% protein binding is to lipoproteins.

Metabolism:

• It is metabolized by the liver via cytochrome (CYP) P450 3A4

Excretion:

• Feces (78.4% as metabolites; <1% as unchanged drug)

Half-life elimination:

• Terminal half-life after oral administration is about 30 to 40 hours.

Time to peak serum concentration when applied topically:

• two to six hours

International Brands of Pimecrolimus:

• Elidel
• Pimecroderm
• Pimoroyal

Pimecrolimus Brand Names in Pakistan:

No Brands Available in Pakistan.