Pimecrolimus (Elidel)

Trade Name : ELIDEL

Valeant Pharmaceuticals North America LLC

CREAM

Strength 10 mg/g

PIMECROLIMUS Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Pimecrolimus (Elidel) which is also known as ELIDEL and Manufactured by Valeant Pharmaceuticals North America LLC. It is available in strength of 10 mg/g per ml. Read more

Pimecrolimus (Elidel) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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WARNING: LONG-TERM SAFETY OF TOPICAL CALCINEURIN INHIBITORS HAS NOT BEEN ESTABLISHED
See full prescribing information for complete boxed warning.

Continuous long-term use of topical calcineurin inhibitors, including ELIDEL Cream, 1%, in any age group should be avoided and application limited to areas of involvement with atopic dermatitis. (, )
ELIDEL Cream, 1% is not indicated for use in children less than 2 years of age. (, , )

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, 1% is not indicated for use in children less than 2 years of agen- Array
ELIDEL Cream, 1% is a calcineurin inhibitor immunosuppressant 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. ()

Apply a thin layer of ELIDEL Cream, 1% to the affected skin twice daily. The patient should stop using ELIDEL Cream, 1% 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 healthcare provider to confirm the diagnosis of atopic dermatitis.
Continuous long-term use of ELIDEL Cream, 1% should be avoided, and application should be limited to areas of involvement with atopic dermatitis [see ].
The safety of ELIDEL Cream, 1% under occlusion, which may promote systemic exposure, has not been evaluated. Avoid use of ELIDEL Cream, 1% with occlusive dressings.

Cream, 1%.
Each gram of ELIDEL Cream, 1% contains 10 mg of pimecrolimus in a whitish cream base.
Cream, 1%. ()

ELIDEL Cream, 1% is contraindicated in individuals with a history of hypersensitivity to pimecrolimus or any of the components of the cream.
ELIDEL Cream, 1% is contraindicated in individuals with a history of hypersensitivity to pimecrolimus or any of the components of the cream. (, )

No data

The most commonly reported adverse reactions (u22651%) were application site burning, headache, nasopharyngitis, cough, influenza, pyrexia and viral infection. ()
To report SUSPECTED ADVERSE REACTIONS, contact Valeant Pharmaceuticals North America LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Potential interactions between ELIDEL Cream, 1% and other drugs, including immunizations, have not been systematically evaluated. Due to low blood levels of pimecrolimus detected in some patients after topical application, systemic drug interactions are not expected, but cannot be ruled out. The concomitant administration of known CYP3A family of inhibitors in patients with widespread and/or erythrodermic disease should be done with caution. Some examples of such drugs are erythromycin, itraconazole, ketoconazole, fluconazole, calcium channel blockers and cimetidine.

No data

ELIDEL Cream, 1%, for topical use, contains the compound pimecrolimus, the immunosuppressant 33-epi-chloro-derivative of the macrolactam ascomycin.
Chemically, pimecrolimus is (1R,9S,12S,13R,14S,17R,18E,21S,23S,24R,25S,27R)-12-[(1E)-2-{(1R,3R,4S)-4-chloro-3-methoxycyclohexyl}-1-methylvinyl]-17-ethyl-1, 14-dihydroxy-23,25-dimethoxy-13,19,21,27-tetramethyl-11,28-dioxa-4-aza-tricyclo[22.3.1.04,9]octacos-18-ene-2,3,10,16-tetraone. The compound has the empirical formula CHClNO and the molecular weight of 810.47. The structural formula is:
Pimecrolimus is a white to off-white fine crystalline powder. It is soluble in methanol and ethanol and insoluble in water.
Each gram of ELIDEL Cream, 1% contains 10 mg of pimecrolimus in a whitish cream base of benzyl alcohol, cetyl alcohol, citric acid anhydrous, mono- and diglycerides, oleyl alcohol, propylene glycol, sodium cetostearyl sulphate, sodium hydroxide, stearyl alcohol, triglycerides and water.

No data

In a 2-year rat dermal carcinogenicity study using ELIDEL Cream, 1%, a statistically significant increase in the incidence of follicular cell adenoma of the thyroid was noted in low, mid and high dose male animals compared to vehicle and saline control male animals. Follicular cell adenoma of the thyroid was noted in the dermal rat carcinogenicity study at the lowest dose of 2 mg/kg/day [0.2% pimecrolimus cream; 1.5X the Maximum Recommended Human Dose (MRHD) based on AUC comparisons]. No increase in the incidence of follicular cell adenoma of the thyroid was noted in the oral carcinogenicity study in male rats up to 10 mg/kg/day (66X MRHD based on AUC comparisons). However, oral studies may not reflect continuous exposure or the same metabolic profile as by the dermal route. In a mouse dermal carcinogenicity study using pimecrolimus in an ethanolic solution, no increase in incidence of neoplasms was observed in the skin or other organs up to the highest dose of 4 mg/kg/day (0.32% pimecrolimus in ethanol) 27X MRHD based on AUC comparisons. However, lymphoproliferative changes (including lymphoma) were noted in a 13-week repeat dose dermal toxicity study conducted in mice using pimecrolimus in an ethanolic solution at a dose of 25 mg/kg/day (47X MRHD based on AUC comparisons). No lymphoproliferative changes were noted in this study at a dose of 10 mg/kg/day (17X MRHD based on AUC comparison). However, the latency time to lymphoma formation was shortened to 8 weeks after dermal administration of pimecrolimus dissolved in ethanol at a dose of 100 mg/kg/day (179-217X MRHD based on AUC comparisons).
In a mouse oral (gavage) carcinogenicity study, a statistically significant increase in the incidence of lymphoma was noted in high dose male and female animals compared to vehicle control male and female animals. Lymphomas were noted in the oral mouse carcinogenicity study at a dose of 45 mg/kg/day (258-340X MRHD based on AUC comparisons). No drug-related tumors were noted in the mouse oral carcinogenicity study at a dose of 15 mg/kg/day (60-133X MRHD based on AUC comparisons).
In an oral (gavage) rat carcinogenicity study, a statistically significant increase in the incidence of benign thymoma was noted in 10 mg/kg/day pimecrolimus treated male and female animals compared to vehicle control treated male and female animals. In addition, a significant increase in the incidence of benign thymoma was noted in another oral (gavage) rat carcinogenicity study in 5 mg/kg/day pimecrolimus treated male animals compared to vehicle control treated male animals. No drug-related tumors were noted in the rat oral carcinogenicity study at a dose of 1 mg/kg/day male animals (1.1X MRHD based on AUC comparisons) and at a dose of 5 mg/kg/day for female animals (21X MRHD based on AUC comparisons).
In a 52-week dermal photocarcinogenicity study, the median time to onset of skin tumor formation was decreased in hairless mice following chronic topical dosing with concurrent exposure to UV radiation (40 weeks of treatment followed by 12 weeks of observation) with the ELIDEL Cream, 1% vehicle alone. No additional effect on tumor development beyond the vehicle effect was noted with the addition of the active ingredient, pimecrolimus, to the vehicle cream.
A 39-week oral monkey toxicology study was conducted with pimecrolimus doses of 15, 45 and 120 mg/kg/day. A dose-dependent increase in expression of immunosuppressive-related lymphoproliferative disorder (IRLD) associated with lymphocryptovirus (a monkey strain of virus related to human Epstein Barr virus) was observed. IRLD in monkeys mirrors what has been noted in human transplant patients after chronic systemic immunosuppressive therapy, post-transplantation lymphoproliferative disease (PTLD), after treatment with chronic systemic immunosuppressive therapy. Both IRLD and PTLD can progress to lymphoma, which is dependent on the dose and duration of systemic immunosuppressive therapy. A dose-dependent increase in opportunistic infections (a signal of systemic immunosuppression) was also noted in this monkey study. A no observed adverse effect level (NOAEL) for IRLD and opportunistic infections was not established in this study. IRLD occurred at the lowest dose of 15 mg/kg/day for 39 weeks [31X the Maximum Recommended Human Dose (MRHD) of ELIDEL Cream, 1% based on AUC comparisons] in this study. A partial recovery from IRLD was noted upon cessation of dosing in this study.
A battery of in vitro genotoxicity tests, including Ames assay, mouse lymphoma L5178Y assay, and chromosome aberration test in V79 Chinese hamster cells and an in vivo mouse micronucleus test revealed no evidence for a mutagenic or clastogenic potential for the drug.
An oral fertility and embryofetal developmental study in rats revealed estrus cycle disturbances, post-implantation loss and reduction in litter size at the 45 mg/kg/day dose (38X MRHD based on AUC comparisons). No effect on fertility in female rats was noted at 10 mg/kg/day (12X MRHD based on AUC comparisons). No effect on fertility in male rats was noted at 45 mg/kg/day (23X MRHD based on AUC comparisons), which was the highest dose tested in this study.
A second oral fertility and embryofetal developmental study in rats revealed reduced testicular and epididymal weights, reduced testicular sperm counts and motile sperm for males and estrus cycle disturbances, decreased corpora lutea, decreased implantations and viable fetuses for females at 45 mg/kg/day dose (123X MRHD for males and 192X MRHD for females based on AUC comparisons). No effect on fertility in female rats was noted at 10 mg/kg/day (5X MRHD based on AUC comparisons). No effect on fertility in male rats was noted at 2 mg/kg/day (0.7X MRHD based on AUC comparisons).

Three randomized, double-blind, vehicle-controlled, multi-center, Phase 3 trials were conducted in 589 pediatric subjects ages 3 months-17 years old to evaluate ELIDEL Cream, 1% for the treatment of mild to moderate atopic dermatitis. Two of the three trials support the use of ELIDEL Cream, 1% in subjects 2 years and older with mild to moderate atopic dermatitis [see ]. Three other trials in 1619 pediatric and adult subjects provided additional data regarding the safety of ELIDEL Cream, 1% in the treatment of atopic dermatitis. Two of these other trials were vehicle-controlled with optional sequential use of a medium potency topical corticosteroid in pediatric subjects and one trial was an active comparator trial in adult subjects with atopic dermatitis [see and ].
Two identical 6-week, randomized, vehicle-controlled, multi-center, Phase 3 trials were conducted to evaluate ELIDEL Cream, 1% for the treatment of mild to moderate atopic dermatitis. A total of 403 pediatric subjects 2-17 years old were included in the trials. The male/female ratio was approximately 50% and 29% of the subjects were African American. At trial entry, 59% of subjects had moderate disease and the mean body surface area (BSA) affected was 26%. About 75% of subjects had atopic dermatitis affecting the face and/or neck region. In these trials, subjects applied either ELIDEL Cream, 1% or vehicle cream twice daily to 5% to 96% of their BSA for up to 6 weeks. At endpoint, based on the physicianu2019s global evaluation of clinical response, 35% of subjects treated with ELIDEL Cream, 1% were clear or almost clear of signs of atopic dermatitis compared to only 18% of vehicle-treated subjects. More ELIDEL subjects (57%) had mild or no pruritus at 6 weeks compared to vehicle subjects (34%). The improvement in pruritus occurred in conjunction with the improvement of the subjectsu2019 atopic dermatitis.
In these two 6-week trials of ELIDEL Cream, 1%, the combined efficacy results at endpoint are presented in Table 2 as follows:
In the two pediatric trials that independently support the use of ELIDEL Cream, 1% in mild to moderate atopic dermatitis, a significant treatment effect was seen by day 15. Of the key signs of atopic dermatitis, erythema, infiltration/papulation, lichenification, and excoriations were reduced at day 8 when compared to vehicle.
Figure 1 depicts the time course of improvement in the percent body surface area affected as a result of treatment with ELIDEL Cream, 1% in 2-17 year olds.
Figure 1
Figure 2 shows the time course of improvement in erythema as a result of treatment with ELIDEL Cream, 1% in 2-17 year olds.
Figure 2

ELIDEL Cream, 1% is a whitish cream available in tubes of 30 grams, 60 grams, and 100 grams.
Store at 25u00b0C (77u00b0F); excursions permitted to 15u00b0 to 30u00b0C (59u00b0 to 86u00b0F) [see USP Controlled Room Temperature]. Do not freeze.

See FDA-approved patient labeling (Medication Guide).
Patients using ELIDEL Cream, 1% should receive the following information and instructions:

Manufactured for:
By:
U.S. Patent 6,423,722
Produced under license from MEDA Pharma S.A.R.L., Luxembourg, by Valeant International Bermuda.
Elidel is a trademark of MEDA PHARMAS.A.R.L. used under license.
u00a9Valeant Pharmaceuticals North America LLC

ELIDEL (ELu00b4-ee-del)n- (pimecrolimus)n- Cream, 1%
Important: ELIDEL Cream, 1% is for use on the skin only (topical).
What is the most important information I should know about ELIDEL Cream, 1%?
It is not known if ELIDEL Cream, 1% is safe to use for a long period of time. A very small number of people who have used ELIDEL Cream, 1% have developed cancer (for example, skin cancer or lymphoma). But a link that ELIDEL Cream, 1% use caused these cancers has not been shown. Because of this concern:
What is ELIDEL Cream, 1%?
ELIDEL Cream, 1% is a prescription medicine used on the skin (topical) to treat mild to moderate eczema (atopic dermatitis). ELIDEL Cream, 1% is for adults and children age 2 years and older who do not have a weakened immune system. ELIDEL Cream, 1% is used on the skin for short periods, and if needed, treatment may be repeated with breaks in between. ELIDEL Cream, 1% is for use after other prescription medicines have not worked for you or if your doctor recommends that other prescription medicines should not be used.
It is not known if ELIDEL Cream, 1% is safe and effective in people who have a weakened immune system.
ELIDEL Cream, 1% is not for use in children under 2 years of age
Who should not use ELIDEL Cream, 1%?
Do not use ELIDEL Cream, 1%
What should I tell my doctor before using ELIDEL Cream, 1%?
Before using ELIDEL Cream, 1%, tell your doctor about all of your medical conditions, including if you:
Tell your doctor about all the medicines you take,
Know the medicines you take. Keep a list of them with you to show your doctor and pharmacist each time you get a new medicine.
How should I use ELIDEL Cream, 1%?
What should I avoid while using ELIDEL Cream, 1%?
What are the possible side effects of ELIDEL Cream, 1%?
ELIDEL Cream, 1% may cause serious side effects.
Other common side effects include:
Tell your doctor if you get a skin infection or if you have any side effect (for example, swollen glands) that bothers you or that does not go away.
These are not all the possible side effects with ELIDEL Cream, 1%. Ask your doctor or pharmacist for more information.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store ELIDEL Cream, 1%?
General information about the safe and effective use of ELIDEL Cream, 1%
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ELIDEL Cream, 1% for conditions other than which it was prescribed. Do not give ELIDEL Cream, 1% to other people even if they have the same symptoms you have. It may harm them.
You can ask your doctor or pharmacist for information about ELIDEL Cream, 1% that is written for health professionals.
For more information, go to www.Elidel.com or call 1-800-321-4576.
What are the ingredients in ELIDEL Cream, 1%?
Active ingredient:
Inactive ingredients:
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Manufactured for:
By:
U.S. Patent 6,423,722
Produced under license from MEDA Pharma S.A.R.L., Luxembourg, by Valeant International Bermuda.
Elidel is a trademark of MEDA PHARMA S.A.R.L. used under license.
u00a9Valeant Pharmaceuticals North America LLC
Rev. 12/2017946040125329.1

NDC
Arrayn- Array
Net Wt. 100 g
FOR TOPICAL USE ONLY.n- NOT FOR OPHTHALMIC USE.
If ELIDEL Cream gets in your eyes,n- rinse your eyes with cold water.
ATTENTION PHARMACIST:n- Each patient is required to receiven- the enclosed Medication Guide.
Rx only

NDC
Arrayn- Array
Net Wt. 60 g
FOR TOPICAL USE ONLY.n- NOT FOR OPHTHALMIC USE.
If ELIDEL Cream gets in your eyes,n- rinse your eyes with cold water.
ATTENTION PHARMACIST:n- Each patient is required to receiven- the enclosed Medication Guide.
Rx only

NDC
Arrayn- Array
Net Wt. 30 g
FOR TOPICAL USE ONLY.n- NOT FOR OPHTHALMIC USE.
If ELIDEL Cream gets in your eyes,n- rinse your eyes with cold water.
ATTENTION PHARMACIST:n- Each patient is required to receiven- the enclosed Medication Guide.
Rx only

NDC
Arrayn- Array
Net Wt. 5 g
FOR TOPICAL USE ONLY.n- NOT FOR OPHTHALMIC USE.
If ELIDEL Cream gets in your eyes,n- rinse your eyes with cold water.
ATTENTION PHARMACIST:n- Each patient is required to receiven- the enclosed Medication Guide.
Rx only
SAMPLE u2013 NOT FOR RESALE

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Pimecrolimus (Elidel)

Trade Name : ELIDEL

CREAM

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Pimecrolimus (Elidel)

Trade Name : ELIDEL

CREAM

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

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