ELIDEL- pimecrolimus cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Pimecrolimus (UNII: 7KYV510875) (Pimecrolimus - UNII:7KYV510875)

Available from:

Bausch Health US, LLC

INN (International Name):

Pimecrolimus

Composition:

Pimecrolimus 10 mg in 1 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

ELIDEL Cream, 1% is contraindicated in individuals with a history of hypersensitivity to pimecrolimus or any of the components of the cream. There are no adequate and well-controlled studies with ELIDEL Cream, 1% in pregnant women. Therefore, ELIDEL Cream, 1% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. In dermal embryofetal developmental studies, no maternal or fetal toxicity was observed up to the highest practicable doses tested, 10 mg/kg/day (1% pimecrolimus cream) in rats (0.14X MRHD based on body surface area) and 10 mg/kg/day (1% pimecrolimus cream) in rabbits (0.65X MRHD based on AUC comparisons). The 1% pimecrolimus cream was administered topically for 6 hours/day during the period of organogenesis in rats and rabbits (gestational days 6-21 in rats and gestational days 6-20 in rabbits). A second dermal embryofetal development study was conducted in rats using pimecrolimus cream applied dermally to pregnant rats (1 g cream/kg body weight of 0

Product summary:

ELIDEL Cream, 1% is a whitish cream available in tubes of 30 grams, 60 grams, and 100 grams. 30 gram tube NDC 0187-5100-01 60 gram tube NDC 0187-5101-02 100 gram tube NDC 0187-5102-03 Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Do not freeze.

Authorization status:

New Drug Application

Patient Information leaflet

Bausch Health US, LLC
----------
MEDICATION GUIDE
ELIDEL® (EL-ee-del)
(pimecrolimus)
Cream, 1%
Important: ELIDEL Cream, 1% is for use on the skin only (topical). Do
not get ELIDEL Cream, 1% in
your eyes, nose, mouth, vagina, or rectum.
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:
•
Do not use ELIDEL Cream, 1% continuously for a long time.
•
Use ELIDEL Cream, 1% only on areas of your skin that have eczema.
•
Do not use ELIDEL Cream, 1% on a child under 2 years of age.
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% if you are allergic to pimecrolimus or any
of the ingredients in ELIDEL
Cream, 1%. See the end of this Medication Guide for a complete list of
ingredients in 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:
•
have a skin disease called Netherton’s syndrome (a rare inherited
condition).
•
have any infection on

Summary of Product characteristics

ELIDEL- PIMECROLIMUS CREAM
BAUSCH HEALTH US, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ELIDEL SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR ELIDEL.
ELIDEL (PIMECROLIMUS) CREAM, FOR TOPICAL USE
INITIAL U.S. APPROVAL: 2001
WARNING: LONG-TERM SAFETY OF TOPICAL CALCINEURIN INHIBITORS HAS NOT
BEEN
ESTABLISHED
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
ALTHOUGH A CAUSAL RELATIONSHIP HAS NOT BEEN ESTABLISHED, RARE CASES OF
MALIGNANCY (E.G., SKIN AND
LYMPHOMA) HAVE BEEN REPORTED IN PATIENTS TREATED WITH TOPICAL
CALCINEURIN INHIBITORS, INCLUDING ELIDEL
CREAM, 1%. (5.1).
T HE RE FO RE :
•
•
INDICATIONS AND USAGE
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. (1)
DOSAGE AND ADMINISTRATION
•
•
•
•
DOSAGE FORMS AND STRENGTHS
Cream, 1%. (3)
CONTRAINDICATIONS
ELIDEL Cream, 1% is contraindicated in individuals with a history of
hypersensitivity to pimecrolimus or any of the
components of the cream. (4, 6.2)
WARNINGS AND PRECAUTIONS
•
•
•
ADVERSE REACTIONS
The most commonly reported adverse reactions (≥1%) were application
site burning, headache, nasopharyngitis, cough,
influenza, pyrexia and viral infection. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT BAUSCH HEALTH US, LLC
AT 1-800-321-4576 OR FDA AT 1-
800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION AND MEDICATION GUIDE.
REVISED: 9/2020
®
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. (2,
5.1)
ELIDEL CREAM, 1% IS NOT INDICATED FOR