ACITRETIN capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ACITRETIN (UNII: LCH760E9T7) (ACITRETIN - UNII:LCH760E9T7)

Available from:

Actavis Pharma, Inc.

INN (International Name):

ACITRETIN

Composition:

ACITRETIN 10 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ACITRETIN- ACITRETIN CAPSULE
ACTAVIS PHARMA, INC.
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ACITRETIN
CAPSULES USP
RX ONLY
CONTRAINDICATIONS AND WARNINGS: PREGNANCY
ACITRETIN MUST NOT BE USED BY FEMALES WHO ARE PREGNANT, OR WHO INTEND
TO BECOME PREGNANT
DURING THERAPY OR AT ANY TIME FOR AT LEAST 3 YEARS FOLLOWING
DISCONTINUATION OF THERAPY.
ACITRETIN ALSO MUST NOT BE USED BY FEMALES WHO MAY NOT USE RELIABLE
CONTRACEPTION WHILE
UNDERGOING TREATMENT AND FOR AT LEAST 3 YEARS FOLLOWING
DISCONTINUATION OF TREATMENT.
ACITRETIN IS A METABOLITE OF ETRETINATE (TEGISON ), AND MAJOR HUMAN
FETAL ABNORMALITIES
HAVE BEEN REPORTED WITH THE ADMINISTRATION OF ACITRETIN AND
ETRETINATE. POTENTIALLY, ANY FETUS
EXPOSED CAN BE AFFECTED.
CLINICAL EVIDENCE HAS SHOWN THAT CONCURRENT INGESTION OF ACITRETIN AND
ETHANOL HAS BEEN
ASSOCIATED WITH THE FORMATION OF ETRETINATE, WHICH HAS A SIGNIFICANTLY
LONGER ELIMINATION HALF-
LIFE THAN ACITRETIN. BECAUSE THE LONGER ELIMINATION HALF-LIFE OF
ETRETINATE WOULD INCREASE THE
DURATION OF TERATOGENIC POTENTIAL FOR FEMALE PATIENTS, ETHANOL MUST
NOT BE INGESTED BY FEMALE
PATIENTS OF CHILDBEARING POTENTIAL EITHER DURING TREATMENT WITH
ACITRETIN OR FOR 2 MONTHS AFTER
CESSATION OF THERAPY. THIS ALLOWS FOR ELIMINATION OF ACITRETIN, THUS
REMOVING THE SUBSTRATE
FOR TRANSESTERIFICATION TO ETRETINATE. THE MECHANISM OF THE METABOLIC
PROCESS FOR
CONVERSION OF ACITRETIN TO ETRETINATE HAS NOT BEEN FULLY DEFINED. IT
IS NOT KNOWN WHETHER
SUBSTANCES OTHER THAN ETHANOL ARE ASSOCIATED WITH TRANSESTERIFICATION.
ACITRETIN HAS BEEN SHOWN TO BE EMBRYOTOXIC AND/OR TERATOGENIC IN
RABBITS, MICE, AND RATS AT
ORAL DOSES OF 0.6, 3, AND 15 MG PER KG, RESPECTIVELY. THESE DOSES ARE
APPROXIMATELY 0.2,
0.3, AND 3 TIMES THE MAXIMUM RECOMMENDED THERAPEUTIC DOSE,
RESPECTIVELY, BASED ON A
MG-PER-M COMPARISON.
MAJOR HUMAN FETAL ABNORMALITIES ASSOCIATED WITH ACITRETIN AND/OR
ETRETINATE ADMINISTRATION
HAVE BEEN REPORTED INCLUDING MENINGOMYELOCELE; MENINGOENCEPHALOCELE;
MULTIPLE
SYNOSTOSES; FACIAL DYSMORPHIA; SYNDACTYLY; ABSENCE OF TERMINAL
PHALANGES; MALFORMATIONS OF
HIP,