SORIATANE- acitretin capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Stiefel Laboratories Inc

INN (International Name):

ACITRETIN

Composition:

ACITRETIN 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

SORIATANE is indicated for the treatment of severe psoriasis in adults. Because of significant adverse effects associated with its use, SORIATANE should be prescribed only by those knowledgeable in the systemic use of retinoids. In females of reproductive potential, SORIATANE should be reserved for non-pregnant patients who are unresponsive to other therapies or whose clinical condition contraindicates the use of other treatments (see boxed CONTRAINDICATIONS AND WARNINGS — SORIATANE can cause severe birth defects). Most patients experience relapse of psoriasis after discontinuing therapy. Subsequent courses, when clinically indicated, have produced efficacy results similar to the initial course of therapy. See boxed CONTRAINDICATIONS AND WARNINGS. SORIATANE is contraindicated in patients with severely impaired liver or kidney function and in patients with chronic abnormally elevated blood lipid values (see boxed WARNINGS:Hepatotoxicity, WARNINGS:Lipids and Possible Cardiovascular Effects, and PRECAUTIONS). An

Product summary:

Brown and white capsules, 10 mg, imprinted “A-10 mg”; bottles of 30 (NDC 0145-0090-25). Brown and yellow capsules, 25 mg, imprinted “A-25 mg”; bottles of 30 (NDC 0145-0091-25). Store between 15° and 25°C (59° and 77°F). Protect from light. Avoid exposure to high temperatures and humidity after the bottle is opened.

Authorization status:

New Drug Application

Patient Information leaflet

Stiefel Laboratories Inc
----------
MEDICATION GUIDE
SORIATANE (sor-RYE-uh-tane)
(acitretin)
Capsules
Read this Medication Guide carefully before you start taking SORIATANE
and read it each time you get
more SORIATANE. There may be new information.
The first information in this Medication Guide is about birth defects
and how to avoid pregnancy. After
this section there is important safety information about possible
effects for any patient taking
SORIATANE. All patients should read this entire Medication Guide
carefully. This information does not
take the place of talking with your prescriber about your medical
condition or treatment.
What is the most important information I should know about SORIATANE?
SORIATANE can cause serious side effects, including:
•
Severe birth defects. If you are a female who can get pregnant, you
should use SORIATANE only
if you are not pregnant now, can avoid becoming pregnant for at least
3 years, and other medicines
do not work for your severe psoriasis or you cannot use other
psoriasis medicines. Information
about effects on unborn babies and about how to avoid pregnancy is
found in the next section:
“What are the important warnings and instructions for females taking
SORIATANE?”
•
Liver problems, including abnormal liver function tests and
inflammation of your liver (hepatitis).
Your prescriber should do blood tests to check how your liver is
working before you start taking
and during treatment with SORIATANE. Stop taking SORIATANE and call
your prescriber right
away if you have any of the following signs or symptoms of a serious
liver problem:
o
yellowing of your skin or the whites of your eyes
o
nausea and vomiting
o
loss of appetite
o
dark urine
What are the important warnings and instructions for females taking
SORIATANE?
•
Before you receive your first prescription for SORIATANE, you should
have discussed and signed
a Patient Agreement/Informed Consent for Female Patients form with
your prescriber. This is to
help make sure you understand the risk of birth defects an

Summary of Product characteristics

SORIATANE- ACITRETIN CAPSULE
STIEFEL LABORATORIES INC
----------
SORIATANE
(ACITRETIN)
CAPS ULES
CONTRAINDICATIONS AND WARNINGS: PREGNANCY
SORIATANE 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. SORIATANE 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
SORIATANE 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