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You are here: Home » Products Listed by Brand » McKesson Products » Drug Reference (A's) » Acitretin



DESCRIPTION

CONTRAINDICATIONS AND WARNINGS: 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 or 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 etretinate and acitretin. 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 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 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 doses approximately 0.6, 3 and 15 times the maximum recommended therapeutic dose, respectively.

Major human fetal abnormalities associated with etretinate and/or acitretin administration have been reported including meningomyelocele, meningoencephalocele, multiple synostoses, facial dysmorphia, syndactylies, absence of terminal phalanges, malformations of hip, ankle and forearm, low set ears, high palate, decreased cranial volume, cardiovascular malformation and alterations of the skull and cervical vertebrae on x-ray.

Females of reproductive potential must not be given Soriatane until pregnancy is excluded. It is contraindicated in females of reproductive potential unless the Patient meets ALL of the following conditions:

has severe psoriasis and is unresponsive to other therapies or whose clinical condition contraindicates the use of other treatments; 

has received both oral and written warnings of the hazards of taking Soriatane during pregnancy; 

has received both oral and written warnings of the risk of possible contraception failure and of the need to use two reliable forms of contraception simultaneously both during therapy and for at least 3 years after discontinuation of therapy and has acknowledged in writing her understanding of these warnings and of the need for using dual contraceptive methods (unless the patient has undergone a hysterectomy or practices abstinence);

has had a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 1 week prior to beginning therapy;

will begin therapy only on the second or third day of the next normal menstrual period;

is capable of complying with the mandatory contraceptive measures; and 

is reliable in understanding and carrying out instructions.

A prescription for Soriatane should not be issued by the physician until a report of a negative pregnancy test has been obtained and the patient has begun her menstrual period. Pregnancy testing and contraception counseling should be repeated on a regular basis. To encourage compliance with this recommendation, the physician should prescribe a limited supply of the drug.

Effective contraception must be used for at least 1 month before beginning Soriatane therapy, during therapy and for at least 3 years following discontinuation of therapy even where there has been a history of infertility, unless due to hysterectomy. It is recommended that two reliable forms of contraception be used simultaneously unless abstinence is the chosen method. Patients who have undergone tubal ligation should use a second form of contraception.

It is not known whether residual acitretin in seminal fluid poses risk to a fetus while a male patient is taking the drug or after it is discontinued. There have been five pregnancies reported in which the male partner was undergoing Soriatane treatment. One pregnancy resulted in a normal infant. Two pregnancies ended in spontaneous abortions. In another case, the fetus had bilateral cystic hygromas and multiple cardiopulmonary malformations. The relationship of these malformations to the drug is unknown. The outcome of the fifth case is unknown.

Samples of seminal fluid from 3 male patients treated with acitretin and 6 male patients treated with etretinate have been assayed for the presence of acitretin. The maximum concentration of acitretin observed in the seminal fluid of these men was 12.5 ng/mL. Assuming an ejaculate volume of 10 mL, the amount of drug transferred in semen would be 125 ng, which is 1/200,000 of a single 25 mg capsule. 

Females who have taken Tegison (etretinate) must continue to follow the contraceptive recommendations for Tegison.

Acitretin, the active metabolite of etretinate, is teratogenic and is contraindicated during pregnancy. The risk of severe fetal malformations is well established when systemic retinoids are taken during pregnancy. Pregnancy must also be prevented after stopping acitretin therapy, while the drug is being eliminated to below a threshold blood concentration that would be associated with an increased incidence of birth defects. Because this threshold has not been established for acitretin in humans and because elimination rates vary among patients, the duration of posttherapy contraception to achieve adequate elimination cannot be calculated precisely. It is strongly recommended that contraception be continued for at least 3 years after stopping treatment with acitretin, based on the following considerations:

In the absence of transesterification to form etretinate, greater than 98% of the acitretin would be eliminated within 2 months, assuming a mean elimination half-life of 49 hours. 

In cases where etretinate is formed, as has been demonstrated with concomitant administration of acitretin and ethanol,

greater than 98% of the etretinate formed would be eliminated in 2 years, assuming a mean elimination half-life of 120 days.

greater than 98% of the etretinate formed would be eliminated in 3 years, based on the longest demonstrated elimination half-life of 168 days. 

However, etretinate was found in plasma and subcutaneous fat in one patient reported to have had sporadic alcohol intake, 52 months after she stopped acitretin therapy.1 

An increased incidence of birth defects was estimated based on a limited number of cases which have been reported to Roche, which were identified before the outcome was known, and where pregnancy occurred during the time interval when the patient was being treated with acitretin or etretinate. For cases identified after the outcome was known, severe birth defects have been reported where pregnancy occurred during the time interval when the patient was being treated with acitretin or etretinate.

There have been 202 cases reported before the outcome was known where pregnancy occurred after the last dose of etretinate or acitretin. Fetal outcome remained unknown in approximately one-half of these cases, of which 62 were terminated and 11 were spontaneous abortions. Fetal outcome is known for 103 of these prospectively reported cases. Fifteen of the outcomes were abnormal: hernia, hypocalcemia, hypotonia, undescended testicle, laparoschisis, absent hand/wrist, clubfoot, ichthyosis, apnea/anemia, placental disorder/death and premature birth (5). Birth defects have also been reported retrospectively (i.e., after the outcome was known). Among the retrospectively reported cases where pregnancy occurred more than 2 years after the last dose of etretinate or acitretin, there are 2 normal outcomes, 3 unknown outcomes and 7 abnormal outcomes. The 7 abnormal outcomes reported are: malformation unspecified, aplasia of the forearm, stillbirth, right ventricular/aortic duct defect, heart malformation unspecified, and chromosomal disorder (2). For these listed reports, the relationship of the birth defects to the drug is unknown.

If pregnancy does occur during Soriatane therapy or at any time for at least 3 years following discontinuation of Soriatane therapy, the physician and patient should discuss the possible effects on the pregnancy.

Soriatane should be prescribed only by physicians who have special competence in the diagnosis and treatment of severe psoriasis, are experienced in the use of systemic retinoids, and understand the risk of teratogenicity.

Soriatane (acitretin), a retinoid, is available in 10 mg and 25 mg gelatin capsules for oral administration. Chemically, acitretin is all-trans-9-(4-methoxy-2,3, 6-trimethylphenyl)-3,7-dimethyl-2,4,6,8-nonatetraenoic acid. It is a metabolite of etretinate and is related to both retinoic acid and retinol (vitamin A). It is a yellow to greenish-yellow powder with a molecular weight of 326.44.

Each capsule contains acitretin, microcrystalline cellulose, sodium ascorbate, gelatin, black monogramming ink and maltodextrin (a mixture of polysaccharides).

Gelatin capsule shells contain gelatin, parabens (methyl and propyl), iron oxide (yellow, black, and red), and titanium dioxide. They may also contain benzyl alcohol, butyl paraben, carboxymethylcellulose sodium, edetate calcium disodium, potassium sorbate and/or sodium propionate.





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