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Soriatane Drug Description
SORIATANE®
(acitretin) Capsules
CAUSES BIRTH DEFECTS
DO NOT GET PREGNANT

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 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 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/kg, respectively. These doses
are approximately 0.2, 0.3 and 3 times the maximum recommended therapeutic dose,
respectively, based on a mg/m² 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, ankle and forearm, low-set ears, high palate, decreased
cranial volume, cardiovascular malformation and alterations of the skull and
cervical vertebrae.
Soriatane should be prescribed only by those 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.
Because of Soriatane's teratogenicity, a program called the Do Your P.A.R.T
program, Pregnancy Prevention Actively Required During and After Treatment,
has been developed to educate women of childbearing potential and their healthcare
providers about the serious risks associated with acitretin and to help prevent
pregnancies from occurring with the use of this drug and for 3 years after
its discontinuation. The Do Your P.A.R.T. program requirements are
described below (see also PRECAUTIONS section).

Important Information for Women of Childbearing Potential:
Soriatane should be considered only for women with severe psoriasis unresponsive
to other therapies or whose clinical condition contraindicates the use of other
treatments.
Females of reproductive potential must not be given a prescription for Soriatane
until pregnancy is excluded. Soriatane is contraindicated in females of reproductive
potential unless the patient meets ALL of the following conditions:

Must have had 2 negative urine or serum pregnancy tests with a sensitivity
of at least 25 mIU/mL before receiving the initial Soriatane prescription.
The first test (a screening test) is obtained by the prescriber when the decision
is made to pursue Soriatane therapy. The second pregnancy test (a confirmation
test) should be done during the first 5 days of the menstrual period immediately
preceding the beginning of Soriatane therapy. For patients with amenorrhea,
the second test should be done at least 11 days after the last act of unprotected
sexual intercourse (without using 2 effective forms of contraception [birth
control] simultaneously).
Must have a pregnancy test repeated every month during Soriatane treatment.
The patient must have a negative result from a urine or serum pregnancy test
before receiving a Soriatane prescription. To encourage compliance with this
recommendation, a limited supply of the drug should be prescribed.
For at least 3 years after discontinuing Soriatane therapy, a pregnancy test
must be repeated every 3 months.
Must have selected and have committed to use 2 effective forms of contraception
(birth control) simultaneously, at least 1 of which must be a primary form,
unless absolute abstinence is the chosen method, or the patient has undergone
a hysterectomy or is clearly postmenopausal.
Patients must use 2 effective forms of contraception (birth control)
simultaneously for at least 1 month prior to initiation of Soriatane therapy,
during Soriatane therapy, and for at least 3 years after discontinuing Soriatane
therapy. A Soriatane Patient Referral Form is available so that patients can
receive an initial free contraceptive counseling session and pregnancy testing.
Counseling about contraception and behaviors associated with an increased
risk of pregnancy must be repeated on a monthly basis by the prescriber during
Soriatane therapy and every 3 months for at least 3 years following discontinuation
of Soriatane therapy.

Effective forms of contraception include both primary and secondary forms
of contraception. Primary forms of contraception include: tubal ligation, partner's
vasectomy, intrauterine devices, birth control pills, and injectable/implantable/insertable/topical
hormonal birth control products. Secondary forms of contraception include latex
condoms (with or without spermicide), diaphragms and cervical caps (which must
be used with a spermicide).
Any birth control method can fail. Therefore, it is critically important
that women of childbearing potential use 2 effective forms of contraception
(birth control) simultaneously. It has not been established if there is a pharmacokinetic
interaction between acitretin and combined oral contraceptives. However, it
has been established that acitretin interferes with the contraceptive effect
of microdosed progestin preparations.1 Microdosed “minipill”
progestin preparations are not recommended for use with Soriatane. It is
not known whether other progestational contraceptives, such as implants and
injectables, are adequate methods of contraception during acitretin therapy.

Prescribers are advised to consult the package insert of any medication
administered concomitantly with hormonal contraceptives, since some medications
may decrease the effectiveness of these birth control products. Patients should
be prospectively cautioned not to self-medicate with the herbal supplement
St. John's Wort because a possible interaction has been suggested with hormonal
contraceptives based on reports of breakthrough bleeding on oral contraceptives
shortly after starting St. John's Wort. Pregnancies have been reported by
users of combined hormonal contraceptives who also used some form of St. John's
Wort (see PRECAUTIONS).

Must have signed a Patient Agreement/Informed Consent for Female Patients
that contains warnings about the risk of potential birth defects if the fetus
is exposed to Soriatane, about contraceptive failure, about the fact that
they must not ingest beverages or products containing ethanol while taking
Soriatane and for 2 months after Soriatane treatment has been discontinued,
and about preventing pregnancy while taking Soriatane and for at least 3 years
after discontinuing Soriatane therapy.

If pregnancy does occur during Soriatane therapy or at any time for at least
3 years following discontinuation of Soriatane therapy, the prescriber and patient
should discuss the possible effects on the pregnancy. The available information
is as follows:
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.2

Severe birth defects have been reported where conception occurred during
the time interval when the patient was being treated with acitretin and/or
etretinate. In addition, severe birth defects have also been reported when
conception occurred after the mother completed therapy. These cases have been
reported both prospectively (before the outcome was known) and retrospectively
(after the outcome was known). The events below are listed without distinction
as to whether the reported birth defects are consistent with retinoid-induced
embryopathy or not.

There have been 318 prospectively reported cases involving pregnancies
and the use of etretinate, acitretin or both. In 238 of these cases, the
conception occurred after the last dose of etretinate (103 cases), acitretin
(126) or both (9). Fetal outcome remained unknown in approximately one-half
of these cases, of which 62 were terminated and 14 were spontaneous abortions.
Fetal outcome is known for the other 118 cases and 15 of the outcomes
were abnormal (including cases of absent hand/wrist, clubfoot, GI malformation,
hypocalcemia, hypotonia, limb malformation, neonatal apnea/anemia, neonatal
ichthyosis, placental disorder/death, undescended testicle and 5 cases
of premature birth). In the 126 prospectively reported cases where conception
occurred after the last dose of acitretin only, 43 cases involved conception
at least 1 year but less than 2 years after the last dose. There were
3 reports of abnormal outcomes out of these 43 cases (involving limb malformation,
GI tract malformations and premature birth). There were only 4 cases where
conception occurred at least 2 years after the last dose but there were
no reports of birth defects in these cases.
There is also a total of 35 retrospectively reported cases where
conception occurred at least one year after the last dose of etretinate,
acitretin or both. From these cases there are 3 reports of birth defects
when the conception occurred at least 1 year but less than 2 years after
the last dose of acitretin (including heart malformations, Turner's Syndrome,
and unspecified congenital malformations) and 4 reports of birth defects
when conception occurred 2 or more years after the last dose of acitretin
(including foot malformation, cardiac malformations [2 cases] and unspecified
neonatal and infancy disorder). There were 3 additional abnormal outcomes
in cases where conception occurred 2 or more years after the last dose
of etretinate (including chromosome disorder, forearm aplasia, and stillbirth).

Females who have taken Tegison (etretinate) must continue to follow
the contraceptive recommendations for Tegison. Tegison is no longer marketed
in the US; for information, call Stiefel at 1-888-500-DERM (3376).
Patients should not donate blood during and for at least 3 years
following the completion of Soriatane therapy because women of childbearing
potential must not receive blood from patients being treated with Soriatane.





Important Information For Males Taking Soriatane:


Patients should not donate blood during and for at least 3 years following
Soriatane therapy because women of childbearing potential must not receive
blood from patients being treated with Soriatane.
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 y00,000
of a single 25 mg capsule. Thus, although it appears that residual acitretin
in seminal fluid poses little, if any, risk to a fetus while a male patient
is taking the drug or after it is discontinued, the no-effect limit for teratogenicity
is unknown and there is no registry for birth defects associated with acitretin.
The available data are as follows:

There have been 25 cases of reported conception when the male partner was
taking acitretin. The pregnancy outcome is known in 13 of these 25 cases. Of
these, 9 reports were retrospective and 4 were prospective (meaning the pregnancy
was reported prior to knowledge of the outcome)3.




Timing of Paternal Acitretin Treatment Relative to Conception
Delivery of Healthy Neonate
Spontaneous Abortion
Induced Abortion
Total


At time of conception
5*
5
1
11


Discontinued ~4 weeks prior
0
0
1**
1


Discontinued ~6 to 8 months prior
0
1
0
1


*Four of 5 cases were prospective.
**With malformation pattern not typical of retinoid embryopathy (bilateral cystic hygromas of neck, hypoplasia of lungs bilateral, pulmonary atresia, VSD with overriding truncus arteriosus).



For All Patients: A SORIATANE MEDICATION
GUIDE MUST BE GIVEN TO THE PATIENT EACH TIME SORIATANE IS DISPENSED, AS
REQUIRED BY LAW.

DRUG DESCRIPTION



What are the possible side effects of acitretin (Soriatane)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using acitretin and call your doctor at once if you have any of these serious side effects:

blurred vision, headache or pain behind your eyes, sometimes with vomiting;
sudden decrease in night vision;
depressed mood, aggression, unusual thoughts or behavior, thoughts of hurting yourself;
chest...
Read All Potential Side Effects for Soriatane »




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. The structural formula is:









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

Gelatin capsule shells contain gelatin, iron oxide (yellow, black, and red),
and titanium dioxide. They may also contain benzyl alcohol, carboxymethylcellulose
sodium, edetate calcium disodium.
REFERENCES
1. Berbis Ph, et al.: Arch Dermatol Res (1988) 280:388-389.
2. Maier H, Honigsmann H: Concentration of etretinate in plasma and
subcutaneous fat after long-term acitretin. Lancet 348:1107, 1996.
3. Geiger JM, Walker M: Is there a reproductive safety risk in male
patients treated with acitretin (Neotigason®/Soriatane®)? Dermatology
205:105-107, 2002.Last reviewed on RxList: 11/16/2007




Soriatane Drug Description
SORIATANE®
(acitretin) Capsules
CAUSES BIRTH DEFECTS
DO NOT GET PREGNANT

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 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 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/kg, respectively. These doses
are approximately 0.2, 0.3 and 3 times the maximum recommended therapeutic dose,
respectively, based on a mg/m² 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, ankle and forearm, low-set ears, high palate, decreased
cranial volume, cardiovascular malformation and alterations of the skull and
cervical vertebrae.
Soriatane should be prescribed only by those 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.
Because of Soriatane's teratogenicity, a program called the Do Your P.A.R.T
program, Pregnancy Prevention Actively Required During and After Treatment,
has been developed to educate women of childbearing potential and their healthcare
providers about the serious risks associated with acitretin and to help prevent
pregnancies from occurring with the use of this drug and for 3 years after
its discontinuation. The Do Your P.A.R.T. program requirements are
described below (see also PRECAUTIONS section).

Important Information for Women of Childbearing Potential:
Soriatane should be considered only for women with severe psoriasis unresponsive
to other therapies or whose clinical condition contraindicates the use of other
treatments.
Females of reproductive potential must not be given a prescription for Soriatane
until pregnancy is excluded. Soriatane is contraindicated in females of reproductive
potential unless the patient meets ALL of the following conditions:

Must have had 2 negative urine or serum pregnancy tests with a sensitivity
of at least 25 mIU/mL before receiving the initial Soriatane prescription.
The first test (a screening test) is obtained by the prescriber when the decision
is made to pursue Soriatane therapy. The second pregnancy test (a confirmation
test) should be done during the first 5 days of the menstrual period immediately
preceding the beginning of Soriatane therapy. For patients with amenorrhea,
the second test should be done at least 11 days after the last act of unprotected
sexual intercourse (without using 2 effective forms of contraception [birth
control] simultaneously).
Must have a pregnancy test repeated every month during Soriatane treatment.
The patient must have a negative result from a urine or serum pregnancy test
before receiving a Soriatane prescription. To encourage compliance with this
recommendation, a limited supply of the drug should be prescribed.
For at least 3 years after discontinuing Soriatane therapy, a pregnancy test
must be repeated every 3 months.
Must have selected and have committed to use 2 effective forms of contraception
(birth control) simultaneously, at least 1 of which must be a primary form,
unless absolute abstinence is the chosen method, or the patient has undergone
a hysterectomy or is clearly postmenopausal.
Patients must use 2 effective forms of contraception (birth control)
simultaneously for at least 1 month prior to initiation of Soriatane therapy,
during Soriatane therapy, and for at least 3 years after discontinuing Soriatane
therapy. A Soriatane Patient Referral Form is available so that patients can
receive an initial free contraceptive counseling session and pregnancy testing.
Counseling about contraception and behaviors associated with an increased
risk of pregnancy must be repeated on a monthly basis by the prescriber during
Soriatane therapy and every 3 months for at least 3 years following discontinuation
of Soriatane therapy.

Effective forms of contraception include both primary and secondary forms
of contraception. Primary forms of contraception include: tubal ligation, partner's
vasectomy, intrauterine devices, birth control pills, and injectable/implantable/insertable/topical
hormonal birth control products. Secondary forms of contraception include latex
condoms (with or without spermicide), diaphragms and cervical caps (which must
be used with a spermicide).
Any birth control method can fail. Therefore, it is critically important
that women of childbearing potential use 2 effective forms of contraception
(birth control) simultaneously. It has not been established if there is a pharmacokinetic
interaction between acitretin and combined oral contraceptives. However, it
has been established that acitretin interferes with the contraceptive effect
of microdosed progestin preparations.1 Microdosed “minipill”
progestin preparations are not recommended for use with Soriatane. It is
not known whether other progestational contraceptives, such as implants and
injectables, are adequate methods of contraception during acitretin therapy.

Prescribers are advised to consult the package insert of any medication
administered concomitantly with hormonal contraceptives, since some medications
may decrease the effectiveness of these birth control products. Patients should
be prospectively cautioned not to self-medicate with the herbal supplement
St. John's Wort because a possible interaction has been suggested with hormonal
contraceptives based on reports of breakthrough bleeding on oral contraceptives
shortly after starting St. John's Wort. Pregnancies have been reported by
users of combined hormonal contraceptives who also used some form of St. John's
Wort (see PRECAUTIONS).

Must have signed a Patient Agreement/Informed Consent for Female Patients
that contains warnings about the risk of potential birth defects if the fetus
is exposed to Soriatane, about contraceptive failure, about the fact that
they must not ingest beverages or products containing ethanol while taking
Soriatane and for 2 months after Soriatane treatment has been discontinued,
and about preventing pregnancy while taking Soriatane and for at least 3 years
after discontinuing Soriatane therapy.

If pregnancy does occur during Soriatane therapy or at any time for at least
3 years following discontinuation of Soriatane therapy, the prescriber and patient
should discuss the possible effects on the pregnancy. The available information
is as follows:
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.2

Severe birth defects have been reported where conception occurred during
the time interval when the patient was being treated with acitretin and/or
etretinate. In addition, severe birth defects have also been reported when
conception occurred after the mother completed therapy. These cases have been
reported both prospectively (before the outcome was known) and retrospectively
(after the outcome was known). The events below are listed without distinction
as to whether the reported birth defects are consistent with retinoid-induced
embryopathy or not.

There have been 318 prospectively reported cases involving pregnancies
and the use of etretinate, acitretin or both. In 238 of these cases, the
conception occurred after the last dose of etretinate (103 cases), acitretin
(126) or both (9). Fetal outcome remained unknown in approximately one-half
of these cases, of which 62 were terminated and 14 were spontaneous abortions.
Fetal outcome is known for the other 118 cases and 15 of the outcomes
were abnormal (including cases of absent hand/wrist, clubfoot, GI malformation,
hypocalcemia, hypotonia, limb malformation, neonatal apnea/anemia, neonatal
ichthyosis, placental disorder/death, undescended testicle and 5 cases
of premature birth). In the 126 prospectively reported cases where conception
occurred after the last dose of acitretin only, 43 cases involved conception
at least 1 year but less than 2 years after the last dose. There were
3 reports of abnormal outcomes out of these 43 cases (involving limb malformation,
GI tract malformations and premature birth). There were only 4 cases where
conception occurred at least 2 years after the last dose but there were
no reports of birth defects in these cases.
There is also a total of 35 retrospectively reported cases where
conception occurred at least one year after the last dose of etretinate,
acitretin or both. From these cases there are 3 reports of birth defects
when the conception occurred at least 1 year but less than 2 years after
the last dose of acitretin (including heart malformations, Turner's Syndrome,
and unspecified congenital malformations) and 4 reports of birth defects
when conception occurred 2 or more years after the last dose of acitretin
(including foot malformation, cardiac malformations [2 cases] and unspecified
neonatal and infancy disorder). There were 3 additional abnormal outcomes
in cases where conception occurred 2 or more years after the last dose
of etretinate (including chromosome disorder, forearm aplasia, and stillbirth).

Females who have taken Tegison (etretinate) must continue to follow
the contraceptive recommendations for Tegison. Tegison is no longer marketed
in the US; for information, call Stiefel at 1-888-500-DERM (3376).
Patients should not donate blood during and for at least 3 years
following the completion of Soriatane therapy because women of childbearing
potential must not receive blood from patients being treated with Soriatane.





Important Information For Males Taking Soriatane:


Patients should not donate blood during and for at least 3 years following
Soriatane therapy because women of childbearing potential must not receive
blood from patients being treated with Soriatane.
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 y00,000
of a single 25 mg capsule. Thus, although it appears that residual acitretin
in seminal fluid poses little, if any, risk to a fetus while a male patient
is taking the drug or after it is discontinued, the no-effect limit for teratogenicity
is unknown and there is no registry for birth defects associated with acitretin.
The available data are as follows:

There have been 25 cases of reported conception when the male partner was
taking acitretin. The pregnancy outcome is known in 13 of these 25 cases. Of
these, 9 reports were retrospective and 4 were prospective (meaning the pregnancy
was reported prior to knowledge of the outcome)3.




Timing of Paternal Acitretin Treatment Relative to Conception
Delivery of Healthy Neonate
Spontaneous Abortion
Induced Abortion
Total


At time of conception
5*
5
1
11


Discontinued ~4 weeks prior
0
0
1**
1


Discontinued ~6 to 8 months prior
0
1
0
1


*Four of 5 cases were prospective.
**With malformation pattern not typical of retinoid embryopathy (bilateral cystic hygromas of neck, hypoplasia of lungs bilateral, pulmonary atresia, VSD with overriding truncus arteriosus).



For All Patients: A SORIATANE MEDICATION
GUIDE MUST BE GIVEN TO THE PATIENT EACH TIME SORIATANE IS DISPENSED, AS
REQUIRED BY LAW.

DRUG DESCRIPTION



What are the possible side effects of acitretin (Soriatane)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using acitretin and call your doctor at once if you have any of these serious side effects:

blurred vision, headache or pain behind your eyes, sometimes with vomiting;
sudden decrease in night vision;
depressed mood, aggression, unusual thoughts or behavior, thoughts of hurting yourself;
chest...
Read All Potential Side Effects for Soriatane »




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. The structural formula is:









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

Gelatin capsule shells contain gelatin, iron oxide (yellow, black, and red),
and titanium dioxide. They may also contain benzyl alcohol, carboxymethylcellulose
sodium, edetate calcium disodium.
REFERENCES
1. Berbis Ph, et al.: Arch Dermatol Res (1988) 280:388-389.
2. Maier H, Honigsmann H: Concentration of etretinate in plasma and
subcutaneous fat after long-term acitretin. Lancet 348:1107, 1996.
3. Geiger JM, Walker M: Is there a reproductive safety risk in male
patients treated with acitretin (Neotigason®/Soriatane®)? Dermatology
205:105-107, 2002.Last reviewed on RxList: 11/16/2007




Soriatane Drug Description
SORIATANE®
(acitretin) Capsules
CAUSES BIRTH DEFECTS
DO NOT GET PREGNANT

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 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 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/kg, respectively. These doses
are approximately 0.2, 0.3 and 3 times the maximum recommended therapeutic dose,
respectively, based on a mg/m² 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, ankle and forearm, low-set ears, high palate, decreased
cranial volume, cardiovascular malformation and alterations of the skull and
cervical vertebrae.
Soriatane should be prescribed only by those 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.
Because of Soriatane's teratogenicity, a program called the Do Your P.A.R.T
program, Pregnancy Prevention Actively Required During and After Treatment,
has been developed to educate women of childbearing potential and their healthcare
providers about the serious risks associated with acitretin and to help prevent
pregnancies from occurring with the use of this drug and for 3 years after
its discontinuation. The Do Your P.A.R.T. program requirements are
described below (see also PRECAUTIONS section).

Important Information for Women of Childbearing Potential:
Soriatane should be considered only for women with severe psoriasis unresponsive
to other therapies or whose clinical condition contraindicates the use of other
treatments.
Females of reproductive potential must not be given a prescription for Soriatane
until pregnancy is excluded. Soriatane is contraindicated in females of reproductive
potential unless the patient meets ALL of the following conditions:

Must have had 2 negative urine or serum pregnancy tests with a sensitivity
of at least 25 mIU/mL before receiving the initial Soriatane prescription.
The first test (a screening test) is obtained by the prescriber when the decision
is made to pursue Soriatane therapy. The second pregnancy test (a confirmation
test) should be done during the first 5 days of the menstrual period immediately
preceding the beginning of Soriatane therapy. For patients with amenorrhea,
the second test should be done at least 11 days after the last act of unprotected
sexual intercourse (without using 2 effective forms of contraception [birth
control] simultaneously).
Must have a pregnancy test repeated every month during Soriatane treatment.
The patient must have a negative result from a urine or serum pregnancy test
before receiving a Soriatane prescription. To encourage compliance with this
recommendation, a limited supply of the drug should be prescribed.
For at least 3 years after discontinuing Soriatane therapy, a pregnancy test
must be repeated every 3 months.
Must have selected and have committed to use 2 effective forms of contraception
(birth control) simultaneously, at least 1 of which must be a primary form,
unless absolute abstinence is the chosen method, or the patient has undergone
a hysterectomy or is clearly postmenopausal.
Patients must use 2 effective forms of contraception (birth control)
simultaneously for at least 1 month prior to initiation of Soriatane therapy,
during Soriatane therapy, and for at least 3 years after discontinuing Soriatane
therapy. A Soriatane Patient Referral Form is available so that patients can
receive an initial free contraceptive counseling session and pregnancy testing.
Counseling about contraception and behaviors associated with an increased
risk of pregnancy must be repeated on a monthly basis by the prescriber during
Soriatane therapy and every 3 months for at least 3 years following discontinuation
of Soriatane therapy.

Effective forms of contraception include both primary and secondary forms
of contraception. Primary forms of contraception include: tubal ligation, partner's
vasectomy, intrauterine devices, birth control pills, and injectable/implantable/insertable/topical
hormonal birth control products. Secondary forms of contraception include latex
condoms (with or without spermicide), diaphragms and cervical caps (which must
be used with a spermicide).
Any birth control method can fail. Therefore, it is critically important
that women of childbearing potential use 2 effective forms of contraception
(birth control) simultaneously. It has not been established if there is a pharmacokinetic
interaction between acitretin and combined oral contraceptives. However, it
has been established that acitretin interferes with the contraceptive effect
of microdosed progestin preparations.1 Microdosed “minipill”
progestin preparations are not recommended for use with Soriatane. It is
not known whether other progestational contraceptives, such as implants and
injectables, are adequate methods of contraception during acitretin therapy.

Prescribers are advised to consult the package insert of any medication
administered concomitantly with hormonal contraceptives, since some medications
may decrease the effectiveness of these birth control products. Patients should
be prospectively cautioned not to self-medicate with the herbal supplement
St. John's Wort because a possible interaction has been suggested with hormonal
contraceptives based on reports of breakthrough bleeding on oral contraceptives
shortly after starting St. John's Wort. Pregnancies have been reported by
users of combined hormonal contraceptives who also used some form of St. John's
Wort (see PRECAUTIONS).

Must have signed a Patient Agreement/Informed Consent for Female Patients
that contains warnings about the risk of potential birth defects if the fetus
is exposed to Soriatane, about contraceptive failure, about the fact that
they must not ingest beverages or products containing ethanol while taking
Soriatane and for 2 months after Soriatane treatment has been discontinued,
and about preventing pregnancy while taking Soriatane and for at least 3 years
after discontinuing Soriatane therapy.

If pregnancy does occur during Soriatane therapy or at any time for at least
3 years following discontinuation of Soriatane therapy, the prescriber and patient
should discuss the possible effects on the pregnancy. The available information
is as follows:
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.2

Severe birth defects have been reported where conception occurred during
the time interval when the patient was being treated with acitretin and/or
etretinate. In addition, severe birth defects have also been reported when
conception occurred after the mother completed therapy. These cases have been
reported both prospectively (before the outcome was known) and retrospectively
(after the outcome was known). The events below are listed without distinction
as to whether the reported birth defects are consistent with retinoid-induced
embryopathy or not.

There have been 318 prospectively reported cases involving pregnancies
and the use of etretinate, acitretin or both. In 238 of these cases, the
conception occurred after the last dose of etretinate (103 cases), acitretin
(126) or both (9). Fetal outcome remained unknown in approximately one-half
of these cases, of which 62 were terminated and 14 were spontaneous abortions.
Fetal outcome is known for the other 118 cases and 15 of the outcomes
were abnormal (including cases of absent hand/wrist, clubfoot, GI malformation,
hypocalcemia, hypotonia, limb malformation, neonatal apnea/anemia, neonatal
ichthyosis, placental disorder/death, undescended testicle and 5 cases
of premature birth). In the 126 prospectively reported cases where conception
occurred after the last dose of acitretin only, 43 cases involved conception
at least 1 year but less than 2 years after the last dose. There were
3 reports of abnormal outcomes out of these 43 cases (involving limb malformation,
GI tract malformations and premature birth). There were only 4 cases where
conception occurred at least 2 years after the last dose but there were
no reports of birth defects in these cases.
There is also a total of 35 retrospectively reported cases where
conception occurred at least one year after the last dose of etretinate,
acitretin or both. From these cases there are 3 reports of birth defects
when the conception occurred at least 1 year but less than 2 years after
the last dose of acitretin (including heart malformations, Turner's Syndrome,
and unspecified congenital malformations) and 4 reports of birth defects
when conception occurred 2 or more years after the last dose of acitretin
(including foot malformation, cardiac malformations [2 cases] and unspecified
neonatal and infancy disorder). There were 3 additional abnormal outcomes
in cases where conception occurred 2 or more years after the last dose
of etretinate (including chromosome disorder, forearm aplasia, and stillbirth).

Females who have taken Tegison (etretinate) must continue to follow
the contraceptive recommendations for Tegison. Tegison is no longer marketed
in the US; for information, call Stiefel at 1-888-500-DERM (3376).
Patients should not donate blood during and for at least 3 years
following the completion of Soriatane therapy because women of childbearing
potential must not receive blood from patients being treated with Soriatane.





Important Information For Males Taking Soriatane:


Patients should not donate blood during and for at least 3 years following
Soriatane therapy because women of childbearing potential must not receive
blood from patients being treated with Soriatane.
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 y00,000
of a single 25 mg capsule. Thus, although it appears that residual acitretin
in seminal fluid poses little, if any, risk to a fetus while a male patient
is taking the drug or after it is discontinued, the no-effect limit for teratogenicity
is unknown and there is no registry for birth defects associated with acitretin.
The available data are as follows:

There have been 25 cases of reported conception when the male partner was
taking acitretin. The pregnancy outcome is known in 13 of these 25 cases. Of
these, 9 reports were retrospective and 4 were prospective (meaning the pregnancy
was reported prior to knowledge of the outcome)3.




Timing of Paternal Acitretin Treatment Relative to Conception
Delivery of Healthy Neonate
Spontaneous Abortion
Induced Abortion
Total


At time of conception
5*
5
1
11


Discontinued ~4 weeks prior
0
0
1**
1


Discontinued ~6 to 8 months prior
0
1
0
1


*Four of 5 cases were prospective.
**With malformation pattern not typical of retinoid embryopathy (bilateral cystic hygromas of neck, hypoplasia of lungs bilateral, pulmonary atresia, VSD with overriding truncus arteriosus).



For All Patients: A SORIATANE MEDICATION
GUIDE MUST BE GIVEN TO THE PATIENT EACH TIME SORIATANE IS DISPENSED, AS
REQUIRED BY LAW.

DRUG DESCRIPTION



What are the possible side effects of acitretin (Soriatane)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using acitretin and call your doctor at once if you have any of these serious side effects:

blurred vision, headache or pain behind your eyes, sometimes with vomiting;
sudden decrease in night vision;
depressed mood, aggression, unusual thoughts or behavior, thoughts of hurting yourself;
chest...
Read All Potential Side Effects for Soriatane »




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. The structural formula is:









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

Gelatin capsule shells contain gelatin, iron oxide (yellow, black, and red),
and titanium dioxide. They may also contain benzyl alcohol, carboxymethylcellulose
sodium, edetate calcium disodium.
REFERENCES
1. Berbis Ph, et al.: Arch Dermatol Res (1988) 280:388-389.
2. Maier H, Honigsmann H: Concentration of etretinate in plasma and
subcutaneous fat after long-term acitretin. Lancet 348:1107, 1996.
3. Geiger JM, Walker M: Is there a reproductive safety risk in male
patients treated with acitretin (Neotigason®/Soriatane®)? Dermatology
205:105-107, 2002.Last reviewed on RxList: 11/16/2007




Soriatane Drug Description
SORIATANE®
(acitretin) Capsules
CAUSES BIRTH DEFECTS
DO NOT GET PREGNANT

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 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 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/kg, respectively. These doses
are approximately 0.2, 0.3 and 3 times the maximum recommended therapeutic dose,
respectively, based on a mg/m² 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, ankle and forearm, low-set ears, high palate, decreased
cranial volume, cardiovascular malformation and alterations of the skull and
cervical vertebrae.
Soriatane should be prescribed only by those 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.
Because of Soriatane's teratogenicity, a program called the Do Your P.A.R.T
program, Pregnancy Prevention Actively Required During and After Treatment,
has been developed to educate women of childbearing potential and their healthcare
providers about the serious risks associated with acitretin and to help prevent
pregnancies from occurring with the use of this drug and for 3 years after
its discontinuation. The Do Your P.A.R.T. program requirements are
described below (see also PRECAUTIONS section).

Important Information for Women of Childbearing Potential:
Soriatane should be considered only for women with severe psoriasis unresponsive
to other therapies or whose clinical condition contraindicates the use of other
treatments.
Females of reproductive potential must not be given a prescription for Soriatane
until pregnancy is excluded. Soriatane is contraindicated in females of reproductive
potential unless the patient meets ALL of the following conditions:

Must have had 2 negative urine or serum pregnancy tests with a sensitivity
of at least 25 mIU/mL before receiving the initial Soriatane prescription.
The first test (a screening test) is obtained by the prescriber when the decision
is made to pursue Soriatane therapy. The second pregnancy test (a confirmation
test) should be done during the first 5 days of the menstrual period immediately
preceding the beginning of Soriatane therapy. For patients with amenorrhea,
the second test should be done at least 11 days after the last act of unprotected
sexual intercourse (without using 2 effective forms of contraception [birth
control] simultaneously).
Must have a pregnancy test repeated every month during Soriatane treatment.
The patient must have a negative result from a urine or serum pregnancy test
before receiving a Soriatane prescription. To encourage compliance with this
recommendation, a limited supply of the drug should be prescribed.
For at least 3 years after discontinuing Soriatane therapy, a pregnancy test
must be repeated every 3 months.
Must have selected and have committed to use 2 effective forms of contraception
(birth control) simultaneously, at least 1 of which must be a primary form,
unless absolute abstinence is the chosen method, or the patient has undergone
a hysterectomy or is clearly postmenopausal.
Patients must use 2 effective forms of contraception (birth control)
simultaneously for at least 1 month prior to initiation of Soriatane therapy,
during Soriatane therapy, and for at least 3 years after discontinuing Soriatane
therapy. A Soriatane Patient Referral Form is available so that patients can
receive an initial free contraceptive counseling session and pregnancy testing.
Counseling about contraception and behaviors associated with an increased
risk of pregnancy must be repeated on a monthly basis by the prescriber during
Soriatane therapy and every 3 months for at least 3 years following discontinuation
of Soriatane therapy.

Effective forms of contraception include both primary and secondary forms
of contraception. Primary forms of contraception include: tubal ligation, partner's
vasectomy, intrauterine devices, birth control pills, and injectable/implantable/insertable/topical
hormonal birth control products. Secondary forms of contraception include latex
condoms (with or without spermicide), diaphragms and cervical caps (which must
be used with a spermicide).
Any birth control method can fail. Therefore, it is critically important
that women of childbearing potential use 2 effective forms of contraception
(birth control) simultaneously. It has not been established if there is a pharmacokinetic
interaction between acitretin and combined oral contraceptives. However, it
has been established that acitretin interferes with the contraceptive effect
of microdosed progestin preparations.1 Microdosed “minipill”
progestin preparations are not recommended for use with Soriatane. It is
not known whether other progestational contraceptives, such as implants and
injectables, are adequate methods of contraception during acitretin therapy.

Prescribers are advised to consult the package insert of any medication
administered concomitantly with hormonal contraceptives, since some medications
may decrease the effectiveness of these birth control products. Patients should
be prospectively cautioned not to self-medicate with the herbal supplement
St. John's Wort because a possible interaction has been suggested with hormonal
contraceptives based on reports of breakthrough bleeding on oral contraceptives
shortly after starting St. John's Wort. Pregnancies have been reported by
users of combined hormonal contraceptives who also used some form of St. John's
Wort (see PRECAUTIONS).

Must have signed a Patient Agreement/Informed Consent for Female Patients
that contains warnings about the risk of potential birth defects if the fetus
is exposed to Soriatane, about contraceptive failure, about the fact that
they must not ingest beverages or products containing ethanol while taking
Soriatane and for 2 months after Soriatane treatment has been discontinued,
and about preventing pregnancy while taking Soriatane and for at least 3 years
after discontinuing Soriatane therapy.

If pregnancy does occur during Soriatane therapy or at any time for at least
3 years following discontinuation of Soriatane therapy, the prescriber and patient
should discuss the possible effects on the pregnancy. The available information
is as follows:
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.2

Severe birth defects have been reported where conception occurred during
the time interval when the patient was being treated with acitretin and/or
etretinate. In addition, severe birth defects have also been reported when
conception occurred after the mother completed therapy. These cases have been
reported both prospectively (before the outcome was known) and retrospectively
(after the outcome was known). The events below are listed without distinction
as to whether the reported birth defects are consistent with retinoid-induced
embryopathy or not.

There have been 318 prospectively reported cases involving pregnancies
and the use of etretinate, acitretin or both. In 238 of these cases, the
conception occurred after the last dose of etretinate (103 cases), acitretin
(126) or both (9). Fetal outcome remained unknown in approximately one-half
of these cases, of which 62 were terminated and 14 were spontaneous abortions.
Fetal outcome is known for the other 118 cases and 15 of the outcomes
were abnormal (including cases of absent hand/wrist, clubfoot, GI malformation,
hypocalcemia, hypotonia, limb malformation, neonatal apnea/anemia, neonatal
ichthyosis, placental disorder/death, undescended testicle and 5 cases
of premature birth). In the 126 prospectively reported cases where conception
occurred after the last dose of acitretin only, 43 cases involved conception
at least 1 year but less than 2 years after the last dose. There were
3 reports of abnormal outcomes out of these 43 cases (involving limb malformation,
GI tract malformations and premature birth). There were only 4 cases where
conception occurred at least 2 years after the last dose but there were
no reports of birth defects in these cases.
There is also a total of 35 retrospectively reported cases where
conception occurred at least one year after the last dose of etretinate,
acitretin or both. From these cases there are 3 reports of birth defects
when the conception occurred at least 1 year but less than 2 years after
the last dose of acitretin (including heart malformations, Turner's Syndrome,
and unspecified congenital malformations) and 4 reports of birth defects
when conception occurred 2 or more years after the last dose of acitretin
(including foot


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Other reviews about Soriatane on web:

Official site from Stiefel Laboratories, Inc. Includes prescribing information and consumer resources. SORIATANE - Do Your P.A.R.T.


Accurate, FDA approved Soriatane information for healthcare professionals and patients - brought to you by Drugs.com. Soriatane Official FDA information, side effects and uses.


Soriatane information from Drugs.com. Soriatane is prescribed for several types of severe psoriasis, a chronic skin condition that causes inflamed red patches with silvery scales. Soriatane patient advice including side effects


Learn about the prescription medication Soriatane (Acitretin), drug uses, dosage, side effects, drug interactions, warnings, reviews and patient labeling. Soriatane (Acitretin) Drug Information: Uses, Side Effects, Drug ...


Soriatane (acitretin) is used for moderate to severe psoriasis. It is most effective in conjunction with other treatments such as phototherapy and biologics. National Psoriasis Foundation - Treating psoriasis: Soriatane


Buy Soriatane (Acitretin) (Neotigason) from our Canadian Online Pharmacy by calling 1-877-888-3562. Fully licensed, fast delivery, free doctor consultation provided. Buy Soriatane (Acitretin) (Neotigason) Online Now


Learn about Soriatane from the publishers of the Physicians Desk Reference. Find prescription drug information resources including interactions, side effects, symptoms, treatment ... Soriatane | Prescription Drug Information, Side Effects | PDRHealth


The active ingredient in Soriatane is acitretin, a retinoid that is used in the treatment of severe psoriasis resistant to other forms of therapy and in severe congenital ... Soriatane - Kosmix : Reference, Videos, Images, News, Shopping and ...


What is Soriatane (Acitretin)? Acitretin is a retinoid, which is a form of vitamin A. Acitretin is used to treat severe psoriasis in adults. It is usually given after other ... Soriatane - Drugs & Treatments - Revolution Health


Acitretin (trade name Soriatane) is a second generation retinoid. It is taken orally, and is typically used for psoriasis. It is a metabolite of etretinate, which was used prior to ... Acitretin - Wikipedia, the free encyclopedia





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