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acitretin (Rx)Brand and Other Names:Soriatane

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

capsule

  • 10mg
  • 25mg
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Psoriasis

25-50 mg PO qDay

Other Indications & Uses

Off-label: Darier's disease, palmoplantar pustulosis, lichen planus, Sjogren-Larsson syndrome

Safety and efficacy not established

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Interactions

Interaction Checker

acitretin and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Cheilitis (>75%)

            Alopecia (50-75%)

            Hypertriglyceridemia (50-75%)

            Skin peeling (50-75%)

            Dry skin (25-50%)

            Dysglycemia (25-50%)

            Increased LFT (25-50%)

            Nail disorder (25-50%)

            Pruritus (25-50%)

            Rhinitis (25-50%)

            arthralgia (10-25%)

            changes in phosphorus, potassium, sodium, & magnesium levels (10-25%)

            Dry mouth (10-25%)

            Epistaxis (10-25%)

            Erythematous rash (10-25%)

            Hepatotoxicity (10-25%)

            Hyperesthesia (10-25%)

            Paresthesia (10-25%)

            Paronychia (10-25%)

            Rigors (10-25%)

            Skin atrophy (10-25%)

            Spinal hyperostosis (10-25%)

            Sticky skin (10-25%)

            Xerophthalmia (10-25%)

            1-10%

            Edema

            Flushing

            Depression

            Fatigue

            Headache

            Insomnia

            Somnolence

            Abdominal pain

            Anorexia

            Diarrhea

            Gingivitis

            Increased appetite

            Nausea

            Stomatitis

            Vomiting

            Hot flashes

            Vision changes

            Corneal epithelial abnormality

            Sinusitis

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            Warnings

            Black Box Warnings

            Elevated liver enzymes and hepatitis-related deaths reported

            Use only for severe psoriasis in women who are unresponsive or have contraindications to other therapy

            Should be prescribed by those who understand risk of teratogenic effects and those who are competent in the diagnosis and treatment of severe psoriasis and use of systemic retinoids

            Teratogenic agent; do not use in females who are pregnant, who intend to become pregnant during therapy or within 3 years after discontinuation of therapy, or who may not use reliable contraception during this time period

            Alcohol is contraindicated during treatment with acitretin and for 2 months after stopping therapy as ethanol promotes the formation of etretinate, which has prolonged half-life and teratogenic risk

            Females with childbearing potential must participate in Do Your P.A.R.T. program and have signed Patient Agreement/Informed Consent for Female Patients

            Do not use St. John’s wort due to the effect of decreased birth control effectiveness and potential breakthrough bleeding

            If pregnancy occurs during therapy or 3 yr after discontinuation, prescribers should discuss possible risks for the pregnancy

            Patients should not donate blood during therapy and 3 yr after discontinuation because women with childbearing potential should not receive blood from treated patients

            Males have shown residual amounts of acitretin in seminal fluid, which appears to pose little risk to the fetus, but data are limited

            Requirements for use in women of childbearing potential

            • Use is contraindicated in females with childbearing potential unless patient meets ALL of the following conditions:
            • 1) 2 negative urine or serum pregnancy test results (baseline and 1st 5 days of menses immediately before initiating therapy)
            • 2) Repeated urine or serum pregnancy test monthly during therapy and q3mth during the 3 yr following discontinuation of therapy
            • 3) Committed to use 2 (at least one should be primary) effective forms of contraception simultaneously unless the patient is abstinent, postmenopausal, or has undergone a hysterectomy
            • 4) Use 2 effective forms of contraception simultaneously for at least 1 month prior to therapy, during therapy, and for 3 yr after discontinuing therapy
            • 5) Microdosed “minipill” progestin preparations are not recommended because acitretin interferes with contraception effect and it is unknown whether other progestin contraceptives are adequate contraceptive methods during acitretin therapy

            Contraindications

            Hypersensitivity to retinoids (eg, angioedema, urticaria), parabens

            Coadministration with methotrexate (increased risk for hepatitis)

            Coadministration with tetracyclines (increases ICP, pseudotumor cerebri)

            Alcohol (see Black Box Warnings)

            Severely impairment of liver or kidney function and in patients with chronic abnormally elevated blood lipid values (see Black Box Warnings)

            Pregnancy: teratogenic (see Black Box Warnings)

            Cautions

            Check LFTs 1 day before starting, pregnancy test 2 wk prior to starting therapy

            Hyperostosis reported with long-term treatment

            New or progression of preexisting vertebral/skeletal abnormalities (eg, degenerative spurs, anterior bridging of spinal vertebrae, diffuse idiopathic skeletal hyperostosis, ligament calcification, and narrowing and destruction of a cervical disc space)

            Elevated triglycerides and cholesterol reported; monitor for resulting cardiovascular conditions and pancreatitis

            Ophthalmic conditions, including dry eyes, irritation, and brow/lash loss reported

            Pseudotumor cerebri reported

            May cause capillary leak syndrome

            Exfoliative dermatitis and erythroderma reported

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            Pregnancy & Lactation

            Pregnancy Category: X

            Major human fetal abnormalities have been reported including meningomyelocele, meningoencephalocele, multiple synostoses, facial dysmorphia, syndactyly, absence of terminal phalanges, malformations of bones (hip, ankle, forearm, skull, cerebral vertebrae), low-set ears, high palate, decreased cranial volume, and cardiovascular malformations

            Lactation: enters breast milk/not recommended

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Retinoic acid analog

            Pharmacokinetics

            Half-Life: 49 hr

            Peak Plasma Time: 2-5 hr

            Protein Bound: >99.9% (primarily albumin)

            Excretion: 34-54% feces; 16-53% urine

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            Images

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
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            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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