General

Pronunciation
a-si-TRE-tin

Trade Name(s)

• Soriatane

Pregnancy Category
Category X

Ther. class.
antipsoriatics

Pharm. class.
retinoids

Indications

Severe psoriasis unresponsive to other therapies

Action

Mechanism of action is not known

Therapeutic Effect(s):
Improvement in psoriatic lesions

Pharmacokinetics

Absorption: Well absorbed (72%) following oral administration

Distribution: Crosses the placenta; remainder of distribution unknown

Protein Binding: Highly protein bound (99.9%)

Metabolism and Excretion: Mostly metabolized by the liver; metabolites excreted in feces (34–54%) and urine (16–53%)

Half-life: 49–63 hr

TIME/ACTION PROFILE (antipsoriatic effect)

ROUTE	ONSET	PEAK	DURATION
PO	unknown	up to 3 mo	unknown

Contraindication/Precautions

Contraindicated in:

• Hypersensitivity to retinoids or parabens

• Concurrent use of alcohol, in any form

• Patients taking methotrexate or a tetracycline

• Chronically elevated blood lipids

• Severe hepatic or renal impairment

• OB: Lactation: Pedi: Safety not established

Use Cautiously in:
Concurrent phototherapy (intensity of treatment may need to be altered)

Exercise Extreme Caution in:
Women of childbearing age

Adverse Reactions/Side Effects

CNS: depression, fatigue, headache, pseudotumor cerebri (benign intracranial hypertension), rigors, sleep disorders.

EENT: decreased night vision/night blindness, dry eyes, dry mouth, irritation, blurred vision, intolerance to contact lenses, loss of lashes and brows, photophobia, taste disturbances, tinnitus,.

CV: edema.

GI: HEPATOTOXICITY, abdominal pain, anorexia, diarrhea, gingivitis, nausea, PANCREATITIS, stomatitis, vomiting.

Derm: alopecia, dermatitis, dry skin, nail disorder, peeling, pruritis, rash, sunburn, sweating.

GU: hematuria.

Hemat: anemia.

Metabolic: hyperglycemia, hypoglycemia, hyperkalemia, hyperlipidemia (triglycerides, total cholesterol, HDL), hyper/hypomagnesemia, hypernatremia, hyperphosphatemia, hyperuricemia.

MS: arthralgia, hyperostosis, myalgia.

Misc: cheilitis, hot flashes, paresthesia.

Resp: epistaxis.

*CAPITALS indicates life-threatening.
*italic indicates most frequent.

Interactions

Drug-Drug

• May effectiveness of hormonal contraceptives (especially microdosed progestin preparations)

• May hypoglycemic effects of sulfonylureas

• Alcohol conversion to a very long-acting compound (avoid use of alcohol during acitretin therapy and for 2 months after discontinuation)

• Concurrent use with high doses of vitamin A risk of hypervitaminosis A

• Methotrexate risk of hepatotoxicity (avoid concurrent use)

• Tetracyclines may intracranial pressure (avoid concurrent use)

Drug-Food
Food absorption

Route/Dosage

• PO (Adults): 25 or 50 mg once daily with a meal.

Availability

• Capsules: 10 mg, 25 mg

Assessment

• Assess skin lesions before and periodically during therapy. Transient worsening of psoriasis, with increased redness and itching, may occur at initiation of therapy

Lab Test Considerations

• Monitor liver function (AST, ALT, and LDH) every 1–2 wk until stable and periodically thereafter as indicated. Discontinue therapy if hepatotoxicity is suspected

» Monitor fasting blood lipids (cholesterol, HDL, triglycerides) every 1–2 wk until lipid response to the drug is established, usually 4–8 wk, and periodically thereafter. Report cholesterol and triglyceride levels or in HDL

Potential Nursing Diagnoses

• Disturbed body image (Indications)

Implementation

• Therapy in women of childbearing age is started during the first 5 days of the menstrual period immediately preceding therapy, following 2 negative serum or urine pregnancy tests with a sensitivity of at least 25 mIU/ml. The first pregnancy test is used as a screening test and done at time of decision of acitretin therapy. Patients must commit to using 2 forms of birth control for at least 1 month prior to starting therapy, during therapy, and for at least 3 years after discontinuing therapy. For patients with ammenorrhea, the second pregnancy test is done 11 days after unprotected sexual intercourse. Continue pregnancy tests monthly during therapy

» A Patient Agreement/Informed Consent must be signed by female patients before receiving prescription. Limited amounts of acitretin should be prescribed to encourage compliance with pregnancy testing. All patients must receive a Soriatane Medication Guide with each prescription refill

• PO: Absorption is enhanced by taking with food

Patient/Family Teaching

• Instruct patient to take medication as directed. Take missed doses as soon as possible with milk or fatty food; do not take if almost time for next dose. Do not double doses. Inform patient that condition may appear to worsen during initial therapy. Caution patient not to share this medication with others; may be dangerous

• Caution patient not to take vitamin A supplements while taking acitretin. Hypervitaminosis A may result

• Instruct patient to immediately report vision problems or mood disturbances

• Instruct patient to use caution when driving at night

• Instruct patients with diabetes to closely follow blood glucose levels while taking acitretin. and to report significant changes in blood glucose levels to a health care provider

• Inform patient that dry skin and chapped lips will occur and to apply lubricant to lips. Health care professional should be notified if these symptoms become bothersome

• Advise patient that oral rinses, sugarless gum or candy, and frequent oral hygiene may help relieve dry mouth

• Discuss possibility of excessively dry eyes with patient who wears contact lenses. Patient may need to wear glasses during course of therapy

• Acitretin is contraindicated during pregnancy. Teratogenic effects may persist for years. Caution female patients to use two reliable forms of contraception for 1 mo prior to, throughout, and for at least 3 yr after discontinuation of therapy. Patients who have undergone a tubal ligation should also use a second form of contraception. Patient should discuss past use of acitretin with health care professional before attempting pregnancy. Soriatane Patient Referral Form is available to provide patient with initial free contraceptive counseling and pregnancy testing

• Caution female patients with reproductive potential not to ingest beverages or products containing alcohol during or for 2 mo after discontinuation of acitretin

• Instruct female patient to consult health care professional prior to taking other Rx, OTC, or herbal products, especially St. John's Wort

• Caution patient not to donate blood while taking acitretin and for 3 yr after discontinuation to prevent the possibility of a pregnant patient receiving the blood

• Caution patient to minimize exposure to sunlight, to wear sunscreen, and to avoid sunlamps to prevent photosensitivity reactions

• Inform patient of need for follow-up. Periodic ophthalmic exams and bone x-rays may be required

• Emphasize the importance of regular blood tests to check lipids and hepatic function

Evaluation/Desired Outcomes

Improvement or resolution of skin lesions in psoriasis. Therapy may take 2–3 mo before full effects are seen

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