Acitretin

What is Acitretin?

• Acitretin (Soriatane), a retinoid, used for the treatment of severe psoriasis in adults.

Acitretin

Acitretin

What are the uses of this medicine?

• Acitretin (Soriatane) is a medicine used to treat severe forms of psoriasis in adults.
• Because Soriatane can have serious side effects, you should talk with your prescriber about whether possible benefits of Soriatane outweigh its possible risks.
• Soriatane may not work right away.
• You may have to wait 2 to 3 months before you get the full benefit of Soriatane.
• Psoriasis gets worse for some patients when they first start treatment with Soriatane.

Psoriasis:

• Psoriasis is a skin disease that causes cells in the outer layer of the skin to grow faster than normal and pile up on the skin’s surface.
• In the most common type of psoriasis, the skin becomes inflamed and produces red, thickened areas, often with silvery scales.

How does this medicine work?

• Acitretin (a" si tre' tin) is an aromatic retinoid and the major metabolite of etretinate (e tret' i nate). Acitretin has replaced etretinate in clinical practice in the therapy of psoriasis because of its more favorable pharmacokinetics and half-life.
• Its mechanism of action in psoriasis is believed to be mediated by activation of retinoic acid and retinoid X receptors, which regulate gene expression important in growth and differentiation.
• Acitretin is considered a second generation retinoid and its relative lack of receptor specificity accounts for its many adverse side effects.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• can get pregnant
• are breastfeeding
• have severe liver or kidney disease
• have repeated high blood lipids
• take these medicines:
• methotrexate
• tetracyclines
• are allergic to acitretin

What drug interactions can this medicine cause?

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Be sure to mention if you are taking any of the following:

• methotrexate
• tetracyclines
• glyburide
• phenytoin
• vitamin A supplements
• progestin-only oral contraceptives (“minipills”)
• TEGISON or TIGASON (etretinate). Tell your prescriber if you have ever taken this medicine in the past.
• St. John’s wort herbal supplement

• Tell your healthcare provider if you are getting phototherapy treatment. Your doses of phototherapy may need to be changed to prevent a burn.

Is this medicine FDA approved?

• Acitretin was approved for use in psoriasis and acne in the United States in 1996, but is currently used only in therapy of severe psoriasis unresponsive to conventional therapies and under strict regulations regarding monitoring and birth control.

How should this medicine be used?

Recommended dosage:

• Soriatane should be initiated at 25 to 50 mg per day, given as a single dose with the main meal.
• Maintenance doses of 25 to 50 mg per day may be given dependent upon an individual patient’s response to initial treatment.
• Relapses may be treated as outlined for initial therapy.

• You should have blood tests for liver function, cholesterol, and triglycerides before starting treatment and during treatment to check your body’s response to Soriatane. Your prescriber may also do other tests.
• Once you stop taking Soriatane, your psoriasis may return. Do not treat this new psoriasis with leftover Soriatane. It is important to see your prescriber again for treatment recommendations because your situation may have changed.

Administration:

• Take Soriatane with food.
• Be sure to take your medicine as prescribed by your prescriber. The dose of Soriatane varies from patient to patient.
• The number of capsules you must take is chosen specially for you by your prescriber.
• This dose may change during treatment.
• If you miss a dose, do not double the next dose.
• Skip the missed dose and resume your normal schedule.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As 10-mg and 25-mg gelatin capsules for oral administration.

This medicine is available in fallowing brand namesː

• Soriatane

What side effects can this medication cause?

The most common side effects of this medicine include:

• Chapped lips, peeling fingertips, palms, and soles, itching, scaly skin all over, weak nails, sticky or fragile (weak) skin, runny or dry nose, or nosebleeds
• Dry mouth
• Joint pain
• Tight muscles
• Hair loss
• Dry eyes
• Rise in blood fats (lipids)

Soriatane can cause serious side effects, including:

• Severe birth defects
• Liver problems
• Bad headaches, nausea, vomiting, blurred vision
• night blindness
• Depression
• Aches or pains in your bones, joints, muscles, or back, trouble moving, or loss of feeling in your hands or feet
• Frequent urination, great thirst or hunger
• Shortness of breath, dizziness, nausea, chest pain, weakness, trouble speaking, or swelling of a leg
• Blood vessel problems
• Serious allergic reactions
• Serious skin problems

What special precautions should I follow?

• Avoid giving blood. Do not donate blood while you are taking Soriatane and for at least 3 years after stopping treatment with Soriatane. Soriatane in your blood can harm an unborn baby if your blood is given to a pregnant woman. Soriatane does not affect your ability to receive a blood transfusion.
• Avoid progestin-only birth control pills (“minipills”). This type of birth control pill may not work while you take Soriatane. Ask your prescriber if you are not sure what type of pills you are using.
• Avoid night driving if you develop any sudden vision problems. Stop taking Soriatane and call your prescriber if this occurs.
• Avoid non-medical ultraviolet (UV) light. Soriatane can make your skin more sensitive to UV light. Do not use sunlamps, and avoid sunlight as much as possible. If you are taking light treatment (phototherapy), your prescriber may need to change your light dosages to avoid burns.
• Avoid dietary supplements containing vitamin A. Soriatane is related to vitamin A. Therefore, do not take supplements containing vitamin A, because they may add to the unwanted effects of Soriatane. Check with your prescriber or pharmacist if you have any questions about vitamin supplements.
• Do not share Soriatane with anyone else, even if they have the same symptoms. Your medicine may harm them or their unborn child.
• You must not take Soriatane if you are pregnant or might become pregnant during treatment or at any time for at least 3 years after you stop treatment because Soriatane can cause severe birth defects.
• Avoid alcohol. Females who are able to become pregnant must avoid drinks, foods, medicines, and over-the-counter products that contain alcohol. The risk of birth defects may continue for longer than 3 years if you swallow any form of alcohol during treatment with Soriatane and for 2 months after stopping Soriatane.
• Do not take Soriatane if you are breastfeeding. Soriatane can pass into your milk and may harm your baby. You will need to choose either to breast feed or take Soriatane, but not both.
• Acitretin, like many retinoids, can lead to increase in serum aminotransferase levels and has been implicated in cases of acute liver injury which can be severe and even fatal.
• Exfoliative dermatitis/erythroderma has been reported in patients receiving Soriatane. Discontinue Soriatane if exfoliative dermatitis/erythroderma occurs during therapy.
• Capillary leak syndrome, a potential manifestation of retinoic acid syndrome, has been reported in patients receiving Soriatane. Discontinue Soriatane if capillary leak syndrome develops during therapy.
• Soriatane and other retinoids administered orally have been associated with cases of pseudotumor cerebri (benign intracranial hypertension). Since both Soriatane and tetracyclines can cause increased intracranial pressure, their combined use is contraindicated.
• Lipid elevations occur in 25% to 50% of subjects treated with Soriatane. There have been rare reports of pancreatitis during therapy with Soriatane in the absence of hypertriglyceridemia.
• Any patient treated with Soriatane who is experiencing visual difficulties should discontinue the drug and undergo ophthalmologic evaluation.
• Blood lipid determinations should be performed before Soriatane is administered and again at intervals of 1 to 2 weeks until the lipid response to the drug is established, usually within 4 to 8 weeks. Dietary modifications, reduction in dose of Soriatane, or drug therapy should be employed to control significant elevations of triglycerides. If, despite these measures, hypertriglyceridemia and low HDL levels persist, the discontinuation of Soriatane should be considered.

What to do in case of emergency/overdose?

Symptoms of overdose may include:

• headache and vertigo

Management of overdosage:

• In the event of acute overdosage, Soriatane must be withdrawn at once.
• All female patients of childbearing potential who have taken an overdose of Soriatane must:
• Have a pregnancy test at the time of overdose
• contraceptive use for at least 3 years’ duration after the overdose.

Can this medicine be used in 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.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: acitretin
• Inactive ingredients: black monogramming ink, gelatin, maltodextrin (a mixture of polysaccharides), microcrystalline cellulose, and sodium ascorbate. 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.

Who manufactures and distributes this medicine?

Manufactured for: Stiefel Laboratories, Inc., Research Triangle Park, NC

What should I know about storage and disposal of this medication?

• Store Soriatane between 59oF to 77oF (15oC to 25oC).
• Keep Soriatane away from sunlight, high temperature, and humidity.

Antipsoriasis agents

• Acitretin, Alefacept, Apremilast, Cyclosporine, Methotrexate, Psoralen (Methoxsalen)

Monoclonal Antibodies IL-17A Antagonists

• Brodalumab, Ixekizumab, Secukinumab

Tumor Necrosis Factor Antagonists

• Adalimumab, Certolizumab, Etanercept, Golimumab, Infliximab

Other

• Efalizumab, Guselkumab, Tildrakizumab, Ustekinumab

• Dailymed label info on Acitretin
• FDA Acitretin

Acitretin Resources
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