ACITRETIN (Systemic)

Some commonly used brand names are:

In the U.S.?

• Soriatane

Some commonly used brand names are:

In Canada?

• Soriatane

Other commonly used names are 13-cis acitretin, etretin, and isoetretin.

Category

• Antipsoriatic (systemic)
• keratinization stabilizer (systemic)

Description

Acitretin (a-si-TRE-tin) is used to help relieve and control severe skin disorders, such as severepsoriasis. It works by allowing normal growth and development of the skin.Acitretin may continue to work after you stop taking it, but usually aftera time, the skin condition returns and you may need to begin taking it again.

Acitretin must not be used to treat women who are ableto bear children unless other forms of treatment have been tried first andfailed. Acitretin must not be taken during pregnancy because it causes birthdefects in humans. If you are able to bear children, it is very importantthat you read, understand, and follow the pregnancy warnings for acitretin.

You must take important precautions while taking acitretinand continue with them for a period of time after you stop taking the medicine. The precautions are:

• Women should not become pregnant and shoulduse two methods of very effective birth control. The birth control methodsshould begin 1 month before starting the medicine and continue for at least 2 or 3 years after discontinuing the medicineor as directed by your doctor.
• Men and women should not donate bloodfor transfusion purposes during treatment and for 2 or3 years after discontinuing the medicine or as directed by your doctor.
• Men and women should not drink alcoholduring treatment and for 2 months after discontinuing the medicine.

This medicine is available only with your doctor's prescription, in thefollowing dosage form(s):

Oral
• Capsules (U.S. and Canada)

Before Using This Medicine

In deciding to use a medicine,the risks of taking the medicine must be weighed against the good it willdo. This is a decision you and your doctor will make. For acitretin, the followingshould be considered:

Allergies?Tell your doctor if you have ever had any unusual reactionto acitretin, etretinate, isotretinoin, tretinoin, or vitamin A-likepreparations, including vitamin A supplements. Also tell your health careprofessional if you are allergic to any other substances, such as foods, preservatives,or dyes.

Pregnancy?Acitretin must not be taken duringpregnancy. It has been shown to cause serious birth defects and other problemsin humans.

Before taking this medicine, make sure your doctor knows if you are pregnantor if you may become pregnant. Beginning at least 1 monthbefore you start to take acitretin, you should plan on using two effectiveforms of birth control to prevent pregnancy. In addition, since itis not known how long pregnancy should be avoided after treatment stops, youshould plan not to become pregnant for at least 2 or3 years after you stop taking acitretin or as directed by your doctor. If you become pregnant, stop taking the medicine andtell your doctor.

Breast-feeding?It is not known whether acitretin passes into thebreast milk. However, use of acitretin should not beused during breast-feeding because it may cause unwanted effects innursing babies. You also should plan not to breast-feedfor at least 2 or 3 years after you stop taking acitretin.

Children?This medicine has been tested in some children andhas been shown not to cause different side effects or problems in childrenthan it does in adults. However, children may be more sensitive to some ofthe medicine's effect on bones, which may prevent normal bone growth duringpuberty. This can cause them to grow up to be shorter adults than expected.Therefore, it is especially important that you discuss with the child's doctorthe good that this medicine may do as well as the risks of using it.

Older adults?This medicine has been tested and has not been shownto cause different side effects or problems in older people than it does inyounger adults. However, some older patients may have higher levels of themedicine in the blood stream as compared to younger adults, and they may bemore sensitive to its effects. This may increase their chance of developingside effects during treatment.

Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used together,even if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. When you are takingacitretin, it is especially important that your health care professional knowif you are taking any of the following:

• Alcoholic beverages?Drinking alcohol may convert acitretinto a much longer-acting product that can stay in the body 60 times longerthan acitretin does. This may result in a greater chance of developing sideeffects for months or years, depending on how much and how often one drinks.This unusual effect can occur even after you stop taking acitretin, especiallyfor the first 2 months after you stop taking this medicine

• Cyclosporine (e.g., Sandimmune or Neoral) or
• Phenytoin (e.g., Dilantin)?Acitretin may increase the effectsof this medicine

• Etretinate (e.g., Tegison) or
• Isotretinoin (e.g., Accutane) or
• Tretinoin (oral) (e.g., Vesanoid) or
• Tretinoin (topical) (e.g., Avita, Renova, or Retin A) or
• Vitamin A, including vitamin supplements?Etretinate, isotretinoin,and tretinoin are not used together with acitretin; problems in skin, vision,and bone may be more likely to occur when they are used at the same time.If vitamin A is taken with acitretin, the dose of vitamin A should not exceedthe minimum recommended daily allowance (RDA)

• Methotrexate (e.g., Rheumatrex, Trexall)?Should not be usedwith acitretin

• Oral contraceptives, progestin-only or ?mini pills? (birthcontrol pills) (e.g., Micronor, Nor-QD, Ovrette)?Acitretin may preventprogestin-only oral contraceptives from working properly and may result inan unplanned pregnancy. This does not occur with oral contraceptives containingboth estrogens and progestins

• Tetracyclines (demeclocycline [e.g., Declomycin], doxycycline [e.g.,Doxycin] minocycline [e.g., Minocin] oxytetracycline [e.g., Terramycin] tetracycline[e.g., Symycin])?Should not be used with acitretin

Other medical problems?The presence of other medicalproblems may affect the use of acitretin. Make sure you tell your doctor ifyou have any other medical problems, especially:

• Diabetes mellitus (sugar diabetes) or
• High cholesterol or triglycerides, uncontrollable (or history of)or
• Inflammation of pancreas (or history of)?Acitretin may makethese conditions worse or increase cholesterol or triglyceride problems

• Hypervitaminosis A (or history of)?If you have past or currentproblems with toxic symptoms from vitamin A, acitretin may increase the chancethat they will occur again

• Kidney disease, severe or
• Liver disease, severe?May cause acitretin to stay in the bodyfor a longer period of time and increase the chance of side effects

Proper Use of This Medicine

Make certainyour health care provider knows if you are on any special diet, such as alow-sodium, low-cholesterol, or low-sugar diet. Discuss with your doctor howoften you drink alcohol, even if it is only an occasional drink.

Patient information is usually provided with acitretin.Read it carefully before using this medicine.

Take acitretin with a main meal or with a glass ofmilk.

For women? This medicine may cause birth defects. To make sure you are not pregnant before beginning treatment, yourdoctor will ask you to:

• Use two effective forms of birth control (contraception)for at least 1 month before beginning treatment.
• Report when your menstrual periods are normal.
• Take a pregnancy test within 1 week before beginningthe treatment to make sure you are not pregnant.
• Begin your acitretin treatment on Day 2 or Day3 of your next menstrual period.
• Sign a paper to show that you understand theimportance of not becoming pregnant for at least 2 to 3 years after you stoptaking this medicine, according to the advice of your doctor.

Dosing?Take acitretin with food. Taking with foodis important for getting the right amount of medicine out of your stomach.

The dose of acitretin will be different for different patients. Follow your doctor's orders or the directions on the label.The following information includes only the average doses of acitretin. If your dose is different, do not change it unless yourdoctor tells you to do so.

It is important that you do not share this medicine with anyone else becauseof the risk of birth defects and other serious side effects.

The number of tablets that you take depends on the strength of the medicine.Also, the number of doses you take each day, the timeallowed between doses, and the length of time you take the medicine dependon the medical problem for which you are taking acitretin.

• For oral dosage form (tablets):
  • For severe psoriasis:
    • Adults?25 to 50 milligrams (mg) a day as a single dose. Afterfour weeks, your doctor may increase your dose depending on how well thismedicine is working for you
    • Children?Use and dose must be determined by your doctor.
  • For other severe skin disorders (such as bullous or nonbullous erythroderma,lamellar ichthyoses, and keratosis follicularis):
    • Adults?25 milligrams (mg) a day. After four weeks, a dose of10 to 75 mg a day is used.
    • Children?Use and dose must be determined by your doctor.

Missed dose?Take the missed dose as soon as possible. However,if you do not remember the missed dose until the next day, skip the misseddose and go back to your regular dosing schedule. Do not double doses. Ifyou have any questions about this, check with your doctor.

Storage?To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in otherdamp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be surethat any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

It is important that your doctor check your progress at regularvisits while you are taking this medicine. If your condition has improved and you are no longer taking acitretin, yourprogress must still be checked. This is especially important for childrenor elderly patients, who may be more sensitive to the effects of this medicine,and for women who want to become pregnant after they stop taking the medicine.

It is important that you check with your doctor beforetaking any medicines including vitamins, herbal products or over-the-counter(OTC) medicines. Some of these medicines or nutritional supplements(e.g., St. John's wort) may make your birth control pills not work.

Your skin condition may improve or get worse during the first 3 weeksof treatment and you also may notice some skin irritation from the medicine.With continued use, the expected skin irritation will lessen after a few weeks. Check with your health care professional any time skinirritation becomes severe or if your skin condition does not improve within8 to 12 weeks.

Do not drink alcohol while taking this medicine orfor at least 2 months after discontinuing treatment.

• Drinking alcohol can change the medicine in the body to a productthat stays in your body for an extended period of time. This can increaseyour chance of developing side effects for a longer period of time than ifyou hadn't consumed alcohol.
• If a woman consumes alcohol during acitretin treatment, she shouldconsider delaying a pregnancy for longer than 2 or 3 years or as directedby her doctor.

Do not donate blood during treatment with acitretin, for 2 or 3 years following treatment, or as otherwise directed by your doctor. Although problems resulting from a blood transfusion are not likely,this precaution prevents the possibility that your blood would be used inpregnant women.

Acitretin can cause dryness of the eyes, blur your vision, or cause othervision problems. Be aware that while using acitretin you may see a sudden decrease in your night vision (ability to seebefore the sun rises or after the sun goes down). Also, acitretin may causeyour eyes to be more sensitive to light, including sunlight, than they arenormally. These effects can make certain activities dangerous,such as driving or operating machines.

Check with your doctor if you experience any visionor eye problem. Wearing contact lenses may become uncomfortable. Yourdoctor may suggest using artificial tears to keep your eyes from getting toodry.

Acitretin may cause dryness of the mouth, nose, and throat. For temporaryrelief of mouth dryness, use sugarless candy or gum, melt bits of ice in yourmouth, or use a saliva substitute. However, if your mouth continues to feeldry for more than 2 weeks, check with your medical doctor or dentist. Continuingdryness of the mouth may increase the chance of developing dental disease,including tooth decay, gum disease, and fungus infections.

Avoid overexposing your skin to wind, cold weather, and sunlight, evenon cloudy days. Your skin will be more prone to sunburn, dryness, or irritation,especially during the first 2 or 3 weeks. However, you should not stop takingthis medicine, unless the skin irritation becomes too severe. For best results:

• Wear sunglasses that can block ultraviolet (UV) light. Ordinarysunglasses may not protect your eyes.
• Regularly use sunscreen or sunblocking lotions with a sun protectionfactor (SPF) of at least 15.
• Wear protective clothing and hats and stay out of direct sunlight,especially between the hours of 10 a.m. and 3 p.m.
• Apply creams, lotions, or moisturizers often. Your health care professionalcan help you choose the right skin products for you to reduce skin drynessand irritation.
• Do not use an artificial light, such as a sunlamp, unless directedotherwise by your doctor.

Unless your doctor tells you otherwise, it is especially important to avoidusing the following skin products:

• Any topical acne product or skin product containing a peeling agent(such as benzoyl peroxide, resorcinol, salicylic acid, or sulfur).
• Hair products that are irritating, such as permanents or hair removalproducts.
• Skin products that cause sensitivity to the sun, such as those containingspices or limes.
• Skin products containing a large amount of alcohol, such as astringents,shaving creams, or after-shave lotions.
• Skin products that are too drying or abrasive, such as some cosmetics,soaps, or skin cleansers.

Do not take doses of vitamin A or any vitamin supplementcontaining vitamin A that exceeds the minimum recommended allowance (RDA) while you are taking this medicine. Todo so may increase the chance of developing side effects.

Side Effects of This Medicine

Along with its needed effects, a medicine maycause some unwanted effects. Although not all of these side effects may occur,if they do occur they may need medical attention.

Check with your doctorimmediately if any of the following side effects occur:

More common

Headache (severe and continuing); nauseaor vomiting (severe and continuing)

Less common

Blurred vision; eye pain

Rare

Abdominal or stomach pain; bleedinggums; bleeding time increased; chest pain; coughing up blood; ; diarrhea; difficulty in breathing or swallowing; double vision or other problems in seeing, includingdecreased night vision after sunset and before sunrise; darkened urine; increased menstrual flow; or vaginalbleeding; light-colored stools; nosebleeds; pale or cold hands or feet; paralysis; prolonged bleeding fromcuts; red or dark brown urine; shortness of breath; unpleasant breath odor; unusual tiredness or weakness; vomiting of blood;yellowing of the skin or eyes

Incidence not known

Assault; attack; burning, numbness, tingling, or painful sensations; chest pain or discomfort; confusion; difficulty breathing; difficulty inspeaking; doing things to injure oneself; force; inability to move arms, legs,or facial muscles; inability to speak; pain in chest, groin, or legs, especially calves; pain or discomfort in arms, jaw, back or neck; shortness of breath; slurred speech; slow speech; sudden loss of coordination; sudden, severe weakness or numbness in arm or leg; sudden, unexplained shortness of breath; sweating; thoughts of killing oneself; unsteadiness or awkwardness; vision changes; weakness in arms, hands, legs, orfeet

Check withyour doctor as soon as possible if any of the following side effects occur:

More common

Back pain; bad, unusual or unpleasant(after)taste; bone or joint pain; change in taste; continuing ringing or buzzing orother unexplained noise in ears; degenerative diseaseof the joint; difficulty in moving or walking; excessive muscle tone; feeling of warmthredness of the face, neck, arms and occasionally, upper chest; headache; hearing loss; increased sensitivity to pain; increasedsensitivity to touch; muscle stiffness; muscle tension or tightness; rednessof skin; sleeplessness ; stiff, painful muscles; thinning of skin with easybruising; tingling in the hands and feet; tongue irritation; trouble sleeping ; unable to sleep

Less common

Acid or sour stomach; belching; breast pain; eye problems, such as lossof eyebrows or eyelashes, redness or swelling of the eyelid, redness of theeyes, sensitivity of eyes to light, or watery eyes; general feeling of discomfort or illness; heartburn; increased hair growth on forehead, back, arms,and legs; indigestion; itching of the vagina or genital area; looseningof the fingernails; pain during sexual intercourse; redness or soreness around fingernails; sore mouth or tongue; thick, whitevaginal discharge with no odor or with a mild odor; white patches in mouth and/or on tongue

Rare

Coughing, hoarseness, trouble in speaking, or influenza-likesymptoms; itchy or painful ears; skin problems, such as abnormal sensation of burning or stinging of skin,cracking of skin, redness of skin, skin irritation or rash (including a rashthat looks like psoriasis), skin infection, skin ulcers, skin odor (unusual),or small red spots in skin; sore on the edge of theeyelid (stye); thick, white, curd-like vaginal discharge; vaginal itching or irritation

Symptoms of overdose

Dizziness or lightheadedness; feelingof constant movement of self or surroundings; headache; sensation of spinning; vomiting

Other side effects may occur that usually donot need medical attention. These side effects may go away during treatmentas your body adjusts to the medicine. However, check with your doctor if anyof the following side effects continue or are bothersome:

More common

Chapped, red, or swollen lips; difficultyin wearing contact lenses; dryness of eyes; dry or runny nose; increased abilityto sunburn; increased amount of ear wax (unusual); itchy skin; nosebleeds; irritation in mouth or swollen gums; loss of hair (usually reversible); scaling and peeling of eyelids, fingertips, palms, and soles of feet; sticky skin; unusual thirst

Less common

Constipation; diarrhea; fatigue; increased sweating

Incidence not known

Cracking fingernails or fingernails break easily; muscular pain, tenderness, wasting or weakness

Other side effects not listed abovemay also occur in some patients. If you notice any other effects, check withyour doctor.