Pronunciation:

a-si-TRE-tin

Brand Names:

• Soriatane

Dosage Forms:

• Capsule

Warnings:

Acitretin, the active metabolite of etretinate, is teratogenic and major fetal abnormalities have been reported during and after treatment completion. Use in women should be reserved for non-pregnant patients with severe psoriasis that did not respond to alternative treatments or when alternative treatments are contraindicated. Acitretin is contraindicated in women of childbearing potential unless all of the following criteria are met: 1) two negative urine or serum pregnancy tests (sensitivity at least 25 milli-international units/mL) prior to initiation; the first test is a screen test, the second test is a confirmation test done during first 5 days of menstrual period before therapy initiation or done at least 11 days after unprotected sex in amenorrhea patients; initiate treatment within 7 days of second negative pregnancy test; prescription for acitretin is limited to a 1 month supply; 2) pregnancy test must be repeated every month during treatment with a sensitivity of at least 25 milli-international units/mL and test result must be negative before receiving a prescription for the month; after discontinuing therapy, a pregnancy test must be repeated every 3 months for at least 3 years; 3) commitment to use 2 effective forms of contraception (except the minipill) simultaneously for at least 1 month prior to initiation, during, and for at least 3 years following cessation of therapy unless reproductive status is posthysterectomy or postmenopausal; 4) monthly counseling by the prescriber during therapy and every 3 months for at least 3 years following therapy discontinuation about contraception and behaviors associated with an increased risk of pregnancy. Avoidance of St. John's wort during hormonal contraception and signed patient agreement/informed consent form, which includes warning to refrain from consumption of ethanol or ethanol-containing beverages during and for 2 months after treatment discontinuation and avoidance of pregnancy at start of treatment, during, and for at least 3 years after treatment discontinuation. The Pregnancy Prevention Actively Required During and After Treatment (Do Your PART) program requirements are available at www.soriatane.com/doyour-part-Program.html or 1-888-784-3335. Men and women must avoid donation of blood during and for at least 3 years following acitretin therapy. All patients must receive the medication guide each time acitretin is dispensed. Acitretin has also been associated with severe hepatotoxicity. Mild and reversible, severe, and fatal cases of hepatoxicity have been reported .

Classifications:

Therapeutic—

Antipsoriatic

Chemical—

Retinoid

Uses of This Medicine:

Acitretin is used to treat severe skin disorders, such as psoriasis. It works by allowing normal growth and development of the skin. Acitretin will continue to work after you stop taking it, but after a time, the skin condition returns and you may need to take it again.

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

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

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

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of acitretin in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of acitretin in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving acitretin.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together 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 to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Chlortetracycline
• Demeclocycline
• Doxycycline
• Eravacycline
• Lymecycline
• Meclocycline
• Methacycline
• Minocycline
• Omadacycline
• Oxytetracycline
• Rolitetracycline
• Sarecycline
• Tetracycline
• Tigecycline

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Palovarotene
• Pexidartinib

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Levonorgestrel

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Depression, history of or
• Eye or vision problems or
• Heart disease or
• Hypercholesterolemia (high cholesterol in the blood) or
• Hyperostosis (bone growth that is not normal) or
• Hypertriglyceridemia (high triglycerides or fats in the blood) or
• Hypervitaminosis A (too much vitamin A in the body), or history of or
• Pancreatitis (inflammation of the pancreas) or
• Pseudotumor cerebri (brain problem) or
• Psychosis, history of—Use with caution. May make these conditions worse.

• Diabetes mellitus, or family history of or
• Obesity—Use with caution. May increase risk for side effects.

• Hyperlipidemia, severe (high fats in the blood) or
• Kidney disease, severe or
• Liver disease, severe—Should not be used in patients with these conditions.

Proper Use of This Medicine:

It is very important that you take acitretin only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

Acitretin comes with a patient information form and Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions. You will be asked to sign a consent form before you starting taking this medicine to show that you understand the instructions.

You will be given information about the Do Your P.A.R.T. program, which is also called the Pregnancy Prevention Actively Required During and After Treatment program. This is important information about how to prevent pregnancy while you are using this medicine. Ask your doctor about this program if you have any questions.

Take acitretin with your main meal of the day.

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

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

Women who are able to bear children must use two effective forms of birth control together for at least 2 to 3 years after they stop taking acitretin to help prevent an unplanned pregnancy. If you do not think this is reasonable or feel like you can not do this, talk to your doctor before you start taking this medicine.

You must not share this medicine with anyone else because of the risk for birth defects and other serious side effects.

Dosing—

The dose of this medicine 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 this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (capsules):
  • For severe psoriasis:
    • Adults—At first, 25 to 50 milligrams (mg) once a day as a single dose. Your doctor may adjust your dose as needed.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can cause very serious birth defects. You must use 2 forms of birth control together for 1 month before starting this medicine, for the entire time that you are being treated with this medicine, and for 3 years after you take your last dose of this medicine. You will need to have 2 negative pregnancy tests to be sure that you are not pregnant before you start using this medicine. You will also need to have pregnancy tests every month during treatment, and every 3 months for 3 years after you stop taking the medicine. If you think you have become pregnant while using this medicine, call your doctor right away.

Do not use methotrexate (Rheumatrex®, Trexall®) or a tetracycline medicine to treat an infection (eg, doxycycline, minocycline, tetracycline, Minocin®, or Vibramycin®) while you are using this medicine. Using these medicines together may cause unwanted side effects.

Do not take vitamin A or any supplement containing vitamin A while you are using this medicine, unless otherwise directed by your doctor. To do so may increase the chance of side effects.

Your skin condition may improve or get worse during the first few weeks of 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 doctor if the skin irritation becomes worse or if your skin condition does not improve within 8 to 12 weeks.

Women who are able to bear children must avoid all forms of alcohol while they are taking this medicine and for 2 months after they stop. Do not eat foods, drink beverages, or take medicines that contain alcohol. Drinking alcohol will make the medicine remain in the body for an extended period of time and will increase the chance for side effects. If a woman consumes alcohol during acitretin treatment, she should consider delaying a pregnancy for longer than 2 to 3 years. Talk to your doctor if you have any questions about this.

Do not donate blood during treatment with acitretin, for 3 years following treatment, or as directed by your doctor. Women who are able to bear children must not receive blood containing the medicine.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Acitretin may cause bone or muscle problems, including joint pain, muscle pain or stiffness, or difficulty moving. You may get hurt more easily during rough sports. You may also heal more slowly.

Acitretin may cause blurred vision or a decrease in night vision (night blindness). The night blindness may occur suddenly. Do not drive or do anything else that could be dangerous if you are not able to see well. Check with your doctor right away if you have vision changes.

Acitretin may cause dry eyes. Wearing contact lenses may become uncomfortable while using this medicine. To help relieve dry eyes, check with your doctor about using a lubricating solution, such as artificial tears. If severe eye irritation or inflammation occurs, check with your doctor.

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

Avoid exposing your skin to wind, cold weather, and sunlight, even on cloudy days. Your skin will be more prone to sunburn, dryness, or irritation, especially during the first 2 or 3 weeks. You should not stop taking this medicine, unless the skin irritation becomes too severe. Do not use a sunlamp or tanning bed. Use sunscreen or sunblock lotions with a sun protection factor (SPF) of at least 15 on a regular basis. Wear protective clothing and hats and stay out of direct sunlight, especially between the hours of 10 a.m. and 3 p.m.

Unless your doctor tells you otherwise, you should avoid skin products that can irritate the skin. Some examples are:

• Any topical acne product or skin product containing a peeling agent (eg, benzoyl peroxide, resorcinol, salicylic acid, or sulfur).
• Hair products that are irritating, such as permanents or hair removal products.
• Skin products that cause sensitivity to the sun, such as those containing spices 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.

For diabetic patients:

• This medicine may affect blood sugar levels. If you notice a change in the results of your blood or urine sugar tests or if you have any questions, check with your doctor.

Pancreatitis may occur while you are using this medicine. Tell your doctor right away if you have sudden and severe stomach pain, chills, constipation, nausea, vomiting, fever, or lightheadedness.

Acitretin may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you or your caregiver notice any of these side effects, check with you doctor right away.

Call your doctor right away if you have a fever, cloudy urine, decrease or increase in the amount of urine, fainting or lightheadedness, nausea, stomach pain, or swelling of the hands, ankles, feet, or lower legs. These may be symptoms of a rare but serious condition called capillary leak syndrome.

Do not take other medicines without checking first with your doctor. This includes vitamins, herbal products, prescription or nonprescription (over-the-counter [OTC]) medicines. Some of these medicines or nutritional supplements (eg, St. John's wort) may make your birth control pills not work.

Side Effects of This Medicine:

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

Check with your doctor immediately 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 or other unexplained noise in the ears

difficulty with moving or walking

excessive muscle tone

feeling of warmth

headache (severe and continuing)

hearing loss

increased sensitivity to pain

increased sensitivity to touch

muscle stiffness, tension, or tightness

nausea (severe and continuing)

redness of the face, neck, arms, and occasionally, upper chest

redness of the skin

sleeplessness

thinning of the skin with easy bruising

tingling in the hands and feet

tongue irritation

trouble sleeping

vomiting (severe and continuing)

Less common

Abnormal sensation of burning or stinging

blurred vision

belching

breast pain

cracking, redness, skin irritation, or rash (including a rash that looks like psoriasis)

eye pain

general feeling of discomfort or illness

heartburn

increased hair growth on the forehead, back, arms, and legs

indigestion

infection, ulcers, unusual odor, or small red spots in the skin

itching of the vagina or genital area

loosening of the fingernails

loss of eyebrows or eyelashes

pain during sexual intercourse

redness of the eyes

redness or soreness around the fingernails

redness or swelling of the eyelid

sensitivity of the eyes to light

sore mouth or tongue

thick, white vaginal discharge with no odor or with a mild odor

watery eyes

white patches in the mouth or on the tongue

Rare

Bleeding gums

bleeding time increased

chest pain

coughing

coughing up blood

darkened urine

diarrhea

difficulty in breathing or swallowing

double vision or other problems in seeing, including decreased night vision after sunset and before sunrise

hoarseness

increased menstrual flow or vaginal bleeding

itchy or painful ears

light-colored stools

nosebleeds

pale or cold hands or feet

paralysis

prolonged bleeding from cuts

red or dark brown urine

sore on the edge of the eyelid (stye)

stomach pain

thick, white, curd-like vaginal discharge

unpleasant breath odor

unusual tiredness or weakness

vaginal itching or irritation

vomiting of blood

yellowing of the skin or eyes

Incidence not known

Assault

attack

burning, numbness, tingling, or painful sensations

chest discomfort

confusion

difficulty with speaking

doing things to injure oneself

inability to move the arms, legs, or facial muscles

inability to speak

pain in the chest, groin, or legs, especially calves

pain or discomfort in the arms, jaw, back, or neck

slow speech

slurred speech

sudden loss of coordination

sudden, severe weakness or numbness in the arms or legs

sweating

thoughts of killing oneself

unsteadiness or awkwardness

vision changes

weakness in the arms, hands, legs, or feet

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Dizziness or lightheadedness

feeling of constant movement of self or surroundings

sensation of spinning

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Chapped, red, or swollen lips

difficulty in wearing contact lenses

dry or runny nose

dryness of the eyes

increased ability to sunburn

increased amount of ear wax (unusual)

irritation in the mouth or swollen gums

itchy skin

loss of hair (usually reversible)

scaling and peeling of the eyelids, fingertips, palms, and soles of feet

sticky skin

unusual thirst

Less common

Constipation

increased sweating

Incidence not known

Cracking fingernails or fingernails break easily

muscular pain, tenderness, wasting, or weakness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.