Acitretin

Name: Acitretin

What other information should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to acitretin.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Stability

Storage

Oral

Capsules

15–25°C in tight, light-resistant containers.1 Avoid exposing opened product to high temperatures and humidity.1

Commonly used brand name(s)

In the U.S.

  • Soriatane

Available Dosage Forms:

  • Capsule

Therapeutic Class: Antipsoriatic

Chemical Class: Retinoid

Proper Use of acitretin

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. It is very important that you read and understand this information. Be sure to follow these instructions carefully and ask your doctor if you have any questions. You will be asked to sign a consent form before you starting taking acitretin 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 acitretin. Ask your doctor about this program if you have any questions.

It is best to take acitretin with a main meal.

For women—acitretin 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 acitretin.

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 acitretin.

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

Dosing

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 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 acitretin, 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.

Uses of Acitretin

  • It is used to treat psoriasis.

What are some things I need to know or do while I take Acitretin?

For all patients taking this medicine:

  • Tell all of your health care providers that you take acitretin. This includes your doctors, nurses, pharmacists, and dentists.
  • Avoid driving and doing other tasks or actions that call for you to be alert or have clear eyesight until you see how this medicine affects you.
  • It may take a few months to see the full effect.
  • If you have high blood sugar (diabetes), acitretin may sometimes raise blood sugar. Talk with your doctor about how to keep your blood sugar under control.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • Have a bone density test as you have been told by your doctor. Talk with your doctor.
  • Skin may look worse before it looks better.
  • You may get sunburned more easily. Avoid sun, sunlamps, and tanning beds. Use sunscreen and wear clothing and eyewear that protects you from the sun.
  • Lowered night eyesight may happen. Use care at night when driving or doing other tasks that call for clear eyesight. Keep work space well lit.
  • This medicine may cause a very bad and sometimes deadly problem called capillary leak syndrome (CLS). CLS may lead to low blood pressure and harm to the body. It may also lead to a heartbeat that is not normal, chest pain or pressure, heart attack, lung or breathing problems, bleeding or lower blood flow in the stomach or bowel, kidney problems, swelling, or feeling confused. Talk with the doctor.
  • Raised pressure in the brain has happened with this medicine. This can cause long lasting loss of eyesight and sometimes death. Call your doctor right away if you have a bad headache, dizziness, upset stomach or throwing up, or seizures. Call your doctor right away if you have weakness on 1 side of the body, trouble speaking or thinking, change in balance, or change in eyesight.
  • If you are 65 or older, use acitretin with care. You could have more side effects.
  • Do not use progestin-only birth control pills (minipills). They may not work well. Talk with your doctor.
  • If you have sex without using 2 kinds of birth control that you can trust, if you think you may be pregnant, or if you miss your period, call your doctor right away.

Men:

  • Talk with your doctor before you drink alcohol.

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time this medicine is refilled. If you have any questions about acitretin, please talk with the doctor, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about acitretin. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using acitretin.

Review Date: October 4, 2017

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Capsule, Oral:

Soriatane: 10 mg, 17.5 mg, 25 mg [contains edetate calcium disodium]

Generic: 10 mg, 17.5 mg, 25 mg

Pharmacologic Category

  • Retinoid-Like Compound

Onset of Action

May take 2 to 3 months for full effect; improvement may be seen within 8 weeks

Time to Peak

2-5 hours

Half-Life Elimination

Acitretin: 49 hours (range: 33 to 96); cis-acitretin: 63 hours (range: 28 to 157); etretinate: 120 days (range: Up to 168 days)

Protein Binding

>99% bound, primarily to albumin

Special Populations Elderly

Higher plasma concentrations are seen; however, no changes occur in the half-life.

Contraindications

Hypersensitivity (eg, angioedema, urticaria) to acitretin, other retinoids, or any component of the formulation; patients who are pregnant or intend on becoming pregnant during therapy or within 3 years after treatment discontinuation; severe hepatic or renal dysfunction; chronic abnormally elevated blood lipid levels; concomitant use with methotrexate or tetracyclines

Acitretin is contraindicated in females of childbearing potential unless all of the following conditions apply.

1) Patient has severe psoriasis unresponsive to other therapy or if clinical condition contraindicates other treatments.

2) Patient must have two negative urine or serum pregnancy tests prior to therapy.

3) Patient must have pregnancy test repeated monthly during therapy. After discontinuation of therapy, a pregnancy test must be repeated every 3 months for at least 3 years.

4) Patient must commit to using two effective forms of birth control starting 1 month prior to acitretin treatment and for 3 years after discontinuation. Prescriber must counsel patient about contraception every month during therapy and every 3 months following discontinuation for at least 3 years.

5) Patient is reliable in understanding and carrying out instructions.

6) Patient has received, and acknowledged, understanding of a careful oral and printed explanation of the hazards of fetal exposure to acitretin and the risk of possible contraception failure. Patient must sign an agreement/informed consent document stating that she understands these risks and that she should not consume ethanol during therapy or for 2 months after discontinuation.

Canadian labeling: Additional contraindications (not in U.S. labeling): Breastfeeding; concomitant use with Vitamin A or other retinoids

How supplied

Brown and white capsules, 10 mg, imprinted “A-10 mg”; bottles of 30 (NDC 0145-0090-25).

Rich yellow capsules, 17.5 mg, imprinted “A-17.5 mg”; bottles of 30 (NDC 0145-3817-03).

Brown and yellow capsules, 25 mg, imprinted “A-25 mg”; bottles of 30 (NDC 0145-009125).

Store between 15° and 25°C (59° and 77°F). Protect from light. Avoid exposure to high temperatures and humidity after the bottle is opened.

Manufactured for : Stiefel Laboratories, Inc. Research Triangle Park, NC 27709. Revised: May 2015

Side Effects of Acitretin

Common side effects include:

  • chapped lips
  • peeling fingertips, palms, and soles
  • itching
  • scaly skin
  • weak nails
  • sticky or fragile (weak) skin
  • runny or dry nose
  • nosebleeds
  • dry mouth
  • joint pain
  • tight muscles
  • hair loss
  • dry eyes
  • rise in blood fats (lipids)

This is not a complete list of acitretin side effects. Ask your doctor or pharmacist for more information.

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

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

For the Consumer

Applies to acitretin: oral capsule

Along with its needed effects, acitretin 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 while taking acitretin:

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
  • muscle tension or tightness
  • nausea or vomiting (severe and continuing)
  • redness of the face, neck, arms, and occasionally, upper chest
  • redness of the skin
  • sleeplessness
  • stiff, painful muscles
  • thinning of the skin with easy bruising
  • tingling in the hands and feet
  • tongue irritation
  • trouble sleeping
  • unable to sleep
Less common
  • Acid or sour stomach
  • blurred vision
  • belching
  • breast pain
  • eye pain
  • eye problems, such as loss of eyebrows or eyelashes, redness or swelling of the eyelid, redness of the eyes, sensitivity of the eyes to light, or watery eyes
  • general feeling of discomfort or illness
  • heartburn
  • increased hair growth on the forehead, back, arms, and legs
  • indigestion
  • itching of the vagina or genital area
  • loosening of the fingernails
  • pain during sexual intercourse
  • redness or soreness around the fingernails
  • sore mouth or tongue
  • thick, white vaginal discharge with no odor or with a mild odor
  • white patches in the mouth or on the tongue
Rare
  • Abdominal or stomach pain
  • bleeding gums
  • bleeding time increased
  • chest pain
  • coughing, hoarseness, trouble in speaking, or flu-like symptoms
  • 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
  • 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
  • shortness of breath
  • skin problems, such as abnormal sensation of burning or stinging, cracking, redness, skin irritation or rash (including a rash that looks like psoriasis), infection, ulcers, unusual odor, or small red spots in the skin
  • sore on the edge of the eyelid (stye)
  • 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 pain or discomfort
  • confusion
  • difficulty with breathing
  • difficulty with speaking
  • doing things to injure oneself
  • force
  • 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
  • shortness of breath
  • slow speech
  • slurred speech
  • sudden loss of coordination
  • sudden, severe weakness or numbness in the arms or legs
  • sudden, unexplained shortness of breath
  • 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 while taking acitretin:

Symptoms of overdose
  • Dizziness or lightheadedness
  • feeling of constant movement of self or surroundings
  • sensation of spinning

Some side effects of acitretin 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)
  • nosebleeds
  • scaling and peeling of the eyelids, fingertips, palms, and soles of feet
  • sticky skin
  • unusual thirst
Less common
  • Constipation
  • diarrhea
  • increased sweating
Incidence not known
  • Cracking fingernails or fingernails break easily
  • muscular pain, tenderness, wasting, or weakness

Renal Dose Adjustments

Severe renal impairment: Contraindicated

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