Soriatane

Acitretin comes as a capsule to take by mouth in 10 milligrams (mg), 17.5 mg, and 25 mg doses.

It's typically taken once a day with a meal.

Your dose will depend on your condition and response to treatment.

Follow the instructions on your prescription label carefully. Don't take more or less acitretin than is recommended.

Your doctor may start you on a low dose of this drug and then gradually increase it.

Try to take this medicine around the same time each day.

It could take two to three months or longer before you experience the full benefits of acitretin.

Don't stop taking acitretin without first talking with your doctor.

Your symptoms may come back after you stop using acitretin. Ask your doctor what to do if this happens.

Don't use leftover medicine to treat a new psoriasis flare-up if you've stopped taking acitretin.

Acitretin Overdose

Symptoms of an acitretin overdose may include:

• Dizziness
• Headache
• Vomiting
• Upset stomach
• Itchy, dry skin
• Bone or joint pain
• Loss of appetite

If you suspect an overdose, contact a poison control center or emergency room immediately.

You can get in touch with a poison control center at 800-222-1222.

Missed Dose of Acitretin

If you miss a dose of acitretin, skip it and continue with your regular medication schedule.

Don't double up on doses to make up for a missed one.

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Acitretin is a retinoid, which is a form of vitamin A.

Acitretin is used to treat severe psoriasis in adults. Acitretin is not a cure for psoriasis, and you may relapse after you stop taking this medication.

Acitretin may also be used for purposes not listed in this medication guide.

Acitretin can harm an unborn baby or cause birth defects. Do not use acitretin if you are pregnant or plan to become pregnant within 3 years after you stop taking acitretin. Before and during treatment, and for 3 years after treatment, you must have negative pregnancy tests at regular intervals to make sure you are not pregnant.

Do not donate blood while taking acitretin and for at least 3 years after you stop taking it. Donated blood may be given to a pregnant woman and could cause birth defects if the blood contains acitretin.

Women taking acitretin must not drink alcohol during treatment and for at least 2 months after treatment ends. Alcohol can cause acitretin to convert to another substance in your body that can take 3 years or longer to clear from your body. Read the labels of all foods and medicines you consume to make sure they do not contain alcohol.

Acitretin is available only under an agreement that you will use birth control and undergo required pregnancy testing, and that you will not consume alcohol while you are taking acitretin and for 2 months after you stop taking it.

Soriatane is a prescription medication used to treat severe psoriasis. This medication belongs to a group of drugs called retinoids. The exact way it works is unknown.

Soriatane comes in capsule form. It is usually taken once daily with food.

Common side effects include dry skin, chapped lips, and hair loss.

Do not take Soriatane if you are pregnant or plan to become pregnant within the next 3 years. This medication may harm the fetus. You should not begin taking Soriatane until you have taken two pregnancy tests with negative results.

Your doctor will give you a Patient Agreement/Informed Consent to read and sign before you begin treatment. Be sure to read this carefully and ask your doctor if you have any questions.

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Take acitretin with food.

Your psoriasis may seem to get worse at the start of therapy. For best results, keep using the medication as directed. Talk with your doctor if your symptoms do not improve after one course of acitretin treatment.

To be sure this medication is not causing harmful effects, your blood may need to be tested often. Your liver function and cholesterol may also need to be tested.

Never share this medicine with another person, even if they have the same symptoms you have.

Store at room temperature away from moisture, heat, and light.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Women taking acitretin must not drink alcohol during treatment and for at least 2 months after treatment ends. Alcohol can cause acitretin to convert to another substance in your body that can take 3 years or longer to clear from your body. Read the labels of all foods and medicines you consume to make sure they do not contain alcohol.

Do not donate blood while taking acitretin and for at least 3 years after you stop taking it. Donated blood may be given to a pregnant woman and could cause birth defects if the blood contains acitretin.

Avoid taking vitamin supplements that contain vitamin A. Acitretin is a form of vitamin A, and taking too much can cause side effects similar to overdose symptoms.

Avoid exposure to sunlight or tanning beds. Acitretin can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Acitretin may impair your vision, especially at night. Be careful if you drive or do anything that requires you to see clearly.

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with acitretin, especially:

• etretinate;

• glyburide;

• methotrexate;

• phenytoin;

• St. John's wort; or

• hormone replacement therapy or birth control pills (especially "minipills").

This list is not complete. Other drugs may interact with acitretin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

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.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Runny nose.
• Change in nails.
• Itching.
• Eye irritation.
• Dry mouth.
• Dry eyes.
• Dry lips.
• Hair loss.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

1. Berbis Ph, et al.: Arch Dermatol Res (1988) 280:388-389.

2. Maier H, Honigsmann H: Concentration of etretinate in plasma and subcutaneous fat after long-term acitretin. Lancet 348:1107, 1996.

3. Geiger JM, Walker M: Is there a reproductive safety risk in male patients treated with acitretin (Neotigason®/Soriatane®)? Dermatology 205:105-107, 2002.

4. Sigg C, et al.: Andrological investigations in patients treated with etretin. Dermatologica 175:48-49, 1987.

5. Parsch EM, et al.: Andrological investigation in men treated with acitretin (Ro 10-1670). Andrologia 22:479-482, 1990.

6. Kadar L, et al.: Spermatological investigations in psoriatic patients treated with acitretin. In: Pharmacology of Retinoids in the Skin; Reichert U. et al., ed, KARGER, Basel, vol. 3, pp 253-254, 1988.

To be completed by the patient* and signed by her prescriber

*Must also be initialed by the parent or guardian of a minor patient (under age 18)

Read each item below and initial in the space provided to show that you understand each item. Do not sign this consent and do not take Soriatane® (acitretin) if there is anything that you do not understand.

_____________________________________________________________

(Patient’s name)

1. I understand that there is a very high risk that my unborn baby could have severe birth defects if I am pregnant or become pregnant while taking Soriatane in any amount even for short periods of time. Birth defects have also happened in babies of women who became pregnant after stopping treatment with Soriatane.

INITIAL: ___________

2. I understand that I must not become pregnant while taking Soriatane and for at least 3 years after the end of my treatment with Soriatane.

INITIAL: ___________

3. I know that I must avoid all alcohol, including drinks, food, medicines, and over-the-counter products that contain alcohol. I understand that the risk of birth defects may last longer than 3 years if I swallow any form of alcohol during therapy with Soriatane, and for 2 months after I stop taking Soriatane.

INITIAL: ___________

4. I understand that I must not have sexual intercourse, or I must use 2 separate, effective forms of birth control at the same time. The only exceptions are if I have had surgery to remove the womb (a hysterectomy) or my prescriber has told me I have gone completely through menopause.

INITIAL: ___________

5. I understand that I have to use 2 effective forms of birth control (contraception) at the same time for at least 1 month before starting Soriatane, for the entire time of therapy with Soriatane, and for at least 3 years after stopping Soriatane.

INITIAL: ___________

6. I understand that any form of birth control can fail. Therefore, I must use 2 different methods at the same time, every time I have sexual intercourse.

INITIAL: ___________

7. I understand that the following are considered effective forms of birth control: Primary: Tubal ligation (having my tubes tied), partner’s vasectomy, birth control pills (not progestin-only “minipills”), injectable/implantable/insertable/topical (patch) hormonal birth control products, and IUDs (intrauterine devices). Secondary: Condoms (with or without spermicide, which is a special cream or jelly that kills sperm), diaphragms and cervical caps (which must be used with a spermicide), and vaginal sponges (contains spermicide). I understand that at least 1 of my 2 methods of birth control must be a primary method.

INITIAL: ___________

8. I will talk with my prescriber about any medicines or dietary supplements I plan to take while taking Soriatane because certain birth control methods may not work if I am taking certain medicines or herbal products (for example, St. John’s wort).

INITIAL: ___________

9. Unless I have had a hysterectomy or my prescriber says I have gone completely through menopause, I understand that I must have 2 negative pregnancy test results before I can get a prescription to start Soriatane. I understand that if the second pregnancy test is negative, I must start taking my Soriatane within 7 days of the specimen collection. I will then have pregnancy tests on a monthly basis during therapy with Soriatane as instructed by my prescriber. In addition, for at least 3 years after I stop taking Soriatane, I will have a pregnancy test every 3 months.

INITIAL: ___________

10. I understand that I should not start taking Soriatane until I am sure that I am not pregnant and have negative results from 2 pregnancy tests.

INITIAL: ___________

11. I have received information on emergency contraception (birth control).

INITIAL: ___________

12. I understand that my prescriber can give me a referral for a free contraception (birth control) counseling session and pregnancy testing.

INITIAL: ___________

13. I understand that on a monthly basis during therapy with Soriatane and every 3 months for at least 3 years after stopping Soriatane that I should receive counseling from my prescriber about contraception (birth control) and behaviors associated with an increased risk of pregnancy.

INITIAL: ___________

14. I understand that I must stop taking Soriatane right away and call my prescriber if I get pregnant, miss my menstrual period, stop using birth control, or have sexual intercourse without using my 2 birth control methods during and at least 3 years after stopping Soriatane.

INITIAL: ___________

15. If I do become pregnant while on Soriatane or at any time within 3 years of stopping Soriatane, I understand that I should report my pregnancy to Stiefel at 1-888-784-3335 (1-888-STIEFEL) or to the Food and Drug Administration (FDA) MedWatch program at 1-800-FDA-1088. The information I share will be kept confidential (private) unless disclosure is legally required. This will help the company and the FDA evaluate the pregnancy prevention program to prevent birth defects.

INITIAL: ___________

 I have received a copy of the Do Your P.A.R.T™ brochure. My prescriber has answered all my questions about Soriatane. I understand that it is my responsibility to follow my doctor’s instructions, and not to get pregnant during treatment with Soriatane or for at least 3 years after I stop taking Soriatane.

I now authorize my prescriber, ______________________________________________________, to begin my treatment with Soriatane.

Patient signature: ________________________________________

Date: ___________________

Parent/guardian signature (if under age 18): ____________________

Date: ___________________

Please print: Patient name and address: _______________________________________________________________

_______________________________________________________________

Telephone: _____________________________________________________________

I have fully explained to the patient, _________________________________________________, the nature and purpose of the treatment described above and the risks to females of childbearing potential. I have asked the patient if she has any questions regarding her treatment with Soriatane and have answered those questions to the best of my ability.

Prescriber signature: _______________________________________

Date: __________________

Revised 05/2015

SRN:5PI

Applies to acitretin: oral capsule

Along with its needed effects, acitretin (the active ingredient contained in Soriatane) 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:

• 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

• 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

• 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

• 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:

• 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:

• 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

• Constipation
• diarrhea
• increased sweating

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