Known human teratogen; very high risk of severe birth defects, generally characterized by malformations involving craniofacial, cardiovascular, skeletal, and CNS structures, if administered during pregnancy. (See Fetal/Neonatal Morbidity and Mortality and also see Contraindications under Cautions.)
Contraindicated during pregnancy. Acitretin must not be used in female patients who are or may become pregnant during therapy or within at least 3 years following drug discontinuance or in females who may not use reliable contraception during and for at least 3 years following cessation of therapy.
Do Your PART program developed to educate females of childbearing potential and their clinicians about risks associated with acitretin and to aid in the prevention of pregnancies during and for 3 years following drug discontinuance. (See Do Your PART Program under Cautions.)
Counseling about contraception and behaviors associated with increased pregnancy risk must occur monthly during and at 3-month intervals following drug discontinuance for at least 3 years.
If pregnancy occurs during therapy or at any time within at least 3 years following drug discontinuance, the clinician and patient should discuss the possible effects on the pregnancy. (See Pregnancy under Cautions.)
Alcohol
Concomitant use of acitretin and alcohol results in formation of etretinate, a known human teratogen with a longer elimination half-life than acitretin, prolonging the duration of potential teratogenic effects of acitretin; alcohol must not be used in female patients of childbearing potential during acitretin treatment and for 2 months following drug discontinuance. (See Specific Drugs under Interactions.)
Blood Donation
Both male and female patients receiving acitretin should not donate blood during therapy and for at least 3 years following drug discontinuance because women of childbearing potential must not receive blood from patients receiving acitretin.
Hepatotoxicity
Risk of developing potentially serious hepatic injury. (See Hepatic Effects under Cautions.)
Monitor hepatic enzyme levels prior to initiating therapy, at weekly or biweekly intervals until stable, and thereafter at intervals based on clinician's discretion.
If hepatotoxicity is suspected during acitretin therapy, discontinue the drug and investigate the cause of the abnormality.
Take this medicine by mouth with with a glass of water. Follow the directions on the prescription label. Take this medicine with food. Take your medicine at regular intervals. Do not take your medicine more often than directed. Do not stop taking except on your doctor's advice.
A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.
Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.
Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.
What if I miss a dose?
If you miss a dose, skip the missed dose and resume your normal schedule. Do not take double or extra doses.
What may interact with this medicine?
Do not take this medicine with any of the following medications:
alcohol, including alcohol that may be in drinks, food, or medicines including over-the-counter medicines
etretinate - tell your doctor if you have ever taken this medicine in the past
vitamin A type medicines like isotretinoin, tretinoin
This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
What should I watch for while using this medicine?
Your psoriasis may get worse when you first start taking this medicine. You may have to take it for 2 to 3 months before you see the full benefit.
This medicine can cause birth defects. Do not get pregnant while taking this drug. Females will need to have 2 negative pregnancy tests before starting this medicine and then monthly pregnancy tests during treatment, even if you are not sexually active. Use 2 reliable forms of birth control together for 1 month prior to, during, and for at least 3 years after stopping this medicine. Avoid using birth control pills that do not contain estrogen. They may not work while you are taking this medicine. If you become pregnant, miss a menstrual cycle, or stop using birth control, you must immediately stop taking this medicine. Severe birth defects may occur. Do not take this medicine before or during breast-feeding.
Before you receive your prescription you should review the Do Your P.A.R.T. booklet, which includes the Do Your P.A.R.T. Patient Brochure, The Contraceptive Counseling Referral Form for female patients, the Patient Agreement/Informed Consent Form for female patients, and the Medication Guide. If you did not talk to your doctor about this and sign the consent form, contact your health care provider.
Do not share this medicine with anyone else because of the risk of birth defects and other serious adverse effects.
Do not give blood during your treatment and for 3 years after you stop taking it. This medicine in your blood can harm an unborn baby if the blood is given to a pregnant woman. You can still receive blood transfusions while taking this medicine.
If you wear contact lenses, they may feel uncomfortable.
This medicine can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and use sunscreen. Do not use sun lamps or tanning beds/booths. If you are receiving light treatment (phototherapy), your doctor may need to change your light dosages to avoid burns.
Your mouth may get dry. Chewing sugarless gum or sucking hard candy, and drinking plenty of water may help. Contact your doctor if the problem does not go away or is severe.
This medicine can increase cholesterol and triglyceride levels and decrease HDL (the 'good' cholesterol) levels. Your health care provider will monitor these levels and recommend appropriate therapy, including dietary changes or prescription drugs, if necessary.
This medicine may affect your blood sugar levels. If you are diabetic check with your doctor or health care professional if you notice any change in your blood sugar tests.
During therapy with this medicine and for 2 months after stopping treatment, you must avoid drinks, foods, and all medicines that contain alcohol. This includes over-the-counter products that contain alcohol. Avoiding alcohol is important because alcohol changes this medicine into a drug that may take longer than 3 years to leave your body. The chance of birth defects may last longer than 3 years if you take any form of alcohol while taking this medicine or for 2 months after stopping treatment.
What side effects may I notice from receiving this medicine?
Side effects that you should report to your doctor or health care professional as soon as possible:
itching and peeling of your fingers, palms, or soles of the feet
ringing in the ears
scaly skin all over
weak nails
This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Where should I keep my medicine?
Keep out of the reach of children.
Store at room temperature between 15 and 25 degrees C (59 and 77 degrees F). Protect from light. Avoid exposure to high temperatures and humidity after the bottle is opened. Throw away any unused medicine after the expiration date.
NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.
Remember, keep this and all other medicines out of the reach of children,
never share your medicines with others, and use this medication only for the indication prescribed.
