Drug Information Sheet - acitretin

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1 Acitretin worksheet Baseline: 4 weeks 8 weeks 12 weeks

2 Questionnaire for acitretin (Soriatane ) 1. If you are a woman, please complete the following: A. I have gone through menopause B. I have had my tubes tied C. I have had my uterus (womb) removed D. I am able to bear children E. Last menstrual period 2. Are you currently breastfeeding? 3. Do you plan to have children? (men should also answer this question) 4. Do you have a history of liver or kidney disease? DK* 5. Do you have high cholesterol or blood fat levels? DK* 6. Do you have a history of diabetes? DK* 7. Do you have a low blood count? DK* 8. Do you eat large amounts of carrots, beef liver, spinach, sweet potatoes or greens? 9. Do you take daily vitamins (including Vitamin A) or nutritional supplements? 10. Do you get headaches on a regular basis? 11. Do you have a history of headaches? 12. Do you do strenuous physical exercise? 13. Do you drink alcohol? 14. Do you have a history of drinking alcohol in the past? 15. Do you have a history of hair loss?

3 16. Do you take any of the following medications? A. Methotrexate B. Birth control pills 17. Do you have a history of depression and/or suicide attempts? *DK = Don t know

4 Patient information sheet- side effects of acitretin (Soriatane ) Common: 1. Birth defects: acitretin can cause severe birth defects, even after it has been discontinued. You will need two forms of birth control for at least 3 years after discontinuation of the medication. This period may need to be increased if you drink alcohol while taking the acitretin. For this reason, alcohol should be avoided 2. Dryness: Dryness of the skin, lips, mouth, nose (sometimes causing nose bleeds), and eyes is very common. These side effects can be minimized by the use of moisturizers and eye drops, placement of vaseline in the nose, and the use of a vaporizer in your bedroom; you may need to wear eye glasses rather than contact lenses 3. Fragility: Fragility of the skin can occur. For example, if you hit your hand against a sharp surface, the skin tears easily 4. Thinning of the hair 5. Elevation in blood fats (triglycerides and cholesterol): These usually can be reduced by a low-fat, low carbohydrate diet and avoidance of alcohol 6. Joint aches and pains 7. Inflammation of the liver (hepatitis), usually mild Less Common: 1. Sun sensitivity 2. Blurred vision, difficulty seeing at night 3. Muscle aches: These can be minimized by decreasing intense physical activity such as weight lifting 4. Decrease in the white blood cell count 5. Bony changes similar to those seen with excess vitamin A; in part depends on dose and duration of treatment 6. Ingrown toenails

5 Unusual/Rare side effects: 1. Pancreatitis (inflammation of the pancreas) 2. Severe headaches 3. Severe diarrhea 4. Increased blood sugar levels 5. Depression/suicidal thoughts and/or actions 6. Severe allergic reaction (anaphylaxis) Waxing of hair for removal should not be done as there is an increased likeliness of irritation or removal of the skin. Also, all elective surgery should be postponed until you have been off acitretin for at least six months. This includes dermabrasion and laser treatments. Do not donate blood while taking acitretin or for three years after discontinuing acitretin. Do not drink alcohol (wine, liquor or beer) during or for two months after discontinuing acitretin. Acitretin is absorbed better when taken with food.

6 Checklist for physicians for acitretin A. may increase risk of hepatotoxicity B. acitretin interferes with the contraceptive effect of micro-dosed progestin preparations

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