• Antipsoriatic, systemic

Etretinate (e-TRET-i-nate) is used to treat severe psoriasis. It is usually used only after other medicines have been tried and have failed to help the psoriasis.

Etretinate 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. Etretinate must not be taken during pregnancy, because it causes birth defects in humans. In addition, if you take etretinate, you must plan on never having children in the future. If you are able to bear children, it is very important that you read, understand, and follow the pregnancy warnings for etretinate.

It is also recommended that etretinate not be used to treat children unless all other forms of treatment have been tried first and have failed. Etretinate may interfere with bone growth. In addition, children may be more sensitive to the side effects of the medicine.

This medicine was withdrawn from the U.S. market in March 1998 and the Canadian market in January 1996.

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 etretinate, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to etretinate, isotretinoin, tretinoin, or vitamin A–like preparations. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Etretinate must not be taken during pregnancy, because it causes birth defects in humans. In addition, since it is not known how long pregnancy should be avoided after treatment stops, you must plan on never having children if you are treated with etretinate . If you are able to bear children, you must have a pregnancy test within 2 weeks before beginning treatment with etretinate to make sure you are not pregnant. Therapy with etretinate will then be started on the second or third day of your next normal menstrual period. Also, etretinate must not be taken unless an effective form of contraception (birth control) is used for at least 1 month before beginning treatment. Contraception must be continued during treatment and for as long as you are able to become pregnant after etretinate is stopped. Be sure you have discussed this information with your doctor.

Breast-feeding—It is not known whether etretinate passes into the breast milk. However, etretinate is not recommended during breast-feeding or if you plan to breast-feed in the future, because it may cause unwanted effects in nursing babies.

Children—It is recommended that etretinate not be used to treat children, unless all other forms of treatment have been tried first and have failed. Etretinate may interfere with bone growth. In addition, children may be more sensitive to the side effects of the medicine.

Older adults—Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of etretinate in the elderly with use in other age groups.

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 using etretinate, it is especially important that your health care professional know if you are using any of the following:

• Abrasive or medicated soaps or cleansers or
• Cosmetics or soaps that dry the skin or
• Medicated cosmetics or “cover-ups” or
• Topical acne preparation or preparation containing a peeling agent, such as benzoyl peroxide, resorcinol, salicylic acid, sulfur, or tretinoin (vitamin A acid), or
• Topical alcohol-containing preparation, such as after-shave lotion, astringent, cologne, perfume, or shaving cream or lotion, or
• Topical medicine for the skin, other—Use of etretinate with these products will increase the chance of dryness and other irritation of the skin

• Isotretinoin (e.g., Accutane) or
• Methotrexate (e.g., Mexate) or
• Tretinoin (vitamin A acid) (e.g., Retin-A) or
• Vitamin A or any preparation containing vitamin A (e.g., Alphalin)—Use of etretinate with these products will cause an increase in side effects

• Tetracyclines (medicine for infection)—Use of etretinate may increase the chance of the side effect called pseudotumor cerebri, which is a swelling of the brain

• Alcoholism or excess use of alcohol (or history of) or
• Diabetes mellitus (sugar diabetes) (or a family history of) or
• Heart or blood vessel disease (or history of increased risk of or family history of) or
• High triglyceride (a fat-like substance) levels in the blood (history of or a family history of) or
• Severe weight problems—Use of etretinate may increase blood levels of triglyceride (a fat-like substance), which may increase the chance of heart or blood vessel problems in patients who have a family history of high triglycerides, are greatly overweight, are diabetic, or use a lot of alcohol. For persons with diabetes mellitus, use of etretinate may also change blood sugar levels

• Liver disease (or history of or family history of)—Use of etretinate may make the condition worse

Take each dose of etretinate with milk or a fatty food. This is important because taking fats with etretinate will help your body absorb the medicine better. However, you should follow a low-fat diet during the rest of the day because eating a high-fat diet while you are taking this medicine may cause high triglyceride (fat-like substance) levels in the blood. This may increase the chance of heart and blood vessel disease.

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

Dosing—

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

The number of capsules 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 taking etretinate.

• For oral dosage form (capsules):
  • For psoriasis:
    • Adults and teenagers—Dose is based on body weight and must be determined by your doctor. The usual dose is 0.75 to 1 milligram (mg) per kilogram (kg) (0.34 to 0.45 mg per pound) of body weight a day, divided into several doses.
    • Children—Use is usually not recommended.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible with milk or a fatty food. 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—

To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Your doctor should check your progress at regular visits to make sure this medicine does not cause unwanted effects.

Etretinate causes birth defects in humans if taken during pregnancy. In addition, it is not known how long pregnancy should be avoided after treatment stops, to prevent birth defects. Therefore, you must plan on never having children if you are treated with etretinate. For as long as you are able to become pregnant, you must use a reliable form of birth control. In addition, you must not change your birth control method unless you have checked with your doctor first. If you suspect that you may have become pregnant while taking etretinate, stop taking the medicine immediately and check with your doctor. Also, if you become pregnant at any time after you have stopped taking this medicine, check with your doctor as soon as possible. In either case, you should talk to your doctor about the risks of continuing the pregnancy.

It is not known how long etretinate stays in the blood. Therefore, to prevent the possibility of a pregnant patient receiving your blood, you must plan on never donating blood to a blood bank if you are being treated with etretinate or if you have ever been treated with etretinate.

Do not take vitamin A or any vitamin supplement containing vitamin A while you are taking this medicine. To do so may increase the chance of side effects.

Drinking too much alcohol while you are taking this medicine may cause high triglyceride (fat-like substance) levels in the blood. This may increase the chance of heart and blood vessel disease. Therefore, while taking this medicine, do not drink alcoholic beverages or, at least, reduce the amount you usually drink. If you have any questions about this, check with your doctor.

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.

In some patients, etretinate may cause a decrease in night vision. This decrease may occur suddenly. If it does occur, do not drive, use machines, or do anything else that could be dangerous if you are not able to see well. Also, check with your doctor.

Etretinate may cause dryness of the eyes. Therefore, if you wear contact lenses, your eyes may be more sensitive to them while you are taking etretinate and for several weeks or longer after you stop taking it. To help relieve dryness of the eyes, check with your doctor about using an eye lubricating solution, such as artificial tears. If your eyes become inflamed, check with your doctor.

Some people who take this medicine may become more sensitive to sunlight than they are normally. When you begin taking this medicine:

• Stay out of direct sunlight, especially between the hours of 10:00 a.m. and 3:00 p.m., if possible.
• Wear protective clothing, including a hat and sunglasses.
• Apply a sun block product that has a skin protection factor (SPF) of at least 15. Some patients may require a product with a higher SPF number, especially if they have a fair complexion. If you have any questions about this, check with your health care professional.
• Do not use a sunlamp or tanning bed or booth.

If you have a severe reaction, check with your doctor .

This medicine may cause dryness of the mouth and nose. 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 dental disease, including tooth decay, gum disease, and fungus infections.

During the first month of treatment with etretinate, your psoriasis may seem to get worse before it gets better. There may be more redness or itching, but this usually goes away during treatment. It may take 2 or 3 months before the full effects of etretinate are seen. If irritation or other symptoms of your condition become severe, check with your doctor.

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.

Stop taking this medicine and check with your doctor immediately if any of the following side effects occur:

• Less common
  • Blurred or double vision or other changes in vision;  dark-colored urine;  flu-like symptoms ;  yellow eyes or skin 
  
  

• Rare
  • Headache (severe or continuing);  nausea and vomiting 
  
  

Check with your doctor as soon as possible if any of the following side effects occur:

• More common
  • Bone or joint pain, tenderness, or stiffness;  burning, redness, itching, feeling of dryness, pain, tenderness, excessive tearing (continuing), or other sign of inflammation or irritation of eyes ;  cramps or pain in upper abdomen or stomach area ;  muscle cramps;  unusual bruising 
  
  

• Less common
  • Change in hearing, earache or pain in ear, or drainage from ear  
  
  

• Rare
  • Bleeding or inflammation of gums;  confusion ;  mental depression;  mood or mental changes 
  
  

Other 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. However, check with your doctor if any of the following side effects continue or are bothersome:

• More common
  • Changes in appetite;  chapped lips;  dryness of nose or nosebleeds;  dryness, redness, scaling, itching, rash, or other sign of inflammation or irritation of the skin;  headache (mild);  increased sensitivity to contact lenses (may occur during and after treatment) ;  increased sensitivity of skin to sunlight;  peeling of skin on fingertips, palms of hands, or soles of feet ;  thinning of hair;  unusual thirst;  unusual tiredness 
  
  

• Less common
  • Dizziness;  dryness of mouth;  fever;  nausea (mild);  redness or soreness around fingernails;  loosening of the fingernails;  soreness of tongue;  soreness, cracking, swelling, or unusual redness of lips 
  
  

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