Tretinoin, Oral

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KEY POINTS

• This medicine is taken by mouth to treat acute promyelocytic leukemia. Take it exactly as directed.
• This medicine can cause severe birth defects. It must not be used by women who are pregnant.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause a serious or life-threatening problem called retinoic-acid-APL syndrome or other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: antineoplastic (anticancer)

Generic and brand names: tretinoin, oral

What is this medicine used for?

This medicine is taken by mouth to treat acute promyelocytic leukemia.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine, or to vitamin A preparations, foods, preservatives, or dyes
• Bleeding problems, blood clots, or blood disorders
• Heart disease
• High cholesterol or high triglycerides
• Liver problems
• Lung problems

Females of childbearing age: Do not take this medicine during pregnancy because it will harm the baby. You must have a pregnancy test that is negative before you start taking this medicine. You may need to have a pregnancy test each month while you are taking this medicine. You must use 2 effective forms of birth control at the same time starting 1 month before you start taking this medicine, during treatment, and for 1 month after you stop this medicine. Talk to your healthcare provider if you need birth control. If you think you have become pregnant during this treatment or within 1 month after you stop this medicine, contact your healthcare provider right away. Do not breast-feed while you are taking this medicine.

How do I take it?

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. Do not take more or less or for a longer period than directed by your healthcare provider. How many doses you need is based on your response to the medicine, your size, and how the medicine affects your blood. Treatment usually stops 30 days after complete remission or after 90 days of treatment, whichever comes first.

Check with your healthcare provider before using this medicine in children under age 1 year.

Take this medicine with food. Do not crush, chew, or dissolve the capsules. Swallow them whole.

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: headache, dizziness, weakness, flushing, stomach pain, cracked lips.

What should I watch out for?

This medicine may cause a serious or life-threatening problem called retinoic-acid-APL syndrome. This usually happens during the first month of treatment, and sometimes after the first dose of this medicine. Contact your healthcare provider right away if you have

• Fever
• Breathing problems
• Unusual swelling or weight gain
• Severe dizziness
• Signs of liver problems such as yellowing of your skin or eyes, dark urine, light-colored bowel movements, severe nausea or vomiting, or severe tiredness or weakness
• Signs of kidney problems such as changes in urination, or blood in your urine

This medicine may raise your cholesterol or triglycerides levels. You will need to have blood tests regularly to see how this medicine affects you. Keep all appointments for these tests.

This medicine may make your skin more sensitive to the sun, which may lead to painful sunburns. While you are taking this medicine, avoid long exposure to the sun. Wear protective clothing, a hat, and sunscreen lotion when you need to be outdoors. Do not use a sunlamp. If you get a severe sunburn, contact your healthcare provider right away.

This medicine may make you dizzy or drowsy. Do not drink alcohol while receiving this medicine. Do not drive or operate machinery unless you are fully alert.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; chest pain or tightness in your chest; swelling of your lips, tongue, and throat); sudden weakness, numbness, or tingling, especially on one side of your body; sudden or severe headache; sudden trouble with vision, speech, balance, or walking.

Serious (Report these to your healthcare provider right away.): Trouble breathing; chest pain; swelling of fingers, hands, feet, lower legs, or any unexplained swelling; unusual bruising or bleeding; yellowing of your skin or eyes; dark urine; light-colored bowel movements; severe nausea or vomiting; severe tiredness or weakness; black or tarry bowel movements; bone pain; seizures; unexplained fever; mouth sores; irregular heartbeat; unexplained weight gain; decreased urination; bloody urine; severe dizziness or fainting; confusion; hearing loss.

Other: Dry skin or mouth, dry eyes, mild headache, mild fever, loss of appetite, mild weakness or tiredness, sensitivity to the sun, hair loss, diarrhea, constipation, mild nausea or vomiting, restlessness, increased sweating, trouble sleeping.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Antibiotics such as doxycycline (Doryx, Monodox, Vibramycin), erythromycin (E.E.S., Ery-Tab, Erythrocin), minocycline (Dynacin, Minocin, Solodyn), rifampin (Rifadin), and tetracycline
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), phenytoin (Dilantin, Phenytek), and primidone (Mysoline)
• Barbiturates such as butabarbital (Butisol), pentobarbital (Nembutal), phenobarbital, and secobarbital (Seconal)
• Calcium channel blockers such as diltiazem (Cardizem, Cartia, Tiazac) and verapamil (Calan, Covera, Verelan)
• Cimetidine (Tagamet)
• Corticosteroids such as betamethasone, cortisone, dexamethasone, fludrocortisone, hydrocortisone (A-Hydrocort, Cortef), methylprednisolone (Medrol, Solu-Medrol), prednisolone (Omnipred, Orapred, Prelone), prednisone (Prednisone Intensol), and triamcinolone (Aristospan, Kenalog)
• Cyclosporine (Gengraf, Neoral, Sandimmune)
• Gemfibrozil (Lopid)
• Ketoconazole (Nizoral)
• Medicines to treat or prevent bleeding such as aminocaproic acid (Amicar) and tranexamic acid (Cyklokapron, Lysteda)
• Natural remedies such as dong quai, echinacea, and St. John’s wort
• Ritonavir (Norvir)
• Vitamin A supplements or multivitamins that contain vitamin A

Other medicines may interact with this one. Be sure your healthcare provider knows about all medicines you are taking or receiving by injection.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.