Hydroxyurea oral tablets

What is this medication?

HYDROXYUREA (hye drox ee yoor EE a) is a chemotherapy drug. This medicine is used to control the painful crises of sickle cell anemia.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Mylocel, Siklos

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• gout or high levels or uric acid in the blood
• HIV or AIDS
• kidney disease or on hemodialysis
• leg wounds or ulcers
• liver disease
• low blood counts, like low white cell, platelet, or red cell counts
• prior or current interferon therapy
• scheduled to receive a vaccine
• an unusual or allergic reaction to hydroxyurea, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

Take this medicine by mouth with a glass of water. If you are not able to swallow the tablet, you can dissolve the dose in a small amount of water in a teaspoon and swallow it right away. Follow the directions on the prescription label. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice.

People who are not taking this medicine should not be exposed to it. Wash your hands before and after handling your bottle or medicine. Wear disposable gloves when touching the bottle or medicine. Clean up any medicine powder that spills with a damp disposable towel and throw the towel away in a closed container, such as a plastic bag.

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. While this drug may be prescribed for children as young as 2 years for selected conditions, precautions do apply.

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, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

This medicine may interact with the following medications:

• didanosine
• live virus vaccines
• stavudine

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 medication?

Tell your doctor or healthcare professional if your symptoms do not start to get better or if they get worse.

Call your doctor or health care professional for advice if you get a fever, chills or sore throat, or other symptoms of a cold or flu. Do not treat yourself. This drug decreases your body's ability to fight infections. Try to avoid being around people who are sick.

This medicine may increase your risk to bruise or bleed. Call your doctor or health care professional if you notice any unusual bleeding.

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.

Talk to your doctor about your risk of cancer. You may be more at risk for certain types of cancers if you take this medicine.

Do not become pregnant while taking this medicine or for at least 6 months after stopping it. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. Men should not father a child while taking this medicine and for at least 6 months after stopping it. There is a potential for serious side effects to an unborn child. Talk to your health care professional or pharmacist for more information. Do not breast-feed an infant while taking this medicine.

This may interfere with the ability to have or father a child. You should talk with your doctor or health care professional if you are concerned about your fertility.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• breathing problems
• low blood counts - this medicine may decrease the number of white blood cells, red blood cells and platelets. You may be at increased risk for infections and bleeding
• signs of decreased platelets or bleeding - bruising, pinpoint red spots on the skin, black, tarry stools, blood in the urine
• signs of decreased red blood cells - unusually weak or tired, feeling faint or lightheaded, falls
• signs of infection - fever or chills, cough, sore throat, pain or difficulty passing urine
• skin ulcers

Side effects that usually do not require medical attention (report these to your doctor or health care professional if they continue or are bothersome):

• changes in skin and nail color
• constipation
• dry skin
• headache
• nausea, vomiting
• weight gain

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 medication?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). 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.