Hydroxyurea (hye-drox-ee-ure-EE-a)

Treats leukemia and head and neck cancer. Prevents painful episodes and reduces the need for blood transfusions in patients with sickle cell anemia.

Brand Name(s):

Droxia, Hydrea, Siklos

When This Medicine Should Not Be Used:

How to Use This Medicine:

Capsule, Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Capsule:
  • Swallow the capsule whole. Do not crush, break, chew, or open it.
  • Do not touch this medicine with bare hands.
    • Wear disposable gloves when you handle the capsules or medicine bottles.
    • Wash your hands before and after you handle the capsules or bottles.
    • If powder from the capsule gets into your eyes, rinse them with water or an isotonic eyewash for 15 minutes.
    • Do not open the capsule. If powder from the capsule spills out, wipe it up right away with a damp disposable towel. Place the towel in a plastic bag and throw it away. Wash the area thoroughly with detergent 3 times.
• Tablet:
  • Take the tablet at the same time each day. Swallow it whole with a glass of water.
  • If you cannot swallow the tablet whole, you may dissolve it with a small quantity of water in a teaspoon for about 1 minute. Swallow this mixture right away, then drink a glass of water.
  • Do not touch this medicine with bare hands.
    • Wear disposable gloves when you handle the tablets or medicine bottles.
    • Wash your hands before and after you handle the tablets or bottles.
    • If powder from the crushed tablet gets on your skin, wash the skin area right away with soap and water. If the powder gets into your eyes, rinse them with water or an isotonic eyewash for at least 15 minutes.
    • If powder from a broken tablet is spilled, wipe it up right away with a damp disposable towel. Place the towel in a plastic bag and throw it away. Wash the area thoroughly with detergent.
• You may receive other medicines (including folic acid) before starting this medicine to prevent unwanted effects.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Store the broken tablets in the bottle and use them within 3 months. Throw away any unused broken tablet after 3 months.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how hydroxyurea works. Tell your doctor if you are using any of the following:
  • Interferon
  • Cancer medicines and radiation treatment
  • Medicine to treat HIV/AIDS (including didanosine, stavudine)
• This medicine may interfere with vaccines. Ask your doctor before you get a flu shot or any other vaccines. Avoid live vaccines while using this medicine.

Warnings While Using This Medicine:

• This medicine may cause birth defects if either partner is using it during conception or pregnancy. Tell your doctor right away if you or your partner becomes pregnant. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting this medicine. Use an effective form of birth control during treatment with this medicine and for at least 6 months after the last dose. Male patients with female partners should use an effective form of birth control during treatment and for at least 1 year for Droxia® and Hydrea® and at least 6 months for Siklos® after the last dose.
• Do not breastfeed while you are using this medicine.
• Tell your doctor if you have kidney disease, liver disease, bone marrow problems, leg ulcers, lung disease, or HIV infection.
• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• This medicine may cause the following problems:
  • Blood problem, including hemolytic anemia
  • Increased risk of cancer, including leukemia or skin cancer
  • Severe skin ulcers
  • Increased risk of lung or breathing problems
• This medicine may make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury. Wash your hands often.
• Talk with your doctor before using this medicine if you plan to have children. Some men who use this medicine have become infertile (unable to have children).
• This medicine may make your skin more sensitive to sunlight. Wear sunscreen. Do not use sunlamps or tanning beds.
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Fever, chills, cough, sore throat, body aches
• Skin sores or ulcers, red or purple bumps
• Trouble breathing, tiredness, uneven heartbeat, yellow skin or eyes
• Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

• Dry skin
• Headache

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088