Hydroxyurea, Oral

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KEY POINTS

• This medicine is taken by mouth to treat certain kinds of cancer or sickle cell anemia. Take it exactly as directed.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may increase the risk that you will develop cancer or cause severe, life-threatening 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: hydroxyurea, oral; Droxia; Hydrea

What is this medicine used for?

This medicine is taken by mouth to treat:

• Cancer of the ovaries
• Certain types of leukemia
• Melanoma
• Sickle cell anemia

It is often prescribed with radiation to treat certain cancers of the head and neck.

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 provider if you have ever had:

• An allergic reaction to any medicine
• Bone marrow problems
• Chemotherapy or radiation therapy
• HIV/AIDS
• Kidney or liver disease

This medicine may decrease your ability to have children, whether you are a man or a woman. If you plan to have children someday, talk with your healthcare provider before you start treatment.

Females of childbearing age: This medicine is not given to pregnant women because it can harm the baby. If you are pregnant, tell your healthcare provider. Do not become pregnant during treatment with this medicine. Use an effective method of birth control while you are receiving this medicine and for at least 6 months after your therapy is completed. Talk to your healthcare provider if you need birth control. If you become pregnant, contact your healthcare provider right away. Do not breast-feed while you are receiving this medicine.

How do I take it?

Check the label on the medicine for directions about your specific dose. Take the medicine exactly as your healthcare provider prescribes. Do not stop taking this medicine without your healthcare provider's approval. Follow directions carefully.

Check with your healthcare provider before using this medicine in children under age 18.

If you cannot swallow the capsules, open them and empty the contents into a glass of water. Swallow all the liquid right away. However, do not allow the powder in the capsule to touch your skin, and do not inhale the powder.

People not taking this medicine should not touch the medicine. Wash your hands before and after taking a dose of this medicine. You should wear disposable gloves when you handle this medicine. If powder from a capsule is spilled, wipe up with a damp paper towel and put the paper towel in a plastic bag or other closed container. Wash your hands right away. Keep the plastic bag or other closed container safely away from children and pets. Talk with your healthcare provider or pharmacist about how to dispose of this medicine.

Your healthcare provider may tell you to drink extra liquid while taking this medicine.

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: severe redness, scaling, soreness, or swelling of the palms of the hands or soles of the feet; unusual tiredness or weakness; unusual bruising or bleeding.

What should I watch out for?

This is a very strong medicine. Only healthcare providers experienced with this drug should prescribe it.

This medicine may cause severe, life-threatening side effects. Call your healthcare provider right away if you have fever, sore throat, or cough; unusual tiredness or weakness; dizziness; confusion; fast heartbeat, shortness of breath; trouble sleeping; or unusual bruising or bleeding.

This medicine may increase the risk that you will develop cancer. This risk may be greater if you take the medicine for a long time. Make sure you understand what the risks and benefits of treatment are.

You will need to have blood tests regularly to see how this medicine affects you. Keep all appointments for these tests.

This medicine may cause skin sores. Contact your provider if you develop a skin rash or painful sores on your skin.

This medicine may make you drowsy. Do not drive or operate machinery unless you are fully alert.

You may get infections more easily when you are taking this medicine. Stay away from people with colds, flu, or other infections. Also, do not have any vaccines without getting your healthcare provider's approval first.

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).

Serious (Report these to your healthcare provider right away.): Fever and chills; sore throat; nausea; vomiting; diarrhea; loss of appetite; mouth, lip, or skin sores; unusual bruising or bleeding; numbness or tingling in hands or feet; black or tarry bowel movements; yellowing of your skin or eyes, dark urine; light-colored bowel movements; unusual tiredness; severe confusion; hallucinations; seizures.

Other: Drowsiness, constipation, red face, itching, hair loss, headache, dizziness, weight gain.

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:

• Clozapine (Clozaril, FazaClo)
• HIV medicines such as didanosine (Videx) and stavudine (Zerit)
• Immunosuppressants such as azathioprine (Azasan, Imuran), cyclosporine (Gengraf, Neoral, Sandimmune), mycophenolate (CellCept, Myfortic), sirolimus (Rapamune), and tacrolimus (Astagraf, Prograf, Protopic)
• Interferon medicines such as interferon alfa-2b (Intron-A), interferon alfa-n3 (Alferon N), interferon beta-1a (Avonex, Rebif), interferon beta-1b (Betaseron, Extavia), peginterferon alfa-2a (Pegasys), peginterferon alfa-2b (Sylatron), and peginterferon beta-1a (Plegridy)
• Medicines to raise white blood cell counts such as filgrastim (Neupogen), pegfilgrastim (Neulasta), and sargramostim (Leukine)
• Natalizumab (Tysabri)
• Probenecid
• Vaccines

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.