Mylocel - Hydroxyurea Tablets

What is this medication?

HYDROXYUREA (hye drox ee yoor EE a) prevents the symptoms of sickle cell disease, such as pain crises and acute chest syndrome. It may also reduce the need for blood transfusions. It works by keeping red blood cells round and flexible, which prevents blood cells from clumping together. This also increases blood flow and the amount of oxygen that gets to your tissues.

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
• HIV or AIDS
• Kidney disease
• Leg wounds or ulcers
• Liver disease
• Low blood cell levels (white cells, platelets, or red cells)
• On dialysis
• Prior or current interferon therapy
• Recent or upcoming vaccine
• An unusual or allergic reaction to hydroxyurea, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth with a full glass of water. Take it as directed on the prescription label at the same time every day. If you are not able to swallow the tablet, you can dissolve it in a small amount of water in a teaspoon and swallow it right away. Your care team may change your dose or tell you stop taking this medication if you get side effects. Do not change your dose or stop taking it unless your care team tells you to.

Handling this medication may be harmful. Wash your hands before and after touching the medication or the bottle. Wear gloves while touching the medication or bottle. Talk to your care team about how to handle this medication. Special instructions may apply.

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 care team about the use of this medication in children. While it 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 medication may interact with the following:

• 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?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse.

This medication may increase your risk of getting an infection. Call your care team for advice if you get a fever, chills, sore throat, or other symptoms of a cold or flu. Do not treat yourself. Try to avoid being around people who are sick.

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

Talk to your care team if you or your partner wish to become pregnant or think either of your might be pregnant. This medication can cause serious birth defects if taken during pregnancy or for 6 months after stopping therapy. A negative pregnancy test is required before starting this medication. A reliable form of contraception is recommended while taking this medication and for 6 months after stopping treatment. Talk to your care team about reliable forms of contraception. Men should not father a child while taking this medication and for at least 6 months after stopping it. Use a condom during sex during and for 6 months after stopping treatment. Tell your care team right away if you think you or your partner may be pregnant.

This medication may cause infertility. Talk to your care team if you are concerned about your fertility.

Talk to your care team before breastfeeding. Changes to your treatment plan may be needed.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Hemolytic anemia—unusual weakness or fatigue, dizziness, headache, trouble breathing, dark urine, yellowing skin or eyes
• Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell
• Painful swelling, warmth, or redness of the skin, blisters or sores
• Unusual bruising or bleeding

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

• Constipation
• Dry skin
• Headache
• Nausea

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 and pets.

Store between 15 and 30 degrees C (59 and 86 degrees F). Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, ask your pharmacist or care team how to get rid of this medication safely.

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.