Hydroxyurea Solution

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): Xromi

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 of uric acid in your blood
• HIV or AIDS
• Kidney disease or on hemodialysis
• Leg wounds or ulcers
• Liver disease
• Prior or current interferon therapy
• Recent or ongoing radiation
• Recent or upcoming vaccine
• Use a continuous glucose monitor (CGM)
• An unusual or allergic reaction to hydroxyurea, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

Take this medication by mouth. Take it as directed on the prescription label at the same time every day. Take it with or after meals. You should take it the same way each day. Drink some water after each dose. Do not shake. Use a specially marked oral syringe, spoon, or dropper to measure each dose. Ask your pharmacist if you do not have one. Household spoons are not accurate. Your care team may change your dose or tell you to 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.

This medication comes with INSTRUCTIONS FOR USE. Ask your pharmacist for directions on how to use this medication. Read the information carefully. Talk to your pharmacist or care team if you have questions.

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 6 months 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, but only if it is on the same day. If this is not possible, skip it. Take your next dose at the normal time. Do not take double or extra doses.

What may interact with this medication?

• Antivirals for HIV, such as didanosine or stavudine
• Live virus vaccines

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. Report any side effects. Continue your course of treatment even if you have side effects unless your care team tells you to stop.

You may need blood work done while you are taking this medication.

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 vaccination history. Some vaccines are not recommended in people taking this medication. Your care team can help you decide which vaccines are safe for you.

Talk to your care team about your risk of cancer. You may be more at risk for certain types of cancer if you take this medication. To lower your risk of skin cancer, keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and sunscreen. Do not use sun lamps, tanning beds, or tanning booths.

If you wear a continuous glucose monitor (CGM), this medication may affect your sensor blood sugar (glucose) results. Talk to your care team about whether it is safe to use your CGM to dose insulin.

Do not handle this medication if you may be or could become pregnant.

Do not handle this medication if you are breastfeeding.

This medication may cause infertility. Talk to your care team 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 care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Dry cough, shortness of breath or trouble breathing
• 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 at the infusion site
• Unusual bruising or bleeding

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

• Diarrhea

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 in the refrigerator. Do not freeze. Keep the container tightly closed. Get rid of any unused medication after it expires or 12 weeks after opening the bottle, whichever is first.

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.