IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

HYDROXYUREA - ORAL

(hi-DROX-ee-you-REE-uh)

COMMON BRAND NAME(S): Hydrea

WARNING: Along with its benefits, hydroxyurea treatment may cause severe, sometimes fatal side effects (see also Side Effects section). Your doctor will follow you closely while you are taking this medication. Keep all medical and laboratory appointments.

Cancers have been reported with the use of this medication but it is not known if these cancers are due to the drug or the disease being treated. Consult your doctor for more details.

USES: This medication is used in people with sickle cell anemia to reduce the number of painful crises caused by the disease and to reduce the need for blood transfusions. It is also used to treat several types of cancer (such as melanoma, chronic myelogenous leukemia, squamous cell carcinomas).

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This drug may also be used to treat polycythemia vera and thrombocythemia.

HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start taking hydroxyurea and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with or without food, usually once daily or as directed by your doctor. Swallow the capsules whole. Do not crush, chew, or open the capsules. Wash your hands after taking this medication.

Dosage is based on your weight, medical condition, laboratory test results, and response to treatment. Your treatment may be stopped for a short time if your blood counts are too low. Keep all medical and laboratory appointments.

Do not increase your dose or take this medication more often than prescribed. Your condition will not improve any faster, and the risk of serious side effects may be increased.

Caregivers should wear disposable gloves when handling this medication or its container. If the powder inside the capsule spills, wipe it up with a wet paper towel and immediately dispose of the towel in a closed plastic bag. Make sure not to breathe the powder from the capsules. Wash hands after handling the medication.

Since this drug can be absorbed through the skin and lungs, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the capsules.

Tell your doctor if your condition does not improve or if it worsens.

SIDE EFFECTS: Nausea, vomiting, loss of appetite, mouth sores, diarrhea, or constipation may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Many people using this medication have serious side effects. However, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

This medication decreases bone marrow function, an effect that may lead to a low number of blood cells such as red cells, white cells, and platelets. This effect can cause anemia, decrease your body's ability to fight an infection, or cause you to bruise or bleed more easily. Tell your doctor immediately if you develop any of the following symptoms: signs of an infection (such as fever, chills, persistent sore throat), easy bruising/bleeding, pale skin, unusual tiredness.

Tell your doctor immediately if any of these unlikely but serious side effects occur: skin problems (such as ulcers, darkened/blackened/reddened skin, unusual growths/moles).

Tell your doctor immediately if any of these rare but serious side effects occur: mental/mood changes (such as confusion, hallucinations), seizures, shortness of breath, chest pain, persistent nausea/vomiting, severe stomach/abdominal pain, dark urine, yellowing skin/eyes, numbness/tingling of arms/legs, change in the amount of urine.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking hydroxyurea, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, blood/bone marrow disorders (such as bone marrow suppression, neutropenia, thrombocytopenia, anemia), HIV infection, high uric acid level in the blood.

Hydroxyurea can make you more likely to get infections or may worsen any current infections. Therefore, wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.

Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this drug.

It is unknown if this medication affects the sperm. If you plan to father a child, discuss the risks and benefits of this medication with your doctor.

Hydroxyurea is not recommended for use during pregnancy. It may harm an unborn baby. Discuss the use of reliable forms of birth control with your doctor. If you become pregnant or think you may be pregnant, tell your doctor immediately.

Hydroxyurea passes into breast milk and may have undesirable effects on a nursing infant. Breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring.

To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval.

Some products that may interact with this drug include: didanosine, stavudine, interferon.

This document does not contain all possible drug interactions. Keep a list of all the products you use. Share this list with your doctor and pharmacist to lessen your risk for serious medication problems.

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose include: swelling/scaling of hands and feet.

NOTES: Do not share this medication with others.

Laboratory and/or medical tests (such as complete blood count, kidney/liver function) must be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-800-854-1166 (US) or 1-800-668-1507 (Canada).

Information last revised June 2010 Copyright(c) 2010 First DataBank, Inc.

About Rx Outreach

Rx Outreach is a non-profit pharmacy whose mission is to provide affordable medications to people in need. Each year, we serve over 85,000 people across all fifty states, Puerto Rico, the U.S. Virgin Islands, and Guam. We believe that everyone deserves access to affordable medications. No one should ever have to choose between filling a prescription and feeding their family. That’s why Rx Outreach exists, and why our team is so passionate about the work we do.

Our Medications & Services

Rx Outreach offers more than 600 medication strengths, representing more than 250 different types of medications. There are many online pharmacies that claim to offer cheap drugs. Rx Outreach is different in that we work directly with pharmaceutical manufacturers to ensure we are providing high-quality products at an affordable price. Rx Outreach does not currently offer a Drug Discount Card or prescription coupons, but plans to expand beyond mail order pharmacy services in the future.

Our Pharmacy

The Rx Outreach pharmacy is located in St. Louis, MO and is staffed by more than 60 pharmacists and patient care advocates. We are licensed to dispense medications in all 50 states and U.S. territories. Since we are a mail order pharmacy, we are able to ship medications directly to our patients’ homes. To make it simple and cost-effective for our patients, we usually ship enough medication for 90 or 180 days at a time.