Hydroxyurea-oral

Hydrea, Droxia

For treating cancer: Dose should be titrated based on individual patient response. Capsules should be swallowed whole. Hydroxyurea capsules should be handled with extreme care and disposed of properly because it causes cell damage.

For the treatment of solid tumors

• Intermittent therapy: 80 mg/kg administered orally as single dose every third day
• Continuous therapy: 20 to 30 mg/kg administered orally as a single daily dose
• Concomitant therapy with irradiation: Cancer of the head and neck, administer 80 mg/kg orally as a single dose every third day

For the treatment of chronic myelocytic leukemia

20 to 30 mg/kg administered orally as a single daily dose is recommended.

As hydroxyurea is mainly eliminated from the body via the kidneys, dose reductions may be necessary in patients with reduced kidney function.

For the treatment of sickle cell disease

Adults: administer 15 mg/kg by mouth once daily. Dose adjustments are made based on patient's blood counts. Patient's blood counts are monitored every two weeks. If the blood counts are in an "acceptable" range, the dose may be increased by 5 mg/kg/day every 12 weeks until a maximum tolerated dose (highest dose that does not produce toxic blood counts) or 35 mg/kg/day is reached.

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 chronic myelogenous leukemia, squamous cell carcinomas).

How to use Hydroxyurea

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.

See also Warning section.

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, radiation treatment.

Hydroxyurea can make you more likely to get infections or may worsen any current infections. 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. To avoid pregnancy, both men and women taking this drug should use reliable form(s) of birth control (such as birth control pills, condoms) during treatment, and for 6 months after treatment for women, and for 1 year after treatment for men. Consult with your doctor for more details. If you or your partner becomes pregnant or may be pregnant, tell your doctor right away.

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 may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

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

This medication may interfere with certain laboratory tests, possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center 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.

Lab and/or medical tests (such as complete blood count, kidney/liver function) must be done before you start taking this medication and while you are taking it. Keep all medical and lab appointments. 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 themissed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Storage

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications 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.Information last revised June 2017. Copyright(c) 2017 First Databank, Inc.