Droxia

Generic Name: hydroxyurea (hye-DROX-ee-ure-EE-a)
Brand Name: Droxia

Droxia may cause severe, sometimes life-threatening side effects. With long-term use in patients with cell development disorders, secondary leukemias have been reported. It is unknown if this is related to Droxia or to the patient's underlying cell disorder. Your doctor will perform lab tests to check for side effects while you take Droxia. Be sure to keep all doctor and lab appointments. Talk with your doctor and be sure you understand the risks and benefits of using Droxia.


Droxia is used for:

Reducing the number of painful episodes and blood transfusions needed by adults with sickle cell anemia experiencing recurrent episodes associated with moderate to severe pain. It may also be used for other conditions as determined by your doctor.

Droxia is an antineoplastic agent. Exactly how it works is not known, but it is thought to increase the ability of deformed red blood cells to change shape, which may lessen pain associated with sickle cell anemia.

Do NOT use Droxia if:

  • you are allergic to any ingredient in Droxia
  • you have severe bone marrow depression, low white blood cell counts, low blood platelet levels, or severe anemia
  • you are taking didanosine or stavudine

Contact your doctor or health care provider right away if any of these apply to you.

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Before using Droxia:

Some medical conditions may interact with Droxia. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you are able to become pregnant or father a child
  • if you have anemia, folic acid deficiency, or kidney or liver problems
  • if you have HIV, especially if you take medicine for HIV
  • if you have previously received or are currently receiving chemotherapy, radiation therapy, or interferon therapy

Some MEDICINES MAY INTERACT with Droxia. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Didanosine or stavudine because the risk of side effects, such as inflammation of the pancreas, may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Droxia may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Droxia:

Use Droxia as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with Droxia. Talk to your pharmacist if you have questions about this information.
  • Take Droxia by mouth with or without food.
  • People who are not taking Droxia should not come into contact with it.
  • Wash your hands before and after handling Droxia or the bottle it comes in. Wear disposable gloves while you are handling Droxia or its bottle. Follow your doctor's instructions for disposing of the gloves after you remove them.
  • Do not open the capsules. Avoid exposure to crushed or opened capsules. If contact with crushed or opened capsules occurs, wash immediately and thoroughly. If the powder from the capsule is spilled, it should be wiped up immediately with a damp towel and disposed of in a closed container (eg, plastic bag), as should the empty capsules.
  • Drinking extra fluids while you are taking Droxia is recommended. Check with your doctor for instructions.
  • Do not use Droxia if the expiration date has passed. Ask your doctor or pharmacist how to properly dispose of expired medicine.
  • Taking Droxia at the same time each day will help you remember to take it.
  • If you miss a dose of Droxia, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once. If you miss more than one dose, call your doctor for instructions.

Ask your health care provider any questions you may have about how to use Droxia.

Important safety information:

  • Droxia may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Droxia with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Check with your doctor before you drink alcohol or smoke while you are taking Droxia.
  • Your doctor may prescribe a folic acid supplement for you to take while you are taking Droxia. Be sure to follow your doctor's instructions. Discuss any questions or concerns with your doctor.
  • To avoid painful sickle cell episodes, be sure to avoid extreme temperature changes and dress appropriately in hot and cold weather.
  • Do NOT take more than the recommended dose without checking with your doctor.
  • Tell your doctor or dentist that you take Droxia before you receive any medical or dental care, emergency care, or surgery.
  • Droxia may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
  • Droxia may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.
  • Droxia may harm your liver; cause pancreas problems; or cause burning, numbness, or tingling of your arms, hands, legs, or feet if you take it with certain HIV medicines (eg, didanosine, stavudine). Talk to your doctor if you have any questions about this information.
  • Skin cancer has been reported with long-term use of Droxia. Contact your doctor right away if you notice a change in the appearance of a mole, new growth on the skin, or any unusual skin change.
  • Do not receive a live vaccine (eg, measles, mumps) while you are taking Droxia. Talk with your doctor before you receive any vaccine.
  • Droxia may affect your ability to become pregnant or to father a child. Discuss any questions or concerns with your doctor.
  • Women who may become pregnant should use effective birth control while they are taking Droxia. Check with your doctor if you have questions about effective birth control.
  • Droxia may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Droxia.
  • Lab tests, including complete blood cell counts, kidney function, and liver function, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
  • Use Droxia with caution in the ELDERLY; they may be more sensitive to its effects.
  • Droxia should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Droxia may cause harm to the fetus. Do not become pregnant while you are using it. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Droxia while you are pregnant. Droxia is found in breast milk. Do not breast-feed while taking Droxia.

Possible side effects of Droxia:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; dizziness; hair loss; loss of appetite; nausea; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); change in the amount of urine produced; confusion; difficult or painful urination; fever, chills, or persistent cough or sore throat; hallucinations; headache; seizures; severe or persistent diarrhea, nausea, loss of appetite, or vomiting; shortness of breath; skin sores or ulcers; sudden, unusual weight gain; swelling of the hands, ankles, or feet; swelling or soreness of the mouth, lips, or tongue; symptoms of liver problems (eg, yellowing of the eyes or skin, pale stools, dark urine, persistent loss of appetite, severe stomach pain); unusual bruising or bleeding; unusual tiredness or weakness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include dark discoloration of the skin; swelling or soreness of the mouth, lips, or tongue; swelling, soreness, or redness of the palms of the hands and soles of the feet, followed by scaling of the skin.

Proper storage of Droxia:

Store Droxia at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Droxia out of the reach of children and away from pets.

General information:

  • If you have any questions about Droxia, please talk with your doctor, pharmacist, or other health care provider.
  • Droxia is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Droxia or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Droxia. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Droxia. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Droxia.

Issue Date: September 3, 2014
Database Edition 14.3.1.003
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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