September 2, 2015
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Droxia

"The US Food and Drug Administration (FDA) is ordering stricter warnings and contraindications for the anemia drug ferumoxytol (Ferumoxytol, AMAG Pharmaceuticals), stating that even with current warnings, there have been 79 anaphylactic r"...

Droxia




PATIENT INFORMATION

DROXIA®
(drock-SEE-yuh)
(hydroxyurea) Capsules, USP

Read this Patient Information before you start using DROXIA (hydroxyurea) and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment. You and your healthcare provider should talk about DROXIA when you start taking it and at regular checkups.

What is the most important information I should know about DROXIA?

DROXIA can cause serious side effects including:

  • Low blood counts are common with DROXIA, including low red blood cells, white blood cells, and platelets, and can be severe and life-threatening. If your white blood cell count becomes very low, you are at increased risk for infection. Your healthcare provider will check your blood cell counts before and during treatment with DROXIA. Your healthcare provider may change your dose or tell you to stop taking DROXIA if you have low blood cell counts. Tell your healthcare provider right away if you get any of the following symptoms:
    • fever
    • feeling very tired
    • chills
    • shortness of breath
    • body aches
    • bleeding
  • Cancer. Some people have developed cancer, such as leukemia and skin cancer, after taking DROXIA for a long time. Your healthcare provider will check you for cancer. You should protect your skin from the sun using sunblock, hats, and sun-protective clothing.

DROXIA may cause harm to your unborn baby.

For females taking DROXIA who can become pregnant:

  • You should talk with your healthcare provider about the risks of DROXIA to your unborn child.
  • You should use effective birth control during and after treatment with DROXIA for at least 30 days after treatment.
  • Tell your healthcare provider right away if you become pregnant or think you may be pregnant.

For males taking DROXIA:

  • Males should use effective contraception during and after treatment with DROXIA for at least 1 year after therapy.

For females NOT taking DROXIA who can become pregnant:

  • You should ensure that your male partner, who is/has taken DROXIA, uses effective contraception during and after treatment for at least 1 year after therapy.

DROXIA may cause fertility problems in males and females. Talk to your healthcare provider if this is a concern for you.

See “What are the possible side effects of DROXIA?” for more information about side effects.

What is DROXIA?

DROXIA is a prescription medicine that is used to reduce the frequency of painful crises and reduce the need for blood transfusions in people with sickle cell anemia with recurrent moderate to severe painful crises.

It is not known if DROXIA is safe and effective in children.

Who should not take DROXIA?

Do not take DROXIA if you are allergic to hydroxyurea or any of the ingredients in DROXIA. See the end of this leaflet for a list of the ingredients in DROXIA.

Before taking DROXIA, tell your healthcare provider about all of your medical conditions, including if you:

  • have kidney problems or are receiving hemodialysis
  • have liver problems
  • have human immunodeficiency virus (HIV). Taking DROXIA with certain HIV medicines can cause serious reactions and may lead to death.
  • have increased level of uric acid in your blood (hyperuricemia)
  • have a history of receiving interferon therapy or are currently receiving interferon therapy
  • are pregnant or plan to become pregnant. See “What is the most important information I should know about DROXIA?”
  • are breastfeeding or plan to breastfeed. DROXIA can pass into your breast milk. Do not breastfeed during treatment with DROXIA. Talk to your healthcare provider about the best way to feed your baby.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take an antiretroviral medicine. Taking DROXIA with certain antiretroviral medicines can cause serious side effects and may lead to death.

How should I take DROXIA?

  • Take DROXIA exactly as your healthcare provider tells you.
  • DROXIA is taken 1 time a day.
  • Your healthcare provider will determine the right starting dose of DROXIA for you based on your weight. Your dose will then be increased slowly to your maximum tolerated dose (a dose that does not produce severely low blood counts).
  • If you take too much DROXIA, call your healthcare provider or go to the nearest hospital emergency room right away.
  • DROXIA is a medicine that must be handled with care. People who are not taking DROXIA should not be exposed to it. To decrease the risk of exposure, you or your caregivers should do the following when handling DROXIA:
    • Wear disposable gloves when handling DROXIA capsules or bottles containing DROXIA.
    • Wash your hands before and after handling DROXIA capsules or bottles containing DROXIA.
    • Do not open the capsules.
    • Avoid contact with crushed or opened capsules. If contact from crushed or opened capsules happens on the skin, wash the skin area right away with soap and water. If contact from crushed or opened capsules happens on the eye(s), flush the eye(s) thoroughly with water or isotonic eyewash designated for that purpose for at least 15 minutes.
    • If the powder from the capsule is spilled, wipe it up right away with a damp disposable towel, and throw it away in a closed container, such as a plastic bag; as should the empty capsules. The spill areas should then be cleaned three times using a detergent solution followed by clean water.

What are the possible side effects of DROXIA?

DROXIA may cause serious side effects, including:

  • See “What is the most important information I should know about DROXIA?”
  • Skin ulcers have happened in people who take DROXIA. This has occurred most often in people who receive interferon therapy or have a history of interferon therapy. Your healthcare provider will stop treatment with DROXIA if you develop any skin ulcers.

The most common side effects of DROXIA include:

  • hair loss
  • enlarged red blood cells (macrocytosis). Macrocytosis can make it difficult to detect a decrease of folic acid in people taking DROXIA. Your healthcare provider may prescribe a folic acid supplement for you.
  • bleeding
  • brown or black colored nails

These are not all the possible side effects of DROXIA. For more information, ask your healthcare provider or pharmacist.

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

How Should I store DROXIA?

  • Store DROXIA at room temperature between 68°F to 77°F (20°C to 25°C). Keep the bottle tightly closed.
  • Call your healthcare provider for instructions on how to throw away (dispose of) DROXIA that is out of date or no longer needed.

Keep DROXIA and all medicines out of the reach of children. Keep DROXIA away from pets.

General information about the safe and effective use of DROXIA

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use DROXIA for a condition for which it was not prescribed. Do not give DROXIA to other people, even if they have the same symptoms you have. It may harm them. You can ask your healthcare provider or pharmacist for information about DROXIA that is written for health professionals.

What are the ingredients of DROXIA?

Active ingredient: hydroxyurea

Inactive ingredients: citric acid, gelatin, lactose, magnesium stearate, sodium phosphate, titanium dioxide, and capsule colorants: FD&C Blue No. 1 and FD&C Green No. 3 (200 mg capsules); D&C Red No. 28, D&C Red No. 33, and FD&C Blue No. 1 (300 mg capsules); D&C Red No. 28, D&C Red No. 33, and D&C Yellow No. 10 (400 mg capsules).

Last reviewed on RxList: 8/6/2015
This monograph has been modified to include the generic and brand name in many instances.

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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