Droxia

PATIENT INFORMATION

DROXIA®
Capsules (generic name = hydroxyurea)

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

DROXIA (pronounced drock-SEE-yuh) capsules are used to treat sickle cell anemia in adults. DROXIA reduces the frequency of painful crises and reduces the need for blood transfusions.

  • It is VERY IMPORTANT that you have regular blood counts so that your doctor can decrease or increase the DROXIA dose as needed to avoid serious complications.
  • The most serious side effects of DROXIA involve the blood and may include severely low white blood cell counts (leukopenia, neutropenia), which can decrease your resistance to infections, severely low red blood cell counts (anemia), or severely low platelet counts (thrombocytopenia), which can cause bleeding. Almost all patients who received DROXIA in clinical studies needed to have their medication stopped for a time to allow their low blood counts to return to acceptable levels.
  • If you get pregnant, DROXIA may harm or cause death to your unborn child. You should not become pregnant while taking DROXIA. Make sure you use a contraceptive method. Tell your doctor if you become pregnant or plan to become pregnant while taking DROXIA.
  • DROXIA may decrease the ability of men to father children and women to have children.
  • Laboratory tests and reports in humans suggest DROXIA may increase your risk of developing cancer, especially if it is taken for a long time. However, it is still uncertain whether DROXIA causes cancer.

What is DROXIA?

DROXIA (hydroxyurea capsules, USP) is a prescription medicine that is used to reduce the frequency of painful crises and reduce the need for blood transfusions in adults with sickle cell anemia. How DROXIA works is not certain but it may work by reducing the number of white blood cells and/or increasing red blood cells that carry fetal hemoglobin (HbF). Fetal hemoglobin may prevent sickling.

What is Sickle Cell Anemia?

Sickle cell anemia is an inherited disorder of the red blood cells. Red blood cells carry oxygen to all parts of the body by using a protein called hemoglobin. Normal red blood cells contain only normal hemoglobin and are shaped like indented disks. These cells are very flexible and move easily through small blood vessels.

In sickle cell anemia, the red blood cells contain sickle hemoglobin, which causes them to change to a rigid, spiked shape (sickle shape) after oxygen is released. Sickled cells get stuck and form plugs in small blood vessels. These plugs restrict blood flow, causing damage to surrounding tissues resulting in a painful crisis.

Because there are blood vessels in all parts of the body, painful crises can occur anywhere in your body. In addition, sickle cells are trapped and destroyed in the liver and spleen. This results in a shortage of red blood cells (anemia).

Will DROXIA cure my Sickle Cell Anemia?

No. However, DROXIA may help you better control your sickle cell anemia, but it is important to follow your doctor's instructions carefully.

In a study of adults taking recommended doses, daily treatment with DROXIA resulted in fewer painful crises, fewer patients with “acute chest syndrome” (a pneumonia-like condition that leads to difficulty in breathing) and less need for blood transfusions.

Who should not take DROXIA capsules?

Do not take DROXIA capsules if you are allergic to any of the ingredients. Besides the active ingredient hydroxyurea, DROXIA capsules contain the following inactive ingredients: citric acid, gelatin, lactose, magnesium stearate, sodium phosphate, titanium dioxide, and capsule colorants. Tell your doctor if you think you have ever had an allergic reaction.

If you get pregnant, DROXIA may harm or cause death to your unborn child. You should not become pregnant while taking DROXIA. Make sure you use a contraceptive method. Tell your doctor if you become pregnant or plan to become pregnant while taking DROXIA.

How do I take DROXIA capsules?

Always follow your doctor's instructions carefully when taking DROXIA capsules or any prescription medication. The usual dose of DROXIA may range from as few as one to several capsules per day. DROXIA is usually taken once a day. You should try to take it at the same time each day. Your doctor will determine the proper starting dose of DROXIA for you based on your weight and blood count. The dose will then be increased slowly to your maximum tolerated dose (maximum dose that does NOT produce severely low blood counts). Your doctor should measure your blood counts every two weeks after you begin treatment with DROXIA. Depending on the results, your dosage may be adjusted or the drug may be stopped for a while.

If you accidentally take an overdose of DROXIA capsules, seek medical attention immediately. Contact your doctor, local Poison Control Center, or emergency room.

How do I handle DROXIA capsules safely?

DROXIA is a medication that must be handled with care. People who are not taking DROXIA should not be exposed to it. To decrease the risk of exposure, wear disposable gloves when handling DROXIA or bottles containing DROXIA. Anyone handling DROXIA should wash their hands before and after contact with the bottle or capsules. If the powder from the capsule is spilled, it should be wiped up immediately with a damp disposable towel and discarded in a closed container, such as a plastic bag. DROXIA should be kept out of the reach of children and pets. Contact your doctor or pharmacist for instructions on how to dispose of outdated capsules.

What if I miss a dose of DROXIA capsules?

Try not to miss your dose of DROXIA, but if you do, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses during the same day. If you miss more than one dose, call your doctor for instructions.

What should I avoid while taking DROXIA capsules?

Some other medications can increase your risk of experiencing serious side effects from DROXIA. While you are taking DROXIA capsules, you should inform your doctor of all prescription and over-the-counter medicines that you are taking.

In nursing mothers, DROXIA is present in breast milk. Because of the potential for side effects in the newborn, you should discontinue nursing your baby while taking DROXIA.

What are the possible side effects of DROXIA capsules?

As with other medicines, DROXIA may cause unwanted effects, although it is not always possible to tell whether such effects are caused by DROXIA, another medication you may be taking, or your sickle cell anemia. Any side effects or unusual symptoms that you experience should be reported to your doctor, particularly if they persist or are troublesome.

The most serious side effects of DROXIA involve the blood, and may include severely low white blood cell counts (leukopenia, neutropenia), which can decrease your resistance to infections, severely low red blood cell counts (anemia), or severely low platelet counts (thrombocytopenia), which can cause bleeding. Almost all patients who received DROXIA in clinical studies needed to have their medication stopped for a time to allow their low blood counts to return to acceptable levels.

The side effects reported most often by adults with sickle cell anemia participating in studies of DROXIA included hair loss, skin rash, fever, stomach and/or bowel disturbances, weight gain, bleeding, virus infection, and discolored nails (melanonychia), but these were equally common in people getting a placebo (sugar pill).

Skin cancer and leukemia, which can be fatal, have been reported in patients receiving long-term hydroxyurea for conditions other than sickle cell anemia. In laboratory tests, DROXIA causes changes in chromosomes and DNA (genetic material) that strongly suggest it can cause cancer in people, especially if it is taken for a long time.

Skin ulcers have been seen in patients taking DROXIA therapy. Contact your doctor if skin ulcers develop while you are taking DROXIA.

Are regular blood counts necessary while taking DROXIA capsules?

Yes. Your doctor should measure your blood counts every two weeks while you are taking DROXIA. Your DROXIA dose will require adjustment based on these regular blood counts. Serious problems can occur if the DROXIA dose is not adjusted on time.

What else should I know about DROXIA capsules?

If you have kidney or liver disease, close monitoring of your blood count, kidney and liver function will be required. If you have kidney disease, your dose of DROXIA may be started at a lower level and increased gradually.

Because it may not be possible to detect a deficiency of folic acid in patients taking DROXIA, your doctor may prescribe a folic acid supplement for you.

What else should I do to control my sickle cell crises?

Because painful crises can be brought on by factors such as infection, dehydration, worsening anemia, emotional stress, extreme temperature exposure, or ingestion of substances such as alcohol or other recreational drugs, you should be aware of the following general guidelines that will help keep you pain-free:

  • Seek immediate medical attention when a fever develops or signs of infection appear.
  • Avoid smoking and drinking more than 1 to 2 alcoholic beverages a day.
  • Drink 8 to 10 glasses of water or other fluid each day.
  • Avoid any types of physical exertion that seem to bring on painful crises or other discomfort.
  • Avoid extreme temperature changes and dress appropriately in hot and cold weather.

What should I know if I am HIV-positive?

Because of serious, life-threatening side effects associated with DROXIA used in combination with certain medications for HIV, your doctor should closely monitor your pancreas and liver function with frequent physical examinations and laboratory blood tests. The combination of DROXIA, ZERIT® (stavudine) and VIDEX® (didanosine) should be avoided. Some studies have shown a decrease in the number of CD4 (T-cells) for HIV-positive patients taking DROXIA. Although DROXIA is approved by the U.S. Food and Drug Administration for treating sickle cell anemia, it is not approved for treating HIV infection.

This medicine was prescribed for your particular condition. Do not use DROXIA capsules for another condition or give it to others.

This summary does not include everything there is to know about DROXIA capsules. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. If you have questions or concerns, or want more information about DROXIA capsules, your physician and pharmacist have the complete prescribing information upon which this guide is based. You may want to read it and discuss it with your doctor. Remember, no written summary can replace careful discussion with your doctor.

This Patient Information has been approved by the U.S. Food and Drug Administration.

Last reviewed on RxList: 2/16/2012
This monograph has been modified to include the generic and brand name in many instances.

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