Mylocel

Hydroxyurea is a prescription medication used to reduce the frequency of episodes of severe pain from sickle cell anemia and to reduce the need for blood transfusions in adults with sickle cell anemia. Hydroxyurea belongs to a group of drugs called antineoplastic agents. How it works is not known. It may prevent red blood cells from bending into the wrong shape, and by reducing the number of white blood cells and/or increasing red blood cells that carry fetal hemoglobin (HbF).

This medication comes in capsule form and is usually taken once a day, with or without food. Drink 8 to 10 glasses of water each day while you are taking hydroxyurea.

Some of the common side effects of hydroxyurea include hair loss, fever, and stomach problems. 

Hydroxyurea is a prescription medicine that is used to reduce the frequency of painful crises (episodes of severe pain) and reduce the need for blood transfusions in adults with sickle cell anemia. 

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• actual or ideal weight, whichever is less
• how you respond to this medication
• your blood counts

WARNING

Treatment of patients with hydroxyurea may be complicated by severe, sometimes life-threatening, adverse effects. Hydroxyurea should be administered under the supervision of a physician experienced in the use of this medication for the treatment of sickle cell anemia.

Hydroxyurea is mutagenic and clastogenic, and causes cellular transformation to a tumorigenic phenotype. Hydroxyurea is thus unequivocally genotoxic and a presumed transspecies carcinogen which implies a carcinogenic risk to humans. In patients receiving long-term hydroxyurea for myeloproliferative disorders, such as polycythemia vera and thrombocythemia, secondary leukemias have been reported. It is unknown whether this leukemogenic effect is secondary to hydroxyurea or is associated with the patient’s underlying disease. The physician and patient must very carefully consider the potential benefits of hydroxyurea relative to the undefined risk of developing secondary malignancies.

Hydroxyurea capsules are used to treat sickle cell anemia in adults. Hydroxyurea 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 hydroxyurea dose as needed to avoid serious complications.
• The most serious side effects of hydroxyurea 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 hydroxyurea 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, hydroxyurea may harm or cause death to your unborn child. You should not become pregnant while taking hydroxyurea. Make sure you use a contraceptive method. Tell your doctor if you become pregnant or plan to become pregnant while taking hydroxyurea.
• Hydroxyurea may decrease the ability of men to father children and women to have children.
• Laboratory tests and reports in humans suggest hydroxyurea may increase your risk of developing cancer, especially if it is taken for a long time. However, it is still uncertain whether hydroxyurea causes cancer.

Do not take hydroxyurea capsules if you are allergic to any of the ingredients.  Tell your doctor if you think you have ever had an allergic reaction.

As with other medicines, hydroxyurea may cause unwanted effects, although it is not always possible to tell whether such effects are caused by hydroxyurea, 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 hydroxyurea 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 hydroxyurea 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 hydroxyurea 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, hydroxyurea 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 hydroxyurea therapy. Contact your doctor if skin ulcers develop while you are taking hydroxyurea.

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

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

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

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

If you get pregnant, hydroxyurea may harm or cause death to your unborn child. Make sure you use a contraceptive method. Tell your doctor if you become pregnant or plan to become pregnant while taking hydroxyurea.

Hydroxyurea may decrease the ability of men to father children and women to have children.

It is VERY IMPORTANT that you have regular blood counts so that your doctor can decrease or increase the hydroxyurea dose as needed to avoid serious complications. Your doctor will monitor your blood counts every two weeks.

Drink 8 to 10 glasses of water each day while you are taking hydroxyurea.

Hydroxyurea is a medication that must be handled with care. People who are not taking hydroxyurea should not be exposed to it. To decrease the risk of exposure, wear disposable gloves when handling hydroxyurea.