Generic Name: hydroxyurea (Oral route)
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 patients’ underlying disease. The physician and patient must very carefully consider the potential benefits of hydroxyurea relative to the undefined risk of developing secondary malignancies .
Treatment of patients with hydroxyurea may be complicated by severe, sometimes life-threatening, adverse effects. Hydroxyurea is mutagenic and clastogenic, and causes cellular transformation to a tumorigenic phenotype 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 patients’ underlying disease .
Commonly used brand name(s):
In the U.S.
Available Dosage Forms:
Therapeutic Class: Antineoplastic Agent
Pharmacologic Class: Antimetabolite
Hydroxyurea belongs to the group of medicines called antimetabolites. It is used to treat some kinds of cancer and to prevent painful episodes associated with sickle cell anemia.
Hydroxyurea seems to interfere with the growth of cancer cells, which are eventually destroyed. Since the growth of normal body cells may also be affected by hydroxyurea, other effects will also occur. Some of these may be serious and must be reported to your doctor. Other effects may not be serious but may cause concern. Some effects may not occur for months or years after the medicine is used.
When used in sickle cell anemia, hydroxyurea appears to increase the flexibility of sickled cells.
Before you begin treatment with hydroxyurea, you and your doctor should talk about the good this medicine will do as well as the risks of using it.
Hydroxyurea is available only with your doctor's prescription.
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Side effects may be likely to occur in children, who may be more sensitive to the effects of hydroxyurea.
Side effects may be more likely to occur in the elderly, who may be more sensitive to the effects of hydroxyurea. And, because elderly people are more likely to have kidney problems, the doctor may want to adjust the dose and monitor kidney function.
|All Trimesters||D||Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.|
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
This section provides information on the proper use of a number of products that contain hydroxyurea. It may not be specific to Droxia. Please read with care.
Take hydroxyurea only as directed by your doctor. Do not use more or less of it, and do not use it more often than your doctor ordered. The exact amount of medicine you need has been carefully worked out. Taking too much may increase the chance of side effects, while taking too little may not improve your condition.
Hydroxyurea should be handled with care and people who are not taking this medicine should take proper precautions to avoid it. To decrease the chances of coming into contact with hydroxyurea:
For patients who cannot swallow the capsules:
This medicine is sometimes given together with certain other medicines. If you are using a combination of medicines, make sure that you take each one at the right time and do not mix them. Ask your health care professional to help you plan a way to take your medicine at the right times.
While you are using this medicine, your doctor may want you to drink extra fluids so that you will pass more urine. This will help prevent kidney problems and keep your kidneys working well.
This medicine commonly causes nausea, vomiting, and diarrhea. However, it is very important that you continue to use the medicine, even if you begin to feel ill. Ask your health care professional for ways to lessen these effects.
If you vomit shortly after taking a dose of hydroxyurea, check with your doctor. You will be told whether to take the dose again or to wait until the next scheduled dose.
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.
While you are being treated with hydroxyurea, and after you stop treatment with it, do not have any immunizations (vaccinations) without your doctor's approval. Hydroxyurea may lower your body's resistance and there is a chance you might get the infection the immunization is meant to prevent. In addition, other persons living in your household should not take oral polio vaccine since there is a chance they could pass the polio virus on to you. Also, avoid persons who have recently taken oral polio vaccine. Do not get close to them and do not stay in the same room with them for very long. If you cannot take these precautions, you should consider wearing a protective face mask that covers the nose and mouth.
Hydroxyurea can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:
Along with their needed effects, medicines like hydroxyurea can sometimes cause unwanted effects such as blood problems and other side effects. These and others are described below. Also, because of the way these medicines act on the body, there is a chance that they might cause other unwanted effects that may not occur until months or years after the medicine is used. These delayed effects may include certain types of cancer, such as leukemia. Ask your health care professional for ways to lessen these effects.
Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:More common
Check with your doctor as soon as possible if any of the following side effects occur:Less common
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:More common
Hydroxyurea may cause temporary loss of hair in some people. After treatment has ended, normal hair growth should return, although the new hair may be a slightly different color or texture.
After you stop using this medicine, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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