Hydroxyurea (patient information)
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Alberto Plate [2]
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Black Box Warning
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Warning
See full prescribing information for complete Boxed Warning.
Condition Name: Treatment of patients with DROXIA may be complicated by severe, sometimes life-threatening, adverse effects. DROXIA 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 DROXIA relative to the undefined risk of developing secondary malignancies.
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Overview
Hydroxyurea (patient information) is an antimetabolite, antineoplastic agent that is FDA approved for the treatment of sicle cell anemia. There is a Black Box Warning for this drug as shown here. Common adverse reactions include myelosuppression.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Sickle Cell Anemia
Procedures for proper handling and disposal of cytotoxic drugs should be considered. Several guidelines on this subject have been published. To minimize the risk of dermal exposure, always wear impervious gloves when handling bottles containing DROXIA capsules. DROXIA capsules should not be opened. Personnel should avoid exposure to crushed or opened capsules. If contact with crushed or opened capsules occurs, wash immediately and thoroughly. More information is available in the references listed below.
Dosage should be based on the patient’s actual or ideal weight, whichever is less. The initial dose of DROXIA is 15 mg/kg/day as a single dose. The patient’s blood count must be monitored every two weeks. If blood counts are in an acceptable range, the dose may be increased by 5 mg/kg/day every 12 weeks until a maximum tolerated dose (the highest dose that does not produce toxic blood counts over 24 consecutive weeks), or 35 mg/kg/day, is reached.
If blood counts are between the acceptable rangeand toxic, the dose is not increased. If blood counts are considered toxic, DROXIA should be discontinued until hematologic recovery. Treatment may then be resumed after reducing the dose by 2.5 mg/kg/day from the dose associated with hematologic toxicity. DROXIA may then be titrated up or down, every 12 weeks in 2.5 mg/kg/day increments, until the patient is at a stable dose that does not result in hematologic toxicity for 24 weeks. Any dosage on which a patient develops hematologic toxicity twice should not be tried again.
- Acceptable range
- Neutrophils ≥2500 cells/
- Platelets ≥95,000/
- Hemoglobin >5.3 g/dL
- Reticulocytes ≥95,000/mm3 if the hemoglobin concentration <9 g/dL.
- Toxic
- Neutrophils <2000 cells/mm3,
- Platelets <80,000/mm3,
- Hemoglobin <4.5 g/dL and
- Reticulocytes <80,000/mm3 if the hemoglobin concentration <9 g/dL.
Since hydroxyurea may raise the serum uric acid level, dosage adjustment of uricosuric medication may be necessary.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Hydroxyurea (patient information) in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Hydroxyurea (patient information) in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Hydroxyurea (patient information) FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Hydroxyurea (patient information) in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Hydroxyurea (patient information) in pediatric patients.
Contraindications
There is limited information regarding Hydroxyurea (patient information) Contraindications in the drug label.
Warnings
|
Warning
See full prescribing information for complete Boxed Warning.
Condition Name: Treatment of patients with DROXIA may be complicated by severe, sometimes life-threatening, adverse effects. DROXIA 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 DROXIA relative to the undefined risk of developing secondary malignancies.
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There is limited information regarding Hydroxyurea (patient information) Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Hydroxyurea (patient information) Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Hydroxyurea (patient information) Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Hydroxyurea (patient information) Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Hydroxyurea (patient information) in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Hydroxyurea (patient information) in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Hydroxyurea (patient information) during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Hydroxyurea (patient information) in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Hydroxyurea (patient information) in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Hydroxyurea (patient information) in geriatric settings.
Gender
There is no FDA guidance on the use of Hydroxyurea (patient information) with respect to specific gender populations.
Race
There is no FDA guidance on the use of Hydroxyurea (patient information) with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Hydroxyurea (patient information) in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Hydroxyurea (patient information) in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Hydroxyurea (patient information) in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Hydroxyurea (patient information) in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Hydroxyurea (patient information) Administration in the drug label.
Monitoring
There is limited information regarding Hydroxyurea (patient information) Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Hydroxyurea (patient information) and IV administrations.
Overdosage
There is limited information regarding Hydroxyurea (patient information) overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Hydroxyurea (patient information) Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Hydroxyurea (patient information) Mechanism of Action in the drug label.
Structure
There is limited information regarding Hydroxyurea (patient information) Structure in the drug label.
Pharmacodynamics
There is limited information regarding Hydroxyurea (patient information) Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Hydroxyurea (patient information) Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Hydroxyurea (patient information) Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Hydroxyurea (patient information) Clinical Studies in the drug label.
How Supplied
There is limited information regarding Hydroxyurea (patient information) How Supplied in the drug label.
Storage
There is limited information regarding Hydroxyurea (patient information) Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Hydroxyurea (patient information) Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Hydroxyurea (patient information) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Hydroxyurea (patient information) Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Hydroxyurea (patient information) Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.
Template:Drug header Editor-In-Chief: C. Michael Gibson, M.S., M.D. [3]
IMPORTANT WARNING
Hydroxyurea may cause severe, life-threatening side effects, including a low blood count (decrease in the number of blood cells in your body) Tell your doctor if you have or have ever had a blood disease. Tell your doctor and pharmacist about all the medications you are taking. If you take hydroxyurea with other medications that may cause a low blood count, the side effects of the medications may be more severe. If you experience any of the following symptoms, call your doctor immediately: fever, sore throat, chills, cough, and other signs of infection; excessive tiredness; weakness; pale skin; dizziness; confusion; fast heartbeat, shortness of breath; difficulty falling asleep or staying asleep; or unusual bleeding or bruising.
Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests on a regular basis to check your body's response to hydroxyurea and to see if your blood count has dropped. Your doctor may need to change your dose or tell you to stop taking hydroxyurea for a period of time to allow your blood count to return to normal if it has dropped too low. Follow your doctor's directions carefully and ask your doctor if you do not know how much hydroxyurea you should take.
Taking hydroxyurea may increase the risk that you will develop cancer. This risk may be greater if you take hydroxyurea for a long time.
Talk to your doctor about the risks of taking hydroxyurea.
Women who are taking hydroxyurea, or whose male partners are taking hydroxyurea, may be less likely to become pregnant than women who are not taking hydroxyurea or whose partners are not taking the medication. However, you should not assume that you or your partner cannot become pregnant during your treatment. Tell your doctor if you are pregnant or plan to become pregnant. Use a reliable method of birth control to prevent pregnancy while you are taking hydroxyurea. If you become pregnant while taking hydroxyurea, call your doctor immediately. Hydroxyurea may cause harm or death to the fetus.
About your treatment
Your doctor has ordered hydroxyurea to help treat your illness. Hydroxyurea comes as a capsule to take by mouth.
This medication is used:
- to treat melanoma (a type of skin cancer)
- to treat chronic myelocytic leukemia (CML; cancer of the white blood cells)
- to treat recurrent, metastatic, or inoperable ovarian cancer [cancer of the ovary (a female reproductive organ) that has returned after treatment, that has spread, or that cannot be treated with surgery]
- with radiation therapy to control primary squamous cell carcinoma (a type of skin cancer) that affects any part of the head or neck except the lips
- to prevent crises (episodes of severe pain) and decrease the need for blood transfusions (transfer of one person's blood to another person's body) in people who have sickle cell anemia (a blood disease that may cause painful crises, a low number of red blood cells, infection, and damage to the internal organs).
Hydroxyurea is in a class of medications known as antineoplastic agents.Hydroxyurea treats cancer by slowing or stopping the growth of cancer cells. Hydroxyurea treats sickle cell anemia by changing red blood cells so that they are less likely to bend in an abnormal shape. The length of treatment depends on the condition you have and how well your body responds to this medication.
Hydroxyurea is usually taken once a day. When hydroxyurea is used to treat certain types of cancer, it may be taken once every third day. Try to take hydroxyurea at about the same time of day on the days that you are scheduled to take the medication. Follow the directions on your prescription label carefully and ask your doctor or pharmacist to explain anything you do not understand. Take hydroxyurea exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Your doctor may start you on a low dose of hydroxyurea and gradually increase your dose.
Hydroxyurea may help control the symptoms of sickle cell anemia but does not cure the condition. Continue to take hydroxyurea even if you feel well. Do not stop taking this medication without talking to your doctor.
If you forget to take a dose of hydroxyurea, take the missed dose as soon as you remember it. However, if it is almost time for your next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed dose and do not take more than one dose in one day. Call your doctor if you miss more than one dose of hydroxyurea.
Other uses for this medicine
Hydroxyurea is also sometimes used to treat polycythemia vera (a condition in which the body produces too many blood cells), psoriasis (a skin disease in which red, scaly patches form on some areas of the body), and hypereosinophilic syndrome (a condition in which the body produces too many of a certain type of white blood cell). Talk to your doctor about the possible risks of using this medication for your condition.
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
Precautions
Before taking hydroxyurea:
- tell your doctor and pharmacist if you are allergic to hydroxyurea, any other medications, or any of the inactive ingredients in hydroxyurea capsules. Ask your pharmacist for a list of the ingredients.
- tell your doctor if you are taking or have ever taken an interferon. (Interferons are a group of medications similar to substances produced by the body. They are used to treat diseases that involve the immune system such as certain types of cancer, hepatitis, multiple sclerosis, and genital warts. Brand names include Actimmune, Avonex, Betaseron, Rebif and others.) If you are taking or have ever taken an interferon, there is a greater chance that you will develop severe skin problems during your treatment with hydroxyurea. Ask your doctor or pharmacist if you are not sure if you are taking or have ever taken an interferon.
- tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: medications to treat human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS), especially didanosine (Videx) and stavudine (Zerit); probenecid;or sulfinpyrazone (Anturane). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor if you have human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS), if you are being treated with or have ever been treated with radiation therapy or cancer chemotherapy; if you have or have ever had kidney, or liver disease.
- tell your doctor if you are breast-feeding. You should not breastfeed during your treatment with hydroxyurea.
- your doctor may prescribe a folic acid supplement for you to take during your treatment with hydroxyurea. Take this medication exactly as directed.
- you should know that hydroxyurea may be harmful if it gets on the skin. People who are not taking hydroxyurea should avoid touching hydroxyurea capsules or the bottle that contains the capsules.Always wear disposable gloves when handling hydroxyurea capsules or bottles containing hydroxyurea capsules and wash your hands before and after you touch the bottle or capsules. If the powder from a capsule spills, wipe it up immediately with a damp disposable towel, place the towel in a closed container, such as a plastic bag and throw it away in a trash can that is out of the reach of children and pets.
Side effects
Minor side effects
Hydroxyurea may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- nausea
- vomiting
- diarrhea
- constipation
- drowsiness
Severe side effects
Some side effects can be serious. If you experience any of the following symptoms, or those listed in the IMPORTANT WARNING section, call your doctor immediately.
- rash
- purple, blue, or black discoloration of the skin or nails
- loss of feeling in one area of the body
- sores on the skin or in the mouth
- foul-smelling substance oozing from the skin.
- swelling of the hands, feet, ankles, or lower legs
Hydroxyurea may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/MedWatch/report.htm] or by phone [1-800-332-1088].
Storage conditions
Keep hydroxyurea in the container it came in, tightly closed and out of reach of children and pets. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your doctor or pharmacist about the proper disposal of your medication.
In case of emergency/overdose
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
Symptoms of overdose may include:
- violet discoloration, swelling, and soreness of the palms and soles
- scaling of the skin on the hands and feet
- darkening of the skin
- sores in the mouth
Special instructions
Do not let anyone else take your medication. Ask your pharmacist if you have any questions about refilling your prescription.
Brand names
- Droxia®
- Hydrea®
Other names
- Hydroxycarbamide