Hydroxyurea (patient information)

Hydroxyurea (patient information)
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

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

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.

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

DROXIA is contraindicated in patients who have demonstrated a previous hypersensitivity to hydroxyurea or any other component of its formulation.

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.

DROXIA is a cytotoxic and myelosuppressive agent. DROXIA should not be given if bone marrow function is markedly depressed, as indicated by neutrophils below 2000 cells/mm3; a platelet count below 80,000/mm3; a hemoglobin level below 4.5 g/dL; or reticulocytes below 80,000/mm3 when the hemoglobin concentration is below 9 g/dL. Neutropenia is generally the first and most common manifestation of hematologic suppression. (See DOSAGE AND ADMINISTRATION.) Thrombocytopenia and anemia occur less often, and are seldom seen without a preceding leukopenia. Recovery from myelosuppression is usually rapid when therapy is interrupted. DROXIA causes macrocytosis, which may mask the incidental development of folic acid deficiency. Prophylactic administration of folic acid is recommended.

In HIV-infected patients during therapy with hydroxyurea and didanosine, with or without stavudine, fatal and nonfatal pancreatitis have occurred. Hepatotoxicity and hepatic failure resulting in death have been reported during postmarketing surveillance in HIV-infected patients treated with hydroxyurea and other antiretroviral agents. Fatal hepatic events were reported most often in patients treated with the combination of hydroxyurea, didanosine, and stavudine. This combination should be avoided.

Peripheral neuropathy, which was severe in some cases, has been reported in HIV-infected patients receiving hydroxyurea in combination with antiretroviral agents, including didanosine, with or without stavudine.

Cutaneous vasculitic toxicities, including vasculitic ulcerations and gangrene, have occurred in patients with myeloproliferative disorders during therapy with hydroxyurea. These vasculitic toxicities were reported most often in patients with a history of, or currently receiving, interferon therapy. Due to potentially severe clinical outcomes for the cutaneous vasculitic ulcers reported in patients with myeloproliferative disease, hydroxyurea should be discontinued if cutaneous vasculitic ulcerations develop.

Carcinogenesis and Mutagenesis

Hydroxyurea is genotoxic in a wide range of test systems and is thus presumed to be a human carcinogen. In patients receiving long-term hydroxyurea for myeloproliferative disorders, such as polycythemia vera and thrombocythemia, secondary leukemia has been reported. It is unknown whether this leukemogenic effect is secondary to hydroxyurea or is associated with the patient’s underlying disease. Skin cancer has also been reported in patients receiving long-term hydroxyurea.

Conventional long-term studies to evaluate the carcinogenic potential of DROXIA have not been performed. However, intraperitoneal administration of 125 to 250 mg/kg hydroxyurea (about 0.6-1.2 times the maximum recommended human oral daily dose on a mg/m2 basis) thrice weekly for 6 months to female rats increased the incidence of mammary tumors in rats surviving to 18 months compared to control. Hydroxyurea is mutagenic in vitro to bacteria, fungi, protozoa, and mammalian cells. Hydroxyurea is clastogenic in vitro (hamster cells, human lymphoblasts) and in vivo (SCE assay in rodents, mouse micronucleus assay). Hydroxyurea causes the transformation of rodent embryo cells to a tumorigenic phenotype.

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

Prospective studies on the potential for hydroxyurea to interact with other drugs have not been performed. Studies have shown that there is an analytical interference of hydroxyurea with the enzymes (urease, uricase, and lactate dehydrogenase) used in the determination of urea, uric acid and lactic acid, rendering falsely elevated results of these in patients treated with hydroxyurea.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): D DROXIA can cause fetal harm when administered to a pregnant woman. Hydroxyurea has been demonstrated to be a potent teratogen in a wide variety of animal models, including mice, hamsters, cats, miniature swine, dogs, and monkeys at doses within 1-fold of the human dose given on a mg/m2 basis. Hydroxyurea is embryotoxic and causes fetal malformations (partially ossified cranial bones, absence of eye sockets, hydrocephaly, bipartite sternebrae, missing lumbar vertebrae) at 180 mg/kg/day (about 0.8 times the maximum recommended human daily dose on a mg/m2 basis) in rats and at 30 mg/kg/day (about 0.3 times the maximum recommended human daily dose on a mg/m2 basis) in rabbits. Embryotoxicity was characterized by decreased fetal viability, reduced live litter sizes, and developmental delays. Hydroxyurea crosses the placenta. Single doses of ≥375 mg/kg (about 1.7 times the maximum recommended human daily dose on a mg/m2 basis) to rats caused growth retardation and impaired learning ability. There are no adequate and well-controlled studies in pregnant women. If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus. Women of childbearing potential should be advised to avoid becoming 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

Hydroxyurea is excreted in human milk. Because of the potential for serious adverse reactions with hydroxyurea, a decision should be made either to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

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

Acute mucocutaneous toxicity has been reported in patients receiving hydroxyurea at dosages several times the therapeutic dose. Soreness, violet erythema, edema on palms and soles followed by scaling of hands and feet, severe generalized hyperpigmentation of the skin, and stomatitis have been observed.

Pharmacology

Mechanism of Action

The precise mechanism by which hydroxyurea produces its cytotoxic and cytoreductive effects is not known. However, various studies support the hypothesis that hydroxyurea causes an immediate inhibition of DNA synthesis by acting as a ribonucleotide reductase inhibitor, without interfering with the synthesis of ribonucleic acid or of protein.

The mechanisms by which DROXIA produces its beneficial effects in patients with sickle cell anemia (SCA) are uncertain. Known pharmacologic effects of DROXIA that may contribute to its beneficial effects include increasing hemoglobin F levels in RBCs, decreasing neutrophils, increasing the water content of RBCs, increasing deformability of sickled cells, and altering the adhesion of RBCs to endothelium.

Structure

Hydroxyurea is an essentially tasteless, white crystalline powder. Its structural formula is:

Pharmacodynamics

There is limited information regarding Hydroxyurea (patient information) Pharmacodynamics in the drug label.

Pharmacokinetics

Absorption

Hydroxyurea is readily absorbed after oral administration. Peak plasma levels are reached in 1 to 4 hours after an oral dose. With increasing doses, disproportionately greater mean peak plasma concentrations and AUCs are observed. There are no data on the effect of food on the absorption of hydroxyurea.

Distribution

Hydroxyurea distributes rapidly and widely in the body with an estimated volume of distribution approximating total body water. Plasma to ascites fluid ratios range from 2:1 to 7.5:1. Hydroxyurea concentrates in leukocytes and erythrocytes.

Metabolism

Up to 60% of an oral dose undergoes conversion through metabolic pathways that are not fully characterized. One pathway is probably saturable hepatic metabolism. Another minor pathway may be degradation by urease found in intestinal bacteria. Acetohydroxamic acid was found in the serum of three leukemic patients receiving hydroxyurea and may be formed from hydroxylamine resulting from action of urease on hydroxyurea.

Excretion

Excretion of hydroxyurea in humans is likely a linear first-order renal process. In adults with SCA, mean cumulative urinary recovery of hydroxyurea was about 40% of the administered dose.

Nonclinical Toxicology

There is limited information regarding Hydroxyurea (patient information) Nonclinical Toxicology in the drug label.

Clinical Studies

The efficacy of hydroxyurea in sickle cell anemia was assessed in a large clinical study (Multicenter Study of Hydroxyurea in Sickle Cell Anemia).1

The study was a randomized, double-blind, placebo-controlled trial that evaluated 299 adult patients (≥18 years) with moderate to severe disease (≥3 painful crises yearly). The trial was stopped by the Data Safety Monitoring Committee, after accrual was completed but before the scheduled 24 months of follow-up was completed in all patients, based on observations of fewer painful crises among patients receiving hydroxyurea.

Compared to placebo treatment, treatment with hydroxyurea resulted in a significant decrease in the yearly rate of painful crises, the yearly rate of painful crises requiring hospitalization, the incidence of chest syndrome, the number of patients transfused, and units of blood transfused. Hydroxyurea treatment significantly increased the median time to both first and second painful crises.

Although patients with 3 or more painful crises during the preceding 12 months were eligible for the study, most of the benefit in crisis reduction was seen in the patients with 6 or more painful crises during the preceding 12 months.

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