Hydroxyurea

What is Hydroxyurea?

Hydroxyurea (Hydrea) is an antimetabolite used to treat:

• Chronic myelogenous leukemia
• Squamous cell carcinoma of the head and neck

• The use of hydroxyurea to treat cancer is approved for the Hydrea brand.
• Hydroxyurea is also approved to treat sickle cell anemia. This use is approved for the Droxia brand.

Hydroxyurea2DACS

Hydroxyurea-3D-balls

Hydroxyurea

What are the uses of this medicine?

Hydroxyurea (Hydrea) is used to treat:

• Chronic myelogenous leukemia that is refractory (does not respond to treatment).
• Squamous cell carcinoma of the head and neck (excluding the lip) that is locally advanced. It is used with chemoradiation.

How does this medicine work?

• Hydroxyurea (hye drox” ee ure ee’ a) is a hydroxylated analogue of urea and an antimetabolite which inhibits the enzyme ribonucleotide reductase, which is necessary for DNA synthesis and cell cycle replication.
• Blocking the enzyme results in cell cycle arrest in the S phase, but does not interfere with RNA or protein synthesis.
• Hydroxyurea is used in the treatment of solid tumors and myeloproliferative diseases, the latter because of its effects in reducing excessive production of red blood cells (polycythemia vera), white blood cells (chronic myelogenous leukemia) or platelets (essential thrombocythemia).

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• have demonstrated a previous hypersensitivity to hydroxyurea or any other component of the formulation.

What drug interactions can this medicine cause?

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:

• certain medications for HIV (human immunodeficiency virus) such as didanosine (Videx) and stavudine (Zerit) and interferon (Actimmune, Avonex, Betaseron, Infergen, Intron A, others).

• Hydroxyurea interfere with Uric Acid, Urea, or Lactic Acid Assays. Falsely elevated results of these in patients treated with hydroxyurea.

Is this medicine FDA approved?

• Hydroxyurea was first approved for use in the United States in 1967 as an antineoplastic agent for therapy of melanoma, chronic myelogenous leukemia, ovarian carcinoma, and head and neck cancers.
• The indications were expanded to sickle cell disease in 1998, which is the major indication for its use at present.

How should this medicine be used?

Recommended dosage:

• Hydroxyurea is used alone or in conjunction with other antitumor agents or radiation therapy to treat neoplastic diseases.
• Individualize treatment based on tumor type, disease state, response to treatment, patient risk factors, and current clinical practice standards.

Renal impairment:

• Reduce the dose of hydroxyurea by 50% in patients with creatinine clearance less than 60 mL/min.

• Prophylactic administration of folic acid is recommended.
• Monitor blood counts at least once a week during Hydroxyurea capsules therapy.
• Severe anemia must be corrected before initiating therapy with Hydroxyurea capsules.

Administration:

• Swallow hydroxyurea capsules whole.
• Do NOT open, break, or chew capsules because hydroxyurea is a cytotoxic drug.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Capsules: 500 mg

This medicine is available in fallowing brand namesː

• Hydrea; Droxia; Siklos

What side effects can this medication cause?

The most common side effects of this medicine include: Common side effects include bone marrow suppression (particularly thrombocytopenia), nausea, vomiting, anorexia, diarrhea, mucositis, hair loss, headache, rash and fever.

Uncommon, but potentially severe adverse reactions include severe skin ulcers, neuropathy, renal dysfunction, severe bone marrow

• suppression and pulmonary fibrosis.
• Long term hydroxyurea therapy may increase the risk of cancer.

What special precautions should I follow?

• Hydroxyurea causes severe myelosuppression. Do not give if bone marrow function is markedly depressed. Monitor hematology labs and interrupt, reduce dose as appropriate.
• Hydroxyurea is a human carcinogen. In patients receiving long-term hydroxyurea for myeloproliferative disorders, secondary leukemia has been reported. Advise protection from sun exposure and monitor for secondary malignancies.
• Hydroxyurea Can cause fetal harm. Advise of potential risk to a fetus and use of effective contraception.
• Cutaneous vasculitic toxicities, including vasculitic ulcerations and gangrene, have occurred in patients with myeloproliferative disorders during therapy with hydroxyurea. Discontinue hydroxyurea and initiate treatment if this occurs.
• Avoid live vaccine use in a patient taking hydroxyurea capsules.
• Pancreatitis, hepatotoxicity, and peripheral neuropathy have occurred when hydroxyurea was administered concomitantly with antiretroviral drugs, including didanosine and stavudine. Monitor for signs and symptoms in patients with HIV infection using antiretroviral drugs; discontinue hydroxyurea capsules, and implement treatment.
• Monitor for skin erythema in patients who previously received radiation and manage symptomatically.
• Hydroxyurea capsules may cause macrocytosis. This may mask the diagnosis of pernicious anemia. Prophylactic administration of folic acid is recommended.
• Monitor patients developing pyrexia, cough, dyspnea, or other respiratory symptoms frequently, investigate and treat promptly. Discontinue Hydroxyurea capsules and manage with corticosteroids.
• Interference with Uric Acid, Urea, or Lactic Acid Assays is possible, rendering falsely elevated results of these in patients treated with hydroxyurea.
• Hydroxyurea is associated with a low rate of transient serum enzyme and bilirubin elevations during therapy, and has been implicated in rare cases of clinically apparent acute liver injury with jaundice.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• Acute mucocutaneous toxicity
• Soreness
• violet erythema
• edema on palms and soles followed by scaling of hands and feet
• severe generalized hyperpigmentation of the skin
• stomatitis

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Hydroxyurea capsules can cause fetal harm based on findings from animal studies and the drug’s mechanism of action.
• There are no data with hydroxyurea capsules use in pregnant women to inform a drug-associated risk.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• HYDROXYUREA

Inactive ingredients:

• SILICON DIOXIDE
• MAGNESIUM STEARATE
• D&C YELLOW NO. 10
• FD&C BLUE NO. 1
• FD&C RED NO. 40
• GELATIN, UNSPECIFIED
• TITANIUM DIOXIDE
• FD&C BLUE NO. 2
• SHELLAC
• PROPYLENE GLYCOL
• AMMONIA
• FERROSOFERRIC OXIDE

Who manufactures and distributes this medicine?

Distributed by:

• American Health Packaging
• Columbus, OH

What should I know about storage and disposal of this medication?

• Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F).
• Hydroxyurea capsules is a cytotoxic drug.
• Follow applicable special handling and disposal procedures.

Alphabetic list of antineoplastic agents - 0-9 - A1 - A2 - A3 - A4 - A5 -A6 - B - C - D - E - F - G - H - I - JK - L - M - NO - PQ - R - S - T - UVW - XYZ

 

• Dailymed label info on Hydroxyurea
• FDA Hydroxyurea

Hydroxyurea Resources
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