Clinical Information
Gen. Code and Des.
8775 hydroxyurea ORAL CAPSULE 500 MG
GCN and Des.
38400 hydroxyurea ORAL CAPSULE 500 MG
Strength
500MG
Dose Form
CAPSULE
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family
AHFS Class
10000000 ANTINEOPLASTIC AGENTS
Active Ingredients
2635 hydroxyurea 127071
Inactive Ingredients
10138 blue dye
10141 red dye
10143 yellow dye
2432 lactose 64044515
2549 gelatin 9000708
These highlights do not include all the information needed to use HYDREA safely and effectively. See full prescribing information for HYDREA.
HYDREA (hydroxyurea) capsules, for oral use
Initial U.S. Approval: 1967
RECENT MAJOR CHANGES
Warnings and Precautions, Laboratory Test Interference (5.11) 11/2023
Drug Interactions, Laboratory Test Interference (7.2) 11/2023
INDICATIONS AND USAGE
HYDREA is an antimetabolite indicated for the treatment of:
Resistant chronic myeloid leukemia. (1)
Locally advanced squamous cell carcinomas of the head and neck, (excluding lip) in combination with concurrent chemoradiation. (1)
DOSAGE AND ADMINISTRATION
Individualize treatment based on tumor type, disease state, response to treatment, patient risk factors, and current clinical practice standards. (2.1)
Renal impairment: Reduce the dose of HYDREA by 50% in patients with creatinine clearance less than 60 mL/min. (2.3, 8.6, 12.3)
DOSAGE FORMS AND STRENGTHS
Capsules: 500 mg (3)
CONTRAINDICATIONS
In patients who have demonstrated a previous hypersensitivity to hydroxyurea or any other component of its formulation. (4)
WARNINGS AND PRECAUTIONS
Myelosuppression: Do not give if bone marrow function is markedly depressed. Monitor blood counts at baseline and throughout treatment. Interrupt treatment and reduce dose as necessary. (5.1)
Hemolytic anemia: Monitor blood counts throughout treatment. If hemolysis persists, discontinue HYDREA. (5.2)
Malignancies: Advise protection from sun exposure and monitor for secondary malignancies. (5.3)
Embryo-Fetal toxicity: Can cause fetal harm. Advise of potential risk to a fetus and use of effective contraception. (5.4, 8.1, 8.3)
Vasculitic toxicities: Discontinue HYDREA and initiate treatment if this occurs. (5.5)
Live Vaccinations: Avoid live vaccine use in a patient taking HYDREA. (5.6)
Risks with concomitant use of antiretroviral drugs: Pancreatitis, hepatotoxicity, and neuropathy have occurred. Monitor for signs and symptoms in patients with HIV infection using antiretroviral drugs; discontinue HYDREA and implement treatment. (5.7)
Radiation recall: Monitor for skin erythema in patients who previously received radiation and manage symptomatically. (5.8)
ADVERSE REACTIONS
Most common adverse reactions (≥30%) are hematological, gastrointestinal symptoms, and anorexia. (6)
To report SUSPECTED ADVERSE REACTIONS, contact CHEPLAPHARM Arzneimittel GmbH at 1-888-877-5884 or FDA at 1-800-FDA-1088 or WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
Antiretroviral drugs (7.1)
Laboratory Test Interference. (7.2)
USE IN SPECIFIC POPULATIONS
Lactation: Advise women not to breastfeed. (8.2)
Geriatric Use: Care should be taken in dose selection and may require a lower dose regimen and monitoring of renal function. (8.5)
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 12/2023
