Hydroxyurea

Hydroxyurea is an FDA-registered drug product whose active ingredient is HYDROXYUREA. It is labelled by Major Pharmaceuticals taken by oral and marketed as a human prescription drug product. Identifiers on file: NDC 0904-6939, application ANDA075340, label effective 20260527. It is one of 2 FDA drug label records sharing the active ingredient HYDROXYUREA. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing HYDROXYUREA are most often described in connection with: hydroxyurea capsules, treatment resistant, chronic myeloid, leukemia locally, advanced squamous, cell carcinomas, neck excluding, lip combination. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

1 INDICATIONS AND USAGE Hydroxyurea capsules are indicated for the treatment of: • Resistant chronic myeloid leukemia. • Locally advanced squamous cell carcinomas of the head and neck (excluding the lip) in combination with chemoradiation. Hydroxyurea capsules are 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 )

2 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 hydroxyurea capsules by 50% in patients with creatinine clearance less than 60 mL/min. (2.3, 8.6, 12.3) 2.1 Dosing Information Hydroxyurea capsules are 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. Base all dosage on the patient’s actual or ideal weight, whichever is less. Hydroxyurea capsules are a cytotoxic drug. Follow applicable special handling and disposal procedures [see References (15) ] . Swallow hydroxyurea capsules whole. Do NOT open, break, or chew capsules because hydroxyurea capsules are a cytotoxic drug. Prophylactic administration of folic acid is recommended [see Warnings and Precautions (5.8) ] . Monitor blood counts at least once a week during hydroxyurea capsules therapy. Severe anemia must be corrected before initiating therapy with hydroxyurea capsules. 2.2 Dose Modifications for Toxicity Monitor for the following and reduce the dose or discontinue hydroxyurea capsules accordingly: • Myelosuppression [ see Warnings and Precautions (5.1) ]. • Cutaneous vasculitis [ see Warnings and Precautions (5.5) ] Consider dose modifications for other toxicities. 2.3 Dose Modifications for Renal Impairment Reduce the dose of hydroxyurea capsules by 50% in patients with measured creatinine clearance of less than 60 mL/min or with end-stage renal disease (ESRD) [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3) ]. Creatinine Clearance (mL/min) Recommended Hydroxyurea Capsules Initial Dose (mg/kg once daily) ≥60 15 <60 or ESRD* 7.5 *On dialysis days, administer hydroxyurea capsules to patients following hemodialysis. Close monitoring of hematologic parameters is advised in these patients.

4 CONTRAINDICATIONS Hydroxyurea capsules are contraindicated in patients who have demonstrated a previous hypersensitivity to hydroxyurea or any other component of the formulation. • In patients who have demonstrated a previous hypersensitivity to hydroxyurea or any other component of its formulation. ( 4 )

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described in detail in other labeling sections: • Myelosuppression [see Warnings and Precautions ( 5.1 )] • Hemolytic anemia [see Warnings and Precautions ( 5.2 )] • Malignancies [see Warnings and Precautions ( 5.3 )] • Vasculitic toxicities [see Warnings and Precautions ( 5.5 )] • Risks with concomitant use of antiretroviral drugs [see Warnings and Precautions ( 5.7 )] • Radiation recall [see Warnings and Precautions ( 5.8 )] • Macrocytosis [see Warnings and Precautions ( 5.9 )] • Pulmonary Toxicity [see Warnings and Precautions ( 5. 10 )] Most common adverse reactions (≥30%) are hematological, gastrointestinal symptoms, and anorexia. (6) To report SUSPECTED ADVERSE REACTIONS, contact Par Health at 1-800-828-9393 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Postmarketing Experience The following adverse reactions have been identified during post-approval use of hydroxyurea capsules. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency. • Reproductive System and Breast disorders: azoospermia, and oligospermia • Gastrointestinal disorders: stomatitis, nausea, vomiting, diarrhea, and constipation • Metabolism and Nutrition disorders: anorexia, tumor lysis syndrome • Skin and subcutaneous tissue disorders: maculopapular rash, skin ulceration, cutaneous lupus erythematosus, dermatomyositis-like skin changes, peripheral and facial erythema, hyperpigmentation, nail hyperpigmentation, atrophy of skin and nails, scaling, violet papules, and alopecia • Renal and urinary disorders: dysuria, elevations in serum uric acid, blood urea nitrogen (BUN), and creatinine levels • Nervous system disorders: headache, dizziness, drowsiness, disorientation, hallucinations, and convulsions • General Disorders: fever, chills, malaise, edema, and asthenia • Hepatobiliary disorders: elevation of hepatic enzymes, cholestasis, and hepatitis • Respiratory disorders: diffuse pulmonary infiltrates, dyspnea, and pulmonary fibrosis, interstitial lung disease, pneumonitis, alveolitis, allergic alveolitis and cough • Immune disorders: systemic lupus erythematosus • Hypersensitivity: Drug-induced fever (pyrexia) (>39°C, >102°F) requiring hospitalization has been reported concurrently with gastrointestinal, pulmonary, musculoskeletal, hepatobiliary, dermatological or cardiovascular manifestations. Onset typically occurred within 6 weeks of initiation and resolved upon discontinuation of hydroxyurea. Upon re-administration fever re-occurred typically within 24 hours. • Blood and lymphatic system disorders: hemolytic anemia Adverse reactions observed with combined hydroxyurea and irradiation therapy are similar to those reported with the use of hydroxyurea or radiation treatment alone. These effects primarily include bone marrow depression (anemia and leukopenia), gastric irritation, and mucositis. Almost all patients receiving an adequate course of combined hydroxyurea and irradiation therapy will demonstrate concurrent leukopenia. Platelet depression (<100,000 cells/mm 3 ) has occurred in the presence of marked leukopenia. Hydroxyurea capsules may potentiate some adverse reactions usually seen with irradiation alone, such as gastric distress and mucositis.

FDA lists 2 drug label records with HYDROXYUREA as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

5 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is Hydroxyurea used for?
1 INDICATIONS AND USAGE Hydroxyurea capsules are indicated for the treatment of: • Resistant chronic myeloid leukemia. • Locally advanced squamous cell carcinomas of the head and neck (excluding the lip) in combination with chemoradiation. Hydroxyurea capsules are an antimetabolite indicated for the treatment of: • Resistant chronic myeloid leukemia. ( 1) • Locally advanced squamous cell …

Who makes Hydroxyurea?
Major Pharmaceuticals is the labeler of record for Hydroxyurea. 2 FDA label records share the active ingredient HYDROXYUREA, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Hydroxyurea come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Hydroxyurea prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing HYDROXYUREA?
Yes. 2 FDA drug label records list HYDROXYUREA as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Hydroxyurea been recalled?
5 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.