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 )

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.