Hydroxyurea — Discount Pricing

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What Hydroxyurea is approved for (FDA label)

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 )

Source: Read the full FDA label on DailyMed. Label effective date: May 27, 2026.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Dosage forms and strengths for Hydroxyurea (FDA label)

Capsules: 500 mg dark green opaque (cap) printed “724” in white ink/ pink opaque (body) printed “par” in black ink. • Capsules: 500 mg (3)

Source: FDA prescribing information (DailyMed). Set ID: e76fd60e-7644-48c5-9857-3608a045000b. SPL document ID: 52e7e651-0f75-47a3-8faa-164416aaae7a. Label effective date: May 27, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Adverse reactions for Hydroxyurea (FDA label)

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.

Source: FDA prescribing information (DailyMed). Set ID: e76fd60e-7644-48c5-9857-3608a045000b. SPL document ID: 52e7e651-0f75-47a3-8faa-164416aaae7a. Label effective date: May 27, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Contraindications for Hydroxyurea (FDA label)

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 )

Source: FDA prescribing information (DailyMed). Set ID: e76fd60e-7644-48c5-9857-3608a045000b. SPL document ID: 52e7e651-0f75-47a3-8faa-164416aaae7a. Label effective date: May 27, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Warnings and precautions for Hydroxyurea (FDA label)

• 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 hydroxyurea capsules. ( 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 hydroxyurea capsules and initiate treatment if this occurs. ( 5.5 ) • Live Vaccinations: Avoid live vaccine use in a patient taking hydroxyurea capsules. ( 5.6 ) • Risks with concomitant use of antiretroviral drugs: Pancreatitis, hepatotoxicity, and neuropathy have occurred.

Source: FDA prescribing information (DailyMed). Set ID: e76fd60e-7644-48c5-9857-3608a045000b. SPL document ID: 52e7e651-0f75-47a3-8faa-164416aaae7a. Label effective date: May 27, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Drug interactions for Hydroxyurea (FDA label)

• Antiretroviral drugs (7.1) • Laboratory Test Interference. ( 7.2 ) 7.1 Increased Toxicity with Concomitant Use of Antiretroviral Drugs Pancreatitis In patients with HIV infection during therapy with hydroxyurea and didanosine, with or without stavudine, fatal and nonfatal pancreatitis have occurred. Hydroxyurea is not indicated for the treatment of HIV infection; however, if patients with HIV infection are treated with hydroxyurea, and in particular, in combination with didanosine and/or stavudine, close monitoring for signs and symptoms of pancreatitis is recommended. Permanently discontinue therapy with hydroxyurea in patients who develop signs and symptoms of pancreatitis. Hepatotoxicity Hepatotoxicity and hepatic failure resulting in death have been reported during postmarketing surveillance in patients with HIV infection treated with hydroxyurea and other antiretroviral drugs. Fatal hepatic events were reported most often in patients treated with the combination of hydroxyurea, didanosine, and stavudine. Avoid this combination.

Source: FDA prescribing information (DailyMed). Set ID: e76fd60e-7644-48c5-9857-3608a045000b. SPL document ID: 52e7e651-0f75-47a3-8faa-164416aaae7a. Label effective date: May 27, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.