HYDREA 500 mg/1
Hydroxyurea · CAPSULE · Waylis Therapeutics LLC
HYDREA is a capsule containing hydroxyurea at 500 mg/1, taken oral. Manufactured by Waylis Therapeutics LLC.
Key Facts
- Brand Name
- HYDREA
- Generic Name
- Hydroxyurea
- NDC Code (Product)
80725-810- Manufacturer
- Waylis Therapeutics LLC
- Strength
- 500 mg/1
- Dosage Form
- CAPSULE
- Route
- ORAL
- Marketing Status
- Application #
- NDA016295
- Drug Class
- Antimetabolite [EPC]
- Marketing Start
- 09/11/2025
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE HYDREA is 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. 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 & Administration
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 HYDREA by 50% in patients with creatinine clearance less than 60 mL/min. (2.3 , 8.6 , 12.3) 2.1 Dosing Information HYDREA 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. Base all dosage on the patient's actual or ideal weight, whichever is less. HYDREA is a cytotoxic drug. Follow applicable special handling and disposal procedures [see References (15) ]. Swallow HYDREA capsules whole. Do NOT open, break, or chew capsules because HYDREA is 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 HYDREA therapy. Severe anemia must be corrected before initiating therapy with HYDREA. 2.2 Dose Modifications for Toxicity Monitor for the following and reduce the dos…
Contraindications
4 CONTRAINDICATIONS HYDREA is 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)
Drug Interactions
7 DRUG INTERACTIONS 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 HYDREA 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. Peripheral Neuropathy Peripheral neuropathy, which was severe in some cases, has been reported in patients with HIV infection receiving hy…
Adverse Reactions
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 CHEPLAPHARM Arzneimittel GmbH at 1-888-877-5884 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 HYDREA. 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 Gastrointesti…
Frequently Asked Questions
What is HYDREA used for?
HYDREA contains Hydroxyurea. It is a capsule taken oral. Consult your doctor for specific uses.
Is HYDREA a controlled substance?
HYDREA is not classified as a controlled substance by the DEA.
What is the generic name for HYDREA?
The generic name for HYDREA is Hydroxyurea. There are 10 other brand versions of Hydroxyurea.
What is the NDC code for HYDREA 500 mg/1?
The NDC (National Drug Code) for HYDREA 500 mg/1 is 80725-810, listed by Waylis Therapeutics LLC.