HYDREA Capsule (2024)

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E.R. Squibb & Sons, L.L.C.

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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.

2. Dosage and Administration

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, ...

3. Dosage Forms and Strengths

Capsules: 500 mg opaque green cap and opaque pink body imprinted with HYDREA and 830.

4. Contraindications

HYDREA is contraindicated in patients who have demonstrated a previous hypersensitivity to hydroxyurea or any other component of the formulation.

5. Warnings and Precautions

5.1 Myelosuppression Hydroxyurea causes severe myelosuppression. Treatment with HYDREA should not be initiated if bone marrow function is markedly depressed. Bone marrow suppression may occur, and leukopenia ...

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 ...

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 ...

7. Drug Interactions

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 ...

8.1. Pregnancy

Risk Summary HYDREA can cause fetal harm based on findings from animal studies and the drugs mechanism of action [see Clinical Pharmacology (12.1)]. There are no data with HYDREA use in pregnant ...

8.2. Lactation

Risk Summary Hydroxyurea is excreted in human milk. Because of the potential for serious adverse reactions in a breastfed infant from hydroxyurea, including carcinogenicity, discontinue breastfeeding during ...

8.3. Females and Males of Reproductive Potential

Pregnancy Testing Verify the pregnancy status of females of reproductive potential prior to initiating HYDREA therapy. Contraception Females HYDREA can cause fetal harm when administered to a pregnant ...

8.4. Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

8.5. Geriatric Use

Elderly patients may be more sensitive to the effects of hydroxyurea and may require a lower dose regimen. Hydroxyurea is excreted by the kidney, and the risk of adverse reactions to this drug may be greater ...

8.6. Renal Impairment

The exposure to hydroxyurea is higher in patients with creatinine clearance of less than 60 mL/min or in patients with end-stage renal disease (ESRD). Reduce dosage and closely monitor the hematologic ...

8.7. Hepatic Impairment

There are no data that support specific guidance for dosage adjustment in patients with hepatic impairment. Close monitoring of hematologic parameters is advised in these patients.

10. Overdosage

Acute mucocutaneous toxicity has been reported in patients receiving hydroxyurea at dosages several times the therapeutic dose. Soreness, violet erythema, edema on palms and soles followed by scaling of ...

11. Description

HYDREA (hydroxyurea capsules, USP) is an antimetabolite available for oral use as capsules containing 500 mg hydroxyurea. Inactive ingredients include citric acid, colorants (D&C Yellow No. 10, FD&C Blue ...

12.1. Mechanism of Action

The precise mechanism by which hydroxyurea produces its antineoplastic effects cannot, at present, be described. However, the reports of various studies in tissue culture in rats and humans lend support ...

12.3. Pharmacokinetics

Absorption Following oral administration of HYDREA, hydroxyurea reaches peak plasma concentrations in 1 to 4 hours. Mean peak plasma concentrations and AUCs increase more than proportionally with increase ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Conventional long-term studies to evaluate the carcinogenic potential of hydroxyurea have not been performed. However, intraperitoneal administration of 125 to 250 mg/kg hydroxyurea (about 0.6-1.2 times ...

15. References

OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html.

16.1. How Supplied

HYDREA (hydroxyurea capsules, USP) is supplied as 500 mg capsules in HDPE bottles with a plastic safety screw cap. Each bottle contains 100 capsules. The cap is opaque green and the body is opaque pink. ...

16.2. Storage and Handling

Storage Store at 20-25°C (68-77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature]. Keep tightly closed. Handling and Disposal HYDREA is a cytotoxic drug. Follow applicable ...

17. Patient Counseling Information

There is a risk of myelosuppression. Monitoring blood counts weekly throughout the duration of therapy should be emphasized to patients taking HYDREA. Advisepatients to report signs and symptoms of infection ...