Hydroxyurea Capsule

Hydroxyurea capsules, USP 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. Hydroxyurea capsules, USP 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)

• Individualize treatment based on tumor type, disease state, response to treatment, patient risk factors, and current clinical practice standards
• Renal impairment: Reduce the dose of hydroxyurea by 50% in patients with creatinine clearance less than 60 mL/min
• Dosing Information Hydroxyurea 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
• Hydroxyurea is a cytotoxic drug
• Follow applicable special handling and disposal procedures [ see References ]
• Swallow hydroxyurea capsule whole
• Do NOT open, break, or chew capsules because hydroxyurea is a cytotoxic drug
• Prophylactic administration of folic acid is recommended [ see Warnings and Precautions ]
• Monitor blood counts at least once a week during hydroxyurea therapy
• Severe anemia must be corrected before initiating therapy with hydroxyurea. …

Capsules: 500 mg, green opaque cap imprinted in black with “LP 164” and light pink opaque body imprinted in black with “LP 164” • Capsules: 500 mg

• There is a risk of myelosuppression
• Monitoring blood counts weekly throughout the duration of therapy should be emphasized to patients taking hydroxyurea capsules
• Advise patients to report signs and symptoms of infection or bleeding immediately. [see Warnings and Precautions ]
• Advise patients of the risk of hemolytic anemia
• Advise patients that they will have blood tests to evaluate for this if they develop persistent anemia [see Warnings and Precautions ]
• Advise patients that there is a risk of cutaneous vasculitic toxicities and secondary malignancies including leukemia and skin cancers [see Warnings and Precautions ]. …

Hydroxyurea capsules 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)

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. …

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. (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 and initiate treatment if this occurs. …

• 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. …

IN SPECIFIC POPULATIONS Lactation: Advise women not to breastfeed. (8.2) Geriatric Use: Care should be taken in dose selection and may require a lower dose regimen and monitoring of renal function. (8.5) 8.1 Pregnancy Risk Summary Hydroxyurea capsules can cause fetal harm based on findings from animal studies and the drug’s mechanism of action [see Clinical Pharmacology (12.1) ]. …

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 hands and feet, severe generalized hyperpigmentation of the skin, and stomatitis have also been observed.

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.