Adult Dosing

Solid Tumors

• Intermittent Therapy:
• 80 mg/kg PO x 1 q3 days

• Continuous Therapy:
• 20-30 mg/kg/day PO x 1

• Concomitant therapy with irradiation:
• Carcinoma of the head and neck: 80 mg/kg PO x 1 q3 days

Resistant chronic myelocytic leukemia

• 20–30 mg/kg/day PO x 1

Pediatric Dosing

• Safety and effectiveness in pediatric patients have not been established

• Solid tumors
• Resistant chronic myelocytic leukemia

• Hypersensitivity to any of the ingredients of the product
• Myelosuppression
• Pregnancy
• Severe anemia

Droxia

• Administer therapy under the supervision of a physician experienced in the use of this drug for the treatment of sickle cell anemia
• As therapy is mutagenic and clastogenic and may cause cellular transformation to a tumorigenic phenotype
• Secondary leukemias have been reported in patients receiving long-term hydroxyurea for myeloproliferative disorders, such as polycythemia vera and thrombocythemia, however it is not known whether this leukemogenic effect is secondary to hydroxyurea or is linked with the patient’s underlying disease
• Consider potential benefits of therapy relative to the undefined risk of developing secondary malignancies

Renal Dose Adjustment (Based on CrCl)

• 10-50 mL/min: Decrease dose to 50%
• <10 mL/min: Decrease dose to 20%

Hepatic Dose Adjustment

• Hepatic impairment: Dose adjustments not defined

• Do not institute therapy if bone marrow function is markedly depressed as therapy is associated with marrow suppression
• Patients who have received irradiation therapy in the past may have an exacerbation of postirradiation erythema
• Hepatotoxicity and hepatic failure resulting in death have been reported with therapy. Also fatal and nonfatal pancreatitis has occurred in HIV-infected patients during therapy
• Severe peripheral neuropathy has been reported in HIV-infected patients receiving hydroxyurea in combination with antiretroviral agents
• Correct severe anemia before initiating therapy with hydroxyurea
• Elderly patients may be more sensitive to the effects of hydroxyurea, and may require a lower dose regimen
• Myeloproliferative disorders, such as polycythemia vera and thrombocythemia, secondary leukemia may occur with the long term use of hydroxyurea
• Cutaneous vasculitic toxicities, including vasculitic ulcerations and gangrene, have occurred in patients with myeloproliferative disorders during therapy with hydroxyurea. Suspend therapy and institute alternative cytoreductive agents in such conditions

Cautions: Use cautiously in

• Renal impairment
• Long-term use
• Myeloproliferative disorder
• Concurrent myelosuppressive agents
• Interferon use

Pregnancy Category:D

Breastfeeding: Most sources consider breastfeeding to be contraindicated during maternal antineoplastic drug therapy. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 10 March 2011). Due to the potential for serious adverse reactions in nursing infants, manufacturer recommends discontinuation of nursing or discontinuation of drug, taking into account the importance of the drug to the mother.

• CNS: Drowsiness, hallucinations, seizures
• NEURO: Peripheral neuropathy
• GI: Anorexia, diarrhea, nausea, vomiting, constipation, hepatitis, stomatitis, pancreatitis, hepatotoxicity, elevated liver transaminases
• RESP: Pulmonary fibrosis, pulmonary toxicity
• GU: Dysuria, infertility, renal tubular dysfunction
• DERM: Alopecia, exacerbation of post-radiation erythema, erythema, facial erythema, pruritus, rashes, dermatomyositis, vasculitic ulcer, gangrene, severe mucositis, skin/nail atrophy, skin hyperpigmentation
• HEMA: Leukopenia, anemia, thrombocytopenia, myelosuppression, secondary leukemia, erythrocyte abnormalities
• METABOLIC: Hyperuricemia
• MISC: Chills, fever, malaise

• Antimetabolite; interferes with DNA synthesis
• Well absorbed following oral administration
• Metabolized by the liver (50%)
• Excreted in urine (50% unchanged)
• Half-life: 3-4 hrs

US Trade Name(s)

• Droxia
• Hydrea

US Availability

hydroxyurea (generic)

• CAPS: 500 mg

Droxia

• CAPS: 200, 300, 400 mg

Hydrea

• CAPS: 500 mg

Canadian Trade Name(s)

• Hydrea

Canadian Availability

hydroxyurea (generic)

• CAPS: 500 mg

Hydrea

• CAPS: 500 mg

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• Hydrea

Australian Availability

Hydrea

• CAPS: 500 mg

Hematology/Oncology

Antineoplastics

Antimetabolites

Pricing data from www.DrugStore.com in U.S.A.

• Hydrea 500 MG CAPS [Bottle] (B-M SQUIBB ONCOLOGY/IMMUNOLOGY)
  100 mg = $139.08
  300 mg = $406.58
• Hydroxyurea 500 MG CAPS [Bottle] (TEVA PHARMACEUTICALS USA)
  100 mg = $90.99
  300 mg = $251.99
• Droxia 300 MG CAPS [Bottle] (B-M SQUIBB ONCOLOGY/IMMUNOLOGY)
  30 mg = $32.99
  90 mg = $95.97

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.

• Droxia 200 MG Oral Capsule (E.R. Squibb & Sons, L.L.C.)
• Droxia 300 MG Oral Capsule (E.R. Squibb & Sons, L.L.C.)
• Droxia 400 MG Oral Capsule (E.R. Squibb & Sons, L.L.C.)
• Hydrea 500 MG Oral Capsule (E.R. Squibb & Sons, L.L.C.)
• Hydroxyurea 500 MG Oral Capsule (BARR LABORATORIES, INC.)
• Hydroxyurea 500 MG Oral Capsule (Par Pharmaceutical, Inc.)