Droxia and Siklos:

• • Reduction in frequency of painful crises in sickle cell anemia and decreased need for transfusions in patients with a history of recurrent moderate to severe crises.

Hydrea:

• • Head and neck carcinoma.
  • Resistant chronic myelogenous leukemia.

Contraindicated in:

• Hypersensitivity to any component (some products contain tartrazine [FDC yellow dye #5])
• Severe bone marrow depression
• OB: Pregnancy
• Lactation: Lactation.

Use Cautiously in:

• Renal impairment (close monitoring of hematologic parameters recommended, dosage ↓ may be necessary)
• Interferon therapy (may ↑ risk of vasculitic ulcerations and gangrene)
• Active infection
• Previously received radiation or chemotherapy (↑ risk of bone marrow suppression)
• Previously received radiation (↑ risk of postradiation erythema)
• Obese patients or patients with edema (dose should be determined using ideal body weight)
• Rep: Women of reproductive potential and men with female partners of reproductive potential
• Pedi: Safety and effectiveness not established in children
• Geri: Older adults may be more sensitive to effects; lower doses may be required.

Derm: alopecia, cutaneous vasculitis, exacerbation of postradiation erythema, erythema, pruritus, rash.

GU: ↓fertility (males).

Hemat: leukopenia, anemia, hemolytic anemia, macrocytosis, thrombocytopenia.

Metab: hyperuricemia.

Resp: INTERSTITIAL LUNG DISEASE.

Misc: chills, fever, malaise, SECONDARY MALIGNANCY (INCLUDING LEUKEMIA AND SKIN CANCER).

Drug-Drug:

• Additive bone marrow depression with agents that depress bone marrow, including radiation therapy.
• May ↓ antibody response to and ↑ risk of adverse reactions to live-virus vaccines.

(Generic available)

• Capsules: 200 mg; 300 mg ; 400 mg; 500 mg;
• Film-coated tablets: 100 mg; 1000 mg;

Head and Neck Cancer or Resistant Chronic Myelogenous Leukemia

• PO (Adults): 15 mg/kg/day as a single dose.

Sickle Cell Anemia

• PO (Adults): Droxia: 15 mg/kg once daily; may ↑ by 5 mg/kg/day every 12 wk up to 35 mg/kg/day. Siklos: 15 mg/kg once daily; may ↑ by 5 mg/kg/day every 8 wk up to 35 mg/kg/day.
• PO (Children 2 yr): Siklos: 20 mg/kg once daily (based on ideal or actual body weight, whichever is less); may ↑ by 5 mg/kg/day every 8 wk (or if a painful crisis occurs) up to 35 mg/kg/day.

Droxia, Hydrea, Siklos

• Interferes with DNA synthesis (cell-cycle S-phase–specific).
• May alter characteristics of RBCs.

• Decreased frequency of painful crises and decreased need for transfusions in sickle cell anemia.
• Death of rapidly replicating cells, particularly malignant ones.

Therapeutic Classification: antineoplastics

Pharmacologic Classification: antimetabolites

Absorption: Well absorbed following oral administration.

Distribution: Crosses the blood-brain barrier; concentrates in RBCs and leukocytes.

Metabolism/Excretion: 50% excreted unchanged by the kidneys; 50% metabolized by the liver and eliminated as respiratory CO.

Half-life: 3–4 hr.

(effects on blood counts)

• Instruct patient to take medication as directed, even if nausea, vomiting, or diarrhea is a problem. Consult health care professional if vomiting occurs shortly after dose is taken. Take missed doses as soon as remembered unless just before next dose. Do not take double doses. Consult health care professional if more than one dose is missed.
  • Instruct patient to notify health care professional if fever; chills; sore throat; signs of infection; loss of appetite; nausea; vomiting; diarrhea; bleeding gums; bruising; petechiae; or blood in urine, stool, emesis, shortness of breath or cough occurs. Caution patient to avoid crowds and persons with known infections. Instruct patient to use soft toothbrush and electric razor. Patients should be cautioned not to drink alcoholic beverages or to take products containing aspirin or NSAIDs.
  • Instruct patient using continuous glucose-monitoring system for their diabetes to use a traditional glucometer to monitor their glucose levels while taking hydroxyurea.
  • Inform patient that long-term use may increase the risk of developing secondary cancer.
  • Instruct patient to inspect oral mucosa for erythema and ulceration. If ulceration occurs, advise patient to use sponge brush and rinse mouth with water after eating and drinking. Consult health care professional if mouth pain interferes with eating. Stomatitis pain may require treatment with opioid analgesics.
  • Discuss possibility of drowsiness with patients receiving large doses. Advise patient to avoid driving or other activities until response to drug is known.
  • Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
  • Advise patient to use sunscreen and protective clothing to decrease risk of skin cancer.
  • Instruct patient not to receive any vaccinations without advice of health care professional.
  • Rep: May cause fetal harm. Advise women of reproductive potential to use effective contraception during and for at least 6 mo after completion of therapy, even if amenorrhea occurs, and to avoid breastfeeding during therapy. Advise males with a female partner of reproductive potential to use effective contraception during and for at least 1 year after therapy. May cause male infertility.
  • Emphasize need for lab tests and follow-up visits to monitor progress and detect side effects.
• Leukemia: Encourage fluid intake of 2000–3000 mL/day. Allopurinol and alkalinization of urine may be used to help prevent urate stone formation.

hye-drox-ee-yoor-EE-a

NDC Code^*

• 0003- E.R. Squibb and Sons, L.L.C.
  • 0003-0830- HYDREA
    • 0003-0830-50- 100 CAPSULE in 1 BOTTLE (0003-0830-50)

• 0003- E.R. Squibb and Sons, L.L.C.
  • 0003-6335- DROXIA
    • 0003-6335-17- 60 CAPSULE in 1 BOTTLE (0003-6335-17)

• 0003- E.R. Squibb and Sons, L.L.C.
  • 0003-6336- DROXIA
    • 0003-6336-17- 60 CAPSULE in 1 BOTTLE (0003-6336-17)

• 0003- E.R. Squibb and Sons, L.L.C.
  • 0003-6337- DROXIA
    • 0003-6337-17- 60 CAPSULE in 1 BOTTLE (0003-6337-17)

• 0555- Teva Pharmaceuticals USA, Inc.
  • 0555-0882- HYDROXYUREA
    • 0555-0882-02- 100 CAPSULE in 1 BOTTLE (0555-0882-02)

• 0904- Major Pharmaceuticals
  • 0904-6939- Hydroxyurea
    • 0904-6939-61- 100 BLISTER PACK in 1 CARTON (0904-6939-61) > 1 CAPSULE in 1 BLISTER PACK

• 42291- AvKARE, Inc.
  • 42291-321- HYDROXYUREA
    • 42291-321-01- 100 CAPSULE in 1 BOTTLE (42291-321-01)

• 49884- Par Pharmaceutical, Inc.
  • 49884-724- Hydroxyurea
    • 49884-724-01- 100 CAPSULE in 1 BOTTLE (49884-724-01)

• 55154- Cardinal Health
  • 55154-7143- Hydroxyurea
    • 55154-7143-0- 10 BLISTER PACK in 1 BAG (55154-7143-0) > 1 CAPSULE in 1 BLISTER PACK

• 60429- Golden State Medical Supply, Inc.
  • 60429-265- Hydroxyurea
    • 60429-265-01- 100 CAPSULE in 1 BOTTLE (60429-265-01)

• 68084- American Health Packaging
  • 68084-284- Hydroxyurea
    • 68084-284-01- 100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-284-01) > 1 CAPSULE in 1 BLISTER PACK (68084-284-11)

• 70518- REMEDYREPACK INC.
  • 70518-0916- Hydroxyurea
    • 70518-0916-0- 30 CAPSULE in 1 BLISTER PACK (70518-0916-0)

• 71770- Medunik
  • 71770-100- Siklos
    • 71770-100-60- 1 BOTTLE in 1 CARTON (71770-100-60) > 60 TABLET, FILM COATED in 1 BOTTLE

• 71770- Medunik
  • 71770-120- Siklos
    • 71770-120-30- 1 BOTTLE in 1 CARTON (71770-120-30) > 30 TABLET, FILM COATED in 1 BOTTLE