hye-drox-ee-yoor-EE-a

Droxia and Siklos:

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

Hydrea:

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

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

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

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.

Contraindicated in:

• Hypersensitivity to any component (some products contain tartrazine [FDC yellow dye #5])
• Severe bone marrow depression
• OB: Pregnancy (may cause fetal harm)
• 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 post-radiation erythema)
• Concurrent use of didanosine and stavudine (↑ risk of pancreatitis, hepatotoxicity, and peripheral neuropathy)
• 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 post-radiation erythema, erythema, pruritus, rash.

GU: ↓fertility (males).

Hemat: leukopenia, anemia, macrocytosis, thrombocytopenia.

Metab: hyperuricemia.

Resp: INTERSTITIAL LUNG DISEASE.

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

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.
• ↑risk of pancreatitis, hepatotoxicity, and peripheral neuropathy when used with didanosine and stavudine; avoid concurrent use.

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 — 20 mg/kg once daily; may ↑ by 5 mg/kg/day every 8 wk up to 35 mg/kg/day.

• Do not confuse Hydrea (hydroxyurea) with Lyrica (pregabalin). Do not confuse hydroxyurea with hydroxychloroquine or hydroxyzine.
• Administer folic acid prophylactically for macrocytosis.
• PO: DNC: Wear disposable gloves when handling capsules or tablets. Wash hands before and after handling capsules. Do not open capsule; exposure to powder may cause serious skin toxicities. If powder from capsule is spilled, wipe up immediately with damp disposable towel and discard in a closed container, such as a plastic bag. Do not break tablets. For patients unable to swallow, tablet may be dispersed immediately before use in a small amount of water in a teaspoon.

Droxia, Hydrea, Siklos

Therapeutic Classification: antineoplastics

Pharmacologic Classification: antimetabolites

(Generic available)

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

(effects on blood counts)

• Assess for signs of infection (fever, sore throat, cough, hoarseness, pain in lower back or side, difficult or painful urination). If these symptoms occur, notify health care professional immediately.
• Anemia may occur. Monitor for increased fatigue, dyspnea, and orthostatic hypotension.
• Assess for bleeding (bleeding gums, bruising, petechiae, guaiac stools, urine, and emesis). Avoid IM injections and taking rectal temperatures. Hold pressure on all venipuncture sites for at least 10 min.
• Monitor intake and output, appetite, and nutritional intake. Adjust diet as tolerated to maintain nutritional status.
• Monitor for signs and symptoms of cutaneous vasculitis (vasculitic ulcerations, gangrene) during therapy. If signs occur treat vasculitis and discontinue hydroxyurea.
• Monitor for signs and symptoms of pulmonary toxicity (pyrexia, cough, dyspnea, or other respiratory symptoms) frequently, investigate and treat promptly. Discontinue hydroxyurea and manage with corticosteroids.

• Verify negative pregnancy status of women with reproductive potential before starting therapy.
  • Monitor CBC and differential in patients with malignancy prior to and at least weekly during therapy. The onset of leukopenia occurs within 10 days of beginning therapy. Recovery usually occurs within 30 days. Notify health care provider if WBC <2500 mm³ or if a precipitous drop occurs. Institute thrombocytopenia precautions if platelet count <100,000/mm³. May cause temporary increase in mean corpuscular volume (MCV).
  • Monitor CBC with differential and platelets in patientswith sickle cell disease every 2 wks. Dose increase may be given until mild myelosuppression (absolute neutrophil count 2,000 cells/mm³ to 4,000 cells/mm³) is achieved, up to a maximum of 35 mg/kg/day. Hydroxyurea should be held if neutrophils <2000 cells/mm³, platelet count <80,000 cells/mm³, hemoglobin level <4.5 g/dL, or reticulocytes <80,000 cells/mm³ when hemoglobin <9 g/dL. After hematologic recovery, reduce dose by 5 mg/kg/day from dose causing toxicity, may titrate up or down 5 mg/kg/day every 8 wks after patient stable with no hematologic toxicity for 24 wks. If hematologic toxicity occurs twice, permanently discontinue hydroxyurea.
  • Monitor renal (BUN, serum creatinine, and uric acid) and liver function tests (AST, ALT, bilirubin, and LDH) prior to and periodically during therapy. May cause ↑ BUN, serum creatinine, and uric acid concentrations.
  • Monitor fetal hemoglobin (HbF) to determine efficacy. Obtain HbF levels every 3–4 months. Monitor for an increase in HbF of at least two-fold over baseline value.

• CBC results in an acceptable range for sickle cell diseaseinclude neutrophils 2500 cells/mm³, platelets 95,000 cells/mm³, hemoglobin >5.3 g/dL and reticulocytes 95,000 cells/mm³if hemoglobin concentration <9 g/dL. Levels are toxic if neutrophils <2000 cells/mm³, platelets <80,000 cells/mm³, hemoglobin <4.5 g/dL and reticulocytes <80,000 cells/mm³if the hemoglobin concentration <9 g/dL.

• 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.
  • 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. Review with patient the need for contraception during therapy. 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. Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected.
  • 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.

• Decrease in size and spread of tumors.
• Improved hematologic values in leukemia. Therapy is held if leukocytes <2500 cells/mm³ or platelets <100,000 cells/mm³ and resumed when these values begin to return to normal limits, usually within 3 days.
• Reduction in frequency of painful crisis of sickle cell anemia.

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