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Siklos Generic Name & Formulations
Legal Class
Rx
General Description
Hydroxyurea 100mg, 1000mg; scored tabs.
Pharmacological Class
Antimetabolite.
How Supplied
Tabs 100mg—60; 1000mg—30
Manufacturer
Generic Availability
NO
Siklos Indications
Indications
To reduce the frequency of painful crises and to reduce the need for blood transfusions in patients with sickle cell anemia with recurrent moderate to severe painful crises.
Siklos Dosage and Administration
Adult
Base dose on ideal or actual weight, whichever is less. If difficulty swallowing, may disperse tab in teaspoonful of water immediately before use. >18yrs: initially 15mg/kg/day as a single dose. May increase dose by 5mg/kg/day every 8 weeks or if painful crisis occurs; give until mild myelosuppression (ANC 2000–4000/uL) is achieved, up to max 35mg/kg/day; increase dose only if blood counts are in an acceptable range; do not increase if myelosuppression occurs. Discontinue until hematologic recovery if blood counts are considered toxic; see full labeling for dosage adjustments. Renal impairment (CrCl <60mL/min or ESRD): initially 7.5mg/kg/day; give dose following dialysis (monitor).
Children
<2yrs: not established. Base dose on ideal or actual weight, whichever is less. If difficulty swallowing, may disperse tab in teaspoonful of water immediately before use. ≥2–18yrs: initially 20mg/kg/day as a single dose. May increase dose by 5mg/kg/day every 8 weeks or if painful crisis occurs; give until mild myelosuppression (ANC 2000–4000/uL) is achieved, up to max 35mg/kg/day; increase dose only if blood counts are in an acceptable range; do not increase if myelosuppression occurs. Discontinue until hematologic recovery if blood counts are considered toxic; see full labeling for dosage adjustments. Renal impairment (CrCl <60mL/min or ESRD): initially 10mg/kg/day; give dose following dialysis (monitor).
Siklos Contraindications
Not Applicable
Siklos Boxed Warnings
Boxed Warning
Myelosuppression. Malignancies.
Siklos Warnings/Precautions
Warnings/Precautions
Risk of severe myelosuppression. Monitor blood counts at baseline and every 2 weeks during therapy; interrupt or reduce dose if necessary; resume at lower dose. Markedly depressed bone marrow function: do not initiate. Monitor for secondary malignancies (eg, leukemia, skin cancer). Avoid sun exposure. Macrocytosis may mask folic acid deficiency; prophylactic folic acid is recommended. Myeloproliferative disorders; reduce dose or discontinue if cutaneous vasculitic ulcerations occur. Avoid in those with leg ulcers. Evaluate for hemolysis if acute jaundice or hematuria develops in the presence of anemia. Obtain fetal hemoglobin (HbF) levels every 3–4 months; may be used to assess efficacy. Renal or hepatic impairment: monitor closely. Embryo-fetal toxicity. Pregnancy: exclude status prior to initiation. Advise females with reproductive potential and males (w. female partners) to use effective contraception during and for ≥6 months after therapy. Nursing mothers: not recommended.
Siklos Pharmacokinetics
See Literature
Siklos Interactions
Interactions
Avoid concomitant didanosine, with or without stavudine, or other antiretrovirals (may cause pancreatitis [permanently discontinue if occurs], fatal hepatotoxicity, peripheral neuropathy). Avoid live vaccines. Increased risk of vasculitic toxicities with interferon therapy. May cause falsely elevated results in urea, uric acid, and lactic acid assays.
Siklos Adverse Reactions
Adverse Reactions
Infections, leukopenia, thrombocytopenia, anemia, neutropenia, skin and subcutaneous disorders, GI upset, headache, fever; secondary malignancies, vasculitic toxicities, macrocytosis, hemolytic anemia.
Siklos Clinical Trials
See Literature
Siklos Note
Notes
Wear disposable gloves when handling tabs or bottle.
Siklos Patient Counseling
See Literature
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