Hydroxycarbamide Sandoz

Pre-TKI treatment phase for chronic myeloid leukaemia before confirmation of BCR-ABL fusion w/ immediate need for therapy due to high leukocyte & thrombocyte counts. Palliative care for chronic myeloid leukaemia patients in blastic phase w/ leucocytosis & thrombocytosis. In conjunction w/ RT for cervical cancer.

Adult Start 7 days before concurrent irradiation therapy. Continuous therapy: 20-30 mg/kg daily in single doses. Dosage should be based on patient's actual or ideal wt, whichever is less. Therapy should be monitored by repeat blood counts. Suitable for chronic myeloid leukaemia. Intermittent therapy: 80 mg/kg in single doses every 3rd day. In case of low WBC counts, ≥1 doses should be omitted. Suitable for management of cervical cancer.

Should be taken on an empty stomach: If patient prefers or is unable to swallow, contents of cap may be emptied into a glass of water & taken immediately. Should not be inhaled or allowed to come into contact w/ skin or mucous membranes.

Hypersensitivity. Marked leucopenia (<2.5 x 10⁹/L), thrombocytopenia (<100 x 10⁹/L), or severe anaemia.

Determine complete blood status, including bone marrow exam, if indicated, as well as kidney & liver function prior to & repeatedly during treatment. Risk of bone marrow suppression. Severe anaemia must be corrected w/ whole blood replacement before initiating therapy. Macrocytosis may mask the incidental development of folic acid deficiency. Patients who have previously received irradiation therapy may have an exacerbation of post-irradiation erythema when hydroxycarbamide is given. Not licensed for use in combination w/ HIV antiretroviral agents. Reports of skin cancer in patients receiving long-term therapy; protect skin from sun exposure & self-inspect during treatment & after discontinuation. Risk of cutaneous vasculitic toxicities including vasculitic ulcerations & gangrene; risk is increased in patients who received prior or concomitant interferon therapy. Possibility of increased serum uric acid resulting in gout or uric acid nephropathy; monitor uric acid levels regularly & maintain high fluid intake during treatment. Reports of ILD including pulmonary fibrosis, lung infiltration, pneumonitis, & alveolitis/allergic alveolitis. Avoid use of live vaccines during treatment & for at least 6 mth after finishing treatment. Caution in patients who have previously received RT or cytotoxic cancer chemotherapeutic agents; patients w/ marked renal dysfunction. May impair ability to drive or operate machinery. Can cause fetal harm. Should not be administered during pregnancy or lactation unless potential benefits outweigh possible hazards. Male & female patients should be counselled concerning use of contraception before & during treatment. Dosage regimens have not been established in childn. Elderly patients may require a lower dosage regimen.

Bone marrow failure, decreased CD4 lymphocytes, leukopenia, thrombocytopenia, decreased platelet count, anaemia; anorexia; pancreatitis, nausea, vomiting, diarrhoea, stomatitis, constipation, mucositis, stomach discomfort, dyspepsia, abdominal pain, melaena; cutaneous vasculitis, dermatomyositis, alopecia, rash maculo-papular, rash papular, skin exfoliation, skin atrophy, skin ulcer, erythema, skin hyperpigmentation, nail disorder; dysuria, increased blood creatinine/urea/uric acid; pyrexia, asthenia, chills, malaise; azoospermia, oligospermia. Skin cancer; hallucination, disorientation; convulsion, dizziness, peripheral neuropathy, somnolence, headache; pulmonary fibrosis, pulmonary oedema, lung infiltration, dyspnoea; hepatotoxicity, increased hepatic enzyme, cholestasis, hepatitis.

Myelosuppressive activity may be potentiated by previous or concomitant RT or cytotoxic therapy. Risk of peripheral neuropathy, & fatal & non-fatal pancreatitis in HIV patients treated w/ combination of hydroxycarbamide & didanosine, w/ or w/o stavudine. Reports of fatal hepatic events w/ didanosine & stavudine. Reports of hepatotoxicity & hepatic failure w/ other antiretroviral agents. Analytical interference w/ urease, uricase, & lactic dehydrogenase in the determination of urea, uric acid & lactic acid, rendering falsely elevated results. Increased risk of severe or fatal infections w/ concomitant use of live vaccines.

Cytotoxic Chemotherapy

L01XX05 - hydroxycarbamide ; Belongs to the class of other antineoplastic agents. Used in the treatment of cancer.

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