Xpreza 100

Azacitidine

Patients w/ the following myelodysplastic syndrome subtypes: refractory anaemia, refractory anaemia w/ ringed sideroblasts (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia w/ excess blasts, refractory anemia w/ excess blasts in transformation [or AML w/ 20-30% bone marrow blasts & multi-lineage dysplasia according to World Health Organisation (WHO) classification], chronic myelomonocytic leukemia. Elderly ≥65 yr ineligible for haematopoietic stem cell transplantation w/ AML w/ >30% marrow blasts according to WHO classification.

Premed w/ anti-emetics. IV/SC Administer w/in 1 hr after reconstitution. Administer IV over 10-40 min. Inj SC into upper arm, thigh or abdomen. 1st treatment cycle: Initially 75 mg/m² daily for 7 days, regardless of baseline haematology lab values. Subsequent treatment cycle: Repeat cycle every 4 wk. May increase dose to 100 mg/m² if no beneficial effect is seen after 2 cycles. Min: 4-6 cycles, may continue as long as patient continues to benefit. Dose reduction (dose in next course): ANC >1 x 10⁹/L & platelets >50 x 10⁹/L 100%, ANC 0.5-1 x 10⁹/L & platelets 25-50 x 10⁹/L 67%, ANC <0.5 x 10⁹/L & platelets <25 x 10⁹/L 50%; >75% WBC or platelet nadir decrease w/ 30-60% bone marrow biopsy cellularity 75%, 15-30% bone marrow biopsy cellularity 50%, <15% bone marrow biopsy cellularity 33%; 50-75% WBC or platelet nadir decrease w/ 30-60% bone marrow biopsy cellularity 100%, 15-30% bone marrow biopsy cellularity 50%, <15% bone marrow biopsy cellularity 33%. Cycle duration should return to 28 days following dose modifications. Unexplained reduction in serum bicarbonate levels to <20 mEq/L, unexplained elevation of BUN or serum creatinine Reduce dose to 50% on next course.

Hypersensitivity. Advanced malignant hepatic tumours. Lactation.

Discontinue treatment in patients who develop necrotising fasciitis. Reduce dose or delay subsequent cycles based on nadir counts & hematologic response after 1st cycle administration. Reduce or withhold dose if unexplained reductions in serum bicarbonate <20 mEq/L or elevations of BUN or serum creatinine occur. Closely monitor patients w/ high tumour burden prior treatment for risk of tumor lysis syndrome. Patients w/ MDS & hepatic or renal impairment. Anemia, neutropenia & thrombocytopenia; necrotising fasciitis; renal tubular acidosis. Perform CBC as needed to monitor response & toxicity at min prior each dosing cycle. Obtain liver chemistries & serum creatinine prior initiating therapy. May affect ability to drive & use machines. Patients w/ liver disease. Closely monitor for toxicity in patients w/ renal impairment. Women of childbearing potential should avoid pregnancy while receiving treatment. Men should not father a child while on treatment. Lactation. Elderly.

Pneumonia (including bacterial, viral & fungal), nasopharyngitis; febrile neutropenia, neutropenia, leukopenia, thrombocytopenia, anaemia; anorexia, decreased appetite, hypokalemia; insomnia; dizziness, headache; dyspnoea, epistaxis; diarrhoea, vomiting, constipation, nausea, abdominal pain (including upper & abdominal discomfort); petechiae, pruritus (including generalized), rash, ecchymosis; arthralgia, musculoskeletal pain (including back, bone & pain in extremity); pyrexia, fatigue, asthenia, chest pain, inj site erythema, pain & reaction (unspecified); decreased wt. Sepsis (including bacterial, viral & fungal), neutropenic sepsis, resp tract infection (including upper & bronchitis), UTI, cellulitis, diverticulitis, oral fungal infection, sinusitis, pharyngitis, rhinitis, herpes simplex, skin infection; pancytopenia, bone marrow failure; dehydration; confusional state, anxiety; intracranial haemorrhage, syncope, somnolence, lethargy; eye & conjunctival haemorrhage; pericardial effusion; hypotension, HTN, orthostatic hypotension, haematoma; pleural effusion, exertional dyspnoea, pharyngolaryngeal pain; haemorrhoidal & GI haemorrhage (including mouth haemorrhage), stomatitis, gingival bleeding, dyspepsia; purpura, alopecia, urticaria, erythema, macular rash; muscle spasms, myalgia; renal failure, haematuria, elevated serum creatinine; bruising, haematoma, induration, inflammation, discoloration, inj site nodule & haemorrhage, malaise, chills, catheter site hemorrhage.

Cytotoxic Chemotherapy

L01BC07 - azacitidine ; Belongs to the class of antimetabolites, pyrimidine analogues. Used in the treatment of cancer.

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