Andason

Azacitidine

Adults who are not eligible for haematopoietic stem cell transplantation (HSCT) w/ intermediate-2 & high-risk myelodysplastic syndromes (MDS); chronic myelomonocytic leukaemia (CMML) w/ 10-29% marrow blasts w/o myeloproliferative disorder; AML w/ 20-30% blasts & multi-lineage dysplasia; AML w/ >30% marrow blasts.

SC Inj into upper arm, thigh or abdomen. 1st treatment cycle: Initially 75 mg/m² daily for 7 days, followed by rest period of 21 days (28-day treatment cycle). Duration: Min of 6 cycles, continued as long as patient continues to benefit or until disease progression. Dose modification (dose in next cycle if recovery is not achieved w/in 14 days): ANC >1 x 10⁹/L & platelets >50 x 10⁹/L 100% of dose, ANC ≤1 x 10⁹/L & platelets ≤50 x 10⁹/L 50% of dose; bone marrow cellularity (recovery ≤21 days) <15-50% 100% of dose; (recovery >21 days) 15-50% 50% of dose, <15% 33% of dose. Cycle duration should return to 28 days following dose modifications. Renal impairment w/ unexplained serum bicarbonate level reductions to <20 mmol/L & serum creatinine or BUN elevations to ≥2-fold above baseline values & ULN Reduce dose by 50% on the next cycle.

Hypersensitivity. Advanced malignant hepatic tumours. Lactation.

Discontinue treatment in patients who develop necrotising fasciitis. Anaemia, neutropenia & thrombocytopenia. Reduce dose or delay administration if unexplained serum bicarbonate reductions (<20 mmol/L) or serum creatinine or BUN elevations occur. Patients w/ extensive tumour burden due to metastatic disease especially those w/ baseline serum albumin <30 g/L; history of severe CHF, clinically unstable cardiac disease or pulmonary disease. Determine LFTs, serum creatinine & bicarbonate prior to initiation of therapy & each treatment cycle. Perform CBC prior to initiation of therapy & at least each treatment cycle. Promptly report febrile episodes; oliguria & anuria. Observe for signs & symptoms of bleeding. Monitor patients at risk of tumour lysis syndrome; w/ renal impairment/severe hepatic organ impairment for toxicity/adverse events. Consider cardiopulmonary assessment before & during treatment. Combination treatment w/ other chemotherapeutic agents; etoposide. May affect ability to drive & use machines. Women of childbearing potential & men should use effective contraception during & up to 3 mth after treatment. Men should not father a child while receiving treatment & seek counselling on sperm storage before treatment. Not to be used during pregnancy (especially during 1st trimester). Childn 0-17 yr. Elderly (monitor renal function).

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; decreased wt. Sepsis (including bacterial, viral & fungal), neutropenic sepsis, oral fungal, skin & resp tract infection (including upper & bronchitis), UTI, cellulitis, diverticulitis, sinusitis, pharyngitis, rhinitis, herpes simplex; 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; GI (including mouth haemorrhage) & haemorrhoidal haemorrhage, stomatitis, gingival bleeding, dyspepsia; hepatic failure, progressive hepatic coma; 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.

Cytotoxic Chemotherapy

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

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