Azadual

Azacitidine

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

Premed w/ anti-emetics. IV/SC 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 for min of 6 cycles, followed by rest period of 21 days (28-day treatment cycle). Dose modification (if recovery is not achieved w/in 14 days): ANC >1x10⁹/L & platelets >50x10⁹/L 100% of the dose, ANC ≤1x10⁹/L & platelets ≤50x10⁹/L 50% of the dose; bone marrow cellularity (recovery >21 days) 15-50% 50% of the dose, <15% 33% of the dose. Cycle duration should return to 28 days following dose modifications. Unexplained reductions in serum bicarbonate levels to <20 mmol/L & serum creatinine or BUN to ≥2-fold above baseline values & ULN Reduce dose to 50% on the next treatment cycle.

Hypersensitivity. Advanced malignant hepatic tumours. Lactation.

Discontinue treatment in patients who develop necrotising fasciitis. Reduce dose or delay administration in unexplained reductions in serum bicarbonate (<20 mmol/L) or elevations of serum creatinine or BUN. Temporarily discontinue treatment at 1st onset of signs or symptoms suggestive of differentiation syndrome (retinoic acid syndrome). Observe for signs & symptoms of bleeding. Closely monitor patients w/ renal impairment for toxicity; at risk of tumour lysis syndrome & those w/ high tumour burden prior to treatment. Anaemia, neutropenia & thrombocytopenia. Patients w/ extensive tumour burden due to metastatic disease; baseline serum albumin <30 g/L; history of severe CHF, clinically unstable cardiac disease or pulmonary disease. Perform CBC at least prior to each treatment cycle. Promptly report febrile episodes; oliguria & anuria. Determine LFTs, serum creatinine & bicarbonate prior to initiation of therapy & each treatment cycle. Consider cardiopulmonary assessment before & during treatment. May affect ability to drive & use machines. Hepatic impairment. Renal abnormalities ranging from elevated serum creatinine to renal failure, renal tubular acidosis. 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. Not to be used during pregnancy (especially during 1st trimester). Childn 0-17 yr. Monitor renal function in elderly patients.

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, 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; GI (including mouth haemorrhage) & haemorrhoidal haemorrhage, stomatitis, gingival bleeding, dyspepsia; purpura, alopecia, urticaria, erythema, macular rash; muscle spasms, myalgia; renal failure, haematuria, elevated serum creatinine; bruising, 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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