Azacytin

Azacytin

azacitidine

Manufacturer:

Dr Reddy's Lab

Distributor:

Dr Reddy's Lab
Concise Prescribing Info
Contents
Azacitidine
Indications/Uses
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.
Dosage/Direction for Use
IV/SC 1st treatment cycle: 75 mg/m2 daily for 7 days, followed by 21 days rest period (28-day treatment cycle). May be increased to 100 mg/m2 if no beneficial effect is seen after 2 treatment cycles, min of 4-6 treatment cycles.
Contraindications
Hypersensitivity. Advanced malignant hepatic tumours.
Special Precautions
Perform CBC as needed to monitor response & toxicity, but at least prior to each treatment cycle. Patients w/ baseline serum albumin <30 g/L may experience progressive hepatic coma & death during treatment. Reduce/delay dose administration if unexplained reductions in serum bicarbonate (<20 mmol/L) or elevations of serum creatinine or BUN occur. Closely monitor for toxicity in renal impaired patients. Determine LFTs, serum creatinine & serum bicarbonate prior to initiation of therapy & each treatment cycle. Patients w/ history of severe CHF, clinically unstable cardiac disease or pulmonary disease; perform cardiopulmonary assessment before & during treatment. Discontinue therapy in patients who develop necrotising fasciitis & promptly initiate appropriate treatment. Closely monitor patients at risk of tumour lysis syndrome. Minor or moderate influence on the ability to drive & use machines. Hepatic impairment. Use effective contraception during & up to 3 mth after treatment in women of childbearing potential & men. Pregnancy & lactation. Childn 0-17 yr. Elderly.
Adverse Reactions
Pneumonia (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 (upper & abdominal discomfort); petechiae, pruritus (generalized), rash, ecchymosis; arthralgia, musculoskeletal pain (back, bone & pain in extremity); pyrexia, fatigue, asthenia, chest pain, inj site erythema/pain/reaction; decreased wt. Sepsis (bacterial, viral & fungal), neutropenic sepsis, resp tract infection (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 haemorrhage (mouth haemorrhage), haemorrhoidal haemorrhage, stomatitis, gingival bleeding, dyspepsia; purpura, alopecia, urticaria, erythema, rash macular; muscle spasms, myalgia; renal failure, haematuria, elevated serum creatinine; bruising, haematoma, induration, rash, pruritus, inflammation, discoloration, nodule & haemorrhage (at inj site), malaise, chills, catheter site hemorrhage.
MIMS Class
Cytotoxic Chemotherapy
ATC Classification
L01BC07 - azacitidine ; Belongs to the class of antimetabolites, pyrimidine analogues. Used in the treatment of cancer.
Presentation/Packing
Form
Azacytin lyo powd for inj 100 mg
Packing/Price
1's
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