Vidaza

Vidaza

azacitidine

Manufacturer:

Celgene

Distributor:

DCH Auriga
Concise Prescribing Info
Contents
Azacitidine
Indications/Uses
Patients w/ the following myelodysplastic syndrome subtypes: Refractory anemia or refractory anemia 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]; elderly ≥65 yr who are not eligible for haematopoietic stem cell transplantation (HSCT) w/ AML w/ >30% marrow blasts according to the WHO classification & chronic myelomonocytic leukemia.
Dosage/Direction for Use
1st treatment cycle: Initially 75 mg/m2 SC or IV daily for 7 days. Subsequent treatment cycles: Repeat cycles every 4 wk. May be increased to 100 mg/m2 if no beneficial effect is seen after 2 cycles. Min: 4-6 cycles.
Contraindications
Hypersensitivity to azacitidine or mannitol. Advanced malignant hepatic tumors.
Special Precautions
Perform complete blood counts prior to each dosing cycle. Patients w/ liver disease. Obtain liver chemistries & serum creatinine prior to initiation of therapy. Discontinue treatment if necrotising fasciitis develops. Closely monitor patients at risk of tumour lysis syndrome. Women of childbearing potential should avoid pregnancy during treatment. Men should not father a child during treatment. Hepatic & renal impairment. Pregnancy & lactation. Childn. Elderly w/ impaired renal function.
Adverse Reactions
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 (upper & abdominal discomfort); petechiae, pruritus (includes generalized), rash, ecchymosis; arthralgia, musculoskeletal pain (includes 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 (includes 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, dyspnoea exertional, pharyngolaryngeal pain; GI haemorrhage (includes 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, nodule & haemorrhage (at inj site), malaise, chills, catheter site hemorrhage. Interstitial lung disease, tumor lysis syndrome, inj site necrosis, Sweet’s syndrome (acute febrile neutrophilic dermatosis).
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
Vidaza powd for inj 100 mg
Packing/Price
(vial) 1's
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