Xpreza

Xpreza

azacitidine

Manufacturer:

Natco Pharma

Distributor:

Natco Lifesciences
Concise Prescribing Info
Contents
Azacitidine
Indications/Uses
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 or w/ >30% marrow blasts.
Dosage/Direction for Use
1st treatment cycle: Initially 75 mg/m2 SC inj daily for 7 days, followed by 21-day rest period (28-day treatment cycle) for min: 6 cycles.
Contraindications
Hypersensitivity. Advanced malignant hepatic tumours. Lactation.
Special Precautions
Discontinue use if necrotising fasciitis develops. Anaemia, neutropenia & thrombocytopenia particularly during the 1st 2 cycles. Perform CBCs & determine LFTs, serum creatinine & bicarbonate prior to initiation of therapy & prior to each cycle. Patients w/ history of severe CHF, clinically unstable cardiac disease or pulmonary disease. Closely monitor patients at risk of tumour lysis syndrome. May affect ability to drive & use machines. Hepatic & renal impairment. Women of childbearing potential & men should use effective contraception during & up to 3 mth after treatment. Not to be used during pregnancy (especially 1st trimester). Childn 0-17 yr.
Adverse Reactions
Pneumonia, nasopharyngitis; febrile neutropenia, neutropenia, leukopenia, thrombocytopenia, anemia; anorexia, decreased appetite, hypokalemia; insomnia; dizziness, headache; dyspnoea, epistaxis; diarrhoea, vomiting, constipation, abdominal pain; petechiae, pruritus, rash, ecchymosis; arthralgia, musculoskeletal pain; pyrexia, fatigue, asthenia, chest pain, inj site erythema, pain & reaction; decreased wt. Sepsis, neutropenic sepsis, resp tract, oral fungal & skin infection, 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; HTN, hypotension, orthostatic hypotension, haematoma; pleural effusion, exertional dyspnoea, pharyngolaryngeal pain; GI & haemorrhoidal haemorrhage, stomatitis, gingival bleeding, dyspepsia; purpura, alopecia, urticaria, erythema, rash macular; myalgia; renal failure. haematuria, elevated serum creatinine; bruising, haematoma, induration, rash, pruritus, inflammation, discoloration, inj site nodule & haemorrhage, 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
Xpreza lyo powd for inj 100 mg
Packing/Price
1's
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