Drug Action
Azacitidine is a pyrimidine analogue.
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Drug reference
Azacitidine is a pyrimidine analogue.
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Treatment of intermediate-2 and high-risk myelodysplastic syndromes, chronic myelomonocytic leukaemia, and acute myeloid leukaemia, in adults who are not eligible for haemotopoietic stem cell transplantation ▶BY SUBCUTANEOUS INJECTION ▶Adult: (consult local protocol)
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Advanced malignant hepatic tumour
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History of severe congestive heart failure. unstable cardiac disease (consider cardiopulmonary assessment before and during treatment). unstable pulmonary disease (consider cardiopulmonary assessment before and during treatment)
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NICE decisions ▶Azactidine for treating acute myeloid leukaemia with more than 30% bone marrow blasts (July 2016) NICE TA399 Azacitidine (Vidaza ®) is not recommended, within its marketing authorisation, for treating acute myeloid leukaemia with greater than 30% bone marrow blasts in patients aged 65 years or above who are not eligible for haematopoietic stem cell transplant. Patients whose treatment was started before this guidance was published should continue treatment until they and their NHS clinician consider it appropriate to stop. www.nice.org.uk/guidance/ta399 ▶Azacitidine for the treatment of myelodysplastic syndromes, chronic myelomonocytic leukaemia and acute myeloid leukaemia (March 2011) NICE TA218 Azacitidine (Vidaza ®) is recommended in adults who are not eligible for haematopoietic stem cell transplantation and have: . intermediate-2 and high-risk myelodysplastic syndromes according to the International Prognostic Scoring System, or . chronic myelomonocytic leukaemia with 10–29% marrow blasts without myeloproliferative disorder, or . acute myeloid leukaemia with 20–30% blasts and multilineage dysplasia, according to the World Health Organization classification, and . if the manufacturer provides azacitidine with the discount agreed as part of the patient access scheme. www.nice.org.uk/guidance/ta218
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→Appendix 1: azacitidine
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▶Common or very common Alopecia. anaemia. anxiety. appetite decreased. arthralgia. asthenia. bone marrow disorders. chest pain. chills. confusion. constipation. dehydration. diarrhoea. dizziness. drowsiness. dyspnoea . fever. gastrointestinal discomfort. haemorrhage. headache. hypertension. hypokalaemia. hypotension. increased risk of infection. induration. inflammation. insomnia. intracranial haemorrhage. laryngeal pain. leucopenia. malaise. muscle complaints. nausea. neutropenia. pain. renal failure. respiratory disorders. sepsis. skin reactions. stomatitis. syncope. thrombocytopenia. vomiting. weight decreased ▶Uncommon Hepatic coma. hepatic failure. pyoderma gangrenosum. renal tubular acidosis ▶Rare or very rare Injection site necrosis. tumour lysis Immune system and malignant disease syndrome
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Manufacturer advises effective contraception during and for 3 months after treatment in men or women.
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Avoid (toxicity in animal studies). See also Pregnancy and reproductive function in Cytotoxic drugs p. 938.
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Discontinue breast-feeding.
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Manufacturer advises caution in severe impairment (no information available)—monitor for adverse drug reactions. Dose adjustments Manufacturer advises consider dose reduction—consult local protocol.
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Dose adjustments Delay next treatment cycle if serum- creatinine or blood urea nitrogen greater than twice baseline value and above the upper level of normal until values return to normal or baseline, and then reduce dose by 50% on the next treatment cycle. Reduce dose by 50% on the next treatment cycle if serum-bicarbonate concentration less than 20 mmol/litre.
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▶Monitor liver function tests, serum creatinine, and serum bicarbonate before initiation of treatment and before each treatment cycle. ▶Monitor full blood count before initiation of treatment, before each treatment cycle, and as clinically indicated. ▶Monitor for bleeding.
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There can be variation in the licensing of different medicines containing the same drug. Powder for suspension for injection ▶Azacitidine (Non-proprietary) Azacitidine 100 mg Azacitidine 100mg powder for suspension for injection vials | 1 vial P £321.00 (Hospital only) ▶Vidaza (Celgene Ltd) Azacitidine 100 mg Vidaza 100mg powder for suspension for injection vials | 1 vial P £321.00 Immune system and malignant disease
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(consult local protocol)
First-line fragment. Read the complete Indications and Dose section above.
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