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Azacitidine Betapharm is a brand name for Azacitidine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Azacitidine betapharm is indicated for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation (HSCT) with: • intermediate-2 and high-risk myelodysplastic syndromes (MDS) according to the International Prognostic Scoring System (IPSS), • chronic myelomonocytic leukaemia (CMML)…
Verbatim from this product's EMA label. Tap a section to expand.
Azacitidine betapharm treatment should be initiated and monitored under the supervision of a physician experienced in the use of chemotherapeutic agents. Patients should be premedicated with anti-emetics for nausea and vomiting. Posology The recommended starting dose for the first treatment cycle, for all patients regardless of baseline haematology laboratory values, is 75 mg/m2 of body surface area, injected subcutaneously, daily for 7 days, followed by a rest period of 21 days (28-day treatment cycle).
It is recommended that patients be treated for a minimum of 6 cycles. Treatment should be continued for as long as the patient continues to benefit or until disease progression. 4); a delay in starting the next cycle or a dose reduction as described below may be necessary.
Azacitidine betapharm should not be used interchangeably with oral azacitidine. Due to differences in the exposure, the dose and schedule recommendations for oral azacitidine are different from those for injectable azacitidine. Healthcare professionals are recommended to verify the name of the medicinal product, dose and administration route.
3 Laboratory tests Liver function tests, serum creatinine and serum bicarbonate should be determined prior to initiation of therapy and prior to each treatment cycle. Complete blood counts should be performed prior to initiation of therapy and as needed to monitor response and toxicity, but at a minimum, prior to each treatment cycle.
0 × 109/L and/or absolute neutrophil count (ANC) ≤ 1 × 109/L. e. 5 × [|baseline count – nadir count|]). e. 0 × 109/L) prior to the first treatment If haematological toxicity is observed following Azacitidine betapharm treatment, the next cycle of the therapy should be delayed until the platelet count and the ANC have recovered.
If recovery is achieved within 14 days, no dose adjustment is necessary. However, if recovery has not been achieved within 14 days, the dose should be reduced according to the following table. Following dose modifications, the cycle duration should return to 28 days.
e. 0 × 109/L) prior to the first treatment Following Azacitidine betapharm treatment, if the decrease in WBC or ANC or platelets from that prior to treatment is ≤ 50 %, or greater than 50 % but with an improvement in any cell line differentiation, the next cycle should not be delayed and no dose adjustment made.
8. Cardiac and pulmonary disease Patients with a history of severe congestive heart failure, clinically unstable cardiac disease or pulmonary disease were excluded from the pivotal registration studies (AZA PH GL 2003 CL 001 and AZA-AML-001) and therefore the safety and efficacy of azacitidine in these patients has not been established.
8). It is therefore advised to exercise caution when prescribing azacitidine to these patients. Cardiopulmonary assessment before and during the treatment should be considered. Necrotising fasciitis Necrotising fasciitis, including fatal cases, have been reported in patients treated with azacitidine.
Azacitidine therapy should be discontinued in patients who develop necrotising fasciitis and appropriate treatment should be promptly initiated. Tumour lysis syndrome The patients at risk of tumour lysis syndrome are those with high tumour burden prior to treatment.
These patients should be monitored closely and appropriate precautions taken. Differentiation syndrome Cases of differentiation syndrome (also known as retinoic acid syndrome) have been reported in patients receiving injectable azacitidine.
8). Treatment with high-dose IV corticosteroids and haemodynamic monitoring should be considered at first onset of symptoms or signs suggestive of differentiation syndrome. Temporary discontinuation of injectable azacitidine should be considered until resolution of symptoms and if resumed, caution is advised.
5 Interaction with other medicinal products and other forms of interaction Based on in vitro data, azacitidine metabolism does not appear to be mediated by cytochrome P450 isoenzymes (CYPs), UDP-glucuronosyltransferases (UGTs), sulfotransferases (SULTs), and glutathione transferases (GSTs); interactions related to these metabolizing enzymes in vivo are therefore considered unlikely.
8). Complete blood counts should be performed as needed to monitor response and toxicity, but at least prior to each treatment cycle. 2). Patients should be advised to promptly report febrile episodes. Patients and physicians are also advised to be observant for signs and symptoms of bleeding.
Hepatic impairment No formal studies have been conducted in patients with hepatic impairment. Patients with extensive tumour burden due to metastatic disease have been reported to experience progressive hepatic coma and death during azacitidine treatment, especially in such patients with baseline serum albumin < 30 g/L.
3). 5 Renal impairment Renal abnormalities ranging from elevated serum creatinine to renal failure and death were reported in patients treated with intravenous azacitidine in combination with other chemotherapeutic agents. In addition, renal tubular acidosis, defined as a fall in serum bicarbonate to < 20 mmol/L in association with an alkaline urine and hypokalaemia (serum potassium < 3 mmol/L) developed in 5 subjects with chronic myelogenous leukaemia (CML) treated with azacitidine and etoposide.
2). Patients should be advised to report oliguria and anuria to the health care provider immediately. 2). Laboratory tests Liver function tests, serum creatinine and serum bicarbonate should be determined prior to initiation of therapy and prior to each treatment cycle.
8. Cardiac and pulmonary disease Patients with a history of severe congestive heart failure, clinically unstable cardiac disease or pulmonary disease were excluded from the pivotal registration studies (AZA PH GL 2003 CL 001 and AZA-AML-001) and therefore the safety and efficacy of azacitidine in these patients has not been established.
8). It is therefore advised to exercise caution when prescribing azacitidine to these patients. Cardiopulmonary assessment before and during the treatment should be considered. Necrotising fasciitis Necrotising fasciitis, including fatal cases, have been reported in patients treated with azacitidine.
1. 4). 6).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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If the decrease in WBC or ANC or platelets is greater than 50 % from that prior to treatment, with no improvement in cell line differentiation, the next cycle of Azacitidine betapharm therapy should be delayed until the platelet count and the ANC have recovered.
If recovery is achieved within 14 days, no dose adjustment is necessary. However, if recovery has not been achieved within 14 days, bone marrow cellularity should be determined. If the bone marrow cellularity is > 50 %, no dose adjustments should be made.
5 × [baseline count – nadir count]) Following dose modifications, the next cycle duration should return to 28 days. Special populations Elderly patients No specific dose adjustments are recommended for the elderly. Because elderly patients are more likely to have decreased renal function, it may be useful to monitor renal function.
2). If unexplained reductions in serum bicarbonate levels to less than 20 mmol/L occur, the dose should be reduced by 50 % on the next cycle. 4). 4). Patients with severe hepatic organ impairment should be carefully monitored for adverse events.
No specific modification to the starting dose is recommended for patients with hepatic impairment prior to starting treatment; subsequent dose modifications should be based on haematology laboratory values. 4). Paediatric population The safety and efficacy of Azacitidine betapharm in children aged 0 to 17 years have not yet been established.
2 but no recommendation on a posology can be made. Method of administration Azacitidine betapharm is for subcutaneous use. […]
2). No interaction studies have been performed. 6 Fertility, pregnancy and lactation Women of childbearing potential/Contraception in males and females Women of childbearing potential have to use effective contraception during and for at least 6 months after treatment.
Men should be advised not to father a child while receiving treatment and must use effective contraception during and for at least 3 months after treatment. Pregnancy There are no adequate data from the use of azacitidine in pregnant women.
3). The potential risk for humans is unknown. Based on results from animal studies and its mechanism of action, azacitidine should not be used during pregnancy, especially during the first trimester, unless clearly necessary. The advantages of treatment should be weighed against the possible risk for the foetus in every individual case.
Breast-feeding It is unknown whether azacitidine/metabolites are excreted in human milk. Due to the potential serious adverse reactions in the nursing child, breast-feeding is contraindicated during azacitidine therapy. Fertility There are no human data on the effect of azacitidine on fertility.
3). Before starting treatment, male patients should be advised to seek counselling on sperm storage. 7 Effects on ability to drive and use machines Azacitidine has minor or moderate influence on the ability to drive and use machines.
Fatigue has been reported with the use of azacitidine. Therefore, caution is recommended when driving or operating machines. 8 Undesirable effects Summary of the safety profile Adult population with MDS, CMML and AML (20 % to 30 % marrow blasts) Adverse reactions considered to be possibly or probably related to the administration of azacitidine have occurred in 97% of patients.
3 %), which were also reported in the supporting studies (CALGB 9221 and CALGB 8921). g. 5 %]). 1 %; usually Grade 1 to 2). 6 %). 1 %). The most commonly reported (≥ 30 %) adverse reactions with azacitidine treatment were gastrointestinal events, […]
Azacitidine therapy should be discontinued in patients who develop necrotising fasciitis and appropriate treatment should be promptly initiated. Tumour lysis syndrome The patients at risk of tumour lysis syndrome are those with high tumour burden prior to treatment.
These patients should be monitored closely and appropriate precautions taken. Differentiation syndrome Cases of differentiation syndrome (also known as retinoic acid syndrome) have been reported in patients receiving injectable azacitidine.
8). Treatment with high-dose IV corticosteroids and haemodynamic monitoring should be considered at first onset of symptoms or signs suggestive of differentiation syndrome. Temporary discontinuation of injectable azacitidine should be considered until resolution of symptoms and if resumed, caution is advised.