Applicant/PHRC: Hetero Drugs South Africa (Pty) Ltd  
Product proprietary name: ELODYST  
Dosage form and strength: Powder for concentrate for Solution for infusion and 50 mg/vial  
FINAL PROFESSIONAL INFORMATION FOR ELODYST  
SCHEDULING STATUS  
S4  
1 NAME OF THE MEDICINE  
ELODYST 50 mg/vial, Powder for concentrate for solution for infusion  
2 QUALITATIVE AND QUANTITATIVE COMPOSITION  
Each 20 mL vial contains 50 mg decitabine. After reconstitution with 10 mL of sterile water for injection,  
each mL of the concentrate of solution for infusion contains 5 mg of decitabine.  
ELODYST is sugar free.  
For a full list of excipients, see section 6.1.  
3 PHARMACEUTICAL FORM  
White to almost white lyophilized cake or powder. After reconstitution it is clear colourless solution.  
4 CLINICAL PARTICULARS  
4.1 Therapeutic indications  
ELODYST is indicated for the treatment of adult patients (≥ 65 years) with newly diagnosed de novo or  
secondary acute myeloid leukaemia (AML), according to the World Health Organisation (WHO)  
classification.  
4.2 Posology and method of administration  
Posology  
Dosing regimen  
A 5-Day dosing regimen in the treatment of AML is recommended. It is recommended that patients be  
treated for a minimum of 4 cycles; however, a response may take longer than 4 cycles to be obtained.  
Initial M.U  
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Product proprietary name: ELODYST  
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In the AML Phase 3 study, the median time to response (complete remission [CR] or CR with incomplete  
platelet recovery [CRp]) was 4,3 months. Treatment may be continued as long as the patient shows  
response, continues to benefit or exhibits stable disease, i.e., in the absence of overt progression.  
If after 4 cycles, the patient’s haematological values (e.g., platelet counts or absolute neutrophil count),  
have not returned to pre-treatment levels, or if disease progression occurs (peripheral blast counts are  
increasing, or bone marrow blast counts are worsening), the patient should be considered to be a non-  
responder and alternative therapeutic options to ELODYST should be considered.  
Pre-medication for the prevention of nausea and vomiting is not routinely recommended but may be  
administered if required.  
Treatment Regimen  
In a treatment cycle, ELODYST is administered at a dose of 20 mg/m2 body surface area by intravenous  
infusion over 1 hour repeated daily for 5 consecutive days (i.e., a total of 5 doses per treatment cycle).  
The total daily dose must not exceed 20 mg/m2 and the total dose per treatment cycle must not exceed 100  
mg/m2.  
The cycle should be repeated every 4 weeks depending on the patient's clinical response and observed  
toxicity.  
If a dose is missed, treatment should be resumed as soon as possible. It is possible to use this regimen in  
an outpatient setting.  
Myelosuppression and associated complications  
Myelosuppression and adverse events related to myelosuppression (thrombocytopaenia, anaemia,  
neutropaenia, and febrile neutropaenia) are common in both treated and untreated patients. Complications  
of myelosuppression include infections and bleeding. Treatment may be modified in patients experiencing  
myelosuppression and associated complications as described below:  
Treatment may be delayed at the discretion of the treating medical practitioner, if the patient experiences  
myelosuppression-associated complications, such as:  
Initial M.U  
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Product proprietary name: ELODYST  
Dosage form and strength: Powder for concentrate for Solution for infusion and 50 mg/vial  
•
•
Febrile neutropaenia (temperature ≥ 38,5 °C and absolute neutrophil count < 1 000/μL).  
Active viral, bacterial or fungal infection (i.e., requiring intravenous anti-infectives or extensive  
supportive care).  
•
Haemorrhage (gastrointestinal, genito-urinary, pulmonary with platelets < 25 000/μL or any central  
nervous system haemorrhage).  
Treatment with ELODYST may be resumed once these conditions have improved or have been stabilised  
with adequate treatment (anti-infective therapy, transfusions, or growth factors).  
Dose reduction is not recommended.  
Method of administration  
ELODYST is for single use only. ELODYST is administered by intravenous infusion. A central venous  
catheter is not required.  
4.3 Contraindications  
•
•
Known hypersensitivity to decitabine or to any of the excipients of ELODYST (see section 6.1).  
ELODYST is contraindicated in lactating women (see section 4.6).  
4.4 Special warnings and precautions for use  
Myelosuppresion  
Myelosuppression and complications of myelosuppression, including infections and bleeding are likely to  
occur with ELODYST treatment.  
Complete blood and platelet counts should be performed regularly, as clinically indicated and prior to each  
treatment cycle.  
In the presence of myelosuppression or its complications, treatment with ELODYST may be interrupted, the  
dose reduced, or supportive measures instituted as recommended (see section 4.2).  
Haematological adverse medicine reactions should be managed by routine monitoring of complete blood  
counts and supportive treatments as required. Supportive treatments include, administration of prophylactic  
Initial M.U  
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Product proprietary name: ELODYST  
Dosage form and strength: Powder for concentrate for Solution for infusion and 50 mg/vial  
antibiotics and/or growth factor support (e.g. G-CSF) for neutropaenia and transfusions for anaemia or  
thrombocytopaenia according to institutional guidelines. For situations where ELODYST administration  
should be delayed (see section 4.2).  
Cardiac disease  
Patients with a history of severe congestive heart failure or clinically unstable cardiac disease were  
excluded from clinical studies and therefore the safety and efficacy of ELODYST in these patients has not  
been established.  
Respiratory, thoracic and mediastinal disorders  
Cases of interstitial lung disease (ILD) (including pulmonary infiltrates, organising pneumonia and  
pulmonary fibrosis) without signs of infectious aetiology have been reported in patients receiving decitabine.  
Careful assessment of patients with an acute onset or unexplained worsening of pulmonary symptoms  
should be performed to exclude ILD. If ILD is confirmed, appropriate treatment should be initiated (see  
section 4.8).  
Special populations  
Hepatic impairment  
Studies in patients with hepatic impairment have not been conducted. The need for dosage adjustment in  
patients with hepatic impairment has not been evaluated. Caution should be exercised in the administration  
of ELODYST to patients with hepatic impairment or in patients who develop signs or symptoms of hepatic  
impairment. Patients should be carefully monitored. (see sections 4.8 and 5.2).  
Renal impairment  
Studies in patients with renal impairment have not been conducted; however, data from clinical trials that  
included patients with mild-moderate impairment indicated no need for dosage adjustment. Patients with  
severe renal impairment were excluded from these trials (see section 5.2).  
Initial M.U  
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Product proprietary name: ELODYST  
Dosage form and strength: Powder for concentrate for Solution for infusion and 50 mg/vial  
The use of ELODYST in patients with severe renal impairment has not been studied. Caution should be  
exercised in the administration of ELODYST to patients with severe renal impairment (creatinine clearance  
[CrCL] < 30 mL/min) and these patients should be monitored closely (see section 4.2).  
Paediatric population  
Treatment of paediatric patients with AML is not recommended because ELODYST was not shown to be  
effective in this patient population  
4.5 Interaction with other medicine and other forms of interaction  
No formal clinical medicine interaction studies with decitabine have been conducted.  
There is the potential for a medicine - medicine interaction with other medicines which are also activated by  
sequential phosphorylation (via intracellular phosphokinase activities) and/or metabolised by enzymes  
implicated in the inactivation of decitabine (e.g., cytidine deaminase). Therefore, caution should be  
exercised if these medicines are combined with ELODYST.  
Impact of co-administered medicines on ELODYST  
CYP450-mediated metabolic medicine interactions are not anticipated as decitabine metabolism is not  
mediated by this system but by oxidative deamination. Displacement of ELODYST from its plasma protein  
binding by co-administered medicines is unlikely given the negligible in vitro plasma protein binding (< 1 %)  
of ELODYST. In vitro data indicated that ELODYST is a poor P-glycoprotein (P-gp) substrate and is  
therefore not prone to interaction with P-gp inhibitors.  
Impact of ELODYST on co-administered medicines  
Given its low in vitro plasma protein binding (< 1 %), ELODYST is unlikely to displace co-administered  
medicines from their plasma protein binding. In vitro studies show that ELODYST does not inhibit nor  
induce CYP 450 enzymes up to more than 20-fold of the therapeutic maximum observed plasma  
concentration (Cmax). Thus, CYP-mediated metabolic medicine interactions are not anticipated and is  
unlikely to interact with medicines metabolised through these pathways. ELODYST has been shown to be a  
Initial M.U  
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Product proprietary name: ELODYST  
Dosage form and strength: Powder for concentrate for Solution for infusion and 50 mg/vial  
weak inhibitor of P-gp mediated transport in vitro and is therefore also not expected to affect P-gp mediated  
transport of co- administered medicines (see section 5.2).  
4.6 Fertility, pregnancy and lactation  
Women of childbearing potential/contraception in males and females  
Women of childbearing potential should be advised to use effective contraceptive measures and avoid  
becoming pregnant while being treated with ELODYST. The time period following treatment with ELODYST  
where it is safe to become pregnant is unknown.  
Use in Males: Men should be advised to not father a child while receiving ELODYST, and for 3 months  
following completion of treatment  
Pregnancy  
There are no adequate data on the use of ELODYST in pregnant women. Studies have shown that  
ELODYST is teratogenic in rats and mice.  
The potential risk for humans is unknown. Based on results from animal studies and its mechanism of  
action, ELODYST should not be used during pregnancy.  
If this medicine is used during pregnancy, or if a patient becomes pregnant while receiving ELODYST, the  
patient should be apprised of the potential hazard to the foetus.  
Breastfeeding  
It is not known whether ELODYST or its metabolites are excreted in breast milk. ELODYST is  
contraindicated during lactation; therefore, if treatment with ELODYST is required, breastfeeding must be  
discontinued (see section 4.3).  
Fertility  
Female patients of childbearing potential should be advised to seek consultation regarding oocyte  
cryopreservation prior to initiation of treatment with ELODYST. Because of the possibility of infertility as a  
consequence of ELODYST therapy, men should seek advice on conservation of sperm prior to any  
Initial M.U  
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Product proprietary name: ELODYST  
Dosage form and strength: Powder for concentrate for Solution for infusion and 50 mg/vial  
treatment.  
4.7 Effects on ability to drive and use machines  
No studies of the effects on the ability to drive and use machines with ELODYST have been performed.  
Patients should be advised that they may experience undesirable effects, such as anaemia, during  
treatment. Therefore, caution should be recommended when driving a car or operating machines.  
4.8 Undesirable effects  
a) Summary of the safety profile  
The most important and frequently occurring adverse medicine reactions are myelosuppression and those  
occurring as a consequence of myelosuppression.  
b) Tabulated list of adverse reactions  
Infections and infestations  
Frequent: Pneumonia*, urinary tract infection*, other infections (all viral, bacterial, fungal infections  
including fatal)*b, septic shock*, sepsis*, sinusitis  
Blood and lymphatic system disorders  
Frequent:  
Fibrile  
neutropaenia*,  
neutropaenia*,  
thrombocytopaeniac*,  
anaemia,  
leucopaenia,  
pancytopaenia*  
Immune system disorders  
Frequent: Hypersensitivity including anaphylactic reactiond  
Metabolism and nutrition disorders  
Frequency unknown: Hyperglycaemia  
Nervous system disorders  
Frequent: Headache  
Initial M.U  
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Product proprietary name: ELODYST  
Dosage form and strength: Powder for concentrate for Solution for infusion and 50 mg/vial  
Cardiac disorders  
Frequency unknown: Cardiomyopathy (including decreased ejection fraction)  
Respiratory, thoracis and mediastinal disorders  
Frequent: Epistaxis  
Frequency unknown: interstitial lung disease  
Gastrointestinal disorders  
Frequent: Diarrhoea, vomiting, stomatitis, nausea  
Frequency unknown: enterocolitis, including neutropaenic colitis, caecitis*  
Hepato-biliary disorders  
Frequency unknown: Abnormal hepatic function, hyperbilirubineamia  
Skin and subcutaneous tissue disorders  
Less frequent: Acute febrile neutrophilic dermatosis (Sweet’s Syndrome)  
General disorders and administration site conditions  
Frequent: Pyrexia  
a Worst National Cancer Institute Common Terminology Criteria for Adverse Events Grade  
b Excluding pneumonia, urinary tract infection, sepsis, septic shock and sinusitis  
c Including haemorrhage associated with thrombocytopaenia, including fatal cases  
d Including preferred terms hypersensitivity, drug hypersensitivity, anaphylactic reaction, anaphylactic shock  
* Included events with fatal outcome  
c) Description of selected adverse reactions  
Haematologic adverse medicine reactions  
The most commonly reported haematologic adverse medicine reactions associated with ELODYST  
treatment included febrile neutropaenia, thrombocytopaenia, neutropaenia, anaemia and leucopaenia.  
Serious infection-related adverse medicine reactions such as septic shock, sepsis, and pneumonia were  
reported in patients receiving ELODYST.  
Initial M.U  
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Product proprietary name: ELODYST  
Dosage form and strength: Powder for concentrate for Solution for infusion and 50 mg/vial  
Serious bleeding-related adverse medicine reactions such as CNS haemorrhage (1 %) and gastrointestinal  
haemorrhage (2 %), in the context of severe thrombocytopaenia, were reported in patients receiving  
ELODYST.  
Reporting of suspected adverse reactions  
Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued  
monitoring of the benefit/risk balance of the medicine. Health care providers are asked to report any  
suspected adverse reactions via the “6.04 Adverse Drug Reactions Reporting Form”, found online under  
SAHPRA’s publications: https://www.sahpra.org.za or to the Holder of certificate of registration through the  
mail: pvg.cdma@heterogroups.com  
4.9 Overdose  
There is no direct experience of human overdose and no specific antidote. However, early clinical study  
data in published literature at doses greater than 20 times higher than the current therapeutic doses,  
reported increased myelosuppression including prolonged neutropaenia and thrombocytopaenia. Toxicity is  
likely to manifest as exacerbations of adverse reactions, primarily myelosuppression (see section 4.8).  
Treatment for overdose should be supportive.  
5 PHARMACOLOGICAL PROPERTIES  
5.1 Pharmacodynamic properties  
Category and Class: A 26 Cytostatic Agents  
Pharmacotherapeutic group: Antineoplastic agents, antimetabolites, pyrimidine analogues, ATC code:  
L01BC08.  
Decitabine (5-aza-2’-deoxycytidine) is a cytosine nucleoside analogue that selectively inhibits DNA  
methyltransferases at low doses, resulting in gene promoter hypomethylation that can result in reactivation  
of tumour suppressor genes, induction of cellular differentiation or cellular senescence followed by  
programmed cell death.  
5.2 Pharmacokinetic properties  
Absorption  
Initial M.U  
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The population pharmacokinetic (PK) parameters of decitabine were pooled from 3 clinical studies [DACO-  
017 (n=11); DACO-020 (n=11) and DACO-016 (n=23)] utilising the 5-Day regimen (20 mg/m2 x 1-hour x 5  
days every 4 weeks) and 1 study, DACO-018 (n=12), utilising the 3-Day regimen (15 mg/ m2 x 3-hours  
every 8 hours x 3 days every 6 weeks) in MDS or AML patients.  
In the 5-Day regimen, decitabine PK was evaluated on the fifth day of the first treatment cycle. Total dose  
per cycle was 100 mg/ m2. In the 3-Day regimen, decitabine PK was evaluated after the first dose of each  
dosing day of the first treatment cycle. Total dose per cycle was 135 mg/m2.  
Distribution  
The pharmacokinetics of decitabine following intravenous administration as a 1-hour (5-Day regimen) or 3-  
hour (3-Day regimen) infusion was described by a linear two compartment model, characterised by rapid  
elimination of the medicine from the central compartment and by relatively slow distribution from the  
peripheral compartment.  
For a typical patient (weight 70 kg/body surface area 1,73 m2) the decitabine PK parameters are listed in  
Table 1 below:  
Table 1: Summary of Population PK Analysis for a Typical Patient (5-Day  
and 3-Day Regimen)  
5-Day Regimen  
Predicted  
Value  
3-Day Regimen  
Predicted  
Value  
Parameter  
95 % Cl  
95 % Cl  
Cmax (ng/mL)  
AUCcum  
107  
88,5 – 129  
42,3  
35,2 – 50,6  
580  
480 – 695  
1 161  
972 – 1390  
(ng.h/mL)  
T1/2 (min)  
Vdss (L)  
68,2  
116  
298  
54,2 – 79,6  
84,1 – 153  
249 - 359  
67,5  
49,6  
201  
53,6 – 78,8  
34,9 – 65,5  
168 – 241  
CL (L/h)  
AUC = area under the plasma concentration-time curve  
CL = total body clearance  
Cmax = maximum observed concentration  
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t1/2 = terminal elimination half life  
Vdss = mean volume of distribution at steady state  
Decitabine exhibits linear PK and following the intravenous infusion, steady-state concentrations are  
reached within 0,5 hour. Based on model simulation, PK parameters were independent of time (i.e., did not  
change from cycle to cycle) and no accumulation was observed with this dosing regimen. Plasma protein  
binding of decitabine is negligible (< 1 %). Decitabine Vdss in cancer patients is large indicating distribution  
of the medicine into peripheral tissues.  
There was no evidence of dependencies on age, creatinine clearance, total bilirubin, or disease.  
Biotransformation  
Intracellularly, decitabine is activated through sequential phosphorylation via phosphokinase activities to the  
corresponding triphosphate, which is then incorporated by the DNA polymerase.  
In light of in vitro metabolism data, the human mass balance study results indicated that the cytochrome  
P450 system is not involved in the metabolism of decitabine. The primary route of metabolism is likely  
through deamination by cytidine deaminase in the liver, kidney, intestinal epithelium, and blood.  
Results from the human mass-balance study showed that unchanged decitabine in plasma accounted for  
approximately 2,4 % of total radioactivity in plasma.  
The major circulating metabolites are not believed to be pharmacologically active. The presence of these  
metabolites in urine together with the high total body clearance and low urinary excretion of unchanged  
medicine in the urine (~4 % of the dose) indicate that decitabine is appreciably metabolised in vivo. In  
addition, in vitro data show that decitabine is a poor P-gp substrate.  
Elimination  
Mean plasma clearance following intravenous administration in cancer subjects was > 200 L/h with  
moderate inter-subject variability (Coefficient of Variation [CV] is approximately 50 %). Excretion of  
unchanged medicine appears to play only a minor role in the elimination of decitabine. Results from a mass  
balance study with radioactive 14C-decitabine in cancer patients showed that 90 % of the administered  
dose of decitabine (4 % unchanged medicine) is excreted in the urine.  
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Product proprietary name: ELODYST  
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Characteristics in specific groups of patients  
The effects of renal or hepatic impairment, gender or age on the pharmacokinetics of decitabine have not  
been formally studied; information on special populations was derived from pharmacokinetic data from the  
4 studies noted above.  
Elderly  
Population pharmacokinetic analysis showed that decitabine PK are not dependent on age (range studied  
40 to 87 years; median 70 years).  
Hepatic impairment  
The PK of decitabine has not been formally studied in patients with hepatic impairment.  
Results from a human mass-balance study and in vitro experiments mentioned above indicated that the  
CYP enzymes are unlikely to be involved in the metabolism of decitabine. In addition, the limited data from  
the population PK analysis indicated no significant PK parameter dependencies on total bilirubin  
concentration despite a wide range of total bilirubin levels. Thus, decitabine exposure is not likely to be  
affected in patients with impaired hepatic function.  
Renal impairment  
The PK of decitabine has not been formally studied in patients with renal insufficiency. The population PK  
analysis on the limited decitabine data indicated no significant PK parameter dependencies on normalised  
creatinine clearance, an indicator of renal function. Thus, decitabine exposure is not likely to be affected in  
patients with impaired renal function.  
6 PHARMACEUTICAL PARTICULARS  
6.1 List of excipients  
•
•
•
Acetonitrile  
Hydrochloric acid  
Nitrogen gas  
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•
•
•
Potassium dihydrogen phosphate  
Sodium hydroxide  
Water for injection  
6.2 Incompatibilities  
This medicine must not be mixed with other medicines except those mentioned in section 6.6.  
6.3 Shelf life  
Unopened vial: 24 months.  
Reconstituted and diluted solution: Within 15 minutes of reconstitution, the concentrate (in 10 mL of  
sterile water for injections) must be further diluted with cold (2 °C to 8 °C) infusion fluids. This prepared  
diluted solution for intravenous infusion can be stored at 2 °C to 8 °C for up to a maximum of 4 hours,  
followed by up to 1 hour at room temperature before administration.  
6.4 Special precautions for storage  
•
•
•
•
Store at or below 25 °C.  
For storage conditions of the reconstituted and diluted solution, see section 6.3.  
Do not freeze the reconstituted solution.  
Keep the vial in the outer carton until required for use.  
6.5 Nature and contents of container  
20 mL Type-I, round clear fiolax tubular crimp neck finish and flat bottom glass vial with 20 mm grey colored  
bromobutyl rubber stopper with equidistant spacers and two semi circles at the center embossed on the top  
and 20 mm green colour aluminium flip off seal, packed in an outer carton.  
Pack size: 1 vial  
6.6 Special precautions for disposal and other handling  
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Skin contact with the solution should be avoided and protective gloves must be worn. Standard procedures  
for dealing with anticancer agents should be adopted. ELODYST should be aseptically reconstituted with  
10 mL of sterile water for injection. Upon reconstitution, each mL contains approximately 5,0 mg of  
ELODYST at pH 6,7 to 7,3. Immediately after reconstitution, the solution should be further diluted with 0,9  
% sodium chloride injection, 5 % dextrose injection, to a final medicine concentration of 0,15 to 1,0 mg/mL.  
Any unused product or waste material should be disposed of in accordance with local requirements as  
medical waste.  
ELODYST must be administered under the supervision of a medical practitioner experienced in the use of  
chemotherapeutic agents.  
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal  
products. ELODYST should not be infused through the same intravenous access/line with other medicinal  
products.  
7 HOLDER OF CERTIFICATE OF REGISTRATION  
Hetero Drugs South Africa (Pty) Ltd  
Waterfall Corporate Campus  
Building No. 2, First floor  
74 Waterfall Drive  
Midrand  
2066  
Telephone number: 012 644 1220  
8 REGISTRATION NUMBER(S)  
56/26/0927  
9 DATE OF FIRST AUTHORISATION  
05 September 2023  
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10 DATE OF REVISION OF THE TEXT  
N/A  
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