AZACITIDINE DRL POWDER

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Dr ReddyÆs Laboratories (Pty) Ltd

Dosage:

100,0 mg

Pharmaceutical form:

POWDER

Composition:

EACH VIAL CONTAINS AZACITIDINE 100,0 mg

Authorization status:

Registered

Patient Information leaflet

DR. REDDY’S LABORATORIES (PTY) LTD.
APPROVED PATIENT INFORMATION LEAFLET:
AZACITIDINE DRL (LYOPHILISED POWDER FOR INJECTION)
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_PAGE 1 OF 13 _
SCHEDULING STATUS:
S4
AZACITIDINE DRL LYOPHILISED POWDER FOR INJECTION
azacitidine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN AZACITIDINE
DRL
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
WHAT IS IN THIS LEAFLET:
1. What AZACITIDINE DRL is and what it is used for
2. What you need to know before you use AZACITIDINE DRL
3. How to use AZACITIDINE DRL
4. Possible side effects
5. How to store AZACITIDINE DRL
6. Contents of the pack and other information
1. WHAT AZACITIDINE DRL IS AND WHAT IT IS USED FOR
_ _
AZACITIDINE DRL contains a medicine called azacitidine.
AZACITIDINE DRL is an anti-cancer medicine which belongs to a group of
medicines called
‘anti-metabolites’. AZACITIDINE DRL prevents cancer cells from
growing.
DR. REDDY’S LABORATORIES (PTY) LTD.
APPROVED PATIENT INFORMATION LEAFLET:
AZACITIDINE DRL (LYOPHILISED POWDER FOR INJECTION)
_ _
_ _
_PAGE 2 OF 13 _
AZACITIDINE DRL is used in adults who suffer from:
•
myelodysplastic syndromes (MDS).
•
chronic myelomonocytic leukaemia (CMML).
These are diseases which affect the bone marrow and can cause problems
with normal blood
cell production.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN AZACITIDINE DRL
YOU SHOULD NOT BE ADMINISTERED WITH AZACITIDINE DRL IF YOU:
-
are hypersensitive (allergic) to azacitidine or any of the other
ingredients of
AZACITIDINE DRL
(see
What AZACITIDINE DRL contains).
-
have malignant liver tumours.
WARNINGS AND PRECAUTIONS
Special care should be taken with AZACITIDINE DRL:
•
if you have decreased counts of platelets, red or white blood cells.
•
if you have liver problems.
•
if you have kidney problems.
•
if you have ever had a heart condition or heart attack or any history
of lung disease.
•
AZACITIDINE DRL may cause a rare infection of the deeper layers of
skin and
subcutaneous t

Summary of Product characteristics

DR. REDDY’S LABORATORIES (PTY) LTD.
APPROVED PROFESSIONAL INFORMATION:
AZACITIDINE DRL (LYOPHILISED POWDER FOR INJECTION)
_ _
_ _
_ _
_ _
_ _
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_PAGE 1 OF 21 _
SCHEDULING STATUS
S4
1. NAME OF THE MEDICINE
AZACITIDINE DRL lyophilised powder for injection.
The reconstituted suspension contains 25 mg/ml azacitidine.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 100 mg azacitidine.
3. PHARMACEUTICAL FORM
White to off - white lyophilised powder for injection.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
AZACITIDINE DRL is indicated for the treatment of
patients with
myelodysplastic syndromes including the following subtypes of the
French-
American- British classification:
•
refractory anaemia or refractory anaemia with ringed sideroblasts (if
accompanied
by neutropenia or thrombocytopenia or requiring transfusions),
•
refractory anaemia with excess blasts,
•
refractory anaemia with excess blasts in transformation,
•
and chronic myelomonocytic leukaemia.
DR. REDDY’S LABORATORIES (PTY) LTD.
APPROVED PROFESSIONAL INFORMATION:
AZACITIDINE DRL (LYOPHILISED POWDER FOR INJECTION)
_ _
_ _
_ _
_ _
_ _
_ _
_PAGE 2 OF 21 _
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended starting dose is 75 mg/m
2
subcutaneously, daily for seven (7) days,
every four (4) weeks.
Patients should be premedicated with anti-emetics for nausea and
vomiting.
The dose may be increased to 100 mg/m
2
if no beneficial effect is seen after two (2)
treatment cycles and if no toxicity except for nausea and vomiting has
occurred. It is
recommended that patients be treated for a minimum of four (4) cycles.
However,
complete and partial response may require more than four (4) treatment
cycles. Treatment
may continue for as long as the patient continues to benefit.
Patients should be monitored for haematologic response and renal
toxicities, and dosage
delay or reduction as described below may be necessary.
_Dose adjustment based on Haematology Laboratory Values: _
•
For patients with baseline (start of trea