AZACITIDINE TEVA

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

AZACITIDINE

Available from:

ABIC MARKETING LTD, ISRAEL

ATC code:

L01BC07

Pharmaceutical form:

LYOPHILIZED POWDER FOR SUSPENSION FOR SC INJECTION / SOLUTION FOR INFUSION

Composition:

AZACITIDINE 100 MG/VIAL

Administration route:

S.C, I.V

Prescription type:

Required

Manufactured by:

TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL

Therapeutic area:

AZACITIDINE

Therapeutic indications:

Azacitidine Teva is indicated for treatment of patients with the following French-American- British (FAB) myelodysplastic syndrome subtypes: refractory anemia (RA) or refractory anemia with ringed sideroblasts (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts (RAEB), refractory anemia with excess blasts in transformation (RAEB-T), and chronic myelomonocytic leukemia (CMMoL).

Authorization date:

2019-05-07

Summary of Product characteristics

Azacitidine Teva OKD 04/2023
1
NAME OF THE MEDICINAL PRODUCT, DOSAGE FORM AND STRENGTH
AZACITIDINE TEVA
®
Lyophilized powder for suspension for SC injection/ solution for IV
infusion
Each vial contains 100 mg Azacitidine
After reconstitution, each ml of suspension contains 25 mg Azacitidine
2
INDICATIONS AND USAGE
MYELODYSPLASTIC SYNDROMES (MDS)
Azacitidine Teva
®
is indicated for treatment of patients with the following French-
American-British (FAB) myelodysplastic syndrome subtypes: refractory
anemia (RA) or
refractory anemia with ringed sideroblasts (if accompanied by
neutropenia or
thrombocytopenia or requiring transfusions), refractory anemia with
excess blasts (RAEB),
refractory anemia with excess blasts in transformation (RAEB-T), and
chronic
myelomonocytic leukemia (CMMoL).
3
DOSAGE AND ADMINISTRATION
3.1
IMPORTANT ADMINISTRATION INFORMATION
DO NOT SUBSTITUTE AZACITIDINE TEVA FOR ORAL AZACITIDINE. THE
INDICATIONS AND DOSING
REGIMEN FOR AZACITIDINE TEVA DIFFER FROM THAT OF ORAL AZACITIDINE [SEE
WARNINGS AND
PRECAUTIONS (5.1)]
3.2
FIRST TREATMENT CYCLE
The recommended starting dose for the first treatment cycle, for all
patients regardless of
baseline hematology laboratory values, is 75 mg/m
2
subcutaneously or intravenously, daily
for 7 days. Premedicate patients for nausea and vomiting.
Obtain complete blood counts, liver chemistries and serum creatinine
prior to the first dose.
3.3
SUBSEQUENT TREATMENT CYCLES
Repeat cycles every 4 weeks. The dose may be increased to 100 mg/m
2
if no beneficial
effect is seen after 2 treatment cycles and if no toxicity other than
nausea and vomiting has
occurred. It is recommended that patients be treated for a minimum of
4 to 6 cycles.
However, complete or partial response may require additional treatment
cycles.
Treatment may be continued as long as the patient continues to
benefit.
Monitor patients for hematologic response and renal toxicities [see
Warnings and
Precautions (5.4)], and delay or reduce dosage if necessary [see
Dosage and Administration
(3.5)].
3.4
DOS