Alkeran

Summary of Product characteristics

                                ALKERAN
Melphalan Tablets 2mg_Datasheet_New Zealand
1
DATA SHEET
1.
PRODUCT NAME (STRENGTH PHARMACEUTICAL FORM)
ALKERAN
(Melphalan Tablets 2mg)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2mg melphalan
3.
PHARMACEUTICAL FORM
Film-coated tablets
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ALKERAN tablets are indicated in the treatment of:
Multiple myeloma;
Advanced ovarian adenocarcinoma;
ALKERAN tablets may be used in the treatment of:
Breast carcinoma: ALKERAN either alone or in combination with other
medicines has
a significant therapeutic effect in a proportion of patients suffering
from advanced
breast carcinoma;
Polycythaemia rubra vera: ALKERAN is effective in the treatment of a
proportion of
patients suffering from polycythaemia vera.
4.2 DOSE AND METHOD OF ADMINISTRATION
GENERAL:
ALKERAN is a cytotoxic medicine which falls into the general class of
alkylating
agents. It should be prescribed only by physicians experienced in the
management of
malignant disease with such agents.
Since ALKERAN is myelosuppressive, frequent blood counts are essential
during
therapy and the dosage should be delayed or adjusted if necessary (see
Special
Warnings and Special Precautions for Use).
Thromboembolic events
Melphalan in combination with lenalidomide and prednisone or in
combination with
thalidomide and prednisone or dexamethasone is associated with an
increased risk of
venous thromboembolism. Thromboprophylaxis should be administered for
at least the
first 5 months of treatment especially in patients with additional
thrombotic risk factors.
The decision to take antithrombotic prophylactic measures should be
made after
careful assessment of an individual patient's underlying risk factors
(see sections
ALKERAN
Melphalan Tablets 2mg_Datasheet_New Zealand
2
Special Warnings And Precautions For Use and Undesirable Effects 4.4
and section
4.8)
The absorption of ALKERAN after oral administration is variable.
Dosage may need to
be cautiously increased until myelosuppression is seen, in order to
en
                                
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