CHEXATE methotrexate (as sodium) 2.5 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

methotrexate sodium, Quantity: 2.742 mg (Equivalent: methotrexate, Qty 2.5 mg)

Available from:

Orion Pharma (AUS) Pty Limited

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: microcrystalline cellulose; lactose monohydrate; magnesium stearate

Administration route:

Oral

Units in package:

30, 24

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Antineoplastic chemotherapy Treatment of breast cancer, gestational choriocarcinoma and in patients with chorioadenoma destruens and hydatidiform mole. Palliation of acute and subacute lymphocytic leukaemia. Greatest effect has been observed in palliation of acute lymphoblastic (stem cell) leukaemias. In combination with corticosteroids, methotrexate may be used for induction of remission. The drug is now most commonly used for the maintenance of induced remissions. CHEXATE is also effective in the treatment of the advanced stages (III and IV, Peters Staging System) of lymphosarcoma, particularly in children and in advanced cases of mycosis fungoides. Psoriasis chemotherapy (See WARNINGS box and Section 4.4) Because of the high risk attending to its use, CHEXATE is only indicated in the symptomatic control of severe, recalcitrant, disabling psoriasis which is not adequately responsive to other forms of therapy, but only when the diagnosis has been established, as by biopsy and / or after dermatologic consultations. Rheumatoid Arthritis Chemotherapy (See WARNINGS box and Section 4.4) Management of severe, recalcitrant, active rheumatoid arthritis in adults not responding to or intolerant of an adequate trial of NSAIDs and one or more disease modifying drugs. Aspirin, NSAIDs and/or low dose steroids may be continued, although the possibility of increased toxicity with concomitant use of NSAIDs including salicylate has not been fully explored (see Section 4.4, and 4.5). Steroids may be reduced gradually in patients who respond to methotrexate. Combined use of methotrexate with gold, penicillamine, hydroxychloroquine, sulfasalazine or cytotoxic agents has not been studied and may increase the incidence of adverse effects. Rest and physiotherapy as indicated should be continued.

Product summary:

Visual Identification: Yellow, round, uncoated, flat tablet, with a cosmetic score line and engraved with ORN 57 on one side, diameter 6 mm; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2022-11-14

Patient Information leaflet

CHEXATE CMI
1
CHEXATE
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
WARNING: Important safety information is provided in a boxed warning
in the full CMI. Read before using this medicine.
1.
WHY AM I TAKING CHEXATE?
CHEXATE tablets contain the active ingredient methotrexate (as
sodium). CHEXATE is used to treat certain types of cancers,
severe psoriasis (a skin condition) or severe rheumatoid arthritis
when the condition does not improve with other medicines.
For more information, see Section 1. Why am I taking CHEXATE? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I TAKE CHEXATE?
Do not use if you have ever had an allergic reaction to CHEXATE or any
of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any
other medicines, or are pregnant or plan to become
pregnant, or are breastfeeding.
For more information, see Section 2. What should I know before I take
CHEXATE?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with CHEXATE and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines?
in the full CMI.
4.
HOW DO I TAKE CHEXATE?
The dose of medicine given to you will depend on the condition being
treated, your medical condition, your age, your size and
how well your kidneys and liver are working.
More instructions can be found in Section 4. How do I take CHEXATE?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE TAKING CHEXATE?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are taking
CHEXATE.
•
You and your partner must use a reliable method of contraception (e.g.
birth control pills or condom)
while taking CHEXATE and for at least six months after you stop
treatment .
•
Discuss with your doctor how much water or fluids you should have
since insufficient fluid intake can
increase the side effects of this medici

Summary of Product characteristics

Page 1 of 28
AUSTRALIAN PRODUCT INFORMATION
CHEXATE
(METHOTREXATE (AS SODIUM) TABLETS)
WARNINGS
Methotrexate must be used only by physicians experienced in
antimetabolite chemotherapy, or in the
case of non-oncological conditions, by a specialist physician.
Because of the possibility of fatal or severe toxic reactions, the
patient should be fully informed by the
physician of the risks involved and should be under their constant
supervision.
Deaths have been reported with the use of methotrexate.
In the treatment of psoriasis and rheumatoid arthritis, methotrexate
should be restricted to severe,
recalcitrant, disabling disease which is not adequately responsive to
other forms of therapy, but only
when the diagnosis has been established by biopsy and/or after
appropriate consultation.
POTENTIAL OF FATAL TOXICITY FROM DOSING ERRORS
Both the physician and the pharmacist should emphasise to the patient
the importance of the weekly
dosing regimen: mistaken daily use may cause serious and sometimes
life-threatening or fatal toxicity
(see Section 4.2 and 4.4, 4.9). For the same reason great care should
be taken with dispensing to ensure
the correct tablet strength of CHEXATE is given to the patient.
CHEXATE is available as 2.5 mg and 10
mg tablets.
ORGAN SYSTEM TOXICITY
_Gastrointestinal _
Diarrhoea and ulcerative stomatitis are frequent toxic effects and
require interruption of therapy;
otherwise, haemorrhage enteritis and death from intestinal perforation
may occur.
Gastrointestinal toxicity has been reported with concomitant
administration of methotrexate (usually
in high doses) along with nonsteroidal anti-inflammatory agents
(NSAIDs).
_Haematological _
Methotrexate may
produce
marked
depression
of
bone
marrow, anaemia, aplastic anaemia,
leukopenia, neutropenia, thrombocytopenia and bleeding.
Unexpectedly severe (sometimes fatal) marrow suppression and aplastic
anaemia have been reported
with concomitant administration of methotrexate (usually in high
doses) along with NSAIDs.
_Hepatic _
Methotrexate may be hepatotox