TREXJECT methotrexate (as sodium) 17.5mg/0.35mL solution for injection pre-filled syringe

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

methotrexate, Quantity: 17.5 mg

Available from:

Link Medical Products Pty Ltd T/A Link Pharmaceuticals

INN (International Name):

Methotrexate

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: sodium chloride; sodium hydroxide; water for injections

Administration route:

Subcutaneous

Units in package:

12 pre-filled syringes, 1 pre-filled syringe, 4 pre-filled syringes, 6 pre-filled syringes, 24 pre-filled syringes

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Psoriasis Therapy (see WARNING box): TREXJECT may be of value in the symptomatic control of severe, recalcitrant, disabling psoriasis in adults which is not adequately responsive to other forms of treatment. However, due to the high risk associated with its use, methotrexate should be used after the diagnosis has been definitely established, as by biopsy and/or after dermatologic consultation.,Rheumatoid Arthritis Therapy (see WARNING box): 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. Steroids may be reduced gradually in patients who respond to methotrexate. Combined use of methotrexate with gold or penicillamine, 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-brown, clear solution, free from turbidity, practically free from visible particles; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2015-08-25

Patient Information leaflet

TREXJECT®
1
TREXJECT®
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 USING TREXJECT?
TREXJECT contains the active ingredient methotrexate (as sodium).
TREXJECT is used to treat inflammatory conditions,
including severe psoriasis, and severe rheumatoid arthritis.
For more information, see Section 1. Why am I using TREXJECT? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE TREXJECT?
Do not use if you have ever had an allergic reaction to TREXJECT 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 use
TREXJECT? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with TREXJECT 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 USE TREXJECT
•
TREXJECT is given as a ONCE WEEKLY injection under the skin
(subcutaneous)
•
You may decide together with your doctor on a suitable weekday each
week to receive your injection
More instructions can be found in Section 4. How do I use TREXJECT? in
the full CMI
5.
WHAT SHOULD I KNOW WHILE USING TREXJECT?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
TREXJECT
•
Ensure you and your partner are using a reliable method of
contraception during, and at least for six
months after treatment with TREXJECT
•
Tell your doctor if you develop an infection or you notice new or
changed spots on your skin
•
Discuss with your doctor, your water and fluid intake. Dehydration can
increase the risk of side effects
•
Tell your doctor if you are schedu

Summary of Product characteristics

TREXJECT, METHOTREXATE (AS SODIUM) INJECTION
VERSION: 8.0
Page 1 of 24
AUSTRALIAN
PRODUCT
INFORMATION
–
TREXJECT (METHOTREXATE (AS SODIUM)) SOLUTION
FOR INJECTION
WARNING
Methotrexate must only be prescribed by physicians experienced in
anti-metabolic therapy and
the treatment of severe rheumatoid arthritis or psoriasis.
Patients should be fully informed of the risk of fatal or severe toxic
reactions involved with the
administration of methotrexate and should be under constant
supervision of the physician.
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 and only
when the diagnosis has
been established.
Methotrexate may produce depression of the bone marrow, anaemia,
aplastic anaemia,
leukopenia, neutropenia, thrombocytopenia and bleeding.
At high or prolonged doses, methotrexate may be hepatotoxic. Liver
atrophy, necrosis, cirrhosis,
fatty changes and periportal fibrosis have been reported. Since
changes may occur without
previous signs of gastro-intestinal or haematological toxicity, it is
imperative that hepatic function
be determined prior to initiation of treatment and monitored regularly
throughout therapy. Special
caution is indicated in the presence of liver damage or impaired
hepatic function. Concomitant
use of other drugs with hepatotoxic potential and alcohol should be
avoided.
Potentially fatal opportunistic infections, especially Pneumocystis
jirovecii pneumonia, may
occur with methotrexate therapy.
Use in pregnancy
Category D. This category specifies drugs, which have caused an
increased incidence of human
foetal malformations or irreversible damage. These drugs may also have
adverse pharmacological
effects.
Methotrexate has caused foetal death and/or congenital anomalies. It
should not be used in
pregnant women or in those who might become pregnant. Methotrexate is
contraindicated in the
treatment