TM Owner Teva Pharmaceuticals
Trexall 15mg Tablet
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Indications & Clinical Uses
- Trexall 15 mg (methotrexate tablets) is an antifolate/antimetabolite that, at this tablet strength, is used mainly at low, once-weekly doses for severe, active rheumatoid arthritis in adults who have not responded adequately to first-line therapy, for polyarticular-course juvenile idiopathic arthritis in children, and for severe, disabling psoriasis not controlled by other treatments.
- At much higher, physician-calculated doses given on defined cycles, methotrexate also treats certain cancers, including acute lymphoblastic leukaemia maintenance therapy, mycosis fungoides and relapsed or refractory non-Hodgkin lymphoma.
- Trexall tablets are manufactured as unscored, film-coated tablets specifically to reduce the risk of accidental splitting and dosing errors seen with older scored methotrexate tablets.
- It is essential to know which of these very different dosing schedules applies: rheumatoid arthritis, juvenile arthritis and psoriasis doses are taken once a week on the same day, never once a day, whereas cancer regimens follow a doctor's specific schedule.
Side Effects
- Trexall carries a boxed warning: it can cause serious, potentially fatal toxicity, including bone marrow suppression, liver damage (including cirrhosis and fibrosis), lung disease, and severe skin reactions, and deaths have occurred when methotrexate tablets meant to be taken once weekly were mistakenly taken once daily.
- Common effects include mouth ulcers (stomatitis), low white blood cell counts, nausea, stomach upset, and, especially in rheumatoid arthritis, raised liver enzymes in around 15 percent of people and nausea or vomiting in about 1 in 10.
- Report unusual bruising or bleeding, sore throat or fever (signs of low blood counts), yellowing of the skin or eyes, persistent cough or breathlessness, mouth sores that will not heal, or severe skin rash urgently, as these can signal serious toxicity.
- Trexall also carries a boxed warning for fetal death and birth defects if used in pregnancy.
Precautions & Warnings
- Confirm the correct once-weekly dosing schedule for arthritis and psoriasis before every prescription refill; this is the single most important safety step with Trexall.
- Regular blood counts, liver and kidney function tests, and a chest X-ray at baseline are needed, with monitoring continuing throughout treatment.
- Trexall is contraindicated in pregnancy for non-cancer uses, in breastfeeding, and in people with significant liver disease, alcohol use disorder, immunodeficiency, pre-existing blood disorders or severe kidney impairment.
- Effective contraception is required for both women and men during treatment and for a defined period afterwards (typically at least 3 to 6 months); discuss family planning with the prescriber before starting.
- Folic acid supplementation is commonly prescribed alongside low-dose methotrexate to reduce certain side effects, on the treating clinician's advice.
- Avoid alcohol, as it increases liver toxicity risk.
- Live vaccines should generally be avoided during treatment because of reduced immune response and infection risk.
Avoid Interactions
- Tell the prescriber about every medicine and supplement being used, since methotrexate interacts with many drugs.
- NSAIDs (including over-the-counter ibuprofen and aspirin) and other drugs that compete for kidney elimination can raise methotrexate levels and toxicity, so combinations are monitored closely, particularly at higher doses.
- Trimethoprim-sulfamethoxazole and other antifolate antibiotics increase the risk of severe blood count suppression.
- Proton pump inhibitors such as omeprazole can raise methotrexate levels.
- Folic acid and folinic acid can reduce methotrexate's effectiveness when treating cancer but are often deliberately used to lessen side effects in arthritis and psoriasis, under specialist direction only.
- Avoid nitrous oxide anaesthesia, which can dangerously worsen methotrexate's effect on bone marrow and nerves.
- Hepatotoxic drugs, including excess alcohol, and other immunosuppressants add to liver and infection risk.
- Live vaccines should be avoided during treatment.
References
Frequently Asked Questions
Trexall (methotrexate) tablets treat severe rheumatoid arthritis, juvenile arthritis and disabling psoriasis at low weekly doses, and certain cancers such as leukaemia and lymphoma at much higher, specialist-directed doses. The dosing schedule differs completely between these uses, so always follow your specific prescription.
For rheumatoid arthritis, juvenile arthritis or psoriasis, Trexall is taken once a week, on the same day each week, never once a day. Cancer treatment follows a different, doctor-specified cycle. Taking a weekly dose daily by mistake has caused fatal poisoning, so always double-check your schedule.
Trexall carries a boxed warning for serious, sometimes fatal toxicity to the bone marrow, liver and lungs. Common effects include mouth ulcers, nausea and raised liver enzymes. Report fever, unusual bruising, yellowing skin, persistent cough or breathlessness urgently, as these can signal dangerous toxicity.
Avoid alcohol, which raises liver damage risk, and live vaccines, which are unsafe during treatment. NSAIDs like ibuprofen, certain antibiotics (co-trimoxazole) and proton pump inhibitors can raise methotrexate levels and toxicity. Tell your prescriber about every medicine, including over-the-counter painkillers and supplements.
Take the missed weekly dose as soon as you remember that same day; if it is almost time for the next weekly dose, skip the missed one and resume your normal weekly schedule. Never take two doses close together or take a dose daily to make up for one missed.
No. Trexall carries a boxed warning that it can cause fetal death and birth defects and must not be used in pregnancy outside certain cancer treatments under specialist care. Effective contraception is needed for both women and men during treatment and for months afterward; discuss this before starting.
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