Trexall (Methotrexate)

Prescription Required.

Product of Canada.

Shipped from Canada.

Prescription Required.Product of Canada.Shipped from Canada.

Trexall (Methotrexate Sodium)

What is Trexall?

Trexall is an anti-metabolite medication that is used in the treatment of juvenile rheumatoid arthritis, adult rheumatoid arthritis, and severe cases of psoriasis. It may also be used alongside other medications and treatment options as maintenance therapy for certain cancers.

How is Trexall Used?

Trexall is most commonly taken as a weekly dose of the medication to manage the condition for which it has been prescribed. It may be used alongside additional medications for treatment or may simply be used by itself.

Patients using this medication should be sure to follow all instructions provided by their physician regarding how to safely handle and take the medication for their specific condition. Patients should not modify their dosage or dosing schedule without explicit instructions to do so from their prescribing physician.

Storage

Trexall tablets should be stored between 68°F(68°C) and 77°F (25°C) and should not be exposed to light.

Keep this medication out of the reach of children at all times.

Uses

Trexall is prescribed for a variety of conditions, including the following:

  • cutaneous T-cell lymphoma
  • acute lymphoblastic leukemia
  • refractory or relapsed non-Hodgkin lymphomas
  • rheumatoid arthritis
  • polyarticular juvenile idiopathic arthritis
  • psoriasis

How Does Trexall Work?

Trexall functions as an immunosuppressant and an anti-cancer agent known as an “anti-metabolite.”

When used for treating various cancers, this medication blocks the enzymes within the body that are associated with folate, and by doing this, it is able to slow down or stop cell division. It is specifically highly toxic to cancerous cells that exhibit rapid cell division, making this medication a powerful option to counteract the various cancers for which it is prescribed.

When using to manage psoriasis, its function is similar, as the medicine once again targets cells that are rapidly dividing and causing the symptoms associated with psoriasis.

When this medication is used to treat rheumatoid arthritis, it functions as an immunosuppressant and reduces the associated inflammation of RA.

Dosage

Trexall is available in tablet form in the following strengths:

  • 5 mg
  • 5 mg
  • 10 mg
  • 15 mg

Patients using Trexall for the management of rheumatoid arthritis will typically take a weekly dose of 7.5 mg of the medication and increase the dosage over time as needed until their condition is well-controlled. Patients using it for RA should avoid weekly dosages that exceed 20 mg as this comes with an increased risk of adverse side effects, including the suppression of the patient’s immune system.

When used for the management of psoriasis, the most common dose of Trexall is between 10 mg and 25 mg, taken once per week. Patients using Trexall for psoriasis should not exceed a maximum weekly dose of 30 mg to avoid the risk of immunosuppression and adverse side effects. The dosage of Trexall should be adjusted in these patients to ensure optimal management of their condition while avoiding adverse reactions to weekly use of the medication.

Patients using Trexall for acute lymphoblastic leukemia will use the medication alongside additional chemotherapy treatments, and their dosage will be determined and adjusted based on their condition’s response to the medication, their platelet count, and their absolute neutrophil count (ANC). When used for the treatment of cutaneous T-cell lymphoma, most patients will begin with a once-weekly dose of Trexall ranging between 25 mg and 75 mg along with their current chemotherapy treatment. In the cases of refractory or relapsed non-Hodgkin lymphomas, the most common dosage for patients is 2.5 mg taken two to four times per week without exceeding a maximum weekly dosage of 10 mg).

Overdose

If an overdose of Trexall has occurred or is suspected, the individual that has consumed too much of this medication should seek emergency medical assistance as soon as possible and contact their doctor immediately. Some of the potential side effects of overdosing can be severe and life-threatening.

Side Effects

Trexall is associated with a variety of side effects, including many that may be severe.

The most common side effects are as follows:

  • abnormal liver function tests
  • chills
  • dizziness
  • fatigue
  • fever
  • malaise
  • mouth sores
  • nausea
  • upset stomach

Some of the following side effects may occur and should be reported to your doctor as soon as possible. Patients experiencing any of the following side effects should seek emergency medical assistance immediately:

  • blood in stools or urine
  • chest pain
  • chills
  • confusion
  • coordination issues
  • cough with mucus
  • dark urine
  • diarrhea
  • drowsiness
  • dry cough
  • fever
  • headache
  • irritability
  • jaundice (yellowing of the eyes or skin)
  • loss of movement in any body parts
  • muscle cramps
  • night sweats
  • no or little urination
  • seizures
  • shortness of breath
  • slow or rapid heart rate
  • stiffness of the neck
  • swelling of the ankles or feet
  • swollen lymph glands
  • tingling or numbness
  • tiredness
  • vision issues
  • vomiting
  • weakness
  • weight loss
  • wheezing
  • white sores or patches on the lips or in the mouth

Warnings & Precautions

Due to the strength and toxicity of Trexall, this medication comes with numerous warnings for those using this drug for treatment. Patients should discuss all current health conditions, current medications, and past medical history with their physician before beginning treatment with this medication.

Additional Malignancies

Patients using Trexall may have secondary malignancies occur during treatment. This risk is higher for patients with psoriasis that use cyclosporine, but some patients experience lymphoproliferative disease when using lower doses without any additional risk factors being present. Additionally, patients with tumors that exhibit rapid growth may develop tumor lysis syndrome when using Trexall, and their physician should discuss the preventative measures that need to be in place to prevent this development from occurring during treatment.

Adverse Gastrointestinal Effects

Severe adverse gastrointestinal side effects have been reported by those using Trexall, especially patients with ulcerative colitis or peptic ulcer disease. Some of the potential conditions and risks include the following: fatal intestinal perforation, hemorrhagic enteritis, stomatitis, vomiting, nausea, and diarrhea.

Infection Risk

Trexall’s immunosuppressant effects place patients using the medication at an increased risk of infection and experiencing infections that can become life-threatening. Patients using Trexall should be monitored closely throughout treatment and should report any symptoms of potential infection to their doctor immediately.

Infertility

Trexall has been reported to cause oligospermia, menstrual dysfunction, and impaired fertility. Patients desiring to have children in the future should discuss the potential fertility-related risks with their physician before beginning treatment with this medication. It has not been determined if the infertility associated with Trexall is reversible.

Myelosuppression

Trexall can strongly inhibit the production of all types of blood cells (hematopoiesis), and this can result in the following potentially fatal conditions: thrombocytopenia, neutropenia, leukopenia, pancytopenia, and anemia. Patients using Trexall should have their blood monitored regularly and their dosage of the medication adjusted as needed to avoid the development of these conditions.

Kidney Failure

Trexall is known to cause irreversible damage to some patients’ kidney function, and this includes the development of acute renal failure. Patients using Trexall should have their kidney function monitored throughout treatment and their dosage of the medication adjusted as needed to prevent such conditions from occurring.

Liver Toxicity

Trexall has been associated with severe and irreversible adverse effects on patients’ kidney function, including conditions such as fatal liver failure, cirrhosis, and fibrosis. Alcohol is known to increase a patient’s risk of developing such conditions when consumed during treatment with Trexall. Patients’ liver function should be regularly monitored throughout treatment, and their dosage of the medication should be adjusted as needed, or use of the medication be ceased entirely, depending on the impact that Trexall is having on hepatic function.

Pulmonary Toxicity

Trexall is capable of causing damage to the lungs, including the development of chronic or acute interstitial pneumonitis, which may become irreversible and even be fatal for some individuals. Patients’ lung health should be monitored during treatment with Trexall as a preventative measure against any serious effects of pulmonary toxicity.

Pregnancy

Trexall is not safe for use during pregnancy, as it has been directly linked to fetal death. Patients capable of becoming pregnant should avoid conception while using Trexall and continue to prevent pregnancy from occurring for at least six months after having received their last dose of the medication. Patients that may potentially impregnate a partner should take measures to avoid pregnancy from occurring while being treated with Trexall and should continue these practices for a minimum of three months after having received their last dose of the medication.

Skin Problems

Patients using Trexall may experience a worsening of their psoriasis if exposed to ultraviolet radiation during treatment. Sunburn reactivation (photodermatitis reactivation) and radiation recall dermatitis may also occur. Some individuals may also experience severe adverse reactions to this medication, such as exfoliative dermatitis, erythema multiforme, skin necrosis, Stevens-Johnson syndrome, and toxic epidermal necrolysis. Patients should exercise caution when outside while taking Trexall and should report any changes in their skin’s health to their prescribing physician as soon as possible.

Vaccine Risks

Due to the immunosuppressant effects of Trexall use, patients using this medication should not receive any live vaccines due to the high risk of infection rather than patients experiencing the appropriate immune response associated with vaccinations. Individuals desiring or requiring vaccinations while using Trexall for treatment should discuss the risks and options available to them with their physician.

Drug Interactions

Speak to your doctor about any medications or herbal supplements you are currently taking before beginning treatment with Trexall. Discuss any concerns you may have with your doctor or a trusted pharmacist.

The following medications are known to interact with Trexall:

  • antifolate medications
  • aspirin
  • dapsone
  • hepatotoxic substances
  • highly protein-bound drugs
  • neomycin
  • nephrotoxic products
  • nitrous oxide
  • nonsteroidal anti-inflammatory drugs (NSAIDs)
  • oral antibiotics
  • oral anticoagulants
  • pemetrexed
  • penicillin (intravenous or oral)
  • phenytoin
  • probenecid
  • proton pump inhibitors
  • pyrimethamine
  • salicylates
  • sulfonamides
  • sulfonamide antibiotics (intravenous or oral)
  • sulfonylureas
  • tetracyclines
  • weak acids

Patients using folic acid during treatment with Trexall should discuss this with their physician to ensure they are receiving safe and appropriate amounts of folic acid when simultaneously using Trexall.

Alternative Medications

For patients who are unable to take Trexall or experiencing significant adverse side effects, alternative medications may be used to treat some of the associated conditions for which this medication is commonly prescribed:

  • abatacept (Orencia)
  • acalabrutinib (Calquence)
  • adalimumab (Humira)
  • anakinra (Kineret)
  • asparaginase erwinia chrysanthemi [Recombinant]-rywn (Rylaze)
  • axacabtagene ciloleucel (Yescarta)
  • azathioprine (Imuran)
  • belinostat (Beleodaq)
  • bendamustine hydrochloride (Treanda)
  • bleomycin sulfate
  • bortezomib (Velcade)
  • brentuximab vedotin (Adcetris)
  • brexucabtagene autoleucel (Tecartus)
  • carmustine (BiCNU)
  • certolizumab pegol (Cimzia)
  • chlorambucil (Leukeran)
  • copanlisib hydrochloride (Aliqopa)
  • crizotinib (Xalkori)
  • cyclophosphamide (Cytoxan)
  • cyclosporine (Sandimmune, Neoral)
  • cytarabine (ara-C)
  • dasatinib (Sprycel)
  • daunorubicin
  • denileukin diftitox (Ontak)
  • dexamethasone
  • doxorubicin (Adriamycin)
  • d-penicillamine (Cuprimine, Depen)
  • etanercept (Enbrel)
  • golimumab (Simponi)
  • hydroxychloroquine
  • ibritumomab tiuxetan (Zevalin)
  • ibrutinib (Imbruvica)
  • imatinib (Gleevec)
  • infliximab (Remicade)
  • leflunomide (Arava)
  • lenalidomide (Relimid)
  • lisocabtagene maraleucel (Breyanzi)
  • loncastuximab tesirine-lpyl (Zynlonta)
  • methotrexate sodium
  • mogamulizumab-kpkc (Poteligeo)
  • nelarabine (Arranon)
  • obinutuzumab (Gazyva)
  • pembrolizumab (Keytruda)
  • pemigatinib (Pemazyre)
  • plerixafor (Mozobil)
  • polatuzumab vedotin-piiq (Polivy)
  • pralatrexate (Folotyn)
  • prednisone
  • recombinant interferon alfa-2b (Intron A)
  • rituximab (Riabni, Rituxan)
  • rituximab and hyaluronidase human (Rituxan Hycela)
  • romidepsin (Istodax)
  • selinexor (Xpovio)
  • sulfasalazine (Azulfidine)
  • tafasitamab-cxix (Mojuvi)
  • tazemetostat hydrobromide (Tazverik)
  • tisagenlecleucel (Kymriah)
  • tocilizumab (Actemra)
  • venetoclax (Venclexta)
  • vinblastine sulfate
  • vincristine
  • vincristine sulfate
  • vorinostat (Zolinza)
  • zanubrutinib (Brukinsa)

Frequently Asked Questions

Patients using Trexall should never take a double dose of the medication to make up for a missed dose. If a dose of Trexall has been missed, the patient should contact their doctor regarding whether they should proceed with taking the missed dose or simply wait until their next scheduled dose. The appropriate response to this situation may vary based on the condition for which it has been prescribed as well as the patient’s current dosage.

Patients using Trexall to manage their psoriasis or rheumatoid arthritis will often continue using it for the long term if the medication is well-tolerated.

Cancer patients using Trexall may have a significantly different treatment schedule based on the type of cancer they have and how well the medication is working to treat their condition.

Trexall is mainly used in the treatment of neoplastic forms of cancer. This includes cancers such as acute lymphoblastic leukemia, chorioadenoma destruens, gestational choriocarcinoma, advanced non-Hodgkin lymphoma, advanced mycosis fungoides (cutaneous T-cell lymphoma), epidermoid cancers, lung cancer, and breast cancer.

Trexall may sometimes be used for off-label purposes. Trexall is not FDA-approved to treat the following conditions but may sometimes be used in the management of Crohn’s disease, ectopic pregnancy, and lupus.

Trexall is an anti-metabolite medication prescribed for the treatment of certain types of cancer, psoriasis, and rheumatoid arthritis.

Trexall should not be crushed, chewed, or split unless the patient has been specifically instructed to do so by their prescribing physician. Trexall should be swallowed whole along with a glass of water and should be handled as little as possible.

When used for the treatment and management of psoriasis, it typically takes about three to six months before its full effects become evident. However, many patients will experience improvement in their skin condition after using for about three to six weeks.

When used for rheumatoid arthritis, its full effects may not be evident until the patient has used the medication for about 12 weeks. Many patients will notice improvement in their joint pain, stiffness, and swelling after using for about three to six weeks.

When used for certain cancers, Trexall may take a few weeks before patients begin to notice any changes in their condition. The patient’s doctor will be able to monitor how their cancer is reacting to treatment by performing a variety of different tests.

In lower doses, such as in the treatment and management of psoriasis and rheumatoid arthritis, Trexall is referred to as a disease-modifying antirheumatic drug (DMARD). However, in higher doses, such as when used to treat certain cancers, its considered a chemotherapy drug.

It is often recommended that patients taking Trexall also take folic acid to help reduce and manage some of the side effects associated with this medication. Patients using folic acid while taking Trexall should follow their physician’s instructions regarding the appropriate dosage and the best time to take this supplement. Cancer patients using Trexall will typically be given leucovorin, which is an injectable version of folic acid that assists in reducing side effects and improving the recovery of healthy cells after treatment.

Trexall comes with numerous boxed warnings due to its high level of toxicity and its ability to negatively impact multiple parts of a patient’s body. Patients taking higher doses of this medication, such as when it is being used as a part of the treatment plan for certain cancers, are at an increased risk of experiencing the most serious side effects associated with Trexall.

Patients using Trexall should avoid receiving any live vaccines while using this medication. Due to its ability to weaken a patient’s immune system, this can result in serious infections if a patient receives any live vaccines while having their immunity impaired.

Trexall may assist in curing certain cancers, but its efficacy to such an extent will depend on the type of cancer the patient has as well as the stage of the particular cancer being treated with the medication. This may also be impacted by any additional treatment methods being used to manage the patient’s condition.

Although this medication may assist in managing the symptoms of psoriasis and rheumatoid arthritis, neither of these conditions is curable.

Patients should not use Trexall if they have any of the following conditions: dehydration, anemia, a bad infection, impaired immunity, low white blood cell levels, alcoholism, low levels of neutrophils, low blood counts resulting from bone marrow failure, fluid in the lungs, interstitial pneumonitis, stomach ulcers, pregnancy, abnormal liver function tests, progressive multifocal leukoencephalopathy, liver hardening, liver disease, diarrhea, pulmonary fibrosis, and more. Please be sure to discuss your medical history and all current health conditions with your physician before beginning treatment with Trexall.

The active ingredient in Trexall is methotrexate sodium. The inactive ingredients in Trexall include the following: titanium dioxide, talc, sodium carbonate monohydrate, pregelatinized corn starch, polysorbate 80, polyethylene glycol, microcrystalline cellulose, magnesium stearate, hydroxypropyl methylcellulose, crospovidone, and anhydrous lactose. Depending on which strength of Trexall the patient has been prescribed, the tablets may also contain one or more of the following ingredients to determine the color of the medication: FD&C red no. 40 aluminum lake, FD&C no. 2 aluminum lake, FD&C red no. 40 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C yellow no. 6 aluminum lake, FD&C blue no. 1 aluminum lake, D&C yellow no. 10 aluminum lake.

Patients that are pregnant or nursing should not use this medication. The safety and efficacy in the pediatric age group have not been determined. Those who are above the age of 60 and using Trexall may require additional monitoring of their condition to avoid some of the serious health risks associated with using this medication.

No. There are currently no known foods or beverages that may interact with Trexall in patients using the medication.

Patients using Trexall should avoid using any other forms of methotrexate as well as any other medications that may lower immunity. However, it may also interact with additional medications, as listed above. Please discuss all current medications with your prescribing physician before beginning treatment.