Trexall

What is Trexall?

Trexall (methotrexate) is a dihydrofolate reductase inhibitor used for the treatment of:

• pediatric patients with acute lymphoblastic leukemia (ALL)
• mycosis fungoides
• relapsed or refractory non-Hodgkin lymphoma
• rheumatoid arthritis
• polyarticular juvenile idiopathic arthritis (pJIA)
• severe psoriasis

Methotrexate

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What are the uses of this medicine?

Trexall (methotrexate) is a prescription medicine used:

• in combination with other chemotherapy medicines in adults and children, for maintenance treatment of acute lymphoblastic leukemia (ALL)
• to treat adults with mycosis fungoides (cutaneous T-cell lymphoma)
• in combination with other therapies to treat adults with non-Hodgkin lymphoma that has come back (relapsed) or did not respond to previous treatment (refractory)
• to treat adults with rheumatoid arthritis
• to treat children with polyarticular juvenile idiopathic arthritis (pJIA)
• to treat adults with severe psoriasis

How does this medicine work?

• Methotrexate acts by inhibition of folate metabolism, blocking dihydrofolic acid reductase, thereby inhibiting synthesis of purines and pyrimidines and decreasing DNA and RNA synthesis.
• Methotrexate inhibits dihydrofolic acid reductase.
• Dihydrofolates must be reduced to tetrahydrofolates by this enzyme before they can be utilized as carriers of one-carbon groups in the synthesis of purine nucleotides and thymidylate.
• Therefore, methotrexate interferes with DNA synthesis, repair, and cellular replication.
• Actively proliferating tissues such as malignant cells, bone marrow, fetal cells, buccal and intestinal mucosa, and cells of the urinary bladder are in general more sensitive to this effect of methotrexate.
• The mechanism of action in rheumatoid arthritis and in psoriasis is unknown.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• are pregnant
• have or had a severe allergic reaction to Trexall in the past

What drug interactions can this medicine cause?

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Trexall and certain other medicines can affect each other and cause serious side effects. Monitor closely for methotrexate adverse reactions when coadministered with:

• Oral antibiotics
• Oral or intravenous penicillin or sulfonamide antibiotics
• Proton pump inhibitors
• anticoagulants, phenytoin, salicylates
• sulfonamides, sulfonylureas, and tetracyclines
• Probenecid
• Nitrous Oxide
• Folic Acid

Is this medicine FDA approved?

• Methotrexate was approved for use in cancer in the United States in 1955, for psoriasis in 1972 and rheumatoid arthritis in 1988 and is still widely used for these indications.

How should this medicine be used?

• Verify pregnancy status in females of reproductive potential before starting Trexall.

Recommended dosage: Acute lymphoblastic leukemia (ALL):

• The recommended dosage is 20 mg/m2 orally once weekly as a part of a combination chemotherapy maintenance regimen.

Mycosis fungoides:

• The recommended dosage is 25 mg to 75 mg orally once weekly as monotherapy; 10 mg/m2 orally twice weekly as part of combination chemotherapy.

Relapsed or refractory non-Hodgkin lymphoma:

• The recommended dosage is 2.5 mg orally two to four times per week as part of metronomic combination chemotherapy.

Rheumatoid Arthritis:

• The recommended starting dosage is 7.5 mg orally once weekly; adjust dose to achieve an optimal response.

Polyarticular juvenile idiopathic arthritis (pJIA):

• The recommended starting dosage is 10 mg/m2 orally once weekly; adjust dose to achieve an optimal response.

Psoriasis:

• The recommended dosage is 10 to 25 mg orally once weekly until adequate response is achieved.

Administration: Trexall for treatment of severe psoriasis, rheumatoid arthritis, or polyarticular juvenile idiopathic arthritis:

• Take your Trexall dose 1 time each week, not every day.
• Severe side effects and death have happened in people who mistakenly have taken Trexall every day instead of 1 time each week.
• Take a folic acid or folinic acid supplement every day during treatment with Trexall, as instructed by your healthcare provider, to help reduce the chance of developing certain side effects, such as mouth sores.

Trexall to treat your cancer:

• Follow your healthcare provider's instructions about how much Trexall to take and when to take it.
• Do not take folic acid or folinic acid during treatment with Trexall unless your healthcare provider tells you to.
• Taking folic acid or folinic acid with Trexall may make your Trexall treatment less effective.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Tablets: 5 mg, 7.5 mg, 10 mg and 15 mg

This medicine is available in fallowing brand namesː

• Trexall

What side effects can this medication cause?

The most common side effects of this medicine include:

• mouth sores
• low white blood cells
• nausea
• upset stomach

Trexall can cause serious side effects that may be severe and lead to death including:

• death
• Harm to an unborn baby
• Severe allergic reactions
• Decreased blood cell counts
• Inflammation of the intestine with severe bleeding and a tear in the intestinal wall
• Liver problems
• Lung problems
• Severe skin reactions
• Serious infections
• Brain and spinal cord (nervous system) problems
• Secondary cancers
• Tumor lysis syndrome
• Possible fertility problems (infertility) in males and females

What special precautions should I follow?

• Methotrexate can cause fetal harm, including fetal death, when administered to a pregnant woman. Methotrexate is contraindicated for use in pregnant women receiving Trexall for the treatment of non-malignant diseases. Advise females of reproductive potential to use effective contraception during treatment with Trexall and for 6 months after the final dose. Advise males with female partners of reproductive potential to use effective contraception during Trexall treatment and for 3 months after the final dose.
• Hypersensitivity reactions, including anaphylaxis, can occur with Trexall. If anaphylaxis or other serious hypersensitivity reaction occurs, immediately and permanently discontinue Trexall.
• Trexall suppresses hematopoiesis and can cause severe and life-threatening pancytopenia, anemia, leukopenia, neutropenia, and thrombocytopenia. Monitor patients for clinical complications of myelosuppression.
• Diarrhea, vomiting, nausea, and stomatitis occurred in up to 10% of patients receiving Trexall. Withhold or discontinue Trexall for severe gastrointestinal toxicity.
• Trexall can cause severe and potentially irreversible hepatotoxicity, including fibrosis, cirrhosis, and fatal liver failure. Monitor liver tests at baseline, periodically during treatment and as clinically indicated.
• Pulmonary toxicity, including acute or chronic interstitial pneumonitis and irreversible or fatal cases, can occur with Trexall. Monitor patients for pulmonary toxicity and withhold or discontinue methotrexate.
• Severe, including fatal dermatologic reactions, such as toxic epidermal necrolysis, Stevens- Johnson syndrome, exfoliative dermatitis, skin necrosis, and erythema multiforme, can occur with Trexall. Monitor patients for dermatologic toxicity and withhold or permanently discontinue Trexall for severe dermatologic reactions.
• Trexall can cause renal toxicity, including irreversible acute renal failure. Monitor renal function at baseline, periodically during treatment and as clinically indicated. Withhold or discontinue Trexall for severe renal toxicity. Administer glucarpidase in patients with toxic plasma methotrexate concentrations.
• Products containing folic acid or its derivatives may decrease the clinical effectiveness of methotrexate. Therefore, instruct patients not to take products containing folic acid or folinic acid.
• Patients treated with Trexall are at increased risk for developing life-threatening or fatal bacterial, fungal, or viral infections, including opportunistic infections. Monitor patients for infection during and after treatment with methotrexate. Withhold or discontinue methotrexate for serious infections.
• Trexall can cause severe acute and chronic neurotoxicity, which can be progressive, irreversible, and fatal. Monitor patients for neurotoxicity and withhold or discontinue Trexall.
• Secondary malignancies can occur with Trexall. . If lymphoproliferative disease occurs, discontinue methotrexate.
• Trexall can induce tumor lysis syndrome in patients with rapidly growing tumors. Institute appropriate prophylactic measures in patients at risk for tumor lysis syndrome prior to initiation of Trexall.
• Disseminated infections following administration of live vaccines have been reported. Immunization with live vaccines is not recommended during treatment.
• Methotrexate can cause impairment of fertility, oligospermia, and menstrual dysfunction. It is not known if the infertility may be reversible.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• leukopenia
• thrombocytopenia
• anemia
• pancytopenia
• bone marrow suppression
• mucositis
• stomatitis
• oral ulceration
• nausea
• vomiting
• gastrointestinal ulceration
• gastrointestinal bleeding

Management of overdosage:

• Leucovorin and levoleucovorin are indicated to diminish the toxicity and counteract the effect of inadvertently administered overdosages of methotrexate.
• Glucarpidase is indicated for the treatment of toxic methotrexate concentrations in patients with delayed methotrexate clearance due to impaired renal function.
• Hydration and urinary alkalinization may be necessary to prevent the precipitation of methotrexate.
• Neither hemodialysis nor peritoneal dialysis has been shown to improve methotrexate elimination.
• Clearance of methotrexate has been reported with acute, intermittent hemodialysis using a high-flux dialyzer.

Can this medicine be used in pregnancy?

• Methotrexate is contraindicated in pregnant women with non-neoplastic diseases.
• Based on published reports and its mechanism of action, methotrexate can cause embryo-fetal toxicity and fetal death when administered to a pregnant woman.
• Advise pregnant women with neoplastic diseases of the potential risk to a fetus.

Can this medicine be used in children?

• It is not known if Trexall is safe and effective in treating children with any disease other than ALL as part of a combination regimen used for maintenance therapy of their cancer, and for the treatment of pJIA.

What are the active and inactive ingredients in this medicine?

Active Ingredient:

• methotrexate

Inactive Ingredients: anhydrous lactose, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized corn starch, sodium carbonate monohydrate, talc and titanium dioxide.

• The 5 mg also contains: D&C Yellow No. 10 Aluminum lake, FD&C Blue No. 1 Aluminum lake and FD&C Yellow No. 6 Aluminum lake.
• The 7.5 mg also contains: FD&C Blue No.1 Aluminum lake.
• The 10 mg also contains: FD&C Red No. 40 Aluminum lake.
• The 15 mg also contains: FD&C Blue No. 2 Aluminum lake and FD&C Red No. 40 Aluminum lake.

Who manufactures and distributes this medicine?

Manufactured In Czech Republic By:

• Teva Czech Industries, s.r.o., Opava-Komarov, Czech Republic

Manufactured For:

• Teva Pharmaceuticals USA, Inc., Parsippany, NJ

What should I know about storage and disposal of this medication?

• Store Trexall at 68°F to 77°F (20°C to 25°C).
• Keep Trexall away from light.

• Dailymed label info on Trexall
• FDA Trexall

Trexall Resources
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