methotrexate

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    For more information, please download leaflet.

    • The brand name of your medication is Trexoma® and the generic name is Methotrexate.
    • Trexoma® is indicated in Rheumatoid Arthritis in adults, Juvenile Idiopathic Arthritis who have had an insufficient response to nonsteroidal anti-inflammatory agents, Sever and non-responsive adult psoriasis in patient who do not have adequate response to other treatments.
    • This product is a sterile solution, presented in single unit prefilled syringe in 7.5mg/0.3mL, 10mg/0.4mL, 15mg/0.6mg, 20mg/0.8mL strength. Each prefilled syringe is single used.

    1 Why is Trexoma® prescribed?

    Trexoma® is used for treatment of Rheumatoid Arthritis and Psoriasis.

    2 How is injection solution of Trexoma® administered?

    Use Trexoma® according to your physician’s order. If you are not sure about using your medication, ask your doctor or pharmacist before starting medication.

    • Trexoma® is administered by or under supervision of doctor or medical staff as a subcutaneous injection, once weekly. Avoid using Trexoma® daily. It can be life-Threatening because of toxicity.
    • In early days of your treatments, administration will be done by doctor or medical staff. If you have necessary educations about administration method, you can inject the drug by yourself according to education and physician’s instruction.
    • Avoid using Prefilled syringe before medical staff’s instruction.

    3 What special precautions should you follow during your treatment with Trexoma®?

    • Before and during treatment, your doctor runs some test periodically, at least once monthly in first 6 months, and then every three months. These tests include Liver and kidney function test, blood test, respiratory test and mouth-throat tests to check mucus alterations.
    • Trexoma® can change immune system, which has effect on vaccines efficacy. This product can also alter result of immunologic tests.
    • Hidden and chronic infections like herpes, Zoster, Tuberclosis, Hepatitis B&C can be flared up while using Trexoma®.It is important to have prescribed diagnostic tests before starting medication.
    • Concomitant use of Trexoma® with radiotherapy can cause effects on your skin and bone.
    • Regarding to increase sensitivity to sun and UV light, it is important to take care of the skin specially in patient who have psoriasis, while using Trexoma®.
    • Contact your doctor immediately if you have diarrhea.
    • If you feel swelling or enlargement of lymph nodes, contact your doctor immediately. Your doctor may stop treatment.
    • Trexoma® can cause fatigue and dizziness, so if you have the symptoms, take care while driving or working with machines which need full attention.
    • Avoid drinking Alcohol while using Trexoma®. Alcohol consumption can increase risk of serious adverse effects.
    • Avoid vaccination while using Trexoma®. Before taking any vaccine by you or your family, consult with your doctor.
    • Talk with your doctor about all prescription or Non-prescription medications, (natural products, Supplements, OTC)
    • Use birth control that you can trust to stop pregnancy while taking this drug. If you become pregnant, contact your doctor immediately. Ask your doctor or pharmacist about safe contraceptive method.
    • Trexoma® can have effect on fertility. This medication can decrease sperm count in men and in women may alter monthly cycles. These changes may be only during treatment or may last after stopping it.
    • Breast feeding should be avoided during treatment

    4 What is the storage condition of Trexoma®?

    Store Trexoma® at room temperature, below 25 C and away from light. keep in original outer carton).

    Product should be clear, yellow and free of any particulate matters, unless avoid using the medicine.

    Each syringe is for single use only.

    Trexoma® should not be dispose in to waste water or home garbage. Ask your pharmacist for how to throw out used product.

    Ask help from your doctor, pharmacist or medical staff before administration of the drug.

    Trexoma® should not be used after expiry date, printed on the box.

  • For more information, please download leaflet.

    • TREXOMA® (METHOTREXATE) injection contains methotrexate in a sterile, preservative-free, un-buffered solution with a 29 gauge ½ inch needle for a single subcutaneous injection.
    • TREXOMA® solution is yellow in color.

    1 INDICATIONS AND USAGE

    1.1. Rheumatoid Arthritis including Polyarticular Juvenile Idiopathic Arthritis:

    TREXOMA® is indicated in the management of selected adults with severe, active rheumatoid arthritis (RA) (ACR criteria), or children with active polyarticular juvenile idiopathic arthritis (pJIA), who have had an insufficient therapeutic response to, or are intolerant of, an adequate trial of first-line therapy including full dose non-steroidal anti-inflammatory agents (NSAIDs).

    1.2. Psoriasis:

    TREXOMA® is indicated in adults for the symptomatic control of severe, recalcitrant, disabling psoriasis that is not adequately responsive to other forms of therapy, but only when the diagnosis has been established, as by biopsy and/or after dermatologic consultation. It is important to ensure that a psoriasis “flare” is not due to an undiagnosed concomitant disease affecting immune responses.

    1.3. Limitation of Use:

    TREXOMA® is not indicated for the treatment of neoplastic diseases. TREXOMA® should not be used for the treatment of children with psoriasis.

    2 DOSAGE AND ADMINISTRATION

    2.1. Important Dosing Information

    TREXOMA® is a single - dose pre-filled syringe for once – weekly subcutaneous use only. Administer TREXOMA® in the abdomen or the thigh. TREXOMA® is available in the following dosage strengths: 7.5mg, 10mg, 15mg, 20 mg. Use another formulation of methotrexate for alternative dosing in patients who require oral, intramuscular, intravenous, intraarterial, or intrathecal dosing, doses less than 7.5 mg per week, doses more than 20 mg per week, high-dose regimens, or dose adjustments between the available doses.

    3 ADMINISTRATION AND HANDLING:

    TREXOMA® is a pre-filled syringe intended for subcutaneous use under the guidance and supervision of a physician.

    Patients may self-inject with TREXOMA® if a physician determines that it is appropriate, if they have received proper training in how to prepare and administer the correct dose, and if they receive medical follow-up, as necessary. TREXOMA® is injected once weekly. The patient must be explicitly informed about the once weekly dosing schedule. It is advisable to determine an appropriate fixed day of the week for the injection.

    Visually inspect TREXOMA® for particulate matter and discoloration prior to administration. Do not use TREXOMA® if the seal is broken. Handle and dispose of TREXOMA® consistent with recommendations for handling and disposal of cytotoxic drugs.

    4 CONTRAINDICATIONS:

    4.1. Pregnancy

    METHOTREXATE can cause fetal death or teratogenic effects when administered to a pregnant woman. METHOTREXATE is contraindicated in pregnant women. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.

    4.2. Nursing Mothers

    Because of the potential for serious adverse reactions from methotrexate in breast fed infants, METHOTREXATE is contraindicated in nursing mothers.

    • Alcoholism or Liver Disease
    • Patients with alcoholism, alcoholic liver disease or other chronic liver disease.
    • Immunodeficiency Syndromes
    • Patients who have overt or laboratory evidence of immunodeficiency syndromes.
    • Preexisting Blood Dyscrasias
    • Patients who have preexisting blood dyscrasias, such as bone marrow hypoplasia, leukopenia, thrombocytopenia, or significant anemia
    • Hypersensitivity
    • Patients with a known hypersensitivity to methotrexate. Severe hypersensitivity reactions have been observed with methotrexate use.
    • Vaccination
    • Concurrent vaccination with live vaccines.
    • Gastrointestinal ulcer
    • Ulcers of the oral cavity and known active gastrointestinal ulcer Disease

    5 USE IN SPECIAL POPULATIONS

      5.1. Pregnancy:

      Pregnancy Risk Factor: X

      Methotrexate has been reported to cause embryotoxicity, fetal death, congenital anomalies, and abortion in humans and is contraindicated in pregnant women.

      5.2. NURSING MOTHERS:

      Because of the potential for serious adverse reactions from methotrexate in breast fed infants, methotrexate is contraindicated in nursing mothers. Therefore, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother. Methotrexate has been detected in human breast milk. The highest breast milk to plasma concentration ratio reached was 0.08:1.

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