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methotrexate

Pronunciation

Generic Name: methotrexate (oral) (meth oh TREX ate)
Brand Name: Rheumatrex Dose Pack, Trexall, Xatmep

What is methotrexate?

Methotrexate interferes with the growth of certain cells of the body, especially cells that reproduce quickly, such as cancer cells, bone marrow cells, and skin cells.

Methotrexate is used to treat certain types of cancer of the breast, skin, head and neck, or lung. Methotrexate is also used to treat severe psoriasis and rheumatoid arthritis.

Methotrexate is usually given after other medications have been tried without successful treatment of symptoms.

Methotrexate may also be used for purposes not listed in this medication guide.

What is the most important information I should know about methotrexate?

Methotrexate is usually not taken every day. You must use the correct dose of methotrexate for your condition. Some people have died after taking methotrexate every day by accident.

Do not use methotrexate if you are pregnant or breast-feeding a baby.

Do not use methotrexate to treat psoriasis or rheumatoid arthritis if you have liver disease (especially if caused by alcoholism), or a blood cell or bone marrow disorder.

Call your doctor if you have unusual bruising or bleeding, or signs of infection (fever, chills, body aches).

Methotrexate can cause serious or life-threatening side effects on your liver, lungs, or kidneys. Tell your doctor if you have upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes), dry cough, shortness of breath, blood in your urine, or little or no urinating.

What should I discuss with my healthcare provider before taking methotrexate?

You should not use this medicine if you are allergic to methotrexate. Do not use methotrexate to treat psoriasis or rheumatoid arthritis if you have:

  • alcoholism, cirrhosis, or other liver disease;

  • a blood cell disorder such as anemia (lack of red blood cells) or leukopenia (lack of white blood cells);

  • a bone marrow disorder; or

  • if you are breast-feeding a baby.

Methotrexate is sometimes used to treat cancer even when patients do have one of the conditions listed above. Your doctor will decide if this treatment is right for you.

To make sure methotrexate is safe for you, tell your doctor if you have:

  • kidney disease;

  • a folate deficiency;

  • pneumonia or lung disease;

  • stomach ulcers;

  • any type of infection; or

  • if you are receiving radiation treatments.

Methotrexate can cause birth defects in an unborn baby. Do not use methotrexate to treat psoriasis or rheumatoid arthritis if you are pregnant. Tell your doctor right away if you become pregnant during treatment.

You may need to have a negative pregnancy test before starting this treatment.

Use birth control to prevent pregnancy while you are using methotrexate, whether you are a man or a woman. Methotrexate use by either parent may cause birth defects.

If you are a man, use a condom to keep from causing a pregnancy while you are using methotrexate. Continue using condoms for at least 3 months after your last dose.

If you are a woman, use an effective form of birth control while you are taking methotrexate, and for 6 months after your last dose.

This medicine may affect fertility (your ability to have children), whether you are a man or a woman.

Methotrexate can pass into breast milk and may harm a nursing baby. You should not breast-feed while using this medicine.

Do not give this medicine to a child without the advice of a doctor.

How should I take methotrexate?

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

You must use the correct dose of methotrexate for your condition. Methotrexate is sometimes taken once or twice per week and not every day. Follow the directions on your prescription label. Some people have died after taking methotrexate every day by accident. Ask your doctor or pharmacist if you have questions about your dose of methotrexate or how often to take it.

Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

Use methotrexate regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Methotrexate can lower blood cells that help your body fight infections and help your blood to clot. Your blood will need to be tested often, and you may need an occasional liver biopsy. Your cancer treatments may be delayed based on the results of these tests.

Store tablets at room temperature away from moisture and heat.

Store the liquid medicine in the refrigerator, do not freeze.

You may also store the liquid at room temperature fr up to 60 days.

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose of methotrexate.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of methotrexate can be fatal.

What should I avoid while taking methotrexate?

Do not receive a "live" vaccine while using methotrexate, or you could develop a serious infection. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

This medicine can pass into body fluids (urine, feces, vomit). Caregivers should wear rubber gloves while cleaning up a patient's body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds), especially if you are being treated for psoriasis. Methotrexate can make your skin more sensitive to sunlight and your psoriasis may worsen.

Avoid drinking alcohol while taking methotrexate.

Methotrexate side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using methotrexate and call your doctor at once if you have:

  • dry cough, shortness of breath;

  • diarrhea, vomiting, white patches or sores inside your mouth or on your lips;

  • blood in your urine or stools;

  • swelling, rapid weight gain, little or no urinating;

  • seizure (convulsions);

  • fever, chills, body aches, flu symptoms;

  • pale skin, easy bruising, unusual bleeding, weakness, feeling light-headed or short of breath;

  • liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

  • severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Older adults may be more likely to have side effects from this medicine.

Common side effects may include:

  • changes in your menstrual periods

  • vomiting, upset stomach;

  • headache, dizziness, tired feeling; or

  • blurred vision.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Methotrexate dosing information

Usual Adult Dose for Acute Lymphoblastic Leukemia:

Note: A variety of combination chemotherapy regimens have been used for both induction and maintenance therapy in acute lymphoblastic leukemia. The physician should be familiar with the new advances in anti-leukemic therapy.

-Induction: 3.3 mg/m2/day orally or parenterally (in combination with prednisone 60 mg/m2) daily for 4 to 6 weeks
-Maintenance dose during remission: 30 mg/m2 orally or IM 2 times a week
-Alternate maintenance dose during remission: 2.5 mg/kg IV every 14 days

Comments:
-When relapse occurs, reinduction of remission can usually be obtained by repeating the initial induction regimen.
-Acute lymphoblastic leukemia in pediatric patients and young adolescents is the most responsive to present day chemotherapy. In young adults and older patients, clinical remission is more difficult to obtain and early relapse is more common.

Use: Acute lymphoblastic leukemia (ALL)

Usual Adult Dose for Choriocarcinoma:

15 to 30 mg orally or IM daily for a 5-day course; courses are usually repeated for 3 to 5 times, with rest periods of one or more weeks between courses, until any manifesting toxic symptoms subside

Comments:
-The effectiveness of therapy is evaluated by 24-hour quantitative analysis of urinary chorionic gonadotropin (hCG), which should return to normal or less than 50 IU/24 hr usually after the third or fourth course and usually be followed by a complete resolution of measurable lesions in 4 to 6 weeks.
-One to two courses of therapy after normalization of hCG is usually recommended.
-Since hydatidiform mole may precede choriocarcinoma, prophylactic chemotherapy with this drug has been recommended.
-Chorioadenoma destruens is an invasive form of hydatidiform mole. This drug is administered in these disease states in doses like those recommended for choriocarcinoma.

Use: Gestational trophoblastic disease (GTD) including gestational choriocarcinoma, chorioadenoma destruens, and hydatidiform mole

Usual Adult Dose for Trophoblastic Disease:

15 to 30 mg orally or IM daily for a 5-day course; courses are usually repeated for 3 to 5 times, with rest periods of one or more weeks between courses, until any manifesting toxic symptoms subside

Comments:
-The effectiveness of therapy is evaluated by 24-hour quantitative analysis of urinary chorionic gonadotropin (hCG), which should return to normal or less than 50 IU/24 hr usually after the third or fourth course and usually be followed by a complete resolution of measurable lesions in 4 to 6 weeks.
-One to two courses of therapy after normalization of hCG is usually recommended.
-Since hydatidiform mole may precede choriocarcinoma, prophylactic chemotherapy with this drug has been recommended.
-Chorioadenoma destruens is an invasive form of hydatidiform mole. This drug is administered in these disease states in doses like those recommended for choriocarcinoma.

Use: Gestational trophoblastic disease (GTD) including gestational choriocarcinoma, chorioadenoma destruens, and hydatidiform mole

Usual Adult Dose for Lymphoma:

-Burkitt's tumor Stages I to II: 10 to 25 mg orally once a day for 4 to 8 days
-Burkitt's tumor Stage III: Methotrexate is commonly given concomitantly with other antitumor agents
-Duration of therapy: All stages usually require several courses of therapy interposed with 7 to 10 day rest periods
-Lymphosarcoma Stage III: 0.625 to 2.5 mg/kg orally daily as a part of combination chemotherapy

Uses:
-Burkitt's tumor
-Lymphoma

Usual Adult Dose for Burkitt's Tumor:

-Burkitt's tumor Stages I to II: 10 to 25 mg orally once a day for 4 to 8 days
-Burkitt's tumor Stage III: Methotrexate is commonly given concomitantly with other antitumor agents
-Duration of therapy: All stages usually require several courses of therapy interposed with 7 to 10 day rest periods
-Lymphosarcoma Stage III: 0.625 to 2.5 mg/kg orally daily as a part of combination chemotherapy

Uses:
-Burkitt's tumor
-Lymphoma

Usual Adult Dose for Meningeal Leukemia:

12 mg (maximum 15 mg) intrathecally every 2 to 5 days until the cell count of the CSF returns to normal; at this point, one additional dose is advisable

Comments:
-Administration at intervals of less than 1 week may result in increased subacute toxicity.
-The preserved formulations of this drug contain benzyl alcohol and must not be used for intrathecal or high dose therapy.

Use: Treatment and prophylaxis of meningeal leukemia

Usual Adult Dose for Mycosis Fungoides:

Early stage dosing: 5 to 50 mg orally or parenterally once a week; alternatively, 15 to 37.5 mg 2 times a week may be used in patients who have responded poorly to weekly therapy

Comments:
-Therapy with this drug as a single agent appears to produce clinical responses in up to 50% of patients treated.
-Dose reduction or cessation is guided by patient response and hematologic monitoring.

Use: Mycosis fungoides (cutaneous T cell lymphoma)

Usual Adult Dose for Osteosarcoma:

Initial Dose: 12 g/m2 IV as a 4-hour infusion (in combination with other chemotherapeutic agents); if this dose is not adequate to achieve a peak serum concentration of 1000 micromolar at the end of the infusion, the dose may be increased to 15 g/m2

Treatments may occur at 4, 5, 6, 7, 11, 12, 15, 16, 29, 30, 44, and 45 weeks after surgery.

Comments:
-If the patient is vomiting or unable to tolerate oral medication, leucovorin given IV or IM should be added to this regimen at the same dose and schedule as the methotrexate.
-Consult product labeling or local protocol for dosage of concomitant medications in the chemotherapy regimen.

Use: Osteosarcoma

Usual Adult Dose for Psoriasis:

Single Dose: 10 to 25 mg/week orally, IM, IV, or subcutaneously until adequate response is achieved
Divided Dose: 2.5 mg orally every 12 hours for 3 doses once a week
Maximum dose: 30 mg/week

Comments:
-Once optimal clinical response has been achieved, each dosage schedule should be reduced to the lowest possible amount of drug and to the longest possible rest period.
-The use of MTX may permit the return to conventional topical therapy, which should be encouraged.

Use: 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.

Usual Adult Dose for Rheumatoid Arthritis:

Single dose: 7.5 mg orally or subcutaneously once a week
Divided dose: 2.5 mg orally every 12 hours for 3 doses once a week
Maximum weekly dose: 20 mg
Duration of therapy: Unknown

Comments:
-Dosages may be adjusted gradually to achieve optimal response.
-Limited experience shows a significant increase in the incidence and severity of serious toxic reactions, especially bone marrow suppression, at doses greater than 20 mg per week.
-Therapeutic response usually begins within 3 to 6 weeks and the patient may continue to improve for another 12 weeks or more.

Use: For severe active rheumatoid arthritis in patients who have had an insufficient therapeutic response to, or are intolerant of, an adequate trial of first-line therapy including full dose nonsteroidal anti-inflammatory agents (NSAIDs)

Usual Pediatric Dose for Acute Lymphoblastic Leukemia:

Note: A variety of combination chemotherapy regimens have been used for both induction and maintenance therapy in acute lymphoblastic leukemia. The physician should be familiar with the new advances in anti-leukemic therapy.

-Induction: 3.3 mg/m2/day orally or parenterally (in combination with prednisone 60 mg/m2) daily for 4 to 6 weeks
-Alternate induction: 20 mg/m2 orally once a week as a component of a multi-agent combination
-Maintenance dose during remission: 30 mg/m2 orally or IM 2 times a week
-Alternate maintenance dose during remission: 2.5 mg/kg IV every 14 days

Comments:
-When relapse occurs, reinduction of remission can usually be obtained by repeating the initial induction regimen.
-Acute lymphoblastic leukemia in pediatric patients and young adolescents is the most responsive to present day chemotherapy. In young adults and older patients, clinical remission is more difficult to obtain and early relapse is more common.

Use: Acute lymphoblastic leukemia (ALL)

Usual Pediatric Dose for Meningeal Leukemia:

-Less than 1 year old: 6 mg intrathecally every 2 to 5 days until the cell count of the CSF returns to normal; at this point, one additional dose is advisable
-One year old: 8 mg intrathecally every 2 to 5 days until the cell count of the CSF returns to normal; at this point, one additional dose is advisable
-Two years old: 10 mg intrathecally every 2 to 5 days until the cell count of the CSF returns to normal; at this point, one additional dose is advisable
-Three years and older: 12 mg intrathecally every 2 to 5 days until the cell count of the CSF returns to normal; at this point, one additional dose is advisable

Comments:
-Administration at intervals of less than 1 week may result in increased subacute toxicity.
-The preserved formulations of this drug contain benzyl alcohol and must not be used for intrathecal or high dose therapy.

Use: Treatment and prophylaxis of meningeal leukemia

Usual Pediatric Dose for Juvenile Rheumatoid Arthritis:

Initial dose: 10 mg/m2 orally or subcutaneously once a week
Maximum dose: 20 mg/m2/week (although there is experience with doses up to 30 mg/m2/week in children, there are too few published data to assess how doses over 20 mg/m2/week might affect the risk of serious toxicity in children; experience suggests that children receiving 20 to 30 mg/m2/week [0.65 to 1 mg/kg/week] may have better absorption and fewer GI side effects if this drug is administered either IM or subcutaneously)

Comments:
-Dosages may be adjusted gradually to achieve optimal response.
-Limited experience shows a significant increase in the incidence and severity of serious toxic reactions, especially bone marrow suppression, at doses greater than 20 mg per week.
-Therapeutic response usually begins within 3 to 6 weeks and the patient may continue to improve for another 12 weeks or more.

Use: For children with active polyarticular-course juvenile rheumatoid arthritis who have had an insufficient therapeutic response to, or are intolerant of, an adequate trial of first-line therapy including full dose nonsteroidal anti-inflammatory agents (NSAIDs)

What other drugs will affect methotrexate?

Many drugs can interact with methotrexate. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any you start or stop using, especially:

  • azathioprine;

  • leucovorin;

  • phenytoin;

  • probenecid;

  • theophylline;

  • an antibiotic or sulfa drugs;

  • isotretinoin, retinol, tretinoin;

  • NSAIDs (nonsteroidal anti-inflammatory drugs)--ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others; or

  • salicylates--aspirin, Nuprin Backache Caplet, Kaopectate, KneeRelief, Pamprin Cramp Formula, Pepto-Bismol, Tricosal, Trilisate, and others.

This list is not complete and many other drugs can interact with methotrexate. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.

See also: Side effects (in more detail)

Where can I get more information?

  • Your pharmacist can provide more information about methotrexate.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 13.01.

Last reviewed: June 29, 2017
Date modified: September 05, 2017

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