Related pages Drug Information Summaries 1 Approval Process for New Cancer Treatments 2 Access to Investigational Drugs: Q & A 3

This page contains brief information about methotrexate and a collection of links to more information from the National Cancer Institute (NCI), the Food and Drug Administration (FDA), and the National Library of Medicine (NLM).

US Brand Name(s):		Abitrexate
		Folex PFS
		Folex
		Methotrexate LPF
		Mexate-AQ
		Mexate
FDA Approved:		Yes

Methotrexate is approved by the Food and Drug Administration (FDA) to be used by itself to treat the following types of gestational trophoblastic tumors:

• Chorioadenoma destruens.
• Choriocarcinoma.
• Hydatidiform mole.

Methotrexate is also approved to be used alone or with other drugs to treat acute lymphoblastic leukemia (ALL) that has spread to the central nervous system (CNS) or to keep it from spreading there, and to treat the following:

• Breast cancer.
• Certain types of head and neck cancer.
• Lung cancer.
• Advanced non-Hodgkin lymphoma (NHL).
• Advanced mycosis fungoides (a type of cutaneous T-cell lymphoma).
• Osteosarcoma that has not spread to other parts of the body, following surgery to remove the primary tumor.

Methotrexate is also approved to treat the following non-cancer conditions:

• Rheumatoid arthritis in certain adults with severe, active disease, or in children with a certain type of rheumatoid arthritis, who have not gotten better with other treatment or who cannot take other drugs.
• Severe psoriasis (a skin condition) that has not gotten better with other types of treatment.

In addition to the uses that have been approved by the FDA, methotrexate is sometimes used alone or with other drugs to treat other conditions or types of cancer. Methotrexate continues to be studied in the treatment of many types of cancer.

Definition from the NCI Drug Dictionary ⁴ - Detailed scientific definition and other names for this drug.

Clinical Trial Results: Ovarian Suppression May Be as Effective as Chemotherapy in High-Risk Breast Cancer (12/06/2006) ⁵ - Important clinical trial results for this drug, background information, and how the trial was done.

Clinical Trial Results: Age and Type of Chemotherapy Affect Women's Chances of Menstruating after Breast Cancer Treatment (02/27/2006) ⁶ - Important clinical trial results for this drug, background information, and how the trial was done.

Clinical Trial Results: Young Children with Medulloblastoma May Be Able to Avoid Post-Surgery Radiotherapy (03/21/2005) ⁷ - Important clinical trial results for this drug, background information, and how the trial was done.

Clinical Trial Results: Pre-Surgical Chemotherapy May Improve Survival in Bladder Cancer (08/28/2003) ⁸ - Important clinical trial results for this drug, background information, and how the trial was done.

Clinical Trial Results: High Doses of Chemotherapy Drug Methotrexate Leads to Better Survival for Children with Leukemia and Lymphoma (05/14/2001) ⁹ - Important clinical trial results for this drug, background information, and how the trial was done.

Medline Plus Information on Methotrexate ¹⁰ - A lay language summary of important information about this drug that may include the following:

• warnings about this drug,
• what this drug is used for and how it is used,
• what you should tell your doctor before using this drug,
• what you should know about this drug before using it,
• other drugs that may interact with this drug, and
• possible side effects.

Drugs are often studied to find out if they can help treat or prevent conditions other than the ones they are approved for. This NLM patient information sheet applies only to approved uses of the drug. However, much of the information may also apply to unapproved uses that are being studied.

Clinical Trials for Methotrexate ¹¹ - Check for trials from NCI's PDQ Cancer Clinical Trials Registry now accepting patients.

Glossary Terms

An aggressive (fast-growing) type of leukemia (blood cancer) in which too many lymphoblasts (immature white blood cells) are found in the blood and bone marrow. Also called acute lymphocytic leukemia and ALL.

Cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment.

Cancer that forms in tissues of the breast, usually the ducts (tubes that carry milk to the nipple) and lobules (glands that make milk). It occurs in both men and women, although male breast cancer is rare.

A term for diseases in which abnormal cells divide without control. Cancer cells can invade nearby tissues and can spread to other parts of the body through the blood and lymph systems. There are several main types of cancer. Carcinoma is cancer that begins in the skin or in tissues that line or cover internal organs. Sarcoma is cancer that begins in bone, cartilage, fat, muscle, blood vessels, or other connective or supportive tissue. Leukemia is cancer that starts in blood-forming tissue such as the bone marrow, and causes large numbers of abnormal blood cells to be produced and enter the blood. Lymphoma and multiple myeloma are cancers that begin in the cells of the immune system. Central nervous system cancers are cancers that begin in the tissues of the brain and spinal cord.

The brain and spinal cord. Also called CNS.

A type of cancer that grows into the muscular wall of the uterus. It is formed after conception (fertilization of an egg by a sperm). It may spread to other parts of the body, such as the vagina, vulva, and lung. Also called invasive hydatidiform mole.

A malignant, fast-growing tumor that develops from trophoblastic cells (cells that help an embryo attach to the uterus and help form the placenta). Almost all choriocarcinomas form in the uterus after fertilization of an egg by a sperm, but a small number form in a testis or an ovary. Choriocarcinomas spread through the blood to other organs, especially the lungs. They are a type of gestational trophoblastic disease. Also called chorioblastoma, chorioepithelioma, and chorionic carcinoma.

Any of a group of T-cell non-Hodgkin lymphomas that begins in the skin as an itchy, red rash that can thicken or form a tumor. The most common types are mycosis fungoides and Sézary syndrome.

An agency in the U.S. federal government whose mission is to protect public health by making sure that food, cosmetics, and nutritional supplements are safe to use and truthfully labeled. The Food and Drug Administration also makes sure that drugs, medical devices, and equipment are safe and effective, and that blood for transfusions and transplant tissue are safe. Also called FDA.

Any of a group of tumors that develops from trophoblastic cells (cells that help an embryo attach to the uterus and help form the placenta) after fertilization of an egg by a sperm. The two main types of gestational trophoblastic tumors are hydatidiform mole and choriocarcinoma. Also called gestational trophoblastic disease.

Cancer that arises in the head or neck region (in the nasal cavity, sinuses, lips, mouth, salivary glands, throat, or larynx [voice box]).

A slow-growing tumor that develops from trophoblastic cells (cells that help an embryo attach to the uterus and help form the placenta) after fertilization of an egg by a sperm. A hydatidiform mole contains many cysts (sacs of fluid). It is usually benign (noncancerous) but it may spread to nearby tissues (invasive mole). It may also become a malignant tumor called choriocarcinoma. Hydatidiform mole is the most common type of gestational trophoblastic tumor. Also called molar pregnancy.

Cancer that forms in tissues of the lung, usually in the cells lining air passages. The two main types are small cell lung cancer and non-small cell lung cancer. These types are diagnosed based on how the cells look under a microscope.

Any of a large group of cancers of the immune system. Non-Hodgkin lymphomas can occur at any age and are often marked by enlarged lymph nodes, fever, and weight loss. There are many different types of non-Hodgkin lymphomas which can be divided into aggressive (fast-growing) and indolent (slow-growing) types and can be classified as either B-cell or T-cell non-Hodgkin lymphoma. B-cell non-Hodgkin lymphomas include Burkitt lymphoma, diffuse large B-cell lymphoma, follicular lymphoma, immunoblastic large cell lymphoma, precursor B-lymphoblastic lymphoma, and mantle cell lymphoma. T-cell non-Hodgkin lymphomas include mycosis fungoides, anaplastic large cell lymphoma, and precursor T-lymphoblastic lymphoma. Lymphomas related to lymphoproliferative disorders following bone marrow or stem cell transplantation are usually B-cell non-Hodgkin lymphomas. Prognosis and treatment depend on the stage and type of disease. Also called NHL.

A cancer of the bone that usually affects the large bones of the arm or leg. It occurs most commonly in young people and affects more males than females. Also called osteogenic sarcoma.

The original tumor.

A chronic disease of the skin marked by red patches covered with white scales.

An autoimmune disease that causes pain, swelling, and stiffness in the joints, and may cause severe joint damage, loss of function, and disability. The disease may last from months to a lifetime, and symptoms may improve and worsen over time.

A procedure to remove or repair a part of the body or to find out whether disease is present. An operation.