Trexall

Methotrexate is a prescription medication used to treat certain types of cancers. It is also used to treat psoriasis, polyarticular juvenile idiopathic arthritis (PJIA), and rheumatoid arthritis (RA).

Methotrexate belongs to a group of drugs called antimetabolites. It decreases the activity of the immune system and slows the growth of cancer cells. Methotrexate treats psoriasis by slowing the growth of skin cells to stop scales from forming. Methotrexate may treat rheumatoid arthritis by decreasing the activity of the immune system.

This medication comes in tablet form and can be taken with or without food.

This medication is also available as a powder to be mixed with liquid to be injected intramuscularly (into a muscle), intravenously (into a vein), intra-arterially (into an artery), or intrathecally (into the fluid-filled space of the spinal canal).

Common side effects of methotrexate include nausea, dizziness, drowsiness, and headache. Do not drive or operate heavy machinery until you know how this medication affects you.

Oral/Injectable:

Methotrexate is a prescription medication used to treat the following conditions:

• severe psoriasis
• rheumatoid arthritis
• polyarticular juvenile idiopathic arthritis (PJIA)
• 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 used to treat the following types of gestational trophoblastic tumors:

• Chorioadenoma destruens.
• Choriocarcinoma.
• Hydatidiform mole.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Barr Laboratories, Inc.

• Teva Select Brands

• Teva Womens Health

Oral/Injectable:

See "Methtrexate FDA Warning" for the most serious reactions.

Methotrexate may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• dizziness
• drowsiness
• headache
• swollen, tender gums
• decreased appetite
• reddened eyes
• hair loss

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• vomiting
• blurred vision or sudden loss of vision
• sudden fever, severe headache, and stiff neck
• seizures
• confusion or memory loss
• weakness or difficulty moving one or both sides of the body
• difficulty walking or unsteady walking
• loss of consciousness
• impaired speech
• decreased urination
• swelling of the face, arms, hands, feet, ankles, or lower legs
• hives
• itching
• skin rash
• difficulty breathing or swallowing

This is not a complete list of this medication’s side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins and herbal supplements. Especially tell your doctor if you take:

• nonsteroidal anti-inflammatory drugs (NSAIDS) such as aspirin, choline magnesium trisalicylate (Tricosal, Trilisate), ibuprofen (Advil, Motrin), magnesium salicylate (Doan's), naproxen (Aleve, Naprosyn) or salsalate.
• acitretin (Soriatane)
• azathioprine (Imuran)
• isotretinoin (Accutane)
• sulfasalazine (Azulfidine)
• tretinoin (Vesanoid)
• chloramphenicol (chloramycetin)
• penicillin
• tetracycline
• folic acid
• phenytoin (Dilantin)
• probenecid (Benemid)
• co-trimoxazole (Bactrim, Septra)
• sulfadiazine
• sulfamethizole (Urobiotic)
• sulfisoxazole (Gantrisin)
• and theophylline (Theocron, Theolair)

This is not a complete list of methotrexate drug interactions. Ask your doctor or pharmacist for more information.

Oral/Injectable:

• Do not drink alcohol while taking methotrexate. Alcohol can increase your risk of liver problems.
• Talk to your doctor before receiving immunizations (vaccinations).
• Do not take NSAIDS (nonsteroidal anti-inflammatory drugs) such as aspirin, ibuprofen, or naproxen without first checking with your doctor.
• Methotrexate may lower the number of white blood cells in your blood, increasing your risk for getting an infection. Avoid people with known infections. Avoid touching your eyes or nose. Wash your hands often.
• Methotrexate may increase your risk of bleeding by lowering the number of platelets in your blood. Tell your doctor right away if you notice any unusual bleeding or bruising.
• Methotrexate may make your skin sensitive to sunlight or ultraviolet light. If you have psoriasis, your sores may get worse if you expose your skin to sunlight while you are taking methotrexate. Plan to avoid unnecessary or prolonged exposure to sunlight or ultraviolet light (tanning beds and sunlamps) and to wear protective clothing, sunglasses, and sunscreen.
• Methotrexate may cause dizziness or make you feel drowsy. Do not drive a car or operate machinery until you know how this medication affects you.

Do not take this medication if:

• you are pregnant women. Use in the treatment of cancer is justified only when the potential benefit outweighs the risk to the fetus.
• are breastfeeding
• if you abuse alcohol (alcoholism), have alcoholic liver disease, or have other chronic liver disease
• have immunodeficiency syndromes along with rheumatoid arthritis (RA) or psoriasis
• have preexisting blood dyscrasias, such as bone marrow hypoplasia, leukopenia, thrombocytopenia, or significant anemia along with RA or psoriasis
• have a known hypersensitivity to methotrexate

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of methotrexate there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking methotrexate, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to methotrexate or any of its ingredients
• have low blood folate levels
• are pregnant or breastfeeding
• are having surgery, including dental surgery

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category X. Methotrexate may cause death or serious harm to your unborn baby.

Tell your doctor if you are breastfeeding or plan to breastfeed. You should not breastfeed while taking methotrexate as it is excreted into human breast milk and may harm your nursing baby.

Oral:

• Methotrexate comes as a tablet to take by mouth. Your doctor will tell you how often you should take methotrexate. The schedule depends on the condition you have and on how your body responds to the medication.
• Depending on your condition, your dosing schedule may require you to take methotrexate once daily for several days, alternating with days when you do not take the medicine. Or, your dosing schedule may require you to take the medicine once a week. Your doctor may also start you on a low dose of the medicine and gradually increase your dose. Take methotrexate exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
• If you miss a dose, take it as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule.
• Continue to take methotrexate even if you feel well. Do not stop taking methotrexate without talking to your doctor.

Injectable:

• Methotrexate injection comes as a powder to be mixed with liquid to be injected intramuscularly (into a muscle), intravenously (into a vein), intra-arterially (into an artery), or intrathecally (into the fluid-filled space of the spinal canal). The length of treatment depends on the types of drugs you are taking, how well your body responds to them, and the type of cancer or condition you have.

Oral/Injectable

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.
The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age
• your gender

Methotrexate starting doses include the following. Dosage adjustment will be made gradually to achieve an optimal response.

• RA is 7.5 mg of an oral (by mouth) formulation once weekly, or
  • 2.5 mg at 12 hour intervals for 3 doses given as a course once weekly
• pJIA is 10 mg/m2 once weekly
• psoriasis is 10 to 25 mg once weekly by mouth or as an injection into the muscle, just under the skin, or into the vein, or
  • 2.5 mg at 12 hour intervals for three doses
• choriocarcinoma and similar trophoblastic diseases is 15 mg to 30 mg by mouth daily for a 5-day course. Such courses are usually repeated for 3 to 5 times as required.

For leukemia:

• When used for induction, the recommended methotrexate tablet dose is 3.3 mg/m2 given daily.
• Maintenance therapy is methotrexate tablets taken 2 times weekly by mouth in total weekly doses of 30 mg/m2.

For lymphoma:

• Recommended dosage is 10 to 25 mg/day orally for 4 to 8 days. Lymphosarcomas in Stage III may respond to combined drug therapy with methotrexate given in doses of 0.625 to 2.5 mg/kg daily.

For mycosis fungoides (cutaneous T cell lymphoma):

• Dosage in early stages is usually 5 mg to 50 mg once weekly. Methotrexate has also been administered twice weekly in doses ranging from 15 mg to 37.5 mg in those who have responded poorly to weekly therapy.

If you take too much this medication, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If this medication is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

Oral:

• Store at room temperature.
• Protect from light.
• Keep this and all medications out of reach of children.

Injectable:

• Store at room temperatures; excursions permitted to 15° to 30°C (59° to 86°F).
• Protect from light.
• Retain in carton until time of use. Discard unused portion.
• This container closure is not made with natural rubber latex.

WARNING:

• METHOTREXATE SHOULD BE USED ONLY BY PHYSICIANS WHOSE KNOWLEDGE AND EXPERIENCE INCLUDE THE USE OF ANTIMETABOLITE THERAPY. BECAUSE OF THE POSSIBILITY OF SERIOUS TOXIC REACTIONS (WHICH CAN BE FATAL):
• METHOTREXATE SHOULD BE USED ONLY IN LIFE THREATENING NEOPLASTIC DISEASES, OR IN PATIENTS WITH PSORIASIS OR RHEUMATOID ARTHRITIS WITH SEVERE, RECALCITRANT, DISABLING DISEASE WHICH IS NOT ADEQUATELY RESPONSIVE TO OTHER FORMS OF THERAPY.
• DEATHS HAVE BEEN REPORTED WITH THE USE OF METHOTREXATE IN THE TREATMENT OF MALIGNANCY, PSORIASIS, AND RHEUMATOID ARTHRITIS. PATIENTS SHOULD BE CLOSELY MONITORED FOR BONE MARROW, LIVER, LUNG AND KIDNEY TOXICITIES.
• PATIENTS SHOULD BE INFORMED BY THEIR PHYSICIAN OF THE RISKS INVOLVED AND BE UNDER A PHYSICIAN’S CARE THROUGHOUT THERAPY.
• THE USE OF METHOTREXATE HIGH DOSE REGIMENS RECOMMENDED FOR OSTEOSARCOMA REQUIRES METICULOUS CARE. HIGH DOSE REGIMENS FOR OTHER NEOPLASTIC DISEASES ARE INVESTIGATIONAL AND A THERAPEUTIC ADVANTAGE HAS NOT BEEN ESTABLISHED. METHOTREXATE FORMULATIONS AND DILUENTS CONTAINING PRESERVATIVES MUST NOT BE USED FOR INTRATHECAL OR HIGH DOSE METHOTREXATE THERAPY
• Methotrexate has been reported to cause fetal death and/or congenital anomalies.Therefore, it is not recommended for women of childbearing potential unless there is clear medical evidence that the benefits can be expected to outweigh the considered risks. Pregnant women with psoriasis or rheumatoid arthritis should not receive methotrexate.
• Methotrexate elimination is reduced in patients with impaired renal functions, ascites, or pleural effusions. Such patients require especially careful monitoring for toxicity, and require dose reduction or, in some cases, discontinuation of methotrexate administration
• Unexpectedly severe (sometimes fatal) bone marrow suppression, aplastic anemia, and gastrointestinal toxicity have been reported with concomitant administration of methotrexate (usually in high dosage) along with some nonsteroidal anti-inflammatory drugs (NSAIDs).
• Methotrexate causes hepatotoxicity, fibrosis and cirrhosis, but generally only after prolonged use. Acutely, liver enzyme elevations are frequently seen. These are usually transient and asymptomatic, and also do not appear predictive of subsequent hepatic disease. Liver biopsy after sustained use often shows histologic changes, and fibrosis and cirrhosis have been reported; these latter lesions may not be preceded by symptoms or abnormal liver function tests in the psoriasis population. For this reason, periodic liver biopsies are usually recommended for psoriatic patients who are under long-term treatment. Persistent abnormalities in liver function tests may precede appearance of fibrosis or cirrhosis in the rheumatoid arthritis population. 
• Methotrexate-induced lung disease, including acute or chronic interstitial pneumonitis, is a potentially dangerous lesion, which may occur acutely at any time during therapy and has been reported at low doses. It is not always fully reversible and fatalities have been reported. Pulmonary symptoms (especially a dry, nonproductive cough) may require interruption of treatment and careful investigation.
• Diarrhea and ulcerative stomatitis require interruption of therapy: otherwise, hemorrhagic enteritis and death from intestinal perforation may occur. Malignant lymphomas, which may regress following withdrawal of methotrexate, may occur in patients receiving low-dose methotrexate and, thus, may not require cytotoxic treatment. Discontinue methotrexate first and, if the lymphoma does not regress, appropriate treatment should be instituted.
• Like other cytotoxic drugs, methotrexate may induce“tumor lysis syndrome” in patients with rapidly growing tumors. Appropriate supportive and pharmacologic measures may prevent or alleviate this complication.
• Severe, occasionally fatal, skin reactions have been reported following single or multiple doses of methotrexate. Reactions have occurred within days of oral, intramuscular, intravenous, or intrathecal methotrexate administration. Recovery has been reported with discontinuation of therapy.
• Potentially fatal opportunistic infections, especially Pneumocystis carinii pneumonia, may occur with methotrexate therapy.
• Methotrexate given concomitantly with radiotherapy may increase the risk of soft tissue necrosis and osteonecrosis.