Generic Name: methotrexate (meth-oh-TREX-sate)
Brand Name: Otrexup
Methotrexate may cause severe and sometimes fatal side effects. These may include stomach, bowel, bone marrow, blood, liver, immune system, nerve, lung, kidney, or skin problems. For this reason, methotrexate is only used to treat certain patients who have severe psoriasis or rheumatoid arthritis that is not relieved by other treatments. Your doctor will perform lab tests to check for side effects while you take methotrexate. Keep all doctor and lab appointments. Talk with your doctor and be sure you understand the risks and benefits of using methotrexate.
Methotrexate may cause birth defects or fetal death. Do not use methotrexate if you are pregnant. Tell your doctor before you take methotrexate if you are pregnant or think you may be pregnant. Do not become pregnant or father a child while using methotrexate. Talk to your doctor about using an effective form of birth control.
Certain medicines and conditions may increase your risk for side effects. Tell your doctor if you take a nonsteroidal anti-inflammatory drug (NSAID) (eg, ibuprofen, celecoxib) or salicylate (eg, aspirin), or if you receive radiation therapy. Tell your doctor if you have excess fluid in your stomach or around your lungs, or if you have any liver, kidney, lung, blood, bone marrow, stomach, bowel, or immune system problems. Tell your doctor right away if you develop any new or worsening symptoms, including black, tarry stools; dry, nonproductive cough; red, swollen, blistered, or peeling skin; red or irritated eyes; severe or persistent diarrhea or vomiting; shortness of breath or trouble breathing; signs of infection (eg, fever, chills, persistent sore throat); sores in your mouth, throat, nose, or eyes; stomach pain; unusual bruising or bleeding; unusual tiredness or weakness; or yellowing of the skin or eyes.
Methotrexate may cause a serious and possibly fatal condition called tumor lysis syndrome (TLS) in certain patients with cancer. Contact your doctor right away if you develop symptoms such as fast or irregular heartbeat; fainting; decreased urination; muscle weakness or cramps; nausea, vomiting, diarrhea, or loss of appetite; or sluggishness.
Methotrexate may increase the risk of developing a certain type of cancer (lymphoma). Discuss any questions or concerns with your doctor.
Methotrexate is used for:
Treating severe rheumatoid arthritis (RA) in certain adults. It is also used to treat polyarticular juvenile idiopathic arthritis in certain children. It is also used to control the symptoms of psoriasis in adults. It may be used alone or with other medicines. It may also be used for other conditions as determined by your doctor.
Methotrexate is an antimetabolite. It works to treat psoriasis by slowing the growth of abnormal skin cells. Exactly how methotrexate works to treat rheumatoid arthritis is unknown. It reduces symptoms of inflammation (eg, swelling, pain, stiffness) caused by rheumatoid arthritis.
Do NOT use methotrexate if:
- you are allergic to any ingredient in methotrexate
- you are pregnant, planning to become pregnant, or are breast-feeding
- you have alcohol problems (alcoholism) or liver problems
- you have a weakened immune system or certain blood problems (eg, anemia, low white blood cell counts, low blood platelet counts)
- you are taking acitretin
- you have taken or will be taking palifermin within 24 hours of taking methotrexate
Contact your doctor or health care provider right away if any of these apply to you.
Before using methotrexate:
Some medical conditions may interact with methotrexate. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you are able to become pregnant or father a child
- if you have a history of lung problems, immune system problems, nervous system problems (eg, seizures), liver problems (eg, hepatitis), kidney problems, diabetes, or blood problems (eg, anemia, low white blood cell levels, low blood platelet levels)
- if you have an active infection or severe vomiting or diarrhea, or if you are dehydrated
- if you have mouth sores, excess fluid in your stomach or around your lungs, stomach or bowel ulcers, bowel inflammation (eg, ulcerative colitis), or a blockage of your stomach or bowel
- if you have a folic acid deficiency, are in very poor health or are very overweight, or have a history of alcohol abuse
- if you are receiving chemotherapy or radiation
Some MEDICINES MAY INTERACT with methotrexate. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Palifermin because if mouth or tongue sores develop, they may be more severe or last longer
- Medicines that may harm the kidney (eg, amphotericin B, tacrolimus, aminoglycoside antibiotics such as gentamicin) or the liver (eg, azathioprine, retinoids such as acitretin or isotretinoin, sulfasalazine, acetaminophen, ketoconazole, isoniazid, certain medicines for HIV infection) because the risk of kidney or liver side effects may be increased. Ask your doctor if you are unsure if any of your medicines might harm the kidney or liver
- Chloramphenicol, certain corticosteroids (eg, prednisone), hydantoins (eg, phenytoin), hydroxychloroquine, NSAIDs (eg, ibuprofen, naproxen, ketorolac), penicillamine, penicillin antibiotics (eg, amoxicillin), phenylbutazone, probenecid, proton pump inhibitors (PPIs) (eg, omeprazole), salicylates (eg, aspirin), sulfonamide medicines (eg, sulfamethoxazole), tetracycline antibiotics (eg, doxycycline), or trimethoprim because they may increase the risk of methotrexate's side effects
- Folic acid or leucovorin because they may decrease methotrexate's effectiveness
- Mercaptopurine or theophylline because the risk of their side effects may be increased by methotrexate
This may not be a complete list of all interactions that may occur. Ask your health care provider if methotrexate may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use methotrexate:
Use methotrexate as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with methotrexate. Talk to your pharmacist if you have questions about this information.
- Methotrexate is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using methotrexate at home, a health care provider will teach you how to use it. Be sure you understand how to use methotrexate. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
- Use the proper technique taught to you by your doctor. Inject deep under the skin, NOT into muscle or a vein.
- Inject methotrexate only one time each week in the stomach or thigh. Do not inject methotrexate within 2 inches of the belly button. Do not inject it in the arms or any other areas of the body.
- Do not inject methotrexate into an area that is tender, bruised, red, scaly, hard, or scarred, or has stretch marks.
- If you are not sure if methotrexate was injected, or if you have a hard time giving the injection, do not inject another dose. Contact your doctor right away.
- Methotrexate is yellow in color. Do not use methotrexate if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
- Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
- Drinking extra fluids while you are taking methotrexate is recommended. Check with your doctor for instructions.
- The dose of methotrexate and how often you use it are based on your medical condition and response to treatment. It is very important that you follow your doctor's instructions carefully. Taking too much of methotrexate may cause serious and sometimes fatal side effects. Be sure you understand exactly how much of methotrexate to take and how often you should take it. Ask your doctor or pharmacist if you have any questions.
- It may take several weeks of continued use for the full benefit of methotrexate to be seen in the management of psoriasis or rheumatoid arthritis. Do not stop using methotrexate without checking with your doctor.
- If you miss a dose of methotrexate, contact your doctor right away.
Ask your health care provider any questions you may have about how to use methotrexate.
Important safety information:
- Methotrexate may cause dizziness or tiredness. These effects may be worse if you take it with alcohol or certain medicines. Use methotrexate with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Do not drink alcohol while you are using methotrexate.
- Nausea, vomiting, and loss of appetite are common with methotrexate. Ask your doctor or pharmacist for ways to decrease these effects if they occur.
- If vomiting or diarrhea occurs, you will need to take care not to become dehydrated. Contact your doctor for instructions.
- Methotrexate may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to methotrexate. Use sunscreen or wear protective clothing if you must be outside for more than a short time.
- Methotrexate may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.
- Methotrexate may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
- Methotrexate may cause tissue and bone problems if you are also having radiation therapy. Discuss any questions or concerns with your doctor.
- Do not receive a live vaccine (eg, measles, mumps) while you are taking methotrexate. Talk with your doctor before you receive any vaccine.
- Methotrexate may affect your ability to become pregnant or father a child. Discuss any questions or concerns with your doctor.
- Men who take methotrexate should always use a condom when having sex with a woman who may become pregnant. Do this for as long as you take methotrexate and for 3 months after you stop using it.
- Lab tests, including liver function, kidney function, lung function, and complete blood cell counts, may be performed while you use methotrexate. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use methotrexate with caution in the ELDERLY; they may be more sensitive to its effects.
- Caution is advised when using methotrexate in CHILDREN; they may be more sensitive to its effects, especially seizures.
- PREGNANCY and BREAST-FEEDING: Methotrexate may cause birth defects and fetal or newborn death if you take it while you are pregnant. Do not become pregnant while you are using it. Use an effective form of birth control while you use methotrexate and for at least 1 ovulatory cycle after you stop using it. If you think you may be pregnant, contact your doctor right away. Methotrexate is found in breast milk. Do not breast-feed while taking methotrexate.
Possible side effects of methotrexate:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Diarrhea; dizziness; general body discomfort; headache; indigestion; loss of appetite; mild hair loss; mild sore throat; mild stomach pain; nausea; stuffy or runny nose; tiredness; vomiting.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); back pain; black or bloody stools; blood in the urine; bone pain; calf or leg pain, redness, swelling, or tenderness; change in amount of urine produced; chest pain; confusion; coughing up blood; decreased coordination; difficult or painful urination; dry cough; enlargement of the breasts (in males); fainting; fever, chills, or persistent sore throat; inability to move; irritability; menstrual changes; mental or mood changes; mouth or tongue sores or swelling; muscle weakness; neck stiffness; night sweats; one-sided weakness; red, swollen, blistered, or peeling skin; red or irritated eyes; seizures; severe or persistent diarrhea or vomiting; severe or persistent headache, drowsiness, dizziness, or light-headedness; shortness of breath; sores in your mouth, throat, nose, or eyes; speech changes; swollen glands; symptoms of liver problems (eg, dark urine, pale stools, persistent loss of appetite, severe stomach pain, yellowing of the skin or eyes); symptoms of pancreas inflammation (eg, severe stomach pain with or without nausea or vomiting); unexplained weight loss; unusual bleeding or bruising; unusual pain and discoloration of the skin; unusual tiredness or weakness; vaginal discharge; vision loss or other vision changes (eg, blurred vision); vomit that looks like coffee grounds.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.Proper storage of methotrexate:
Methotrexate is usually handled and stored by a health care provider. If you are using methotrexate at home, store methotrexate as directed by your pharmacist or health care provider. Keep methotrexate out of the reach of children and away from pets.
- If you have any questions about methotrexate, please talk with your doctor, pharmacist, or other health care provider.
- Methotrexate is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take methotrexate or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about methotrexate. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to methotrexate. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using methotrexate.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.
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