Generic Name: methotrexate (METH-oh-TREX-ate)
Brand Name: Examples include Otrexup and Rasuvo
Otrexup may cause severe and sometimes fatal side effects. These may include infection or stomach, bowel, bone marrow, blood, liver, immune system, nerve, lung, kidney, or skin problems. For this reason, Otrexup 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 Otrexup. Keep all doctor and lab appointments. Talk with your doctor and be sure you understand the risks and benefits of using Otrexup.
Otrexup may cause birth defects or fetal death. Do not use Otrexup if you are pregnant. Tell your doctor before you take Otrexup if you are pregnant or think you may be pregnant. Do not become pregnant or father a child while using Otrexup. 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.
Otrexup 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.
Otrexup may increase the risk of developing a certain type of cancer (lymphoma). Discuss any questions or concerns with your doctor.
Otrexup 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.
Otrexup is an antimetabolite. It works to treat psoriasis by slowing the growth of abnormal skin cells. Exactly how Otrexup works to treat rheumatoid arthritis is unknown. It reduces symptoms of inflammation (eg, swelling, pain, stiffness) caused by rheumatoid arthritis.
Do NOT use Otrexup if:
- you are allergic to any ingredient in Otrexup
- 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 Otrexup
Contact your doctor or health care provider right away if any of these apply to you.
Before using Otrexup:
Some medical conditions may interact with Otrexup. 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 Otrexup. 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 Otrexup's side effects
- Folic acid or leucovorin because they may decrease Otrexup's effectiveness
- Mercaptopurine or theophylline because the risk of their side effects may be increased by Otrexup
This may not be a complete list of all interactions that may occur. Ask your health care provider if Otrexup 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 Otrexup:
Use Otrexup as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with Otrexup. Talk to your pharmacist if you have questions about this information.
- Otrexup is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Otrexup at home, a health care provider will teach you how to use it. Be sure you understand how to use Otrexup. 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 Otrexup only 1 time each week in the stomach or thigh. Do not inject Otrexup within 2 inches of the belly button. Do not inject it in the arms or any other areas of the body.
- Do not inject Otrexup into an area that is tender, bruised, red, scaly, hard, or scarred, or has stretch marks.
- If you are not sure if Otrexup was injected, or if you have a hard time giving the injection, do not inject another dose. Contact your doctor right away.
- Some products should be yellow in color. Other products should be yellow to brown in color. If you are not sure which color your product should be, talk with your doctor or pharmacist. Do not use Otrexup if it contains particles, is cloudy or discolored, or if the container 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 Otrexup is recommended. Check with your doctor for instructions.
- The dose of Otrexup 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 Otrexup may cause serious and sometimes fatal side effects. Be sure you understand exactly how much of Otrexup 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 Otrexup to be seen in the management of psoriasis or rheumatoid arthritis. Do not stop using Otrexup without checking with your doctor.
- If you miss a dose of Otrexup, contact your doctor right away.
Ask your health care provider any questions you may have about how to use Otrexup.
Important safety information:
- Otrexup may cause dizziness or tiredness. These effects may be worse if you take it with alcohol or certain medicines. Use Otrexup 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 Otrexup.
- Nausea, vomiting, and loss of appetite are common with Otrexup. 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.
- Otrexup may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Otrexup. Use sunscreen or wear protective clothing if you must be outside for more than a short time.
- Otrexup 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.
- Otrexup 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.
- Otrexup 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 Otrexup. Talk with your doctor before you receive any vaccine.
- Otrexup may affect your ability to become pregnant or father a child. Discuss any questions or concerns with your doctor.
- Men who take Otrexup should always use a condom when having sex with a woman who may become pregnant. Do this for as long as you take Otrexup 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 Otrexup. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use Otrexup with caution in the ELDERLY; they may be more sensitive to its effects.
- Caution is advised when using Otrexup in CHILDREN; they may be more sensitive to its effects, especially seizures.
- PREGNANCY and BREAST-FEEDING: Otrexup 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 Otrexup and for at least 1 ovulatory cycle after you stop using it. If you think you may be pregnant, contact your doctor right away. Otrexup is found in breast milk. Do not breast-feed while taking Otrexup.
Possible side effects of Otrexup:
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 Otrexup:
Otrexup is usually handled and stored by a health care provider. If you are using Otrexup at home, store Otrexup as directed by your pharmacist or health care provider. Keep Otrexup out of the reach of children and away from pets.
- If you have any questions about Otrexup, please talk with your doctor, pharmacist, or other health care provider.
- Otrexup 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 Otrexup 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 Otrexup. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Otrexup. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using Otrexup.
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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