Brand Names: U.S.
Otrexup; Rasuvo; Rheumatrex; Trexall
Brand Names: Canada
Apo-Methotrexate; JAMP-Methotrexate; Methotrexate Injection USP; Methotrexate Injection, BP; Methotrexate Sodium Injection; Metoject; ratio-Methotrexate Sodium
- This drug may cause very bad and sometimes deadly side effects. This drug is only for use in people with very bad psoriasis or rheumatoid arthritis when other drugs have been used and have not worked. Some products may be used in people with life-threatening cancer. Talk with the doctor.
- Your child will be closely watched by the doctor.
- Have your child’s blood work checked often. Talk with your child’s doctor.
- Some health problems may raise the chance of side effects. Tell the doctor if your child has kidney problems or extra fluid around the stomach area or lungs. Tell the doctor if your child is getting radiation.
- Very bad and sometimes deadly bone marrow problems and stomach or bowel problems have happened when this drug was taken with NSAIDs like ibuprofen or naproxen. Talk with the doctor.
- This drug may cause very bad and sometimes deadly liver problems. Most of the time, this only happens after long-term use. Your child will need to have his/her liver checked while using this drug. Talk with the doctor.
- This drug may cause very bad lung problems. This can happen at any time and with any dose. Sometimes, lung problems will not go back to normal. Call the doctor right away if your child has lung or breathing problems like trouble breathing, shortness of breath, chest pain, or a cough that is new or worse.
- This drug may raise your child’s chance of lymphoma and other cancers.
- Patients with cancer who take this drug may be at greater risk of getting a bad and sometimes deadly health problem called tumor lysis syndrome (TLS). Call your child’s doctor right away if your child has a fast heartbeat; a heartbeat that does not feel normal; any passing out; trouble passing urine; muscle weakness or cramps; upset stomach, throwing up, loose stools, or not able to eat; or feel sluggish.
- Tell the doctor if your child has loose stools (diarrhea) or mouth or tongue sores or irritation. This drug may need to be stopped. If this drug is not stopped, very bad and sometimes deadly bowel problems may happen. Talk with the doctor.
- A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if your child has signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in the mouth, throat, nose, or eyes.
- Very bad and sometimes deadly infections can happen with this drug. Talk with the doctor.
If your child is pregnant:
- This drug may cause harm to the unborn baby if your child takes it during pregnancy. If your child gets pregnant while taking this drug, call the doctor right away.
Psoriasis or rheumatoid arthritis:
- Do not give this drug to your child if she is pregnant.
What is this drug used for?
- It is used to treat rheumatoid arthritis.
- It is used to treat cancer.
- It is used to treat psoriasis.
- It may be given to your child for other reasons. Talk with the doctor.
What do I need to tell the doctor BEFORE my child takes this drug?
- If your child has an allergy to this drug or any part of this drug.
- If your child is allergic to any drugs like this one or any other drugs, foods, or other substances. Tell the doctor about the allergy and what signs your child had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
Psoriasis or rheumatoid arthritis:
- If your child has any of these health problems: Bone marrow disease (like low white blood cell count, low platelet count, or anemia), drinking problem, liver disease, or a weak immune system.
If your child is breast-feeding a baby:
This is not a list of all drugs or health problems that interact with this drug.
Tell the doctor and pharmacist about all of your child’s drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for your child to take this drug with all of their drugs and health problems. Do not start, stop, or change the dose of any drug your child takes without checking with the doctor.
- Be sure your child does not breast-feed a baby while taking this drug.
What are some things I need to know or do while my child takes this drug?
- Tell dentists, surgeons, and other doctors that your child is using this drug.
- Have your child avoid tasks or actions that call for alertness until you see how this drug affects your child. These are things like riding a bike, playing sports, or using items such as scissors, lawnmowers, electric scooters, toy cars, or motorized vehicles.
- Talk with the doctor before your child gets any vaccines. Use with this drug may either raise the chance of very bad infection or make the vaccine not work as well.
- Your child may have more chance of getting infections. Avoid crowds and people with infections, colds, or flu.
- Your child may bleed more easily. Make sure your child is careful and avoids injury. Be sure your child has a soft toothbrush.
- Alcohol may interact with this drug. Be sure your child does not drink beer, wine, or mixed drinks.
- Take care of your child’s teeth. See a dentist often.
- Your child may get sunburned more easily. Avoid lots of sun, sunlamps, and tanning beds. Use sunscreen and dress your child in clothing and eyewear that protects him/her from the sun. Keep protecting your child from sunburn for as long as you were told by the doctor.
- Tell the doctor if your child has too much sweat, fluid loss, loose stools (diarrhea), or more thirst; is throwing up; or is not hungry.
- Do not switch between different forms of this drug without first talking with the doctor.
- This drug may cause your child to not be able to get pregnant later in life. Talk with the doctor.
- This drug may affect sperm in males. This may affect being able to father a child later in life. Talk with the doctor.
- Your child must have a pregnancy test to show that she is NOT pregnant before starting this drug.
If your child is or may be sexually active:
- Have your child use birth control to prevent pregnancy while taking this drug and for at least 1 monthly period (menstrual) cycle after stopping this drug.
- If your child misses her period, has unprotected sex, or thinks that her birth control has not worked, call the doctor right away.
- If your child is a male and has sex with a female who could get pregnant, they must prevent pregnancy during care and for 3 months after care ends. They must use birth control that can be trusted.
What are some side effects that I need to call my child’s doctor about right away?
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your child’s doctor or get medical help right away if your child has any of the following signs or symptoms that may be related to a very bad side effect:
- Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
- Signs of infection. These include a fever of 100.5°F (38°C) or higher, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, wound that will not heal, or anal itching or pain.
- Signs of bleeding like throwing up blood or throw up that looks like coffee grounds; coughing up blood; blood in the urine; black, red, or tarry stools; bleeding from the gums; vaginal bleeding that is not normal; bruises without a reason or that get bigger; or any bleeding that is very bad or that you cannot stop.
- Signs of a pancreas problem (pancreatitis) like very bad stomach pain, very bad back pain, or very bad upset stomach or throwing up.
- Signs of kidney problems like unable to pass urine, change in the amount of urine passed, blood in the urine, or a big weight gain.
- Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
- Pinpoint red spots on your skin.
- Throwing up.
- Very bad belly pain.
- Very bad dizziness or passing out.
- Change in thinking clearly and with logic.
- Change in eyesight.
- Bone pain.
- Swelling, warmth, numbness, change of color, or pain in a leg or arm.
- Change in strength on 1 side is greater than the other, trouble speaking or thinking, change in balance, or blurred eyesight.
- Neck stiffness.
- Not able to move.
What are some other side effects of this drug?
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your child’s doctor or get medical help if any of these side effects or any other side effects bother your child or do not go away:
These are not all of the side effects that may occur. If you have questions about side effects, call your child’s doctor. Call your child’s doctor for medical advice about side effects.
You may report side effects to your national health agency.
- Upset stomach.
- Hair loss.
- Feeling tired or weak.
- Belly pain.
How is this drug best given?
Give this drug as ordered by your child’s doctor. Read and follow the dosing on the label closely.
- Have your child drink lots of noncaffeine liquids every day unless told to drink less liquid by your child’s doctor.
- Give to your child as you have been told by the doctor. This drug is not to be given every day. Be sure you know how to give this drug.
- To gain the most benefit, do not miss giving your child doses.
- How this drug is taken may change based on blood work results, side effects, and how well the drug is working.
Shot (if given under the skin):
- It is given as a shot into the fatty part of the skin on the top of the thigh or the belly area.
- Your child’s doctor may teach you how to give the shot.
- Follow how to give this drug as you have been told by your child’s doctor.
- Do not use if the solution is cloudy, leaking, or has particles.
- Do not give into red or irritated skin.
- Throw away needles in a needle/sharp disposal box. When the box is full, follow all local rules for getting rid of it. Talk with a doctor or pharmacist if you have any questions.
Shot (if given in the muscle or vein):
- It is given as a shot into a muscle or vein.
- This drug may be given as a shot into the spinal fluid.
- Your child’s doctor will give this drug.
What do I do if my child misses a dose?
- Call your child’s doctor to find out what to do.
How do I store and/or throw out this drug?
Shot (if given in the muscle or vein):
- This drug will be given to your child in a hospital or doctor’s office. You will not store it at home.
All other products:
- Store at room temperature.
- Store in a dry place. Do not store in a bathroom.
- Protect from light.
Shot (if given under the skin):
- Keep all drugs out of the reach of children and pets.
- Check with your pharmacist about how to throw out unused drugs.
General drug facts
- If your child’s symptoms or health problems do not get better or if they become worse, call your child’s doctor.
- Do not share your child’s drug with others and do not give anyone else’s drug to your child.
- Keep a list of all your child’s drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your child’s doctor.
- Talk with your child’s doctor before giving your child any new drug, including prescription or OTC, natural products, or vitamins.
- Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your child’s doctor, pharmacist, or other health care provider.
- If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
Consumer Information Use and Disclaimer
This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. 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 the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.
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