Otrexup; Rasuvo; Rheumatrex [DSC]; Trexall; Xatmep
For all uses of this drug:
- Very bad side effects like bone marrow problems, liver problems, lung problems, infections, and skin reactions (Stevens-Johnson syndrome/toxic epidermal necrolysis) can happen with this drug. Some side effects may not go away and can be deadly. You must talk with the doctor about the risks of this drug.
- This drug may cause kidney problems in some patients. Talk with the doctor.
- Regular blood work and other exams will need to be done to check for side effects. Follow what the doctor has told you.
- Tell the doctor if your child has kidney problems or extra fluid around the stomach area or lungs. The chance of side effects may be raised.
- 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 raise your child’s chance of lymphoma and other cancers.
- Patients with cancer may be at greater risk of getting a bad and sometimes deadly health problem called tumor lysis syndrome (TLS). Talk with the doctor.
- Tell the doctor if your child gets diarrhea or mouth or tongue sores or irritation. This drug may need to be stopped. Severe and sometimes deadly bowel problems may happen.
- Talk with the doctor if your child is getting radiation. There may be more chance of harm to tissue and bone.
- Not all methotrexate products are used to treat cancer. Talk with the doctor.
- If your child is of childbearing age, talk with your child’s doctor before your child takes this drug.
If your child is pregnant:
- This drug may cause harm to the unborn baby or loss of the unborn baby if you take it while you are pregnant.
- If your child gets pregnant while taking this drug, call the doctor right away.
For all reasons other than cancer treatment:
- Do not give this drug to your child if she is pregnant.
- This drug must only be used when other drugs cannot be used or have not worked. Talk with your child’s doctor to be sure that the benefits of this drug are more than the risks.
- It is used to treat cancer.
- It is used to treat rheumatoid arthritis.
- It is used to treat juvenile arthritis.
- It is used to treat psoriasis.
- It may be given to your child for other reasons. Talk with the doctor.
- 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.
- 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:
- Be sure your child does not breast-feed a baby while taking this drug.
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 his/her drugs and health problems. Do not start, stop, or change the dose of any drug your child takes without checking with the doctor.
- Tell all of your child’s health care providers that your child is taking this drug. This includes your child’s doctors, nurses, pharmacists, and dentists.
- 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 of some vaccines 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. Have your child wash hands often. 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 alcohol.
- 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, diarrhea, or more thirst; is throwing up; or is not hungry.
- 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.
- If your child is of childbearing age, a pregnancy test will need to be done before starting this drug to make sure she is not pregnant.
If your child is or may be sexually active:
- Have your child use birth control to prevent pregnancy during care and for some time after care ends. Talk with the doctor to see how long your child needs to use birth control 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.
- If your child is a male and his sex partner gets pregnant while he takes this drug or within 3 months after his last dose, call the doctor right away.
- Some products have benzyl alcohol. Do not give a product that has benzyl alcohol in it to a newborn or infant. Talk with the doctor to see if this product has benzyl alcohol in it.
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:
For all uses of this drug:
- 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, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
- Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
- 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 how much urine is 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.
- Signs of lung or breathing problems like shortness of breath or other trouble breathing, cough, or fever.
- Pinpoint red spots on the skin.
- Very bad dizziness or passing out.
- Feeling confused.
- Change in eyesight.
- Bone pain.
- Swelling, warmth, numbness, change of color, or pain in a leg or arm.
- Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
- Neck stiffness.
- Not able to move.
- 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.
- Patients with cancer who take this drug may be at greater risk of getting a severe health problem called tumor lysis syndrome (TLS). This may lead to death. Call your child’s doctor right away if your child has a fast or abnormal heartbeat; any passing out; trouble passing urine; muscle weakness or cramps; upset stomach, throwing up, diarrhea, or not able to eat; or feels sluggish.
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:
- Upset stomach or throwing up.
- Not hungry.
- Hair loss.
- Feeling tired or weak.
- Belly pain.
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.
Give this drug as ordered by your child’s doctor. Read all information given to you. Follow all instructions 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.
- Do not switch between different forms of this drug without first talking with the doctor.
- You will need to take special care when handling this drug. Check with the doctor or pharmacist to see how to handle this drug.
- Measure liquid doses carefully. Use the measuring device that comes with this drug. If there is none, ask the pharmacist for a device to measure this drug.
- Do not use a household teaspoon or tablespoon to measure this drug. Doing so could lead to the dose being too high.
- It is given as a shot into the fatty part of the skin on the top of the thigh or the belly area.
- If you will be giving your child the shot, your child’s doctor or nurse will teach you how to give the shot.
- Follow how to give this drug as you have been told by your child’s doctor or read the package insert.
- Do not give into skin within 2 inches of the belly button.
- Do not use if the solution is cloudy, leaking, or has particles.
- Do not give into skin that is irritated, bruised, red, infected, or scarred.
- If you are not sure if your child’s dose was injected or if you have a hard time giving the dose, talk with your child’s doctor or pharmacist before using another dose.
- Throw away needles in a needle/sharp disposal box. Do not reuse needles or other items. 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.
All other injection products:
- 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.
- Call your child’s doctor to find out what to do.
- Store liquid (solution) in a refrigerator or at room temperature. If stored at room temperature, throw away any part not used after 2 months.
- Keep lid tightly closed.
- Do not freeze.
- Protect from heat.
Tablets and injection (subcutaneous):
- Store at room temperature. Do not freeze.
- Store in a dry place. Do not store in a bathroom.
- Protect from light.
All other injection products:
- If you need to store this drug at home, talk with your child’s doctor, nurse, or pharmacist about how to store it.
- Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
- Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
- 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, nurse, 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.
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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