Humira; Humira Pediatric Crohns Start; Humira Pen; Humira Pen-CD/UC/HS Starter; Humira Pen-Ps/UV Starter
- Very bad and sometimes deadly infections have happened in patients who take this drug. Most people who had these infections were taking other drugs to lower the immune system like methotrexate or steroid drugs. If your child has any infection, is taking antibiotics now or in the recent past, or has had many infections, talk with your child’s doctor.
- TB (tuberculosis) has been seen in patients started on this drug. These patients were exposed to TB in the past, but never got the infection. Your child will be tested to see if he/she has been exposed to TB before starting this drug.
- Lymphoma and other cancers have happened in people who take this drug or drugs like it. This has been deadly in some cases. Talk with the doctor.
- A rare type of cancer called hepatosplenic T-cell lymphoma (HSTCL) has happened with this drug and other drugs like it. These cases have been deadly. Almost all cases were in people who were using drugs like this one along with certain other drugs (azathioprine or 6-mercaptopurine). Most of the time, this happened during treatment for Crohn’s disease or ulcerative colitis. Also, most cases were in male teenagers or young men. Talk with the doctor.
- It is used to treat juvenile arthritis.
- It is used to treat Crohn’s disease.
- 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 is taking any of these drugs: Abatacept or anakinra.
- If your child is using another drug like this one.
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.
- Make sure your child is up to date with all vaccines before treatment with this drug.
- 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. Have your child wash hands often. Avoid crowds and people with infections, colds, or flu.
- If your child has had hepatitis B before or carries the virus, talk with your child’s doctor. Drugs like this one can cause the virus to become active. This can lead to very bad and sometimes deadly liver problems.
- Hepatitis B testing needs to be done as you were told by the doctor. Talk with the doctor.
- Your child may bleed more easily. Make sure your child is careful and avoids injury. Be sure your child has a soft toothbrush.
- Be sure your child does not get a weakened bacteria like BCG for bladder cancer while using this drug. Talk with the doctor.
- Have blood work checked as you have been told by the doctor. Talk with the doctor.
- If your child has a sunburn or other skin problems, talk with the doctor.
- Have your child’s skin checked. Tell your child’s doctor if your child has any skin changes like a new wart, skin sore or reddish bump that bleeds or does not heal, or a change in the color or size of a mole.
- This drug may affect how much of some other drugs are in the body. If your child is taking other drugs, talk with the doctor. Your child may need to have blood work checked more closely while taking this drug with other drugs.
- Use with care in children. Talk with the doctor.
If your child is pregnant or breast-feeding a baby:
- Talk with the doctor if your child is pregnant, becomes pregnant, or is breast-feeding a baby. You will need to talk about the benefits and risks of using this drug.
- If your child used this drug when she was pregnant, tell the baby’s doctor.
Auto-injectors, prefilled pens, and prefilled syringes:
- If your child has a latex allergy, talk with the doctor.
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, 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 a urinary tract infection (UTI) like blood in the urine, burning or pain when passing urine, feeling the need to pass urine often or right away, fever, lower stomach pain, or pelvic pain.
- Signs of lupus like a rash on the cheeks or other body parts, sunburn easy, muscle or joint pain, chest pain or shortness of breath, or swelling in the arms or legs.
- Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
- Chest pain or pressure.
- Night sweats.
- A big weight loss.
- Fever that does not go away.
- Swollen gland.
- A skin lump or growth.
- Blood in the urine.
- Pale skin.
- Very bad irritation where the shot was given.
- Red scaly patches or bumps that are pus filled.
- Rarely, people using drugs like this one have had nervous system problems. Sometimes, these problems have not gone away. Call the doctor right away if your child has a burning, numbness, or tingling feeling that is not normal; change in eyesight; dizziness; seizures; or weakness in the arms or legs.
- Liver problems have happened with drugs like this one. Sometimes, this has been deadly. Call the doctor right away if your child has 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.
- Heart failure has happened with this drug, as well as heart failure that has gotten worse in people who already have it. Tell the doctor if your child has heart disease. Call the doctor right away if your child has shortness of breath, a big weight gain, a heartbeat that is not normal, or swelling in the arms or legs that is new or worse.
- Unsafe blood cell count problems have happened with this drug. This includes a type of anemia called aplastic anemia and a type of low white blood cell count. Report any fever or chills, shortness of breath, feeling very tired or weak, any unexplained bruising or bleeding, or purple “splotches” on your child’s skin to the doctor right away.
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:
- Signs of a common cold.
- Belly pain.
- Upset stomach.
- Back pain.
- Irritation where the shot is given.
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.
- It is given as a shot into the fatty part of the skin.
- If you will be giving your child the shot, your child’s doctor or nurse will teach you how to give the shot.
- Wash your hands before and after use.
- Follow how to give this drug as you have been told by your child’s doctor or read the package insert.
- Do not shake the solution.
- Do not use if the solution is cloudy, leaking, or has particles.
- Do not give into tender, bruised, red, or hard skin.
- Move the site where you give the shot with each shot.
- If it makes the shot feel better, this drug can be taken out of the refrigerator 15 to 30 minutes before using. Allow to sit at room temperature without removing the cap or cover. Do not heat this drug.
- 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.
Adalimumab-adbm and Adalimumab-atto:
- This drug is colorless to a faint yellow. Do not use if the solution changes color.
All other products:
- Do not give if the solution is not clear and colorless.
Auto-injectors, prefilled pens, and prefilled syringes:
- Throw syringe away after use. Do not use the same syringe more than one time.
- Throw away any part of the opened vial not used after the shot is given.
- Give a missed dose as soon as you think about it.
- If it is close to the time for your child’s next dose, skip the missed dose and go back to your child’s normal time.
- Do not take 2 doses at the same time or extra doses.
- If you are not sure what to do if you miss giving your child a dose, call the doctor.
- Store in a refrigerator. Do not freeze.
- Do not use if it has been frozen.
- Store in the carton to protect from light.
- If needed, you may store at room temperature for up to 14 days. Write down the date you take this drug out of the refrigerator. If stored at room temperature and not used within 14 days, throw this drug away.
- Protect from heat.
- 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.
© 2018 Wolters Kluwer Clinical Drug Information, Inc. and its affiliates and/or licensors. All rights reserved.