(in flix' I mab)
Infliximab injection, infliximab-dyyb injection, and infliximab-abda injection are biologic medications (medications made from living organisms). Biosimilar infliximab-dyyb injection and infliximab-abda injection are highly similar to infliximab injection and work the same way as infliximab injection in the body. Therefore, the term infliximab injection products will be used to represent these medications in this discussion.
Infliximab injection products may decrease your ability to fight infection and increase the risk that you will get a serious infection, including severe viral, bacterial, or fungal infections that may spread throughout the body. These infections may need to be treated in a hospital and may cause death. Tell your doctor if you often get any type of infection or if you think you may have any type of infection now. This includes minor infections (such as open cuts or sores), infections that come and go (such as cold sores) and chronic infections that do not go away. Also tell your doctor if you have diabetes or any condition that affects your immune system and if you live or have ever lived in areas such as the Ohio or Mississippi river valleys where severe fungal infections are more common. Ask your doctor if you do not know if infections are more common in your area. Also tell your doctor if you are taking medications that decrease the activity of the immune system such as abatacept (Orencia); anakinra (Kineret); methotrexate (Otrexup, Rasuvo, Trexall, Xatmep); steroids such as dexamethasone, methylprednisolone (Medrol), prednisolone (Orapred ODT, Pediapred, Prelone), or prednisone; or tocilizumab (Actemra).
Your doctor will monitor you for signs of infection during and shortly after your treatment. If you have any of the following symptoms before you begin your treatment or if you experience any of the following symptoms during or shortly after your treatment, call your doctor immediately: weakness; sweating; difficulty breathing; sore throat; cough; coughing up bloody mucus; fever; extreme tiredness; flu-like symptoms; warm, red, or painful skin; diarrhea; stomach pain; or other signs of infection.
You may be infected with tuberculosis (TB, a severe lung infection) or hepatitis B (a virus that affects the liver) but not have any symptoms of the disease. In this case, infliximab injection products may increase the risk that your infection will become more serious and you will develop symptoms. Your doctor will perform a skin test to see if you have an inactive TB infection and may order a blood test to see if you have an inactive hepatitis B infection. If necessary, your doctor will give you medication to treat this infection before you start using an infliximab injection product. Tell your doctor if you have or have ever had TB, if you have lived in or visited a place where TB is common, or if you have been around someone who has TB. If you have any of the following symptoms of TB, or if you develop any of these symptoms during your treatment, call your doctor immediately: cough, weight loss, loss of muscle tone, fever, or night sweats. Also call your doctor immediately if you have any of these symptoms of hepatitis B or if you develop any of these symptoms during or after your treatment: excessive tiredness, yellowing of the skin or eyes, loss of appetite, nausea or vomiting, muscle aches, dark urine, clay-colored bowel movements, fever, chills, stomach pain, or rash.
Some children, teenagers, and young adults who received an infliximab injection product or similar medications developed severe or life-threatening cancers including lymphoma (cancer that begins in the cells that fight infection). Some teenage and young adult males who took an infliximab product or similar medications developed hepatosplenic T-cell lymphoma (HSTCL), a very serious form of cancer that often causes death within a short period of time. Most of the people who developed HSTCL were being treated for Crohn's disease (a condition in which the body attacks the lining of the digestive tract, causing pain, diarrhea, weight loss, and fever) or ulcerative colitis (a condition which causes swelling and sores in the lining of the colon [large intestine] and rectum) with an infliximab injection product or a similar medication along with another medication called azathioprine (Azasan, Imuran) or 6-mercaptopurine (Purinethol, Purixan). Tell your child's doctor if your child has ever had any type of cancer. If your child develops any of these symptoms during his treatment, call his doctor immediately: unexplained weight loss; swollen glands in the neck, underarms, or groin; or easy bruising or bleeding. Talk to your child's doctor about the risks of giving an infliximab injection product to your child.
Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with an infliximab injection product and each time you receive the medication. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.
Talk to your doctor about the risks of using an infliximab injection product.
WHY is this medicine prescribed?
Infliximab injection products are used to relieve the symptoms of certain autoimmune disorders (conditions in which the immune system attacks healthy parts of the body and causes pain, swelling, and damage) including:
Infliximab injection products are in a class of medications called tumor necrosis factor-alpha (TNF-alpha) inhibitors. They work by blocking the action of TNF-alpha, a substance in the body that causes inflammation.
HOW should this medicine be used?
Infliximab injection products come as a powder to be mixed with sterile water and administered intravenously (into a vein) by a doctor or nurse. It is usually given in a doctor's office once every 2 to 8 weeks, more often in the beginning of your treatment and less often as your treatment continues. It will take about 2 hours for you to receive your entire dose of an infliximab, injection product.
Infliximab injection products may cause serious adverse reactions, including allergic reactions during an infusion and for 2 hours afterward. A doctor or nurse will monitor you during this time to be sure you are not having a serious reaction to the medication. You may be given other medications to treat or prevent reactions to an infliximab injection product. Tell your doctor or nurse immediately if you experience any of the following symptoms during or shortly after your infusion: hives; rash; itching; swelling of the face, eyes, mouth, throat, tongue, lips, hands, feet, ankles, or lower legs; difficulty breathing or swallowing; flushing; dizziness; fainting; fever; chills; seizures; vision loss; and chest pain.
Infliximab injection products may help control your symptoms, but they will not cure your condition. Your doctor will watch you carefully to see how well infliximab injection products work for you. If you have rheumatoid arthritis or Crohn's disease, your doctor may increase the amount of medication you receive, if needed. If you have Crohn's disease and your condition has not improved after 14 weeks, your doctor may stop treating you with an infliximab injection product. It is important to tell your doctor how you are feeling during your treatment.
Are there OTHER USES for this medicine?
Infliximab injection products are also sometimes used to treat Behcet's syndrome (ulcers in the mouth and on the genitals and inflammation of various parts of the body). Talk to your doctor about the possible risks of using this medication for your condition.
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What SPECIAL PRECAUTIONS should I follow?
Before using an infliximab injection product,
What SPECIAL DIETARY instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.
What SIDE EFFECTS can this medicine cause?
Infliximab injection products may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them, or those listed in the IMPORTANT WARNING or the SPECIAL PRECAUTIONS sections, call your doctor immediately:
Adults who receive an infliximab injection product may be more likely to develop skin cancer, lymphoma, cervical cancer, and other types of cancer than adults who do not receive the medication. Talk to your doctor about the risks of receiving an infliximab, injection product.
Infliximab injection products may cause other side effects. Call your doctor if you have any unusual problems while using this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online ( http://www.fda.gov/Safety/MedWatch ) or by phone (1-800-332-1088).
What should I know about STORAGE and DISPOSAL of this medication?
Your doctor will store the medication in his or her office.
What should I do in case of OVERDOSE?
In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online athttps://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.
What OTHER INFORMATION should I know?
Keep all appointments with your doctor and the laboratory. Your doctor may order certain laboratory tests to check your body's response to an infliximab injection product.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
AHFS® Consumer Medication Information. © Copyright, The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.
Selected Revisions: November 15, 2019.
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