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Drug Information For:
REMICADE 100MG INJ VIAL
Ingredient Name:INFLIXIMAB (in-FLIX-i-mab)
Common Uses:This medicine is a monoclonal antibody used for treating moderate to severe rheumatoid arthritis when used along with another medicine (methotrexate). It is also used to treat moderate to severe ankylosing spondylitis, psoriatic arthritis, and certain types of skin psoriasis. This medicine is used to treat moderate to severe Crohn disease or ulcerative colitis in certain patients who have not received relief from other treatments. It may also be used for other conditions as determined by your doctor.
Before Using This Medicine:WARNING: Patients who use this medicine have an increased risk of developing serious and sometimes fatal infections (eg, bacterial, viral, or fungal infections; tuberculosis / TB). Most patients who developed these infections were taking medicines that suppressed their immune systems (eg, methotrexate, corticosteroids). TB MAY BE CAUSED by a new infection or by reactivation of a previous infection. You should be tested for TB infection before you start this medicine. If you have a TB infection, treatment for TB should be started before you begin this medicine. Tell your doctor right away if you develop symptoms of infection (eg, fever, chills, persistent cough or sore throat, unusual vaginal discharge, painful or frequent urination, persistent feeling of being unwell). Tell your doctor if you have a history of chronic or recurrent infections. THIS MEDICINE is a tumor necrosis factor (TNF) blocker. Lymphoma and other types of cancer have been reported in children and teenagers treated with TNF blockers. This has been fatal in some cases. A RARE TYPE OF CANCER called hepatosplenic T-cell lymphoma (HSTCL) has rarely occurred in teenagers and young adults using TNF blockers, including this medicine, to treat Crohn disease or ulcerative colitis. These cases have been fatal. Patients who developed this cancer were using this medicine along with certain other medicines (azathioprine or 6-mercaptopurine). Tell your doctor if you have or ever had any type of cancer. Some medicines or medical conditions may interact with this medicine. INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. DO NOT TAKE THIS MEDICINE if you are also taking abatacept, adalimumab, anakinra, canakinumab, certolizumab, etanercept, rilonacept, rituximab, tocilizumab, or tofacitinib. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking anticoagulants (eg, warfarin), cyclosporine, or theophylline. DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions, including any type of infection, fungal infection (eg, coccidiomycosis, histoplasmosis), TB infection, skin infection, open cuts or sores on your body, conditions that may increase your risk of infection (eg, diabetes), any numbness or tingling, a disease that affects your nervous system (eg, multiple sclerosis / MS, Guillain-Barre syndrome, seizures), heart problems (eg, congestive heart failure), chronic obstructive pulmonary disease (COPD), allergies, pregnancy, or breast-feeding. TELL YOUR DOCTOR if you have a history of chronic or recurrent infections, TB or a positive TB skin test, immune system problems (eg, weakened immune system), blood problems, bone marrow problems, lymphoma or other cancers, smoking, liver problems (eg, hepatitis B), liver problems caused bydrinking alcohol (alcoholic hepatitis), or hepatitis B virus reactivation when taking this medicine or other TNF blockers. TELL YOUR DOCTOR if you have had phototherapy to treat psoriasis or other skin conditions, if you have been taking another medicine to treat rheumatoid arthritis, or if you have recently received or are scheduled to receive a vaccine. TELL YOUR DOCTOR if you have traveled to or lived in an area where TB or other certain infections (eg, histoplasmosis, coccidioidomycosis, blastomycosis) are common, or have recently been around someone who has had TB. USE OF THIS MEDICINE IS NOT RECOMMENDED if you have moderate to severe heart failure, unless your doctor has examined you and decided that you are able to take this medicine. Certain doses of this medicine should not be used in patients who have moderate to severe heart failure. Ask your doctor if you have questions about this information. USE OF THIS MEDICINE IS NOT RECOMMENDED if you have an active infection. Contact your doctor or pharmacist if you have any questions or concerns about using this medicine.
How to Use This Medicine:Follow the directions for taking this medicine provided by your doctor. This medicine comes with a MEDICATION GUIDE approved by the U.S. Food and Drug Administration. Read it carefully each time you refill this medicine. Ask your doctor, nurse, or pharmacist any questions that you may have about this medicine. THIS MEDICINE IS USUALLY GIVEN as an injection at your doctor's office, hospital, or clinic. If you will be using this medicine at home, a health care provider will teach you how to use it. Be sure you understand how to use this medicine. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions. YOU MAY RECEIVE OTHER MEDICINES BEFORE EACH TREATMENT with this medicine to decrease the chance of an infusion-related reaction. Discuss any questions with your doctor. DO NOT RECEIVE A LIVE VACCINE (eg, measles, mumps) or treatment with a weakened bacteria (eg, BCG for bladder cancer) while you are taking this medicine. Talk with your doctor before you receive any vaccine. BEFORE YOU USE THIS MEDICINE, discuss your vaccination history with your doctor to be sure that you are up to date on vaccinations. This medicine is usually handled and stored by a health care provider. If you are using this medicine at home, STORE THIS MEDICINE as directed by your pharmacist or health care provider. KEEP THIS MEDICINE, as well as syringes and needles, out of reach of children and pets. IF YOU MISS A DOSE of this medicine, contact your doctor immediately.
Cautions:DO NOT USE THIS MEDICINE if you are allergic to any ingredient in this medicine, including mouse-derived (murine) proteins. BEFORE YOU BEGIN TAKING ANY NEW MEDICINE, either prescription or over-the-counter, check with your doctor or pharmacist. THIS MEDICINE MAY INTERFERE WITH CERTAIN LAB TESTS. Be sure your doctor and lab personnel know you are using this medicine. LAB TESTS may be performed to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments. THIS MEDICINE MAY CAUSE DIZZINESS. This effect may be worse if you take it with alcohol or certain medicines. Do not drive or perform other possibly unsafe tasks until you know how you react to it. TELL YOUR DOCTOR OR DENTIST that you take this medicine before you receive any medical or dental care, emergency care, or surgery. THIS MEDICINE MAY LOWER the ability of your body to fight infection. Avoid contact with people who have colds or infections. Do not touch your eyes or the inside of your nose unless you have thoroughly washed your hands first. THIS MEDICINE 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. THIS MEDICINE MAY INCREASE THE RISK of developing a certain type of blood cancer (lymphoma) or other types of cancer (eg, skin cancer). The risk may increase if you have used this medicine for a long time. Tell your doctor if you have ever had lymphoma or another cancer, or if you have a risk of developing cancer. Contact your doctor right away if any symptoms appear, such as unusual lumps or swelling (eg, in your armpit, groin, or neck), night sweats, recurring fever, unusual tiredness, unexplained cough or breathlessness, persistent unexplained itching, or unexplained weight loss. Use this medicine with caution in the ELDERLY; they may be more sensitive to its effects, especially the risk of infection. Caution is advised when using this medicine in CHILDREN; they may be more likely to develop certain side effects. These effects may include certain blood problems (eg, anemia, low white blood cell levels), blood in the stool, flushing, bone fracture, certain types of infection, and certain allergic reactions. Cases of unusual cancer have occurred in children and teenagers using this medicine. PREGNANCY and BREAST-FEEDING: It is not known if this medicine can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using this medicine while you are pregnant. If you used this medicine during pregnancy, tell your baby's doctor. Your baby may have a higher risk of getting an infection for at least 6 months after birth. Your baby's doctor will also need to decide when your baby shouldreceive any vaccine. Certain vaccines may cause infections. It is not known if this medicine is found in breast milk. Do not breast-feed while taking this medicine.
Possible Side Effects:SIDE EFFECTS that may occur while taking this medicine include: back pain; headache; mild stomach pain or upset; pain, redness, or swelling at the injection site; runny or stuffy nose; tiredness. If they continue or are bothersome, check with your doctor. SOME PATIENTS WHO USE THIS MEDICINE have developed new or worsening psoriasis. Tell your doctor right away if you notice any new or worsening skin problems (eg, red, flaky, or itchy skin patches) RARELY, SEVERE LIVER PROBLEMS HAVE OCCURRED with the use of this medicine. These liver problems may occur from 2 weeks to more than a year after starting this medicine. Contact your doctor right away if you develop dark urine, pale stools, severe or persistent stomach pain, or yellowing of the skin or eyes. NEW OR WORSENING NERVOUS SYSTEM DISORDERS (eg, MS, Guillain-Barre syndrome, seizures) have occurred in patients who take this medicine. Tell your doctor if you have a disease that affects your nervous system. ALLERGIC REACTIONS HAVE OCCURRED up to 12 days after the use of this medicine. Tell your doctor if symptoms such as fever, rash, headache, muscle or joint pain, swelling, or trouble swallowing occur. SEEK MEDICAL ATTENTION RIGHT AWAY if any of these SEVERE side effects occur: bloody, black, or tarry stools; butterfly-shaped rash on the nose and cheeks; change in the amount of urine produced; change in the appearance of a mole; chest pain; dark urine; dizziness; fainting; fast, slow, or irregular heartbeat; flushing; joint or muscle pain; loss of appetite; nausea, vomiting, or diarrhea; numbness or tingling of the skin, arms, or legs; pale stools; red, swollen, blistered, or peeling skin; seizures; severe or persistent headache; severe or persistent stomach or back pain; shortness of breath; sudden, unexplained weight gain or loss; suicidal thoughts or attempts; swelling of the hands, legs, feet, or ankles; symptoms of infection (eg, fever or chills, painful or frequent urination, persistent cough or sore throat, flu-like symptoms, persistent feeling of being unwell, unusual vaginal discharge or odor, white patches in the mouth, red or painful skin); trouble swallowing; unusual bruising or bleeding; unusual lumps; unusual skin growths or other skin changes; unusual tiredness or weakness; very pale skin; vision changes; weakness in the arms or legs; yellowing of the skin or eyes. AN ALLERGIC REACTION to this medicine is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue. 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. You may report side effects toFDA at 1-800-FDA-1088.
Overdose:If overdose is suspected, contact your local poison control center or emergency room immediately.
Additional Information:DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. DO NOT USE THIS MEDICINE for other health conditions. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor, nurse, or pharmacist to explain local regulations for selecting an appropriate container and properly disposing of the container when it is full. CHECK WITH YOUR PHARMACIST about how to dispose of unused medicine.
Copyright 2014 Wolters Kluwer Health, Inc.