Learn more about usage, cautions, and possible side effects .
Chemical Name: INFLIXIMAB (in-FLIX-i-mab)
Remicade 100mg Solution is a monoclonal antibody used along with methotrexate to reduce inflammation and other symptoms associated with moderate to severe rheumatoid arthritis. Remicade 100mg Solution is also used to treat the signs and symptoms of ankylosing spondylitis, psoriatic arthritis, and certain types of severe skin psoriasis. It is used to reduce symptoms of moderate to severe Crohn disease or ulcerative colitis in patients who have not received relief from other treatments. It may also be used to treat other conditions as determined by your doctor.
WARNING: PATIENTS WHO USE REMICADE 100mg SOLUTION HAVE AN INCREASED RISK OF INFECTION. Severe and sometimes fatal infections, including tuberculosis (TB), invasive fungal infections, and sepsis have occurred in patients who use Remicade 100mg Solution. Most patients who developed these infections were using Remicade 100mg Solution along with certain other medicines (methotrexate or corticosteroids). Before receiving and while using Remicade 100mg Solution, patients should be tested for TB infection with a skin test. TB should be treated before starting Remicade 100mg Solution. Tell your doctor right away if you develop symptoms of infection such as fever, persistent sore throat, unusual vaginal discharge, or painful or frequent urination while you use Remicade 100mg Solution. RARELY, TEENAGERS AND YOUNG ADULTS USING REMICADE 100mg SOLUTION TO TREAT CROHN DISEASE OR ULCERATIVE COLITIS HAVE DEVELOPED A RARE TYPE OF CANCER CALLED HEPATOSPLENIC T-CELL LYMPHOMA. This type of cancer is usually fatal. Patients who developed this cancer were using Remicade 100mg Solution 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 Remicade 100mg Solution. INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. DO NOT USE REMICADE 100mg SOLUTION if you are also using anakinra. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are using costimulation modulators (such as abatacept) or immunosuppressants (such as cyclosporine). DO NOT START OR STOP any medicine without doctor or pharmacist approval. INFORM YOUR DOCTOR IF YOU HAVE A HISTORY of chronic or recurrent infections, liver problems (such as Hepatitis B), heart problems (such as congestive heart failure), immune system problems, nervous system problems (such as seizures, multiple sclerosis, Guillain-Barre syndrome, CNS demyelinating disease), blood disorders, bone marrow problems, diabetes, lymphoma, cancer, smoking, or treatment with phototherapy for skin conditions. INFORM YOUR DOCTOR IF YOU HAVE recently been around someone who might have TB, if you were born in an area where TB is common, or if you have visited or lived in an area where TB, histoplasmosis, coccidiodomycosis, or blastomycosis infections are common. Inform your doctor of any other medical conditions including any recent or scheduled vaccination; chronic obstructive pulmonary disease (COPD); any type of infection (including bacterial or viral), skin infection, fungal infection (such as histoplasmosis, coccidioidomycosis), TB infection, or a positive TB test; allergies; pregnancy; or breastfeeding. USE OF REMICADE 100mg SOLUTION IS NOT RECOMMENDED if you have moderate to severe heart failure and you need doses higher than 5 mg/kg of Remicade 100mg Solution, or if you have an active serious infection. Contact your doctor or pharmacist if you have any questions or concerns about taking Remicade 100mg Solution.
Follow the directions for using Remicade 100mg Solution provided by your doctor. Remicade 100mg Solution comes with a MEDICATION GUIDE approved by the U.S. Food and Drug Administration. Read it carefully each time you refill Remicade 100mg Solution. Ask your doctor, nurse, or pharmacist any questions that you may have about Remicade 100mg Solution. Remicade 100mg Solution is usually administered as an infusion at your doctor's office, hospital, or clinic. STORE REMICADE 100mg SOLUTION as directed on the prescription label. IF YOU MISS A DOSE OF REMICADE 100mg SOLUTION, contact your doctor immediately.
DO NOT USE REMICADE 100mg SOLUTION if you have had an allergic reaction to it, to murine (mouse) proteins, or to any ingredient in this product. ALLERGIC REACTIONS HAVE OCCURRED UP TO 12 DAYS after use of Remicade 100mg Solution. Tell your doctor if symptoms such as fever, rash, headache, or muscle or joint pain occur. Laboratory and/or medical tests, including liver function and blood counts, may be performed to monitor your progress or to check for side effects. KEEP ALL DOCTOR AND LABORATORY APPOINTMENTS while you are using Remicade 100mg Solution. BEFORE YOU HAVE ANY MEDICAL OR DENTAL TREATMENTS, EMERGENCY CARE, OR SURGERY, tell the doctor or dentist that you are using Remicade 100mg Solution. REMICADE 100mg SOLUTION MAY LOWER YOUR RESISTANCE TO INFECTION. Prevent infection by avoiding contact with people who have colds or other infections. Do not touch your eyes or the inside of your nose unless you have thoroughly washed your hands first. If you develop a fever, feel very tired, have a cough, or have flu-like symptoms, contact your doctor at once. IF YOU LIVE IN OR HAVE RECENTLY VISITED AN AREA WHERE HISTOPLASMOSIS OR COCCIDIOIDOMYCOSIS fungal infections are common, tell your doctor. Ask your doctor if you have questions about whether these infections are common in a particular area. REMICADE 100mg SOLUTION 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. REMICADE 100mg SOLUTION MAY INCREASE THE RISK OF DEVELOPING LYMPHOMA (blood cancer) or other cancer. Contact your doctor right away if you have unusual lumps or swelling (such as in your neck, armpit, or groin); night sweats; recurring fever; unusual tiredness; unexplained cough or breathlessness; persistent unexplained itching; or unexplained weight loss. RARELY, SEVERE LIVER PROBLEMS HAVE OCCURRED with use of Remicade 100mg Solution. These liver problems may occur more than a year after starting Remicade 100mg Solution. Contact your doctor right away if you develop dark urine, severe or persistent stomach pain, or yellowing of the skin or eyes. Remicade 100mg Solution may cause dizziness. DO NOT DRIVE, OPERATE MACHINERY, OR DO ANYTHING ELSE THAT COULD BE DANGEROUS until you know how you react to Remicade 100mg Solution. BEFORE YOU BEGIN TAKING ANY NEW MEDICINE, either prescription or over-the-counter, check with your doctor or pharmacist. DO NOT RECEIVE A LIVE VACCINE(such as measles or mumps) while you are using Remicade 100mg Solution. CHECK WITH YOUR DOCTOR BEFORE HAVING ANY OTHER IMMUNIZATIONS (VACCINATIONS) while you are using Remicade 100mg Solution. CAUTION IS ADVISED WHEN USING REMICADE 100mg SOLUTION IN THE ELDERLY because they may be more sensitive to the effects of the medicine, especially the risk of infection. CAUTION IS ADVISED WHEN USING REMICADE 100mg SOLUTION IN CHILDREN because they may be more sensitive to the effects of the medicine. FOR WOMEN: IF YOU PLAN ON BECOMING PREGNANT, discuss with your doctor the benefits and risks of using Remicade 100mg Solution during pregnancy. IT IS UNKNOWN IF REMICADE 100mg SOLUTION IS EXCRETED in breast milk. DO NOT BREAST-FEED while taking Remicade 100mg Solution.
SIDE EFFECTS that may occur while using Remicade 100mg Solution include back pain; headache; pain, redness, or swelling at the injection site; runny or stuffy nose; mild stomach pain or upset; or tiredness. If they continue or are bothersome, check with your doctor. CHECK WITH YOUR DOCTOR AS SOON AS POSSIBLE if you experience sudden unexplained weight gain, severe tiredness or weakness, unexplained loss of weight or appetite, or persistent feeling of being unwell. CONTACT YOUR DOCTOR IMMEDIATELY if you experience bloody or black, tarry stools; change in the amount of urine produced; chest pain; dark brown-colored urine; dizziness; fainting; fast, slow, or irregular heartbeat; fever, chills, cough, persistent sore throat, or unusual sweating; flu-like symptoms; flushing; joint or muscle pain; numbness or tingling of the skin, arms, or legs; painful urination; rash on the cheeks or arms that gets worse in the sun; red, warm, or painful skin; seizures; shortness of breath; severe or persistent headache; severe or persistent stomach or back pain; suicidal thoughts or attempts; swelling of the hands, legs, or ankles; trouble swallowing; unusual bruising or bleeding; unusual lumps; unusual vaginal discharge or odor; upper respiratory tract infection; very pale skin; vision changes; weakness in arms or legs; white patches or sores in the mouth; or yellowing of the skin or eyes. An allergic reaction to Remicade 100mg Solution is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include rash; hives; itching; swelling of the mouth, face, lips, or tongue; tightness in the chest; or trouble breathing. This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your healthcare provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Drug interactions can result in unwanted side effects or prevent a medicine from doing its job. Use our drug interaction checker to find out if your medicines interact with each other. Check drug interactions
If overdose is suspected, contact your local poison control center or emergency room immediately.
DO NOT SHARE REMICADE 100mg SOLUTION with others for whom it was not prescribed. DO NOT USE REMICADE 100mg SOLUTION for other health conditions. KEEP THIS PRODUCT, as well as syringes and needles, out of the reach of children and pets. 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.
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