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InFLIXimab-abda

Generic Name: InFLIXimab-abda (in FLIKS e mab)
Brand Name: Renflexis

Warning

  • Very bad and sometimes deadly infections have happened in patients who take inFLIXimab-abda. Most people who had these infections were taking other drugs to lower the immune system like methotrexate or steroid drugs. If you have any infection, are taking antibiotics now or in the recent past, or have had many infections, talk with your doctor.
  • TB (tuberculosis) has been seen in patients started on this medicine. These patients were exposed to TB in the past, but never got the infection. You will be tested to see if you have been exposed to TB before starting inFLIXimab-abda.
  • Lymphoma and other cancers have happened in people who take this medicine 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 inFLIXimab-abda 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.

Uses of InFLIXimab-abda:

  • It is used with methotrexate to prevent more problems in patients with moderate to very bad rheumatoid arthritis.
  • It is used to treat Crohn's disease.
  • It is used to treat psoriatic arthritis.
  • It is used to treat plaque psoriasis.
  • It is used to treat ankylosing spondylitis.
  • It is used to treat ulcerative colitis.
  • It may be given to you for other reasons. Talk with the doctor.

What do I need to tell my doctor BEFORE I take InFLIXimab-abda?

  • If you have an allergy to infliximab or any other part of this medicine.
  • If you are allergic to mouse proteins, talk with the doctor.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you have heart failure (weak heart).
  • If you are taking any of these drugs: Abatacept or anakinra.
  • If you are taking or will be taking another drug like this one.
  • If you are breast-feeding. Do not breast-feed while you take inFLIXimab-abda.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take inFLIXimab-abda with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take InFLIXimab-abda?

  • Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
  • This medicine may lower the ability of your bone marrow to make blood cells that your body needs. This can lead to very bad and sometimes deadly bleeding problems or infections. Tell your doctor right away if you have 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, a wound that will not heal; any bruising or bleeding; or if you feel very tired or weak.
  • Talk with your doctor before getting any vaccines. Use of some vaccines with inFLIXimab-abda may raise the chance of an infection.
  • Do not get a weakened bacteria like BCG for bladder cancer while you use this medicine. Talk with your doctor.
  • Have your skin checked. Tell your doctor if you have 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.
  • If you have had hepatitis B before or carry the virus, inFLIXimab-abda can cause the virus to become active. This can lead to very bad and sometimes deadly liver problems. You will be tested for hepatitis B before starting this medicine. You will need to watch for signs of hepatitis while taking inFLIXimab-abda and for several months after stopping it. Talk with your doctor.
  • Rarely, people using drugs like this one have had nervous system problems. Sometimes, these problems have not gone away. Call your doctor right away if you have a burning, numbness, or tingling feeling that is not normal; change in eyesight; dizziness; seizures; or weakness in your arms or legs.
  • Very bad and sometimes deadly liver problems have happened with this medicine. Call your doctor right away if you have 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.
  • Abnormal heartbeats, heart attacks, high or low blood pressure, and strokes have happened during and within 24 hours after the infusion. Sometimes, heart attacks have been deadly. Loss of eyesight has also happened during and within 2 hours after the infusion. Talk with the doctor.
  • If you are 60 or older, use inFLIXimab-abda with care. You could have more side effects.
  • Use with care in children. Talk with the doctor.
  • If using in a child, make sure your child is up to date with all vaccines.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
  • If you used inFLIXimab-abda when you were pregnant, tell your baby's doctor. Your baby may have a higher chance of getting an infection for at least 6 months after birth. Your baby's doctor will also need to decide when your baby is to get any vaccines. Certain vaccines may cause infections that can lead to very bad health problems or death if given within 6 months after birth.

How is this medicine (InFLIXimab-abda) best taken?

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • It is given as an infusion into a vein over a period of time.
  • You may have more chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take inFLIXimab-abda.

What do I do if I miss a dose?

  • Call your doctor to find out what to do.

Dosage Information (comprehensive)

What are some side effects that I need to call my doctor about right away?

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 doctor or get medical help right away if you have 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 or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • 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 or low blood pressure like very bad headache or dizziness, passing out, change in eyesight.
  • Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
  • Chest pain or pressure.
  • Very bad back pain.
  • Trouble swallowing.
  • Pale skin.
  • Swollen gland.
  • Night sweats.
  • A big weight loss.
  • Loss of eyesight.
  • Black, tarry, or bloody stools.
  • A skin lump or growth.
  • Fast or slow heartbeat.
  • Red scaly patches or bumps that are pus filled.
  • Fever, chills, itching, hives, chest pain or pressure, or shortness of breath when drug is given. Other drugs may be given to avoid these.
  • Heart failure has happened with this medicine, as well as heart failure that has gotten worse in people who already have it. Tell your doctor if you have heart disease. Call your doctor right away if you have 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.
  • 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 you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.

What are some other side effects of InFLIXimab-abda?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Headache.
  • Upset stomach or throwing up.
  • Belly pain.
  • Feeling tired or weak.
  • Flushing.
  • Irritation where the shot is given.
  • Signs of a common cold.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Side Effects (complete list)

If OVERDOSE is suspected:

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.

How do I store and/or throw out InFLIXimab-abda?

  • If you need to store inFLIXimab-abda at home, talk with your doctor, nurse, or pharmacist about how to store it.

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.
  • This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time this medicine is refilled. If you have any questions about inFLIXimab-abda, please talk with the doctor, pharmacist, or other health care provider.
  • Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your 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 inFLIXimab-abda 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 inFLIXimab-abda. 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.

Review Date: December 6, 2017

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