Infliximab-dyyb (in-FLIX-i-mab - dyyb)

Treats ankylosing spondylitis, Crohn disease, plaque psoriasis, psoriatic arthritis, rheumatoid arthritis, and ulcerative colitis.

Brand Name(s):

Inflectra, Zymfentra PFS with Needle Shield, Zymfentra Pen

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your dose and schedule. This medicine is given through an IV placed into a vein or as a shot under your skin of your stomach, thigh, or upper arm.
• You may also receive other medicines (including allergy medicine, fever medicine, steroids) before starting treatment to help prevent possible unwanted effects during the injection.
• A nurse or other health provider will give you this medicine.
• You may be taught how to give your medicine at home. Make sure you understand all instructions before giving yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.
• You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. Do not inject into skin areas that are red, bruised, tender, damaged, hard, or areas with scars
• This medicine is available in 4 forms: vial, prefilled syringe, prefilled pen with needle shield, and prefilled pen.
• To use the prefilled pen:
  • Wash your hands with soap and water before and after using this medicine.
  • Allow 30 minutes for the pen to warm up to room temperature. Do not warm using other heat sources (including hot water or microwave).
  • Check the liquid in the pen. It should be clear, colorless to pale brown. Do not use it if it is cloudy, discolored, or has particles in it. Do not use the pen if it is cracked or damaged. It is normal to see air bubbles in the liquid. Do not shake.
  • Gently pull the cap straight off. Do not recap the prefilled pen. Do not touch the needle.
  • Hold the pen so that you can see the window. Without pinching or stretching the skin, place the pen over the skin at a 90 degree angle.
  • Press the pen firmly against the skin. When the injection starts, you will hear the first loud "click" and the purple plunger rod will begin to fill the window.
  • Keep holding the pen firmly and listen for the second loud "click". This can take up to 10 seconds. Do not change the position of the pen after injection has started.
  • After you hear the second loud "click" continue to hold the pen firmly and slowly count to 5 to make sure you have received the full dose.
  • Make sure that the purple plunger rod is filling the window completely.
• To use the prefilled syringe:
  • Wash your hands with soap and water before and after using this medicine.
  • Allow 30 minutes for the pen to warm up to room temperature. Do not warm using other heat sources (including hot water or microwave).
  • Check the liquid in the syringe. It should be clear, colorless to pale brown. Do not use it if it is cloudy, discolored, or has particles in it. Do not use the pen if it is damaged or has been dropped. It is normal to see air bubbles in the liquid. Do not shake.
  • Gently pull the cap straight off. Do not pull back on plunger rod. Do not touch the needle.
  • Hold the syringe in one hand between your thumb and index finger. Pinch the skin around the injection site with one hand. With a quick "dart-like" motion, insert the needle completely at a 45 degree angle. Do not change the position of the syringe.
  • Push the plunger down slowly and as far as it will go until the syringe is empty. Remove the needle from the skin at the same angle it was inserted.
• To use the prefilled syringe with needle shield:
  • Wash your hands with soap and water before and after using this medicine.
  • Allow 30 minutes for the pen to warm up to room temperature. Do not warm using other heat sources (including hot water or microwave).
  • Check the liquid in the syringe. It should be clear, colorless to pale brown. Do not use it if it is cloudy, discolored, or has particles in it. Do not use the pen if it is cracked or damaged. It is normal to see air bubbles in the liquid. Do not shake.
  • Gently pull the cap straight off. Do not pull back on plunger rod. Do not touch the needle.
  • Hold the syringe in one hand between your thumb and index finger. Pinch the skin around the injection site with one hand. With a quick "dart-like" motion, insert the needle completely at a 45 degree angle. Do not change the position of the syringe.
  • Push the plunger down slowly and as far as it will go until the syringe is empty. Slowly lift your thumb from the plunger until the needle is completely covered by the needle guard.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Call your doctor or pharmacist for instructions.
• If you store this medicine at home, keep it in the refrigerator. Do not freeze.
• Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines may affect how infliximab-dyyb works. Tell your doctor if you are using any of the following:
  • Abatacept, anakinra, cyclosporine, theophylline, tocilizumab
  • Blood thinner (including warfarin)
  • Medicine that weakens immune system (including ciprofloxacin, methotrexate, metronidazole, aminosalicylate medicine, steroid)
• Tell your doctor if you have had light treatment for psoriasis.
• This medicine may interfere with vaccines. Ask your doctor before you get a flu shot or any other vaccines.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have liver disease, heart disease, COPD, a bleeding disorder, blood or bone marrow problems, cancer, diabetes, or any type of infection. Tell your doctor if you have a history of seizures, multiple sclerosis, Guillain-Barré syndrome or a similar nervous system disease, or frequent or serious infections (including tuberculosis or hepatitis B).
• This medicine may cause the following problems:
  • Increased risk for infections
  • Increased risk of certain cancers (including lymphoma, skin cancer, cervical cancer)
  • Liver problems
  • Infusion reaction (including heart attack, stroke, changes in blood pressure, or heart rhythm problems)
  • Lupus-like syndrome
• You will need to have a skin test for tuberculosis (TB) before you start this medicine. Tell your doctor if you or anyone in your home has ever had a positive TB skin test or been exposed to TB.
• This medicine may make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury. Wash your hands often.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Change in how much or how often you urinate, pain while urinating
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Fever, chills, cough, runny or stuffy nose, sore throat, body aches
• Headache, lightheadedness, trouble breathing
• Joint or muscle pain, swelling, trouble swallowing
• Seizures, numbness, tingling, problems with vision, speech, or walking
• Unusual bleeding, bruising, tiredness, weakness
• Warm, red, swollen, or painful skin, blisters, skin sores

If you notice these less serious side effects, talk with your doctor:

• Diarrhea
• Redness, pain, or swelling where the needle is placed

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088