Zymfentra contains the active ingredient infliximab-dyyb, which is a TNF blocker and a chimeric IgG1κ monoclonal antibody. It is formulated as an injection for subcutaneous use and comes in a sterile, preservative-free solution that is either colorless or pale brown. Zymfentra is supplied in a prefilled syringe or pen with a fixed needle.

How should I use this medication?

This medication is injected under the skin. You will be taught how to prepare and give it. Take it as directed on the prescription label. Keep taking it unless your care team tells you to stop.

It is important that you put your used needles and syringes in a special sharps container. Do not put them in a trash can. If you do not have a sharps container, call your pharmacist or care team to get one.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

This medication comes with INSTRUCTIONS FOR USE. Ask your pharmacist for directions on how to use this medication. Read the information carefully. Talk to your pharmacist or care team if you have questions.

Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. Then, take your next dose 2 weeks later. Do not take double or extra doses.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store in a refrigerator. Do not freeze. Keep this medication in the original packaging until you are ready to take it. Protect from light. Get rid of any unused medication after the expiration date.

If needed, this medication may be stored at room temperature between 20 and 25 degrees C (68 and 77 degree F) for up to 14 days. Do not put it back in the refrigerator after it has reached room temperature. Get rid of any unused medication after 14 days.

To get rid of medications that are no longer needed or expired:

• Take the medication to a take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, ask your pharmacist or care team how to get rid of it safely.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Heart failure—shortness of breath, swelling of the ankles, feet, or hands, sudden weight gain, unusual weakness or fatigue
• Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Low red blood cell level—unusual weakness or fatigue, dizziness, headache, trouble breathing
• Lupus-like syndrome—joint pain, swelling, or stiffness, butterfly-shaped rash on the face, rashes that get worse in the sun, fever, unusual weakness or fatigue
• Pain, tingling, or numbness in the hands or feet, muscle weakness, change in vision, confusion or trouble speaking, loss of balance or coordination, trouble walking, seizures
• Unusual bruising or bleeding

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Cough
• Diarrhea
• Headache
• Pain, redness, or irritation at injection site
• Runny or stuffy nose
• Sore throat
• Stomach pain

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Cancer
• COPD, including chronic bronchitis and emphysema
• Cut or sore on your skin that has not healed
• Diabetes
• Have had hepatitis
• Have had light therapy
• Have tuberculosis (TB) or have been in close contact with someone who does
• Heart disease
• Infection
• Infection that does not go away or keeps coming back
• Live or have lived in the Ohio or Mississippi River valleys
• Liver disease
• Nervous system conditions, such as Guillain-Barre syndrome, multiple sclerosis, seizures
• Recent or upcoming vaccine
• Weakened immune system
• An unusual or allergic reaction to infliximab, mouse proteins, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

What may interact with this medication?

Do not take this medication with any of the following:

• Live virus vaccines
• Other TNF blockers

This medication may also interact with the following:

• Abatacept
• Anakinra
• Cyclosporine
• Methotrexate
• Theophylline
• Tocilizumab
• Warfarin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse.

You may need blood work done while you are taking this medication.

This medication may increase your risk of getting an infection. Call your care team for advice if you get a fever, chills, sore throat, or other symptoms of a cold or flu. Do not treat yourself. Try to avoid being around people who are sick.

Your care team will screen you for tuberculosis (TB) before you start this medication. If they think you are at risk, you may be treated with medication for TB. You should start taking the medication for TB before you start this medication. Make sure to finish the full course of TB medication.

Talk to your care team about your vaccination history. You should not receive live vaccines while you're being treated with this medication and until your care team tells you that your immune system is no longer weakened. You may need to get some vaccines before you start treatment. If you need a non-live vaccine while you are being treated, talk to your care team.

Talk to your care team about your risk of cancer. You may be more at risk for certain types of cancer if you take this medication. People with active disease who take this medication for a long time may be at risk of lymphoma. Other people have developed skin, lung, or cervical cancer. The risk of lung cancer is increased in people with chronic obstructive pulmonary disease (COPD). Some people have developed a rare type of lymphoma that affects the liver and spleen. Most of these people were male teens or young adults. Also, they were taking certain other medications for Crohn disease or ulcerative colitis.To lower your risk of skin cancer, keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and sunscreen. Do not use sun lamps, tanning beds, or tanning booths.

Before having surgery or dental work, talk to your care team to make sure it is ok. This medication can increase the risk of poor healing of your surgical site or wound.

What are the most serious risks of this medication?

This medication affects your immune system. It can reduce your body's ability to fight off infections. This increases your risk of infection. It also increases your risk of serious infection. Tell your care team about any infections you have now or have had in the past that keep coming back. Also tell them about all the medications you take. Talk to your care team right away if you have fever, cough, sore throat, wounds that don't heal, or feeling of being unwell while you are taking this medication.