What is the most important information I should know about ZYMFENTRA?

ZYMFENTRA may cause serious side effects, including:
1. Risk of infection
ZYMFENTRA is a medicine that affects your immune system. ZYMFENTRA can lower the ability of your immune system to fight infections. Serious infections have happened in patients receiving ZYMFENTRA. These infections include tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some patients have died from these infections.

• Your doctor should test you for TB before starting ZYMFENTRA.
• Your doctor should monitor you closely for signs and symptoms of TB during treatment with ZYMFENTRA.

• think you have an infection. You should not start receiving ZYMFENTRA if you have any kind of infection.
• are being treated for an infection.
• have signs of an infection, such as a fever, cough, flu-like symptoms.
• have any open cuts or sores on your body.
• get a lot of infections or have infections that keep coming back.
• have diabetes or an immune system problem as people with these conditions have a higher chance for getting infections.
• have TB, or have been in close contact with someone with TB.
• live or have lived in certain parts of the country (such as the Ohio and Mississippi River valleys) where there is an increased risk for getting certain kinds of fungal infections (histoplasmosis, coccidioidomycosis, or blastomycosis); these infections may develop or become more severe if you receive ZYMFENTRA. If you do not know if you have lived in an area where histoplasmosis, coccidioidomycosis, or blastomycosis is common, ask your doctor.
• have or have had hepatitis B.
• use the medicines KINERET (anakinra), ORENCIA (abatacept), or other medicines called biologics used to treat the same conditions as ZYMFENTRA.

After starting ZYMFENTRA, if you have an infection, any sign of an infection including a fever, cough, flu-like symptoms, or have open cuts or sores on your body, call your doctor right away. ZYMFENTRA can make you more likely to get infections or make any infection that you have worse.

2. Risk of Cancer

• There have been cases of unusual cancers in children and teenage patients using tumor necrosis factor (TNF) blocker medicines, such as ZYMFENTRA.
• For people receiving TNF blocker medicines, including ZYMFENTRA, the chances of getting lymphoma or other cancers may increase.
• Some people receiving TNF blockers, including ZYMFENTRA, developed a rare type of cancer called hepatosplenic T-cell lymphoma. This type of cancer often results in death. Most of these people were male teenagers or young men. Also, most people were being treated for Crohn's disease or ulcerative colitis with a TNF blocker and another medicine called azathioprine or 6-mercaptopurine.
• People who have been treated for Crohn's disease and ulcerative colitis, for a long time may be more likely to develop lymphoma. This is especially true for people with very active disease.
• Some people treated with infliximab products, such as ZYMFENTRA, have developed certain kinds of skin cancer. If any changes in the appearance of your skin or growths on your skin occur during or after your treatment with ZYMFENTRA, tell your doctor.
• Patients with Chronic Obstructive Pulmonary Disease (COPD), a specific type of lung disease, may have an increased risk for getting cancer while being treated with ZYMFENTRA.
• Tell your doctor if you have ever had any type of cancer. Discuss with your doctor any need to adjust medicines you may be taking.

• moderately to severely active ulcerative colitis following treatment with an infliximab product given by intravenous infusion (IV).
• moderately to severely active Crohn's disease following treatment with an infliximab product given by intravenous infusion (IV). 

• have had an allergic reaction to ZYMFENTRA, other infliximab products, any murine proteins or any of the ingredients in ZYMFENTRA. See the end of this Medication Guide for a complete list of ingredients in ZYMFENTRA.

Before you receive ZYMFENTRA, tell your doctor all of your medical conditions, including if you: 

• have an infection (see "What is the most important information I should know about ZYMFENTRA?").
• have other liver problems including liver failure.
• have heart failure or other heart conditions. If you have heart failure, it may get worse while you receive ZYMFENTRA.
• have or have had any type of cancer.
• have COPD (Chronic Obstructive Pulmonary Disease), a specific type of lung disease. Patients with COPD may have an increased risk of getting cancer while receiving ZYMFENTRA.
• have or have had a condition that affects your nervous system such as:
  - multiple sclerosis, or Guillain-Barré syndrome, or
  - if you experience any numbness or tingling, or
  - if you have had a seizure.

• have recently received or are scheduled to receive a vaccine. Adults receiving ZYMFENTRA should not receive live vaccines (for example, the Bacille Calmette-Guérin [BCG] vaccine) or treatment with a weakened bacteria (such as BCG for bladder cancer). Adults should have all of their vaccines brought up to date before starting treatment with ZYMFENTRA.
• are pregnant or plan to become pregnant, are breastfeeding or plan to breastfeed. You and your doctor should decide if you should receive ZYMFENTRA while you are pregnant or breastfeeding.

If you have a baby and you were receiving ZYMFENTRA during your pregnancy, it is important to tell your baby's doctor and other healthcare professionals about your ZYMFENTRA use so they can decide when your baby should receive any vaccine. Certain vaccinations can cause infections.

If you received ZYMFENTRA while you were pregnant, your baby may be at higher risk for getting an infection. If your baby receives a live vaccine within 6 months after birth, your baby may develop infections with serious complications that can lead to death. This includes live vaccines such as the BCG, rotavirus, or any other live vaccines. For other types of vaccines, talk with your doctor.

• Use ZYMFENTRA exactly as your doctor tells you to.

Read the detailed Instructions for Use at the end of this Medication Guide for insructions about how to prepare and inject a dose of ZYMFENTRA, and how to properly throw away (dispose of) used needles and syringes. The syringe and needle must never be re-used. After the rubber stopper is puntured, ZYMFENTRA can become contaiminated by harmful bacteria which could cause an infection if re-used. Therefore, throw away any unused portion of ZYMFENTRA.

What should I avoid while taking ZYMFENTRA?
Do not take ZYMFENTRA together with other medicines medicines called biologics that are used to treat the same conditions as ZYMFENTRA.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. These include any other medicines to treat Crohn's disease, or ulcerative colitis.

Know the medicines you take. Keep a list of your medicines and show them to your doctor and pharmacist when you get a new medicine.

Tell your doctor about any side effect that bothers you or does not go away.

These are not all of the side effects with ZYMFENTRA. Ask your doctor or pharmacist for more information.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store ZYMFENTRA? 

• Store ZYMFENTRA prefilled syringes and prefilled pens in a refrigerator between 36°F to 46°F (2°C to 8°C).
• If needed, ZYMFENTRA prefilled syringes and prefilled pens may be stored at room temperature between 68°F to 77°F (20°C to 25°C) for up to 14 days with protection from light.
• When ZYMFENTRA prefilled syringes and prefilled pens have reached room temperature, do not put ZYMFENTRA back in the refrigerator. ZYMFENTRA must be thrown away (discarded) if not used within the 14 days.
• Do not freeze ZYMFENTRA. 
• Do not shake ZYMFENTRA.
• Keep ZYMFENTRA in the original carton until ready to use to protect it from light. 

General information about ZYMFENTRA
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide.

You can ask your doctor or pharmacist for information about ZYMFENTRA that is written for health professionals.

Do not use ZYMFENTRA for a condition for which it was not prescribed. Do not give ZYMFENTRA to other people, even if they have the same symptoms that you have. 

For more information call 1-888-804-3433.

What are the ingredients in ZYMFENTRA?
The active ingredient is infliximab-dyyb.

The inactive ingredients in ZYMFENTRA include: acetic acid, polysorbate 80, sodium acetate, and sorbitol in water for injections. No preservatives are present.