Patient information: uses, side effects, how to take - Zymfentra

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.

Before starting ZYMFENTRA, tell your doctor if you:

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.

See the section "What are the possible side effects of ZYMFENTRA?" below for more information.

What is ZYMFENTRA?

ZYMFENTRA is a prescription medicine used as an injection uner the skin (subcutaneous injection) by adults for the maintenance treatment of:

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).

It is not known if ZYMFENTRA is safe and effective in children under 18 years of age.

Do not take ZYMFNETRA if you:

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.

How should I receive ZYMFENTRA?

Use ZYMFENTRA exactly as your doctor tells you to.

ZYMFENTRA is provided as a single-dose prefilled syringe, single-dose prefilled syringe with needle guard or single-dose prefilled pen. Your healthcare provider will prescribe the type that is best for you.
If your healthcare provider decides that you or your cargiver can give your injections of ZYMFENTRA at home, you or your caregiver should be shown the right way to prepare and inject ZYMFENTRA.
Do not try to inject ZYMFENTRA yourself until you or your caregiver have been shown how to inject ZYMFENTRA by your healthcare provider.
ZYMFENTRA is injected under your skin (subcutaneously) 1 time every two weeks.
Inject ZYMFENTRA under the skin (subcutaneous injection), in your upper arms, stomach area (abdomen), or upper legs (thighs).
Do no give an injection in an area of the skin that is tender, bruised, red or hard.
Use a different injection site each time you use ZYMFENTRA.
If you are not able to inject ZYMFENTRA at your regular scheduled time or you miss a dose of ZYMFENTRA, inject the dose as soon as possible. Then, inject your next dose every two weeks thereafter. If you are not sure when to inject ZYMFENTRA, call your healthcare provider.
If you inject more than prescribed, call your doctor right away.
Be sure to keep all of your scheduled follow-up appointments.

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.

What are the possible side effects of ZYMFENTRA?

ZYMFENTRA can cause serious side effects, including (see "What is the most important information I should know about ZYMFENTRA ?"):

Serious Infections

Some patients, especially those 65 years and older have had serious infections while receiving infliximab products, such as ZYMFENTRA. These serious infections include TB and infections caused by viruses, fungi, or bacteria that have spread throughout the body or cause infections in certain areas (such as skin). Some patients die from these infections. If you get an infection while receiving treatment with ZYMFENTRA your doctor will treat your infection and may need to stop your ZYMFENTRA treatment.
Tell your doctor right away if you have any of the following signs of an infection while receiving or after receiving ZYMFENTRA:

a fever
feel very tired
have a cough

have flu-like symptoms
warm, red, or painful skin

Your doctor will examine you for TB and perform a test to see if you have TB. If your doctor feels that you are at risk for TB, you may be treated with medicine for TB before you begin treatment with ZYMFENTRA and during treatment with ZYMFENTRA.
Even if your TB test is negative, your doctor should carefully monitor you for TB infections while you are receiving ZYMFENTRA. Patients who had a negative TB skin test before receiving infliximab products may develop active TB after receiving infliximab products.
If you are a chronic carrier of the hepatitis B virus, the virus can become active while you are being treated with ZYMFENTRA. In some cases, patients have died as a result of hepatitis B virus being reactivated. Your doctor should do a blood test for hepatitis B virus before you start treatment with ZYMFENTRA, while you are being treated and for several months after you finish treatment. Tell your doctor if you have any of the following symptoms:

feel unwell
poor appetite

tiredness (fatigue)
fever, skin rash, or joint pain

Liver Injury

Some patients receiving infliximab products have developed serious liver problems. Tell your doctor if you have:

jaundice (skin and eyes turning yellow)
dark, brwon-colored urine
pain on the right side of your stomach area (right-sided abdominal pain)

fever
extreme tiredness (sevre fatigue)

Heart Failure

If you have a heart problem called congestive heart failure, your doctor should check you closely while you are receiving ZYMFENTRA. Your congestive heart failure may get worse while you are receiving ZYMFENTRA. Be sure to tell your doctor of any new or worse symptoms including:

shortness of breath
swelling of ankles or feet

sudden weight gain

Treatment with ZYMFENTRA may need to be stopped if you get new or worse congestive heart failure.

Blood Probelms

In some patiens receiving infliximab products, the body may not make enough of the blood cells tha help fight infections or help stop bleeding. Tell your doctor if you:

have a fever that does not go away
bruise or bleed very easily

look very pale

Allergic Reactions

Some patients have had allergic reactions to infliximab products. Some of these reactions were severe. These reactions can happen while you are getting your ZYMFENTRA treatment or shortly afterward. Your doctor may need to stop or pause your treatment with ZYMFENTRA and may give you medicines to treat the allergic reaction. Signs of an allergic reactio can include:

hives (red, raised, itchy patches of skin)
difficulty breathing
chest pain

high or low blood pressure
fever
chills

Some patients treated with infliximab products have had delayed allergic reactions. Tell your doctor right away if you have any of these signs of delayed reaction to ZYMFENTRA:

fever
rash
headache
sore throat

muscle or joint pain
swelling of the face and hands
difficulty swallowing

Nervous System Disorders

Some patients receiving infliximab products have developed problems with their nervous system. Tell your doctor if you have:

changes in your vision
numbness or tingling in any part of your body

seizures
weakness in your arms or legs

Some patients have experienced a stroke within approximately 24 hours of their infusion with infliximab products. Tell your doctor right away if you have symptoms of a stroke which may include: numbness or weakness of the face, arm, or leg, especially on one side of the body; sudden confusion, trouble speaking or understanding; sudden trouble seeing in one or both eyes, sudden trouble walking, dizziness, loss of balance or coordination or a sudden, severe headache.

Lupus-like Syndrome

Some patient have developed symptoms that are like the symptoms of Lupus. If you develop any of the following symptoms, your doctor may decide to stop your treatment with ZYMFENTRA:

chest disomfort or painthat does not go away
shortness of breath

joint pain
rash on the cheeks or arms that gets worse in the sun

The most common side effects of ZYMFENTRA include:

COVID-19
respiratory infections, such as sinus infections and sore throat
injection site reactions
headache
abdominal pain
abnormal liver enzymes

joint pain
diarrhea
high blood pressure
urinary tract infections
dizziness

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.

Manufactured by: CELLTRION, Inc. 23, Academy-ro, Yeonsu-gu, Incheon, 22014, Republic of Korea

U.S. License No. 1996 ^©CELLTRION, Inc.

Distributed by CELLTRION USA, Inc. One Evertrust Plaza Suite 1207, Jersey City, New Jersey, 07302, USA

For more information call 1-888-804-3433

INSTRUCTIONS FOR USE

ZYMFENTRA (Zim fen' trah)

(infliximab-dyyb)

Injection for subcutaneous use only

Single-Dose Prefilled Pen

120 mg/mL

Rx Only

Read and follow the Instruction for Use that come with your ZYMFENTRA Prefilled Pen before you start using it and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.

Figure A: Parts of ZYMFENTRA Prefilled Pen

Important Information

Use the Prefilled Pen only if your healthcare provider has trained you on the right way to prepare for and to give an injection.
Ask your healthcare provider how often you will need to give an injection.
Rotate the injection site each time you give an injection. Each new injection site should be at least 1.2 inches away from the previous injection site.
Do not shake the Prefilled Pen at any time.
Do not remove the Cap until you are ready to inject.
Do not share the Prefilled Pen with anyone.

How to store the Prefilled Pen

Store the Prefilled Pen in a refrigerator between 36°F to 46°F (2°C to 8°C).
Keep the Prefilled Pen in the original carton until use to protect it from light.
Do not use the Prefilled Pen that has been left in direct sunlight.
Do not freeze the Prefilled Pen. If the Prefilled Pen has been frozen, do not use the Prefilled Pen even if it is thawed.
Do not warm the Prefilled Pen using heat sources such as hot water or a microwave. Let the Prefilled Pen naturally warm at room temperature between 68°F to 77°F (20°C to 25°C) for 30 minutes before giving an injection.
When the Prefilled Pen has reached room temperature, do not put it back in the refrigerator. The Prefilled Pen must be thrown away (discarded) if not used within the 14 days.
Keep the Prefilled Pen and all medicines out of the reach of children.

Prepare for the Injection

1. Gather the supplies for the injection.

1a. Prepare a clean, flat surface, such as a table or countertop, in a well-lit area.

1b. Remove 1 Prefilled Pen from the carton stored in your refrigerator.

Note: Return the carton with any unused Prefilled Pens to refrigerator immediately after taking out one Prefilled Pen.

1c. Make sure you have the following supplies:

Prefilled Pen
1 Alcohol swab

Not included in the carton:

1 Cotton ball or gauze
1 Adhesive bandage
FDA-cleared sharps disposal container

2. Inspect the Prefilled Pen.

2a. Make sure you have the correct medicine (ZYMFENTRA).

2b. Check the expiration (EXP) date on the label of the Prefilled Pen (See Figure B).

2c. Look at the Prefilled Pen and make sure it is not cracked or damaged.

Do not use the Prefilled Pen if:
- it is cracked or damaged.
- the expiration (EXP) date has passed.

Figure B

3. Inspect the Medicine.

3a. Look through the Window and make sure that the liquid is clear, colorless to pale brown, and free of particles (see Figure C).

Do not use the Prefilled Pen if the liquid is the discolored (yellow or dark brown), cloudy, or contains particles in it.
You may see air bubbles in the liquid. This is normal.

Figure C

4. Wait 30 minutes.

4a. Leave the Prefilled Pen at room temperature 68°F to 77°F (20°C to 25°C) for 30 minutes to allow it to warm up (see Figure D).

Do not warm the Prefilled Pen using heat sources such as hot water or a microwave.

Figure D

5. Choose an injection site (see Figure E).

5a. You may inject into:

the front of your thighs.
the stomach area (abdomen) except for the 2 inches around the belly button (navel).
the outer area of the upper arm if you are a caregiver.

Do not inject into skin that is within 2 inches of your belly button (navel), or is red, hard, tender, damaged, bruised, or scarred.
Do not inject through your clothes.

5b. Rotate the injection site each time you give an injection.

Do not inject the same injection site each time you give an injection.
Each new injection site should be at least 1.2 inches away from the injection site you used before.

Figure E

6. Wash your han

6a. Wash your hands with soap and water and dry them thoroughly (see Figure F).

Figure F

7. Clean the injection site.

7a. Clean the injection site with an alcohol swab using a circular motion (see Figure G).

7b. Let the skin dry before injecting.

Do not blow on or touch the injection site again before giving the injection.

Figure G

Give the injection

8. Remove the Cap.

8a. Hold the Prefilled Pen by the injector body with the Cap on top using one hand. Gently pull the Cap straight off with the other hand.

Do not recap the Prefilled Pen.
Do not remove the Cap until you are ready to inject.
Do not touch the Needle or Needle Cover. Doing so may result in a needle stick injury.

8b. Dispose of the Cap in an FDA cleared sharps container (see Step 12 and Figure H).

Figure H

9. Place the Prefilled Pen on the injection site.

9a. Hold the Prefilled Pen so that you can see the Window.

9b. Without pinching or stretching the skin, place the Prefilled Pen over the injection site at a 90-degree angle (see Figure I).

Figure I

10. Give the injection (see Figure J).

10a. Press the Prefilled 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.

10b. Keep holding the Prefilled Pen firmly against the skin and listen for the second loud "click." This can take up to 10 seconds.

Do not change the position of the Prefilled Pen after the injection has started.

10c. After you hear the second loud "click" continue to keep holding the Prefilled Pen firmly against the skin and count slowly to 5 to make sure you inject the full dose.

10d. Look at the Prefilled Pen and make sure that the purple Plunger Rod is filling the Window completely.

Figure J

11. Remove the Prefilled Pen from your skin.

11a. Remove the Prefilled Pen from your skin (see Figure K).

After you remove the Prefilled Pen from the injection site, the needle will be automatically covered (see Figure L).
If the Window has not turned completely purple or if the medicine is still injecting, this means you have not received a full dose. Call your healthcare provider immediately.
You may see grey stopper in the Window. This is normal.
Some bleeding may occur.
Do not reuse the Prefilled Pen.
Do not rub the injection site

Figure K

Figure L

After the injection

12. Throw away (dispose of) the Prefilled Pen.

12a. Put the used Prefilled Pen in an FDA-cleared sharps disposal container right away after use (see Figure M).

Do not throw away (dispose of) the Prefilled Pen in your household trash.
- If you do not have an FDA-cleared sharps disposal container, you may use a household container that is:
  - made of a heavy-duty plastic,
  - can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
  - upright and stable during use,
  - leak-resistant, and
  - properly labeled to warn of hazardous waste inside the container.
- When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of it. There may be state or local laws about how you should throw away used needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal.
- Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.

Figure M

13. Care for the injection site.

13a. Treat the injection site by gently pressing, not rubbing, a cotton ball or gauze to the site and apply an adhesive bandage, if necessary.

Manufactured by: CELLTRION, Inc., 23, Academy-ro, Yeonsu-gu, Incheon, 22014, Republic of Korea

US License Number 1996

Distributed by: CELLTRION USA, Inc., 1 Evertrust Plaza Suite 1207, Jersey City, NJ 07302