Pronunciation:

in-FLIX-i-mab - dyyb

Brand Names:

• Inflectra
• Zymfentra

Dosage Forms:

• Powder for Solution
• Solution

Warnings:

ZymfentraSerious InfectionsPatients treated with TNF blockers, including infliximab-dyyb, are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Discontinue Infliximab-dyyb if a patient develops a serious infection or sepsis.Reported infections include: 1) Active tuberculosis, including reactivation of latent tuberculosis. Patients with tuberculosis have frequently presented with disseminated or extrapulmonary disease. Test patients for latent tuberculosis before infliximab-dyyb use and during therapy. Initiate treatment for latent infection prior to infliximab-dyyb use. 2) Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Consider empiric anti-fungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness. 3) Bacterial, viral and other infections due to opportunistic pathogens, including Legionella and Listeria.The risks and benefits of treatment with infliximab-dyyb should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection. Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with infliximab-dyyb, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy. Closely monitor patients for the development of signs and symptoms of infection during and after treatment with infliximab-dyyb, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy.MalignancyLymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including infliximab products. Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers including infliximab products. These cases have had a very aggressive disease course and have been fatal. Almost all patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF-blocker at or prior to diagnosis. The majority of reported cases have occurred in patients with Crohn's disease or ulcerative colitis and most were in adolescent and young adult males .

Warning: Serious Infections and MalignancySerious InfectionsPatients treated with infliximab products are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Infliximab-dyyb should be discontinued if a patient develops a serious infection or sepsis.Reported infections include: 1) Active tuberculosis, including reactivation of latent tuberculosis. Patients with tuberculosis have frequently presented with disseminated or extrapulmonary disease. Patients should be tested for latent tuberculosis before infliximab-dyyb use and during therapy. Treatment for latent infection should be initiated prior to Infliximab-dyyb use. Active tuberculosis, including reactivation of latent tuberculosis. Patients with tuberculosis have frequently presented with disseminated or extrapulmonary disease. Patients should be tested for latent tuberculosis before infliximab-dyyb use and during therapy. Treatment for latent infection should be initiated prior to Infliximab-dyyb use. 2) Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Empiric anti-fungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic illness. 3) Bacterial, viral and other infections due to opportunistic pathogens, including Legionella and Listeria.The risks and benefits of treatment with infliximab-dyyb should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection. Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with infliximab-dyyb, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy.MalignancyLymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including infliximab products.Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers including infliximab products. These cases have had a very aggressive disease course and have been fatal. Almost all patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. The majority of reported cases have occurred in patients with Crohn’s disease or ulcerative colitis and most were in adolescent and young adult males .

Classifications:

Therapeutic—

Immunological Agent

Pharmacologic—

Infliximab

Uses of This Medicine:

Infliximab-dyyb injection is used to reduce the symptoms of moderate to severe active Crohn's disease and ulcerative colitis in adults and children who have been previously treated with other medicines that did not work well. It is also used as a maintenance treatment for moderate to severe active Crohn's disease and ulcerative colitis after receiving an infliximab medicine given by your doctor.

Infliximab-dyyb injection is also used in combination with other medicines (eg, methotrexate) to reduce the symptoms and prevent the progression of moderate to severe active rheumatoid arthritis.

Infliximab-dyyb injection is also used to reduce the symptoms and prevent the progression of active ankylosing spondylitis. It is also used to reduce symptoms and prevent the progression of psoriatic arthritis.

Infliximab-dyyb injection is also used to treat chronic severe (extensive or disabling) plaque psoriasis, which is a skin disease with red patches and white scales that do not go away. It is used in patients who may benefit from receiving other treatments. This medicine is a monoclonal antibody that works on the immune system.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of infliximab-dyyb injection for the treatment of Crohn disease or ulcerative colitis in children 6 years of age and older. However, safety and efficacy have not been established in children younger than 6 years of age.

Appropriate studies have not been performed on the relationship of age to the effects of infliximab-dyyb vial in children with juvenile rheumatoid arthritis and infliximab-dyyb prefilled pen, prefilled syringe, and prefilled syringe with needle shield in the pediatric population. Safety and efficacy has not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of infliximab-dyyb vial in the elderly. However, elderly patients are more likely to have infections, which may require caution in patients receiving infliximab-dyyb injection.

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of infliximab-dyyb prefilled pen, prefilled syringe, and prefilled syringe with needle shield in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abatacept
• Adalimumab
• Adenovirus Vaccine, Live
• Alefacept
• Anakinra
• Anifrolumab-fnia
• Bacillus of Calmette and Guerin Vaccine, Live
• Baricitinib
• Brodalumab
• Certolizumab Pegol
• Cholera Vaccine, Live
• Cyclosporine
• Dengue Tetravalent Vaccine, Live
• Ebola Zaire Vaccine, Live
• Etanercept
• Fosphenytoin
• Golimumab
• Guselkumab
• Influenza Virus Vaccine, Live
• Ixekizumab
• Levoketoconazole
• Measles Virus Vaccine, Live
• Methotrexate
• Mumps Virus Vaccine, Live
• Natalizumab
• Paclitaxel
• Phenytoin
• Poliovirus Vaccine, Live
• Quinidine
• Rilonacept
• Rituximab
• Rotavirus Vaccine, Live
• Rubella Virus Vaccine, Live
• Sarilumab
• Sirolimus
• Smallpox Monkeypox Vaccine, Live Non-Replicating
• Smallpox Vaccine
• Tacrolimus
• Theophylline
• Tocilizumab
• Tofacitinib
• Typhoid Vaccine, Live
• Ustekinumab
• Varicella Virus Vaccine, Live
• Vedolizumab
• Warfarin
• Yellow Fever Vaccine
• Zoster Vaccine, Live

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Blastomycosis (fungus infection), history of or
• Blood or bone marrow problems (eg, pancytopenia), or history of or
• Candidiasis (fungus infection), history of or
• Coccidioidomycosis (fungus infection), history of or
• Diabetes or
• Guillain-Barré syndrome (nervous system disorder), history of or
• Hepatitis B, active or history of or
• Histoplasmosis (fungus infection), history of or
• Legionellosis (bacterial infection), history of or
• Leukopenia or neutropenia (low white blood cells) or
• Listeriosis (bacterial infection), history of or
• Liver disease or
• Multiple sclerosis, history of or
• Optic neuritis (eye problem) or
• Pneumocystosis (fungus infection), history of or
• Psoriasis (skin disease) or
• Seizures, history of or
• Thrombocytopenia (low platelets in the blood)—Use with caution. May make these conditions worse.

• Cancer, active or history of or
• Chronic obstructive pulmonary disease (COPD)—Use with caution. May increase the chance of having new cancers.

• Congestive heart failure, moderate to severe—Should not be given to patients with this condition.

• Tuberculosis, history of—Use with caution. Patients may need additional tuberculosis treatment.

Proper Use of This Medicine:

This medicine is available in 4 forms: vial, prefilled syringe, prefilled syringe with needle shield, and prefilled pen.

Vial: A doctor or other trained health professional will give you this medicine in a medical facility. It is given through an IV that is placed into one of your veins. It must be given slowly, so the needle will have to remain in place for at least 2 hours.

This medicine comes with a Medication Guide and patient instructions. Read and follow the instructions carefully. Ask your doctor if you have questions.

Prefilled syringe, prefilled syringe with needle shield, or prefilled pen: You may also be taught how to give your medicine at home. It is usually given as a shot under the skin of your stomach, thigh, or upper arm. Make sure you understand all instructions before you give yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.

Do not inject into skin areas that are red, bruised, tender, damaged, hard, or areas with scars.

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 (eg, 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 (eg, 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 syringe 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 (eg, 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.

You may also receive medicines (eg, allergy medicine, fever medicine, steroids) to help prevent possible unwanted effects during the injection.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage form (prefilled pen, prefilled syringe, or prefilled syringe with needle shield):
  • For Crohn's disease and ulcerative colitis:
    • Adults—The first 3 doses are given by a doctor through an IV placed in one of your veins at Week 0, Week 2, and Week 6. Then starting at Week 10, you may receive 120 milligrams (mg) injected under your skin and every 2 weeks thereafter.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

Call your doctor or pharmacist for instructions.

Storage—

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store 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.

Precautions While Using This Medicine:

It is very important that your doctor check your or your child's progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Infliximab-dyyb may cause an infusion reaction while you are receiving it or right after the infusion ends. Check with your doctor or nurse right away if you have chest pain, fever, chills, itching, hives, rash, dizziness, fainting, lightheadedness, headache, joint pain, difficulty with swallowing, shortness of breath, trouble breathing, or swelling of the face, tongue, and throat.

Your body's ability to fight an infection may be reduced while you are using infliximab-dyyb. It is very important that you call your doctor at the first sign of any infection. Check with your doctor right away if you have a fever, chills, cough, flu-like symptoms, or unusual tiredness or weakness.

You will need to have a skin test for tuberculosis before you start receiving this medicine. Tell your doctor if you or anyone in your home has ever had a positive reaction to a tuberculosis skin test.

A small number of people (including children and teenagers) who have used this medicine have developed certain types of cancer. This is more common in patients who have lung diseases (eg, COPD) or are heavy smokers, and in psoriasis patients who have had phototherapy treatment for a long time. Phototherapy treatment is ultraviolet light or sunlight combined with oral medicine to make your skin sensitive to light. Some teenagers and young adults with Crohn disease or ulcerative colitis also developed a rare type of cancer called hepatosplenic T-cell lymphoma. Talk with your doctor if you have unusual bleeding, bruising, or weakness, swollen lymph nodes in the neck, underarms, or groin, unexplained weight loss, or red, scaly patches, or raised bumps with pus on the skin.

Receiving this medicine may increase your risk of getting skin cancer (eg, melanoma, Merkel cell carcinoma) or cervical cancer. If you have any changes or growths on your skin, abnormal vaginal bleeding or pelvic pain, check with your doctor right away.

It is important to have your heart checked closely if you receive infliximab-dyyb. Call your doctor right away if you have difficulty breathing, swelling in the ankles and feet, or a sudden weight gain.

This medicine may increase your chance of having a lupus-like syndrome or a liver disease called autoimmune hepatitis. Check with your doctor right away if you have dark brown-colored urine, fever or chills, a general feeling of discomfort, illness, or weakness, joint pain, light-colored stools, nausea and vomiting, a rash on the cheeks or arms that is worse in the sun, severe tiredness, upper right stomach pain, or yellow eyes and skin.

While you are being treated with infliximab-dyyb, do not have any immunizations (vaccines) without your doctor's approval. Live virus vaccines should not be given with infliximab-dyyb. Your child's vaccinations must be current before receiving infliximab-dyyb. Talk to your child's doctor if you have any questions about this.

If you have a baby while receiving infliximab-dyyb, make sure the baby's doctor knows that you were receiving this medicine. You will need to wait a few months before giving certain vaccines to your baby. Talk to the baby's doctor if you have questions.

Serious skin reactions can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, red skin lesions, severe acne or a skin rash, sores or ulcers on the skin, or fever or chills with this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes abatacept (Orencia®), anakinra (Kineret®), tocilizumab (Actemra®), or other medicines called biologics that are used to treat the same conditions as infliximab-dyyb. Using these medicines together with infliximab-dyyb may increase your chance of having serious unwanted effects.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Black, tarry stools

bladder pain

bloody or cloudy urine

blurred vision

body aches or pain

chest pain or tightness

chills

cough

cough producing mucus

difficult, burning, or painful urination

difficulty breathing

dizziness

dryness or soreness of the throat

ear congestion

fever

frequent urge to urinate

headache

hoarseness

itching, rash

loss of voice

lower back or side pain

nervousness

pain or swelling in the arms or legs

pain or tenderness around the eyes and cheekbones

painful or difficult urination

pale skin

pounding in the ears

slow or fast heartbeat

sneezing

sores, ulcers, or white spots on the lips or in the mouth

stuffy or runny nose

swollen glands

tender, swollen glands in the neck

trouble swallowing

trouble breathing

unusual bleeding or bruising

unusual tiredness or weakness

voice changes

Rare

Bleeding gums

blood in the stool

blue lips and fingernails

blurred vision

changes in skin color or tenderness of the foot or leg

chest discomfort

confusion

coughing that sometimes produces a pink frothy sputum

dark urine

decreased urination

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

dry mouth

fast or noisy breathing

feeling of discomfort

general feeling of illness

general tiredness and weakness

high fever

hives

increase in heart rate

increased sweating

inflammation of the joints

irregular heartbeat

light-colored stools

muscle aches

nausea

pinpoint red spots on the skin

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

rapid, shallow breathing

sunken eyes

thirst

upper right abdominal pain

vomiting

weight loss

wrinkled skin

yellow eyes and skin

Incidence not known

Back pain, sudden and severe

blistering, peeling, loosening of the skin

bloody nose

burning, tingling, numbness or pain in the hands, arms, feet, or legs

change in mental status

clay-colored stools

diarrhea

difficulty speaking

dilated neck veins

double vision

heavier menstrual periods

inability to move the arms, legs, or facial muscles

inability to speak

loss of appetite

muscle weakness, sudden and progressing

red, irritated eyes

red skin lesions, often with a purple center

seizures

sensation of pins and needles

slow or irregular breathing

slow speech

stabbing pain

temporary vision loss

vomiting of blood

weight gain

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Belching

difficulty in moving

feeling of warmth

heartburn

indigestion

muscle stiffness

redness of the face, neck, arms and occasionally, upper chest

Less common

Constipation, severe

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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