Pronunciation:

in-FLIX-i-mab

Brand Names:

• AVSOLA
• Inflectra
• Ixifi
• Remicade
• Renflexis

Dosage Forms:

• Powder for Solution

Warnings:

Increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis) and infections due to other opportunistic pathogens. Discontinue infliximab if a patient develops a serious infection. Perform test for latent TB; if positive, start treatment for TB prior to starting infliximab. Monitor all patients for active TB during treatment, even if initial latent TB test is negative. Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with tumor necrosis factor (TNF) blockers, including infliximab. Postmarketing cases of fatal hepatosplenic T-cell lymphoma (HSTCL) have been reported in patients treated with TNF blockers including infliximab. Almost all had received azathioprine or 6-mercaptopurine concomitantly with a TNF-blocker at or prior to diagnosis. The majority of infliximab cases were reported in patients with Crohn’s disease or ulcerative colitis, most of whom were adolescent or young adult males .

Increased risk of serious infections leading to hospitalization or death, including TB, bacterial sepsis, invasive fungal infections (such as histoplasmosis) and infections due to other opportunistic pathogens. Discontinue infliximab-dyyb if a patient develops a serious infection. Perform test for latent TB; if positive, start treatment for TB prior to starting infliximab-dyyb. Monitor all patients for active TB during treatment, even if initial latent TB test is negative. Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with tumor necrosis factor (TNF) blockers, including infliximab. Postmarketing cases of fatal hepatosplenic T-cell lymphoma (HSTCL) have been reported in patients treated with TNF blockers including infliximab products. Almost all had received 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, most of whom were adolescent or young adult males .

Increased risk of serious infections leading to hospitalization or death, including TB, bacterial sepsis, invasive fungal infections (such as histoplasmosis) and infections due to other opportunistic pathogens. Discontinue infliximab-abda if a patient develops a serious infection. Perform test for latent TB; if positive, start treatment for TB prior to starting infliximab-abda. Monitor all patients for active TB during treatment, even if initial latent TB test is negative. Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with tumor necrosis factor (TNF) blockers, including infliximab. Postmarketing cases of fatal hepatosplenic T-cell lymphoma (HSTCL) have been reported in patients treated with TNF blockers including infliximab products. Almost all had received 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, most of whom were adolescent or young adult males .

Increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis) and infections due to other opportunistic pathogens. Discontinue infliximab-qbtx if a patient develops a serious infection. Perform test for latent TB; if positive, start treatment for TB prior to starting infliximab-qbtx. Monitor all patients for active TB during treatment, even if initial latent TB test is negative. Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with tumor necrosis factor (TNF) blockers, including infliximab products. Postmarketing cases of fatal hepatosplenic T-cell lymphoma (HSTCL) have been reported in patients treated with TNF blockers including infliximab products. Almost all had received azathioprine or 6-mercaptopurine concomitantly with a TNF-blocker at or prior to diagnosis. The majority of cases were reported in patients with Crohn disease or ulcerative colitis, most of whom were adolescent or young adult males .

Increased risk of serious infections leading to hospitalization or death, including TB, bacterial sepsis, invasive fungal infections (such as histoplasmosis) and infections due to other opportunistic pathogens. Discontinue infliximab-axxq if a patient develops a serious infection. Perform test for latent TB; if positive, start treatment for TB prior to starting infliximab-axxq. Monitor all patients for active TB during treatment, even if initial latent TB test is negative. Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with tumor necrosis factor (TNF) blockers, including infliximab. Postmarketing cases of fatal hepatosplenic T-cell lymphoma (HSTCL) have been reported in patients treated with TNF blockers including infliximab products. Almost all had received 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, most of whom were adolescent or young adult males .

Classifications:

Therapeutic—

Immunological Agent

Pharmacologic—

Tumor Necrosis Factor Inhibitor

Uses of This Medicine:

Infliximab injection is used to reduce the symptoms of moderate-to-severely active Crohn's disease and ulcerative colitis in adults and children who have been previously treated with other medicines but did not work well.

Infliximab injection is used alone or together with other medicines (eg, methotrexate) to reduce the symptoms and prevent the progression of moderate-to-severely active rheumatoid arthritis, psoriatic arthritis, and active ankylosing spondylitis.

Infliximab 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 cannot be treated with other medicines.

Infliximab is a monoclonal antibody that works to enhance and improve 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 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 injection in children with ankylosing spondylitis, plaque psoriasis, or psoriatic arthritis. Safety and efficacy have not been established.

Appropriate studies performed to date have demonstrated that infliximab injection is not helpful in children with juvenile rheumatoid arthritis. Safety and efficacy have not been established.

Older adults—

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

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 receiving 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 Type 4, Live
• Adenovirus Vaccine Type 7, Live
• Alefacept
• Anakinra
• Anifrolumab-fnia
• Bacillus of Calmette and Guerin Vaccine, Live
• Baricitinib
• Brodalumab
• Certolizumab Pegol
• Cyclosporine
• Dengue Tetravalent 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 Vaccine
• Tacrolimus
• 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:

• Aspergillosis (fungus infection), history of or
• 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 (convulsions), 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) or
• Heart or blood vessel disease—Use with caution. May increase risk for more side effects.

• 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:

A doctor or other trained health professional will give you this medicine in a medical facility. It is given through a needle 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 should come with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have questions.

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

Precautions While Using This Medicine:

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

Infliximab may cause an infusion reaction, including a heart attack, stroke, changes in blood pressure, or heart rhythm problems (eg, arrhythmia), while you or your child 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, trouble breathing, or swelling of the face, tongue, and throat.

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

Serious skin reactions can occur while you or your child are receiving this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, chills, cough, diarrhea, fever, itching, joint or muscle pain, red skin lesions, sore throat, sores, ulcers, or white spots in your mouth, or unusual tiredness or weakness.

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

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, emphysema, 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, tell your doctor right away.

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

Women: If you have a baby while receiving infliximab, make sure the baby's doctor knows that you are 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.

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.

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

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. Using these medicines together with infliximab 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

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

hives, itching, or rash

loss of voice

lower back or side pain

muscle 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

runny or stuffy nose

slow or fast heartbeat

sneezing

sore throat

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

stomach pain

tender, swollen glands in the neck

tightness in the chest

trouble breathing

trouble swallowing

unusual bleeding or bruising

unusual tiredness or weakness

voice changes

Rare

Bleeding gums

blood in the stool

blue lips and fingernails

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

increased sweating

irregular or pounding 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

swelling of the joints

sunken eyes

thirst

upper right abdominal or stomach pain

vomiting

unusual weight loss

wrinkled skin

yellow skin and eyes

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

dark or bloody urine

diarrhea

difficulty with 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

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.