Pronunciation:

in-FLIX-i-mab - abda

Brand Names:

• Renflexis

Dosage Forms:

• Powder for Solution

Warnings:

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 .

Classifications:

Therapeutic—

Immunological Agent

Pharmacologic—

Infliximab

Uses of This Medicine:

Infliximab-abda injection is used in adults to treat Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and chronic severe plaque psoriasis. It is used in children to treat Crohn's disease and ulcerative colitis. Infliximab-abda injection 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-abda injection for the treatment of Crohn's 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-abda injection in children with plaque psoriasis. Safety and efficacy have not been established.

Appropriate studies performed to date have demonstrated that infliximab-abda injection is not helpful in children with juvenile rheumatoid arthritis. 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-abda injection in the elderly. However, elderly patients are more likely to have infections, which may require caution in patients receiving infliximab-abda injection.

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)—Use with caution. May increase the chance of getting 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:

A doctor or other trained health professional will give you this medicine in a medical facility. It is given through a needle placed into one of your veins. The medicine 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 from the injection.

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 and urine tests may be needed to check for unwanted effects.

Infliximab-abda 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, a fever, chills, itching, hives, a rash, dizziness, fainting, lightheadedness, a headache, joint pain, difficulty with swallowing, trouble breathing, or swelling of the face, tongue, and throat.

This medicine may increase your risk for stroke, heart attack, low or high blood pressure, or heart rhythm problems during and within 24 hours of infusion. It may also cause temporary vision loss during or within 2 hours of infusion. Check with your doctor right away if you have confusion, difficulty in speaking, slow speech, inability to speak, inability to move your arms, legs, or facial muscles, double vision headache, blurred vision, dizziness, pounding in the ears, fainting, or a fast, slow, or irregular heartbeat during or after receiving the medicine.

Your body's ability to fight an infection may be reduced while you are receiving infliximab-abda. 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.

Serious skin reactions can occur while you 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 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-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 or if you have abnormal vaginal bleeding, pain in your pelvis, or frequent or painful urination, tell your doctor right away.

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

If you have a baby while receiving infliximab-abda, 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.

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 while you are receiving infliximab-abda, because this medicine may cause new or worsening heart failure. Call your doctor right away if you have trouble with 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-abda. Using these medicines together with infliximab-abda 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

Accumulation of pus

black, tarry stools

blurred vision

chest pain

chills

cough

diarrhea

difficulty in swallowing and breathing

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

fever

general feeling of discomfort or illness

headache

hives, itching, skin rash

muscle pain or stiffness

pain in the joints, lower back, or side

painful or difficult urination

pounding in the ears

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

slow or fast heartbeat

sore throat

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

stuffy or runny nose

swollen glands

swollen, red, tender area of the infection

tightness in the chest

unexplained bleeding or bruising

unusual tiredness or weakness

weight loss

yellowing of the skin and eyes

Less common

Cracks in the skin at the corners of the mouth

soreness or redness around the fingernails and toenails

vaginal burning, itching, or discharge

white patches in the mouth, throat, or on the tongue

Rare

Clay-colored stools

confusion

coughing that sometimes produces a pink frothy sputum

dark or bloody urine

difficult, fast, noisy breathing

dry mouth

fainting or loss of consciousness

fast or irregular breathing

general feeling of discomfort, illness, or weakness

increased sweating

loss of appetite

nausea

pain, tenderness, and swelling of the foot or leg

pale skin with blue lips and fingernails

pinpoint red spots on the skin

severe constipation

stomach pain

sunken eyes

swollen, painful, or tender lymph glands in the armpit

vomiting

Incidence not known

Blistering, peeling, or loosening of the skin

bloody nose

change in mental status

chest discomfort

difficulty in speaking

double vision

heavier menstrual periods

inability to move the arms, legs, or facial muscles

inability to speak

muscle aches and weakness

new mole, change in size, shape, or color of an existing mole, or a mole that leaks fluid or bleeds

numbness or tingling in the fingers, face, or feet

pain or discomfort in the arms, jaw, back, or neck

red, irritated eyes

red, scaling, or crusted skin

red skin lesions often with a purple center

seizures

slow speech

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

discomfort, upset, or pain in the stomach

ear congestion

heartburn

indigestion

loss of voice

nasal congestion

pain or tenderness around the eyes and cheekbones

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.