Inflectra (Intravenous)

Infliximab injection is used to lessen the symptoms of moderate-to-severely active Crohn's disease and ulcerative colitis in adults and children who have already tried other medicines that did not work well.

Infliximab injection can be used on its own or along with other medicines (for example, methotrexate) to reduce symptoms and prevent the worsening 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 condition with red patches and white scales that do not go away. It is for patients who cannot be treated with other medicines.

Infliximab is a monoclonal antibody that helps to enhance and improve the immune system.

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

It is very important for your doctor to closely monitor you or your child's progress during regular visits to ensure that this medicine is working properly. Blood and urine tests may be necessary to check for side effects.

Infliximab can cause an infusion reaction, which may include a heart attack, stroke, changes in blood pressure, or heart rhythm problems (such as arrhythmia) during the infusion or immediately after it ends. Contact your doctor or nurse right away if you experience chest pain, fever, chills, itching, hives, rash, dizziness, fainting, lightheadedness, headache, joint pain, difficulty swallowing, trouble breathing, or swelling of the face, tongue, and throat.

While using infliximab, your or your child's ability to fight infections may be weakened. It is crucial to call your doctor at the first sign of any infection. Contact your doctor immediately if you or your child have a fever, chills, cough, flu-like symptoms, or unusual tiredness or weakness.

Serious skin reactions can occur while receiving this medicine. Contact your doctor right away if you notice 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 the mouth, or unusual tiredness or weakness.

This medicine may increase your or your child's risk of developing a lupus-like syndrome or a liver disease called autoimmune hepatitis. Contact your doctor right away if you or your child have dark brown 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 worsens in the sun, severe tiredness, upper right stomach pain, or yellowing of the eyes and skin.

A small number of people (including children and teenagers) who have taken this medicine have developed certain types of cancer. This is more common in patients with lung diseases (such as emphysema, COPD) or who are heavy smokers, and in psoriasis patients who have undergone long-term phototherapy treatment. Phototherapy treatment involves ultraviolet light or sunlight combined with oral medicine to make your skin sensitive to light. Some teenagers and young adults with Crohn's disease or ulcerative colitis have also developed a rare cancer called hepatosplenic T-cell lymphoma. Speak with your doctor if you experience 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.

Taking this medicine may increase your risk of skin cancer (such as melanoma or Merkel cell carcinoma) or cervical cancer. If you notice any changes or growths on your skin, abnormal vaginal bleeding, or pelvic pain, inform your doctor immediately.

While receiving infliximab, do not get any immunizations (vaccines) without your doctor's approval. Live virus vaccines should not be given with infliximab. Your child's vaccinations must be up to date before starting infliximab. Consult your child's doctor if you have any questions.

Women: If you have a baby while on infliximab, inform the baby's doctor that you are receiving this medicine. You will need to wait a few months before giving certain vaccines to your baby. Discuss any questions with the baby's doctor.

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

It is essential to have your heart monitored closely while receiving infliximab. Call your doctor immediately if you have trouble breathing, swelling in the ankles and feet, or sudden weight gain.

Do not take any other medicines unless you have discussed them with your doctor. This includes abatacept (Orencia®), anakinra (Kineret®), tocilizumab (Actemra®), or other biologics used to treat the same conditions as infliximab. Using these medicines together with infliximab may increase the risk of serious side effects.

In deciding to use a medicine, you and your doctor will weigh the risks against the benefits. The following points should be considered for this medicine:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also let your healthcare professional know if you have any other allergies, like to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies so far have not shown any specific problems in children aged 6 years and older that would limit the use of infliximab injection for treating Crohn disease or ulcerative colitis. However, safety and effectiveness have not been established in children younger than 6 years.

Studies have not been done to determine how age affects the use of infliximab injection in children with ankylosing spondylitis, plaque psoriasis, or psoriatic arthritis. Safety and effectiveness have not been established.

Studies have shown that infliximab injection is not effective in children with juvenile rheumatoid arthritis. Safety and effectiveness have not been established.

Geriatric

Studies have not shown any specific problems in older adults that would limit the use of infliximab injection. However, older patients are more likely to have infections, which may require caution when taking this medicine.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Consider the potential benefits and risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together, while others may be used together with caution. In these cases, your doctor may need to adjust the dose or take other precautions. It is especially important for your healthcare professional to know if you are taking any of the medicines listed below when you are receiving this medicine. The following interactions have been selected based on their potential significance and are not all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some situations. If both medicines are prescribed, your doctor may change the dose or how often you take one or both 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
• Tocilizumab
• Tofacitinib
• Typhoid Vaccine, Live
• Ustekinumab
• Varicella Virus Vaccine, Live
• Vedolizumab
• Warfarin
• Yellow Fever Vaccine
• Zoster Vaccine, Live

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around mealtime or with certain types of food due to potential interactions. Using alcohol or tobacco with certain medicines may also cause interactions. Discuss with your healthcare professional how to use your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect how this medicine works. Be sure to inform your doctor if you have any other medical issues, especially:

• Aspergillosis (fungus infection), history of or
• Blastomycosis (fungus infection), history of or
• Blood or bone marrow problems (e.g., 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 worsen these conditions.

• Cancer, active or history of or
• Chronic obstructive pulmonary disease (COPD) or
• Heart or blood vessel disease—Use with caution. May increase the risk of 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 treatment for tuberculosis.

Along with its intended effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may need medical attention.

Check with your doctor or nurse right away if any of the following side effects happen:

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

• Sudden and severe back pain
• 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 speaking
• Dilated neck veins
• Double vision
• Heavier menstrual periods
• Inability to move the arms, legs, or facial muscles
• Inability to speak
• Loss of appetite
• Sudden and progressing muscle weakness
• 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 happen that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also know ways to prevent or lessen some of these side effects. Check with your health care professional if any of the following side effects continue, 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

• Severe constipation

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.

In the U.S.

• AVSOLA
• Inflectra
• Ixifi
• Remicade
• Renflexis

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Immunological Agent

Pharmacologic Class: Tumor Necrosis Factor Inhibitor

Find detailed information on biosimilars for this medication.

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.

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