Description and Brand Names

Drug information provided by: IBM Micromedex

US Brand Name

  1. Ixifi
  2. Remicade
  3. Renflexis

Descriptions


Infliximab injection is used in adults to treat Crohn disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and chronic severe plaque psoriasis. It is also used in children to treat Crohn disease and ulcerative colitis. Infliximab injection is a monoclonal antibody that works to enhance and improve the immune system.

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

This product is available in the following dosage forms:

  • Powder for Solution

Before Using

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.

Pediatric

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 plaque psoriasis. 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. Efficacy has not been established.

Geriatric

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 infliximab injection.

Pregnancy

Information about this infliximab-intravenous-route
Pregnancy Category Explanation
All Trimesters B Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breastfeeding

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.

Drug Interactions

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
  • Bacillus of Calmette and Guerin Vaccine, Live
  • Brodalumab
  • Certolizumab Pegol
  • Cyclosporine
  • Etanercept
  • Fosphenytoin
  • Golimumab
  • Guselkumab
  • Influenza Virus Vaccine, Live
  • Ixekizumab
  • Measles Virus Vaccine, Live
  • 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
  • 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 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 therapy.

Proper Use

A doctor or other trained health professional will give you this medicine. 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 medicines (eg, allergy medicine, fever medicine, steroids) to help prevent possible unwanted effects during the injection.

Precautions

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood 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 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. 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 using 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.

Using 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 using 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 using 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 using 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 shortness of breath, 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

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

  1. Chest pain
  2. chills
  3. cough
  4. dizziness
  5. fainting
  6. fever
  7. flushing or redness of the face
  8. headache
  9. hives, itching, or rash
  10. muscle pain
  11. nasal congestion
  12. nausea
  13. runny nose
  14. sneezing
  15. sore throat
  16. stomach pain
  17. tightness in the chest
  18. troubled breathing
  19. unusual tiredness or weakness
  20. vomiting

Less common

  1. Back pain
  2. bloody or cloudy urine
  3. cracks in the skin at the corners of the mouth
  4. diarrhea
  5. difficult or painful urination
  6. frequent urge to urinate
  7. pain or tenderness around the eyes and cheekbones
  8. soreness or irritation of the mouth or tongue
  9. soreness or redness around the fingernails or toenails
  10. vaginal burning or itching and discharge
  11. white patches in the mouth or on the tongue

Rare

  1. Abscess (area of infection containing pus)
  2. black, tarry stools
  3. blood in the urine or stools
  4. bone or joint pain
  5. constipation
  6. feeling of fullness
  7. hernia (lump in the abdomen or stomach)
  8. irregular or pounding heartbeat
  9. pain in the rectum
  10. pain spreading from the abdomen or stomach to the left shoulder
  11. pinpoint red spots on the skin
  12. stomach pain (severe)
  13. swollen or painful glands
  14. tendon injury
  15. unusual bleeding or bruising
  16. unusual weight loss
  17. yellow skin and eyes

Incidence not known

  1. Bloody nose
  2. burning, tingling, numbness or pain in the hands, arms, feet, or legs
  3. change in mental status
  4. clay-colored stools
  5. continuing vomiting
  6. dark or bloody urine
  7. difficulty with speaking
  8. difficulty with swallowing
  9. fast heartbeat
  10. general feeling of tiredness or weakness
  11. heavier menstrual periods
  12. hoarseness
  13. inability to move the arms and legs
  14. itching, puffiness, or swelling of the eyelids or around the eyes, face, lips, or tongue
  15. light-colored stools
  16. loss of appetite
  17. loss of bladder control
  18. lower back or side pain
  19. muscle spasm or jerking of all extremities
  20. noisy breathing
  21. painless swelling in the neck, armpits, or groin
  22. pale skin
  23. red, scaling, or crusted skin
  24. redness, soreness, or itching skin
  25. seizures
  26. sensation of pins and needles
  27. severe muscle weakness, sudden and progressing
  28. slow or irregular breathing
  29. sores, welts, or blisters
  30. stabbing pain
  31. sudden loss of consciousness
  32. sudden numbness and weakness in the arms and legs
  33. unpleasant breath odor
  34. upper right stomach pain
  35. vomiting of blood

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.