Description and Brand Names

Drug information provided by: IBM Micromedex

US Brand Name

  1. AVSOLA
  2. Ixifi
  3. Remicade
  4. Renflexis

Descriptions


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.

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 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.

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 this medicine.

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
  • Dengue Tetravalent Vaccine, Live
  • 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) 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

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

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

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. Black, tarry stools
  2. bladder pain
  3. bloody or cloudy urine
  4. blurred vision
  5. body aches or pain
  6. chest pain
  7. chills
  8. cough
  9. cough producing mucus
  10. difficult, burning, or painful urination
  11. difficulty breathing
  12. dizziness
  13. dryness or soreness of the throat
  14. ear congestion
  15. fever
  16. frequent urge to urinate
  17. headache
  18. hoarseness
  19. hives, itching, or rash
  20. loss of voice
  21. lower back or side pain
  22. muscle pain
  23. nervousness
  24. pain or swelling in the arms or legs
  25. pain or tenderness around the eyes and cheekbones
  26. painful or difficult urination
  27. pale skin
  28. pounding in the ears
  29. runny or stuffy nose
  30. slow or fast heartbeat
  31. sneezing
  32. sore throat
  33. sores, ulcers, or white spots on the lips or in the mouth
  34. stomach pain
  35. tender, swollen glands in the neck
  36. tightness in the chest
  37. trouble breathing
  38. trouble swallowing
  39. unusual bleeding or bruising
  40. unusual tiredness or weakness
  41. voice changes

Rare

  1. Bleeding gums
  2. blood in the stool
  3. blue lips and fingernails
  4. changes in skin color or tenderness of the foot or leg
  5. chest discomfort
  6. confusion
  7. coughing that sometimes produces a pink frothy sputum
  8. dark urine
  9. decreased urination
  10. dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  11. dry mouth
  12. fast or noisy breathing
  13. feeling of discomfort
  14. general feeling of illness
  15. general tiredness and weakness
  16. high fever
  17. hives
  18. increased sweating
  19. irregular or pounding heartbeat
  20. light-colored stools
  21. muscle aches
  22. nausea
  23. pinpoint red spots on the skin
  24. puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  25. rapid, shallow breathing
  26. swelling of the joints
  27. sunken eyes
  28. thirst
  29. upper right abdominal or stomach pain
  30. vomiting
  31. unusual weight loss
  32. wrinkled skin
  33. yellow skin and eyes

Incidence not known

  1. Back pain, sudden and severe
  2. blistering, peeling, loosening of the skin
  3. bloody nose
  4. burning, tingling, numbness or pain in the hands, arms, feet, or legs
  5. change in mental status
  6. clay-colored stools
  7. dark or bloody urine
  8. diarrhea
  9. difficulty with speaking
  10. dilated neck veins
  11. double vision
  12. heavier menstrual periods
  13. inability to move the arms, legs, or facial muscles
  14. inability to speak
  15. loss of appetite
  16. muscle weakness, sudden and progressing
  17. red, irritated eyes
  18. red skin lesions, often with a purple center
  19. seizures
  20. sensation of pins and needles
  21. slow or irregular breathing
  22. slow speech
  23. stabbing pain
  24. temporary vision loss
  25. 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

  1. Belching
  2. difficulty in moving
  3. feeling of warmth
  4. heartburn
  5. indigestion
  6. muscle stiffness
  7. redness of the face, neck, arms, and occasionally, upper chest

Less common

  1. 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.