Description and Brand Names

Drug information provided by: IBM Micromedex

Descriptions


Infliximab-dyyb 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 moderate to severely active ulcerative colitis. Infliximab-dyyb is a monoclonal antibody that works to enhance and improve the immune system.

This medicine is to be given only by or under the direct supervision of your doctor.

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-dyyb 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 performed to date have demonstrated that infliximab-dyyb 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-dyyb injection in the elderly. However, elderly patients are more likely to have infections, which may require caution in patients receiving infliximab-dyyb injection.

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:

  • 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, 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 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 comes 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 or your child's progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Infliximab-dyyb 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, 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-dyyb. 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.

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.

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, 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, check with your doctor right away.

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

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 stomach pain, or yellow eyes and skin.

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

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

Serious skin reactions can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, red skin lesions, severe acne or a skin rash, sores or ulcers on the skin, or fever or chills with this medicine.

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-dyyb. Using these medicines together with infliximab-dyyb 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. itching, rash
  20. loss of voice
  21. lower back or side pain
  22. nasal congestion
  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. slow or fast heartbeat
  30. sneezing
  31. sores, ulcers, or white spots on the lips or in the mouth
  32. stuffy or runny nose
  33. swollen glands
  34. tender, swollen glands in the neck
  35. tightness in the chest
  36. trouble swallowing
  37. troubled breathing with exertion
  38. unusual bleeding or bruising
  39. unusual tiredness or weakness
  40. voice changes

Rare

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

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. diarrhea
  8. difficulty speaking
  9. dilated neck veins
  10. double vision
  11. heavier menstrual periods
  12. inability to move the arms, legs, or facial muscles
  13. inability to speak
  14. loss of appetite
  15. muscle weakness, sudden and progressing
  16. red, irritated eyes
  17. red skin lesions, often with a purple center
  18. seizures
  19. sensation of pins and needles
  20. slow or irregular breathing
  21. slow speech
  22. stabbing pain
  23. temporary vision loss
  24. vomiting of blood
  25. weight gain

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.