Infliximab (Intravenous route)
- Powder for Solution
Warnings:Intravenous route(Powder for Solution)
Patients treated with infliximab are at increased risk for infections, some progressing to serious infections leading to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Discontinue infliximab if a serious infection or sepsis develops. These infections have included TB, invasive fungal, and other opportunistic infections, including Legionella and Listeria. Latent TB should be treated prior to infliximab initiation, and patients should be monitored for signs/symptoms of infections during and after treatment with infliximab, including TB in patients who tested negative for latent TB infection prior to initiating therapy. Lymphoma and other malignancies, some fatal, have been reported in pediatric patients treated with infliximab. Rare postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), usually fatal, have been reported in patients treated with infliximab, primarily in adolescent and young adult males with Crohn disease and ulcerative colitis. All of these cases of HSTCL with infliximab have occurred in patients on concomitant treatment with azathioprine or 6-mercaptopurine .
Tumor Necrosis Factor Inhibitor
Uses of This Medicine:
Infliximab injection is a monoclonal antibody. It is used to treat Crohn's disease in children (6 years of age and older) and adults who have not been helped by other medicines, and in adult patients who have a type of Crohn's disease where fistulas form. Infliximab injection is used to treat adults with rheumatoid arthritis and ankylosing spondylitis, which is a type of arthritis that affects the joints in the spine. It is used to treat adults with psoriatic arthritis, which is a type of arthritis that causes pain and swelling of the joints and patches of scaly skin on some areas of the body.
Infliximab injection is also used to treat children (6 years of age and older) and adults with ulcerative colitis. It is also used to treat chronic severe plaque psoriasis, which is a skin disease with red patches and white scales that don't go away.
This medicine is available only with your doctor's prescription.
Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, infliximab injection is used in certain patients with the following medical conditions:
- Takayasu disease (blood vessel problem), refractory.
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:
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.
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of infliximab 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 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.
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.
|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.|
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.
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.
- Adenovirus Vaccine Type 4, Live
- Adenovirus Vaccine Type 7, Live
- Bacillus of Calmette and Guerin
- Bacillus of Calmette and Guerin Vaccine, Live
- Influenza Virus Vaccine, Live
- Measles Virus Vaccine, Live
- Mumps Virus Vaccine, Live
- Poliovirus Vaccine, Live
- Rotavirus Vaccine, Live
- Rubella Virus Vaccine, Live
- Smallpox Vaccine
- Typhoid Vaccine
- Varicella Virus Vaccine
- Yellow Fever Vaccine
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:
- Allergy to murine (mouse) proteins, history of or
- Heart disease or
- Heart failure (congestive heart failure), moderate to severe or
- Infection, active or
- Tuberculosis, active—Should not be used in patients with these conditions.
- 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 number of 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 number of platelets)—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.
- Tuberculosis, history of—Use with caution. Patients may need additional tuberculosis therapy.
Proper Use of This Medicine:
A doctor or other trained health professional will give you or your child this medicine. Infliximab is given through a needle that is placed in one of your veins. This medicine needs to be given slowly. The needle will need to remain in place for at least 2 hours.
This medicine should come with a Medication Guide. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.
You may also receive medicines to help prevent possible unwanted effects from the injection.
Precautions While Using This Medicine:
It is very important that your doctor check the progress of you or your child 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 while you are receiving it or right after the infusion ends. Check with your doctor or nurse right away if you or your child have chest pain, a fever, chills, itching, hives, a rash, dizziness, fainting, lightheadedness, a 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 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 or your child have any of the following symptoms while receiving this medicine: 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 or your child have any of the following symptoms while receiving this medicine: 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 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 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's disease or ulcerative colitis also developed a rare type of cancer called hepatosplenic T-cell lymphoma. Talk with your doctor if you or your child have unusual bleeding, bruising, or weakness, swollen lymph nodes in the neck, underarms, or groin, or unexplained weight loss. Also, check with your doctor right away if your skin has red, scaly patches, or raised bumps that are filled with pus.
Using this medicine may increase your risk of getting skin cancer (eg, melanoma, Merkel cell carcinoma). If you have any changes or growths on your skin, tell your doctor right away.
While you or your child are being treated with infliximab, do not have any immunizations (vaccines) without your doctor's approval. Live virus vaccines should not be given to patients who are using infliximab. Additionally, make sure your doctor knows if you received infliximab while you were pregnant because it may be necessary to wait before giving your child a live vaccine. Your child's vaccinations need to be current before he or she begins using infliximab. Be sure to ask your child's doctor if you have any questions about this.
You will need to have a skin test for tuberculosis before you or your child 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 or your child 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 side effects.
Side Effects of This Medicine:
- More common
- Abdominal or stomach pain
- chest pain
- flushing of the face
- muscle pain
- nasal congestion
- runny nose
- sore throat
- tightness in the chest
- troubled breathing
- unusual tiredness or weakness
- Less common
- Back pain
- bloody or cloudy urine
- cracks in the skin at the corners of the mouth
- difficult or painful urination
- frequent urge to urinate
- pain or tenderness around the eyes and cheekbones
- skin rash
- soreness or irritation of the mouth or tongue
- soreness or redness around the fingernails or toenails
- vaginal burning or itching and discharge
- white patches in the mouth or on the tongue
- Abscess (swollen, red, tender area of infection containing pus)
- back or side pain
- black, tarry stools
- blood in the urine or stools
- bone or joint pain
- feeling of fullness
- general feeling of illness
- hernia (bulge of tissue through the wall of the abdomen)
- irregular or pounding heartbeat
- pain in the rectum
- pain spreading from the abdomen or stomach to the left shoulder
- pinpoint red spots on the skin
- stomach pain (severe)
- swollen or painful glands
- tendon injury
- unusual bleeding or bruising
- weight loss (unusual)
- yellow skin and eyes
- Incidence not known
- Area rash
- bloody nose
- burning, tingling, numbness or pain in the hands, arms, feet, or legs
- change in mental status
- clay-colored stools
- continuing vomiting
- dark or bloody urine
- difficulty with speaking
- difficulty with swallowing
- fast heartbeat
- general feeling of tiredness or weakness
- heavier menstrual periods
- inability to move the arms and legs
- itching, puffiness, or swelling of the eyelids or around the eyes, face, lips, or tongue
- light-colored stools
- loss of appetite
- loss of bladder control
- lower back or side pain
- muscle spasm or jerking of all extremities
- noisy breathing
- painless swelling in the neck, armpits, or groin
- pale skin
- red, scaling, or crusted skin
- redness, soreness, or itching skin
- sensation of pins and needles
- severe abdominal or stomach pain
- severe muscle weakness, sudden and progressing
- slow or irregular breathing
- sores, welting, or blisters
- stabbing pain
- sudden loss of consciousness
- sudden numbness and weakness in the arms and legs
- unpleasant breath odor
- upper right abdominal or stomach pain
- vomiting of blood
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:
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.
Last Updated: 11/4/2014