Infliximab-abda (Intravenous route)
in-FLIX-i-mab - abda
- Powder for Solution
Warnings:Intravenous route(Powder for Solution)
Increased risk of serious infections leading to hospitalization or death, including TB, bacterial sepsis, invasive fungal infections (such as histoplasmosis) and infections due to other opportunistic pathogens. Discontinue infliximab-abda if a patient develops a serious infection. Perform test for latent TB; if positive, start treatment for TB prior to starting infliximab-abda. Monitor all patients for active TB during treatment, even if initial latent TB test is negative. Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with tumor necrosis factor (TNF) blockers, including infliximab. Postmarketing cases of fatal hepatosplenic T-cell lymphoma (HSTCL) have been reported in patients treated with TNF blockers including infliximab products. Almost all had received azathioprine or 6-mercaptopurine concomitantly with a TNF-blocker at or prior to diagnosis. The majority of reported cases have occurred in patients with Crohn’s disease or ulcerative colitis, most of whom were adolescent or young adult males .
Uses of This Medicine:
Infliximab-abda injection is used in adults to treat Crohn disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and chronic severe plaque psoriasis. It is used in children to treat Crohn disease and ulcerative colitis. Infliximab-abda injection is a monoclonal antibody that works to enhance and improve the immune system.
This medicine is available only with your doctor's prescription.
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-abda injection for the treatment of Crohn disease or ulcerative colitis in children 6 years and older. However, safety and efficacy have not been established in children younger than 6 years.
Appropriate studies have not been performed on the relationship of age to the effects of infliximab-abda injection in children with plaque psoriasis. Safety and efficacy have not been established.
Appropriate studies performed to date have demonstrated that infliximab-abda 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-abda injection in the elderly. However, elderly patients are more likely to have infections, which may require caution in patients receiving infliximab-abda injection.
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 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:
- 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 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 this medicine. It is given through a needle that is placed in one of your veins.
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 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-abda 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, 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 an infection may be reduced while you are using infliximab-abda. 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). If you have any changes or growths on your skin, tell your doctor right away.
While you are being treated with infliximab-abda, do not have any immunizations (vaccines) without your doctor's approval. Live virus vaccines should not be given with infliximab-abda. Your child's vaccinations must be current before using infliximab-abda. Talk to your child's doctor if you have any questions about this.
Women: If you have a baby while receiving infliximab-abda, make sure the baby's doctor knows that you were 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-abda. 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-abda. Using these medicines together with infliximab-abda may increase your chance of having serious unwanted effects.
Side Effects of This Medicine:
- More common
- Accumulation of pus
- black, tarry stools
- blurred vision
- chest pain
- difficulty in swallowing and breathing
- faintness or lightheadedness when getting up suddenly from a lying or sitting position
- general feeling of discomfort or illness
- hives, itching, or rash
- muscle pain or stiffness
- pain in the joints, lower back, or side
- painful or difficult urination
- pounding in the ears
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- slow or fast heartbeat
- sore throat
- sores, ulcers, or white spots on the lips or in the mouth
- stuffy or runny nose
- swollen glands
- swollen, red, tender area of the infection
- tightness in the chest
- unexplained bleeding or bruising
- unusual tiredness or weakness
- weight loss
- yellowing of the skin and eyes
- Less common
- Cracks in the skin at the corners of the mouth
- soreness or redness around the fingernails and toenails
- vaginal burning, itching, or discharge
- white patches in the mouth, throat, or on the tongue
- Abdominal or stomach pain
- clay-colored stools
- coughing that sometimes produces a pink frothy sputum
- dark or bloody urine
- difficult, fast, noisy breathing
- dry mouth
- fainting or loss of consciousness
- fast or irregular breathing
- general feeling of discomfort, illness, or weakness
- increased sweating
- loss of appetite
- pain, tenderness, and swelling of the foot or leg
- pale skin with blue lips and fingernails
- pinpoint red spots on the skin
- severe constipation
- sunken eyes
- swollen, painful, or tender lymph glands in the armpit
- Incidence not known
- Blistering, peeling, or loosening of the skin
- bloody nose
- change in mental status
- difficulty in speaking
- heavier menstrual periods
- muscle aches and weakness
- new mole, change in size, shape, or color of an existing mole, or a mole that leaks fluid or bleeds
- numbness or tingling in the fingers, face, or feet
- red, irritated eyes
- red, scaling, or crusted skin
- red skin lesions often with a purple center
- More common
- Acidic or sour stomach
- discomfort, upset, or pain in the stomach
- ear congestion
- loss of voice
- nasal congestion
- pain or tenderness around the eyes and cheekbones
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:
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:
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: 9/4/2017