Ixifi (Intravenous)

Infliximab-qbtx injection is used to treat Crohn disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and chronic severe plaque psoriasis. Infliximab-qbtx injection is a monoclonal antibody that helps to boost and improve the immune system.

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

It is very important for your doctor to check your or your child's progress during regular visits to ensure this medicine is working correctly. Blood tests may be needed to monitor for unwanted effects.

Infliximab-qbtx may cause an infusion reaction while you are receiving it or right after the infusion ends. Contact your doctor or nurse immediately if you experience chest pain, fever, chills, itching, hives, rash, dizziness, fainting, lightheadedness, headache, joint pain, difficulty swallowing, shortness of breath, trouble breathing, or swelling of the face, tongue, or throat.

Your body's ability to fight infections may be reduced while using infliximab-qbtx. It is crucial to call your doctor at the first sign of any infection. Contact your doctor right away if you experience fever, chills, cough, flu-like symptoms, or unusual tiredness or weakness.

Before starting this medicine, you will need to have a skin test for tuberculosis. Inform 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 with lung diseases (e.g., emphysema, COPD) or heavy smokers, and in psoriasis patients who have undergone long-term phototherapy treatment. Phototherapy treatment involves ultraviolet light or sunlight combined with oral medicine to increase skin sensitivity to light. Some teenagers and young adults with Crohn disease or ulcerative colitis have also developed a rare type of cancer called hepatosplenic T-cell lymphoma. Discuss with your doctor if you notice unusual bleeding, bruising, 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 skin cancer (e.g., melanoma, Merkel cell carcinoma) or cervical cancer. If you notice any changes or growths on your skin, abnormal vaginal bleeding, or pelvic pain, contact your doctor immediately.

It is important to have your heart monitored closely while receiving infliximab-qbtx. Call your doctor right away if you have difficulty breathing, swelling in the ankles and feet, or sudden weight gain.

Serious skin reactions can occur during treatment with this medicine. Contact your doctor immediately if you experience 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 risk of developing a lupus-like syndrome or a liver disease called autoimmune hepatitis. Contact your doctor immediately if you have dark brown 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 worsens in the sun, severe tiredness, upper right stomach pain, or yellow eyes and skin.

While being treated with infliximab-qbtx, do not get any immunizations (vaccines) without your doctor's approval. Live virus vaccines should not be given with infliximab-qbtx. Your child's vaccinations must be up to date before receiving infliximab-qbtx. Discuss any questions about this with your child's doctor.

Women: If you have a baby while receiving infliximab-qbtx, make sure the baby's doctor is aware 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.

Do not take other medicines unless you have discussed them with your doctor. This includes abatacept (Orencia®), anakinra (Kineret®), tocilizumab (Actemra®), or other medicines called biologics that treat the same conditions as infliximab-qbtx. Using these medicines together with infliximab-qbtx may increase your risk of serious unwanted effects.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the benefits it will provide. This is a decision you and your doctor will make together. For this medicine, the following points should be considered:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For over-the-counter products, read the label or package ingredients carefully.

Pediatric

Studies conducted so far have not shown any specific problems in children 6 years of age and older that would limit the effectiveness of infliximab-qbtx injection for treating Crohn disease or ulcerative colitis. However, safety and effectiveness have not been established for children younger than 6 years of age.

Studies have shown that infliximab-qbtx injection is not effective for children with juvenile rheumatoid arthritis. Its effectiveness has not been established.

Studies have not been performed on the effects of infliximab-qbtx injection for treating ankylosing spondylitis, psoriatic arthritis, and chronic severe plaque psoriasis in children. Safety and effectiveness have not been established.

Geriatric

Studies conducted so far have not shown specific problems in elderly patients that would limit the effectiveness of infliximab-qbtx injection. However, older patients are more likely to have infections, which may require caution when using infliximab-qbtx injection.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Consider the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together even if there is a potential interaction. In these cases, your doctor may want to adjust the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important for your healthcare professional to know if you are taking any of the following medicines. The following interactions have been selected based on 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 necessary in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both medicines.

• Abatacept
• Adalimumab
• Adenovirus Vaccine, Live
• Alefacept
• Anakinra
• Anifrolumab-fnia
• Bacillus of Calmette and Guerin Vaccine, Live
• Baricitinib
• Brodalumab
• Certolizumab Pegol
• Cholera Vaccine, Live
• Cyclosporine
• Dengue Tetravalent Vaccine, Live
• Ebola Zaire Vaccine, Live
• Etanercept
• Fosphenytoin
• Golimumab
• Guselkumab
• Influenza Virus Vaccine, Live
• Ixekizumab
• Levoketoconazole
• Measles Virus Vaccine, Live
• Methotrexate
• Mumps Virus Vaccine, Live
• Natalizumab
• Paclitaxel
• Phenytoin
• Poliovirus Vaccine, Live
• Quinidine
• Rilonacept
• Rituximab
• Rotavirus Vaccine, Live
• Rubella Virus Vaccine, Live
• Sarilumab
• Sirolimus
• Smallpox Monkeypox Vaccine, Live Non-Replicating
• Smallpox Vaccine
• Tacrolimus
• Tocilizumab
• Tofacitinib
• Typhoid Vaccine, Live
• Ustekinumab
• Varicella Virus Vaccine, Live
• Vedolizumab
• Warfarin
• Yellow Fever Vaccine
• Zoster Vaccine, Live

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used around the time of eating food or specific types of food because interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect the use of this medicine. Make sure you inform your doctor if you have any other medical issues, especially:

• Aspergillosis (fungus infection), history of or
• Blastomycosis (fungus infection), history of or
• Blood or bone marrow problems (e.g., 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 worsen these conditions.

• Cancer, active or history of or
• Chronic obstructive pulmonary disease (COPD)—Use with caution. May increase the chance of 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.

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

• Black, tarry stools
• Bladder pain
• Bloody or cloudy urine
• Blurred vision
• Body aches or pain
• Chest pain
• Chills
• Cough
• Cough producing mucus
• Difficult, burning, or painful urination
• Difficulty breathing
• Dizziness
• Dryness or soreness of the throat
• Ear congestion
• Fever
• Frequent urge to urinate
• Headache
• Hoarseness
• Itching, rash
• Loss of voice
• Lower back or side pain
• Nervousness
• Pain or swelling in the arms or legs
• Pain or tenderness around the eyes and cheekbones
• Painful or difficult urination
• Pale skin
• Pounding in the ears
• Slow or fast heartbeat
• Sneezing
• Sores, ulcers, or white spots on the lips or in the mouth
• Stuffy or runny nose
• Swollen glands
• Tender, swollen glands in the neck
• Tightness in the chest
• Trouble swallowing
• Troubled breathing with exertion
• Unusual bleeding or bruising
• Unusual tiredness or weakness
• Voice changes

Rare

• Bleeding gums
• Blood in the stool
• Blue lips and fingernails
• Changes in skin color or tenderness of the foot or leg
• Chest discomfort
• Confusion
• Coughing that sometimes produces a pink frothy sputum
• Dark urine
• Decreased urination
• Dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• Dry mouth
• Fast or noisy breathing
• Feeling of discomfort
• General feeling of illness
• General tiredness and weakness
• High fever
• Hives
• Increased sweating
• Irregular heartbeat
• Light-colored stools
• Muscle aches
• Nausea
• Pinpoint red spots on the skin
• Puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• Rapid, shallow breathing
• Swelling of the joints
• Sunken eyes
• Thirst
• Upper right abdominal or stomach pain
• Vomiting
• Weight loss
• Wrinkled skin
• Yellow eyes and skin

Incidence not known

• Back pain, sudden and severe
• Blistering, peeling, loosening of the skin
• Bloody nose
• Burning, tingling, numbness or pain in the hands, arms, feet, or legs
• Change in mental status
• Clay-colored stools
• Diarrhea
• Difficulty speaking
• Dilated neck veins
• Double vision
• Heavier menstrual periods
• Inability to move the arms, legs, or facial muscles
• Inability to speak
• Loss of appetite
• Muscle weakness, sudden and progressing
• Red, irritated eyes
• Red skin lesions, often with a purple center
• Seizures
• Sensation of pins and needles
• Slow or irregular breathing
• Slow speech
• Stabbing pain
• Temporary vision loss
• Vomiting of blood
• 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

• Belching
• Diarrhea
• Difficulty in moving
• Feeling of warmth
• Heartburn
• Indigestion
• Muscle stiffness
• Redness of the face, neck, arms, and occasionally, upper chest

Less common

• 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.

In the U.S.

• Ixifi

Pharmacologic Class: Infliximab

Find detailed information on biosimilars for this medication.

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 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.

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