Renflexis (Intravenous)

Infliximab-abda injection is used in adults to treat Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and chronic severe plaque psoriasis. It is used in children to treat Crohn's disease and ulcerative colitis. Infliximab-abda 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 that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Infliximab-abda may cause an infusion reaction while you are getting 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, trouble breathing, or swelling of the face, tongue, and throat.

This medicine may increase your risk for stroke, heart attack, low or high blood pressure, or heart rhythm problems during and within 24 hours of the infusion. It may also cause temporary vision loss during or within 2 hours of the infusion. Contact your doctor right away if you have confusion, difficulty speaking, slow speech, inability to speak, inability to move your arms, legs, or facial muscles, double vision, headache, blurred vision, dizziness, ringing in the ears, fainting, or a fast, slow, or irregular heartbeat during or after receiving the medicine.

Your body may have a reduced ability to fight infections while you are receiving infliximab-abda. It is crucial to call your doctor at the first sign of any infection. Contact your doctor immediately if you have fever, chills, cough, flu-like symptoms, or unusual tiredness or weakness.

Serious skin reactions can happen while you are receiving this medicine. Contact 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 risk of developing a lupus-like syndrome or a liver disease called autoimmune hepatitis. Contact your doctor immediately if you notice 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-side stomach pain, or yellowing of the 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 with lung diseases (e.g., emphysema, COPD) or who are heavy smokers, and in psoriasis patients who have had long-term phototherapy treatment. 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 have also developed a rare type of cancer called hepatosplenic T-cell lymphoma. Talk to your doctor if you notice 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 skin cancer (e.g., melanoma, Merkel cell carcinoma) or cervical cancer. If you notice any changes or growths on your skin or if you have abnormal vaginal bleeding, pelvic pain, or frequent or painful urination, tell your doctor right away.

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

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

You will need to have a skin test for tuberculosis before starting this medicine. Inform your doctor if you or anyone in your home has ever had a positive reaction to a tuberculosis skin test.

It is important to closely monitor your heart while receiving infliximab-abda, because this medicine may cause new or worsening heart failure. Call your doctor right away if you have trouble breathing, swelling in your ankles and feet, or sudden weight gain.

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

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

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your health care professional know if you have other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

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

Studies have not been done on how age affects the use of infliximab-abda injection in children with plaque psoriasis. Safety and efficacy have not been established.

Studies have shown that infliximab-abda injection is not effective in children with juvenile rheumatoid arthritis. Efficacy has not been established.

Geriatric

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

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Weigh 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 can be used together even if an interaction might happen. In these cases, your doctor may want to adjust the dose or take other precautions. It is especially important for your healthcare professional to know if you are taking any of the following medicines while receiving this medicine. The following interactions are based on their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is generally 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 of the 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

Some medicines should not be used at or around the time of eating food or certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also cause interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical problems may affect how this medicine works. Make sure to tell 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 risk 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, they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

• Accumulation of pus
• black, tarry stools
• blurred vision
• chest pain
• chills
• cough
• diarrhea
• difficulty in swallowing and breathing
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fever
• general feeling of discomfort or illness
• headache
• hives, itching, skin 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

Rare

• Clay-colored stools
• confusion
• 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
• nausea
• pain, tenderness, and swelling of the foot or leg
• pale skin with blue lips and fingernails
• pinpoint red spots on the skin
• severe constipation
• stomach pain
• sunken eyes
• swollen, painful, or tender lymph glands in the armpit
• vomiting

Incidence not known

• Blistering, peeling, or loosening of the skin
• bloody nose
• change in mental status
• chest discomfort
• difficulty in speaking
• double vision
• heavier menstrual periods
• inability to move the arms, legs, or facial muscles
• inability to speak
• 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
• pain or discomfort in the arms, jaw, back, or neck
• red, irritated eyes
• red, scaling, or crusted skin
• red skin lesions often with a purple center
• seizures
• slow speech

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
• discomfort, upset, or pain in the stomach
• ear congestion
• heartburn
• indigestion
• loss of voice
• nasal congestion
• pain or tenderness around the eyes and cheekbones

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.

• Renflexis

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Immunological Agent

Pharmacologic Class: Infliximab

Find detailed information on biosimilars for this medication.

A doctor or other trained health professional will give you this medicine in a medical facility. It is given through a needle placed into one of your veins. The medicine 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 from the injection.

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