Infliximab, Injection

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KEY POINTS

• This medicine is given by IV to treat certain kinds of arthritis, Crohn’s disease, and ulcerative colitis.
• You may get serious or life-threatening infections when you are taking this medicine.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: monoclonal antibody for tumor necrosis factor (TNF)

Generic and brand names: infliximab, injection; Inflectra; Remicade

What is this medicine used for?

This medicine is given by IV infusion (slow drip through a needle into a large vein) to treat:

• Ankylosing spondylitis
• Crohn's disease or ulcerative colitis in adults and children 6 years of age or older who have not responded well to other treatment
• Plaque psoriasis
• Psoriatic arthritis
• Rheumatoid arthritis (RA)

This medicine may be used alone or along with another medicine.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine or to mouse proteins
• A blood disorder
• A weakened immune system from cancer treatment, diseases such as HIV/AIDS, or from taking steroid medicines or medicines to prevent organ transplant rejection
• Diabetes
• High blood pressure
• Lung disease such as COPD
• Heart failure
• Hepatitis B or other liver problems
• Lupus or other autoimmune diseases
• Lymphoma or other cancer
• Multiple sclerosis, Guillain-Barré syndrome, neuropathy, or any condition that causes numbness or tingling
• Seizures
• Phototherapy for treatment of psoriasis
• Tuberculosis (TB), a positive skin test for TB, or close contact with someone who has TB (your healthcare provider may give you a skin test to check for this).

You should NOT receive shots of this medicine if you have any kind of infection. Tell your healthcare provider if you:

• Currently have an infection
• Have any open cuts or sores
• Often have infections or infections come back
• Are scheduled to receive any vaccines
• Are scheduled to have major surgery

Some infections are more likely in certain parts of the country. Tell your provider where you have lived or recently traveled or where you plan to travel to during treatment.

Tell your provider if you take any other medicines for RA or JIA, especially anakinra (Kineret), certolizumab (Cimzia), etanercept (Enbrel), golimumab (Simponi), adalimumab (Humira), rituximab (Rituxan), infliximab (Remicade), or tocilizumab (Actemra).

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant. Do not breast-feed while taking this medicine without your healthcare provider's approval.

If you have a baby and you were using his medicine during your pregnancy, tell your baby's healthcare provider before your baby receives any vaccine. Your baby may have an increased chance of getting an infection for up to 6 months after birth.

How do I use it?

Read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you have a treatment.

These infusions are given by your healthcare provider. You will be monitored closely while receiving the infusion and for a period of time afterward for side effects. Your healthcare provider may give you medicine before starting the infusion to prevent or lessen side effects. Keep all appointments for infusions.

What should I watch out for?

This medicine increases your risk for serious or life-threatening infections. Stay away from people with colds, flu, or other infections. Contact your healthcare provider right away if you develop a fever or ANY other symptoms of infection. Also, do not have any vaccines without getting your healthcare provider's approval first.

This medicine may increase your risk for lymphoma, leukemia, melanoma, and other cancers. Talk to your healthcare provider about this.

You need regular checkups to see how this medicine affects you. Keep all appointments.

This medicine may cause severe allergic reactions. These reactions can happen while you are receiving this treatment or 3 to 12 days after receiving this medicine. Tell your healthcare provider right away if you have any symptoms of an allergic reactions, such as hives, trouble breathing, chest pain, fever, trouble swallowing, or swelling in your face or hands. Contact your healthcare provider right away if you have these symptoms.

This medicine may make you dizzy or cause vision changes. Do not drive or operate machinery unless you are fully alert and can see clearly.

Rarely, this medicine causes a condition called lupus-like syndrome. Its symptoms include a rash on your face or other parts of your body, chest pain or discomfort that doesn’t go away, new joint pain, shortness of breath, and sensitivity to sunlight. Talk to your healthcare provider about this.

This medicine may also increase the risk of developing psoriasis or worsen psoriasis. Contact your provider if you notice red scaly patches or raised bumps on the skin that are filled with pus.

Adults over the age of 65 may be at greater risk for side effects. Talk with your healthcare provider about this.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Lupus-like syndrome (new joint pain, rash, sensitivity to sunlight, chest pain); seizures; fever; cough; sore throat; trouble breathing; pain while urinating or urinating more often than usual; unexplained bleeding or bruising; unusually pale skin; yellowing of the eyes and skin; dark urine; severe nausea or vomiting; severe stomach pain; light-colored bowel movements; unexplained loss of appetite; numbness or tingling in any part of your body; trouble walking; vision changes; severe dizziness; blood in vomit, bowel movement, or urine; unexplained swelling in your ankles or feet; increased shortness of breath; unusual tiredness or weakness; new or worsening skin sores, red scaly patches, raised bumps that may be filled with pus, or other skin changes; pain, redness, or swelling around the injection site that doesn’t go away or gets worse.

Other: Headache; runny nose; mild dizziness; itching, redness, or pain at the injection site.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking any other medicines.

• Echinacea
• Fingolimod (Gilenya)
• Immunosuppressants such as azathioprine (Azasan, Imuran), cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune), and tacrolimus (Astagraf, Prograf, Protopic)
• Medicines to treat psoriasis, rheumatoid arthritis, and other immune disorders such as abatacept (Orencia), adalimumab (Humira), anakinra (Kineret), belimumab (Benlysta), canakinumab (Ilaris), certolizumab (Cimzia), etanercept (Enbrel), golimumab (Simponi), infliximab (Remicade), leflunomide (Arava), rituximab (Rituxan), tocilizumab (Actemra), and tofacitinib (Xeljanz)
• Mercaptopurine (Purinethol)
• Natalizumab (Tysabri)
• Rilonacept (Arcalyst)
• Theophylline
• Vaccines
• Vedolizumab (Entyvio)
• Warfarin (Coumadin)

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Keep all medicines out of the reach of children.

Do not share medicines with other people.