Inflectra

The recommended dose of Inflectra (Infliximab) depends on the condition being treated and varies according to body weight.

It is injected intravenously (into a vein) by a health care professional, usually in a clinical setting such as a hospital clinic, over several hours. This process is called an intravenous infusion. You should keep all your appointments and follow-ups as recommended by your doctor.

The appropriate dose for the following conditions is usually given 2 and 6 weeks after the first dose, then every 8 weeks thereafter:

• Crohn's disease
• rheumatoid arthritis
• ulcerative colitis
• psoriatic arthritis
• plaque psoriasis

For ankylosing spondylitis, the appropriate dose is usually given 2 and 6 weeks after the first dose, then every 6 to 8 weeks thereafter.

It is important to receive Inflectra (Infliximab) exactly as recommended by your doctor. If you miss an appointment to receive Inflectra (Infliximab), contact your doctor as soon as possible to reschedule your appointment.

Many things can affect the dose and schedule of medication that a person needs, such as body weight, other medical conditions, and other medications. Your doctor may choose a schedule different from the one above.

Inflectra (Infliximab) must be refrigerated at 2°C to 8°C (do not freeze it) and kept out of the reach of children. Inflectra (Infliximab) does not contain preservatives and must be mixed with sterile water for injection before IV infusion. Once the powder has been mixed, it should be used within 3 hours.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

In addition to its desired action, this medication may cause some adverse effects, notably: it may cause headaches; it may cause stomach ache; it may cause spots or redness of the skin; it may cause unusual tiredness; it could make you more prone to respiratory infections; it may cause nausea or, rarely, vomiting. Each person may react differently to a treatment. If you think this medication may be causing adverse effects (including those described here, or others), talk to your health care professional. He or she can help you to determine whether or not the medication is the source of the problem.

Each vial of sterile white lyophilized powder for intravenous infusion contains 100 mg of Inflectra (Infliximab). Nonmedicinal ingredients: 500 mg of sucrose, 0.5 mg of polysorbate 80, 2.2 mg of sodium dihydrogen phosphate monohydrate, and 6.1 mg of di-sodium hydrogen phosphate dihydrate.

You should not use Inflectra (Infliximab) if you:

• are allergic to Inflectra (Infliximab), mouse proteins, or any ingredients of the medication
• have moderate-to-severe Congestive Heart Failure
• have or are at risk of severe infections such as sepsis, abscesses, Tuberculosis, or opportunistic infections (infections that strike people with weakened immune systems)

There may be an interaction between Inflectra (Infliximab) and any of the following:

• Abatacept
• Adalimumab
• Anakinra
• Belimumab
• Canakinumab
• Certolizumab Pegol
• Denosumab
• echinacea
• Etanercept
• Fingolimod
• Golimumab
• Leflunomide
• natalimumab
• Nivolumab
• Pimecrolimus
• Roflumilast
• sipuleucel-T
• Tacrolimus
• Tocilizumab
• Tofacitinib
• Trastuzumab
• Ustekinumab
• vaccines (e.g., yellow fever, BCG, Cholera, typhoid, varicella)
• Vedolizumab

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Inflectra (Infliximab). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Inflectra (Infliximab).

Allergic reactions: In rare cases, some people may develop an allergic reaction to Inflectra (Infliximab). Signs of an allergic reaction include a severe rash, hives, swollen face or throat, or difficulty breathing. If these occur, contact your doctor immediately.

Blood disorders: Rarely, people taking Inflectra (Infliximab) have become deficient in certain types of blood cells. This may lead to problems with blood clotting, the immune system, or the transport of oxygen through the body. Contact your doctor immediately if you develop a fever, easy bruising, paleness, or bleeding while taking Inflectra (Infliximab).

Cancer: Compared to the general population, people taking Inflectra (Infliximab) have a slightly greater risk of developing a cancer of the immune system (known as lymphoma). However, the risk of developing this type of cancer is still rare.

In general, people with severe rheumatoid arthritis and Crohn's disease who take medications that suppress the immune system over long periods of time may also have a higher risk of developing lymphoma, even if they don't take Inflectra (Infliximab). Contact your doctor if you develop symptoms of lymphoma (such as fatigue, weight loss, fever, swollen glands, night sweats, and itching). (Note though that these may also be symptoms of other conditions.)

Some children and young adults with Crohn's disease who were receiving Inflectra (Infliximab) have developed hepatosplenic T-cell lymphoma, a rare type of cancer that is often fatal. Talk to your doctor if you have any concerns.

Other forms of cancer, such as cervical and certain skin cancers, have also been seen in people who are taking Inflectra (Infliximab). Talk to your doctor about the risks and benefits of using Inflectra (Infliximab).

Heart failure: Inflectra (Infliximab) may worsen congestive heart failure. If you have mild heart failure you should be closely monitored by your doctor while taking Inflectra (Infliximab). If you notice symptoms of congestive heart failure (such as swelling of the hands or feet and difficulty breathing), contact your doctor immediately. People with moderate or severe congestive heart failure should not take Inflectra (Infliximab).

Hepatitis B: People infected with hepatitis B (an infection that can damage the liver) may have a relapse of their condition while taking Inflectra (Infliximab). If you are at risk for hepatitis B, your doctor may want to test you for this infection before starting treatment with Inflectra (Infliximab) and will follow your condition closely while you are taking the medication. If you notice symptoms of a liver problem (see below), contact your doctor immediately.

Immune system disorders: Some people who take Inflectra (Infliximab) have developed lupus-like syndrome, an autoimmune disease (a condition where the body is attacked by its own immune system). Symptoms of lupus-like syndrome include chest pain, joint pain, difficulty breathing, and a skin rash (usually on the cheeks and arms) that is sensitive to the sun. If you develop these symptoms, contact your doctor as soon as possible.

Infections: Inflectra (Infliximab) can increase the risk of developing an infection, including serious infections such as sepsis, pneumonia, and tuberculosis. Before starting Inflectra (Infliximab) treatment, your doctor may test to see if you have tuberculosis. If you notice signs of an infection such as fever, chills, pain, swelling, coughing or pus, contact your doctor as soon as possible. Inflectra (Infliximab) should also not be started while you have an active infection.

Tell your doctor if you have a history of infections that keep coming back, or other conditions that might increase your risk of infections (e.g., Diabetes) or have visited or lived in areas where there is a greater risk of certain kinds of fungal infection (e.g., blastomycosis). While you are taking Inflectra (Infliximab), your doctor will monitor you for signs of infection.

Liver problems: Very rarely, people taking Inflectra (Infliximab) may experience liver problems. Symptoms of liver problems include abdominal pain, dark urine, fatigue, loss of appetite, and yellow eyes or skin. If you notice these symptoms, contact your doctor immediately.

Nervous system disorders: Rarely, Inflectra (Infliximab) may increase the risk of problems with the nervous system or cause existing problems to get worse. If you experience confusion, seizures, vision changes, tingling or numbness, or weakness in your arms or legs while taking Inflectra (Infliximab), contact your doctor immediately.

Vaccines: Live vaccines (e.g., BCG, yellow fever) are not recommended for people taking Inflectra (Infliximab). Talk to your doctor if you need any vaccinations while taking Inflectra (Infliximab). Children with Crohn's should complete the recommended vaccination schedule before receiving their first dose of Inflectra (Infliximab).

Pregnancy: Inflectra (Infliximab) is not recommended for use during pregnancy as it crosses the placenta and the effects on the developing baby are not known. Women who may become pregnant should use an effective method of birth control while they are taking Inflectra (Infliximab) and for at least 6 months after the last treatment.

Breast-feeding: It is not known if Inflectra (Infliximab) passes into breast milk. Women should not breast-feed while they are taking Inflectra (Infliximab) and should not start breast-feeding until at least 6 months after the last treatment.

Children: The safety and effectiveness of Inflectra (Infliximab) have not been established for children.

Seniors: Seniors may be more likely to experience serious infections with Inflectra (Infliximab). Talk to your doctor about the risks and benefits of using Inflectra (Infliximab).

Once diluted, this medication is usually administered into a vein (intravenously) over a number of hours by a health professional.