Inflectra

Inflectra is a prescription medication used to treat Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis.

Inflectra belongs to a group of drugs called tumor necrosis factor-alpha inhibitors. These work by blocking the action of a substance in the body that causes inflammation.

This medication is available in an injectable form to be given directly into a vein (IV) by a healthcare professional.

Common side effects of Inflectra include infections, headache, and stomach pain.

Inflectra is a prescription medication used to treat:

• moderate to severe active Crohn’s disease who have had an inadequate response to conventional therapy in adults and children (six years and older)
• moderate to severe active ulcerative colitis who have had an inadequate response to conventional therapy in adults
• moderate to severe active rheumatoid arthritis (to be given with methotrexate)
• active ankylosing spondylitis (arthritis of the spine)
• active psoriatic arthritis;
• chronic severe plaque psoriasis in adults 

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Inflectra. See the “Inflectra Precautions” section.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take medicines called biologics that are used to treat the same conditions as Inflectra. Especially tell your doctor if you take Kineret (anakinra), Orencia (abatacept), or Actemra (tocilizumab). 

This is not a complete list of Inflectra drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Inflectra including the following: (listed format)

• Increased risk for infection. Since Inflectra affects your immune system, it can lower the ability for your body to fight infections. Serious infections may include tuberculosis (TB). You will be tested for TB before you start receiving Inflectra. In addition, your doctor will monitor you for signs and symptoms of TB throughout your treatment. Tell your doctor right away if you notice any signs or symptoms of an infection such as:
  • a fever
  • have flu-like symptoms
  • feel very tired
  • have a cough
• Increased risk for cancer. Speak with your doctor if you have ever had any type of cancer.
• Heart Failure. If you have heart failure, taking this medication can make it worse. Your doctor will monitor you closely. Tell your doctor right away if you notice:
  • shortness of breath
  • sudden weight gain
  • swelling of ankles or feet
• Liver Injury. Speak with your doctor if you notice any of the following:
  • skin and eyes turning yellow (jaundice)
  • dark brown-colored urine
  • pain on the right side of your stomach area
  • fever
  • severe fatigue
• Blood problems. Tell your doctor if develop:
  • a fever that does not go away
  • look pale
  • bruise or bleed very easily
• Nervous System Disorders. Tell your doctor if you experience:
  • changes in your vision
  • numbness or tingling in any part
  • weakness in your arms or legs
  • seizures
• Allergic reactions. Some patients have had allergic reactions to this medication. In some cases, these reactions were severe. These reactions can occur during administration of Inflectra or even shortly afterward administration. Your doctor may need to stop or pause your treatment. Your doctor may also have to give you medicines to treat the allergic reaction. Signs of an allergic reaction include:
  • hives
  • high or low blood pressure
  • difficulty breathing
  • fever and chills
  • chest pain

Some patients may experience a delayed allergic reaction which should be reported to your doctor right away. Signs and symptoms of a delayed allergic reaction include fever, rash, headache, muscle or joint pain, swelling of the face and hands, and difficulty swallowing.

• Lupus-Like Syndrome. Tell your doctor if you notice any of the following signs and symptoms:
  • chest discomfort
  • shortness of breath
  • joint pain
  • rash on the cheeks or arms that gets worse in the sun
• Psoriasis. Some patients receiving Inflectra developed psoriasis or experienced worsening of their psoriasis. Tell your doctor if you notice red scaly patches or pus-filled, raised bumps. 

In moderate to severe heart failure, doses >5 mg/kg is contraindicated (should not be given). 

Do not receive Inflectra if you are allergic to Inflectra or to any of its ingredients.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Inflectra, there are no specific foods that you must exclude from your diet when receiving this medication.

Before receiving Inflectra , tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Inflectra or to any of its ingredients
• have heart failure or other heart conditions
• have an infection
• have liver problems including liver failure
• have had or have any type of cancer
• have had phototherapy (treatment with ultraviolet light or sunlight along with a medicine to make your skin sensitive to light) for psoriasis.
• have COPD (Chronic Obstructive Pulmonary Disease), a specific type of lung disease.
• have or have had a condition that affects your nervous system
• have recently received or are scheduled to receive a vaccine. Adults and children receiving this medication should not receive live vaccines. Children receiving this medication should have all of their vaccines brought up to date before starting treatment.
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Inflectra falls into category B. It is not known whether infliximab products can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Inflectra should be given to a pregnant woman only if clearly needed.

If you were using Inflectra during your pregnancy, speak with your baby's pediatrician. This is important, because they will need to determine when your baby should receive any vaccine as certain vaccinations can cause infections.

If you received Inflectra while you were pregnant, your baby may be at higher risk for getting an infection. If your baby receives a live vaccine within 6 months after birth, your baby may develop infections with serious complications that can lead to death. 

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Inflectra crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if you will stop nursing or stop the medication. 

Receive Inflectra exactly as prescribed.

Inflectra is available as a solution that will be administered into the vein by a healthcare provider. It will typically be infused over 2 hours.

Your doctor may administer medications before Inflectra to prevent or lessen possible side effects. 

Your doctor will monitor you during treatment and may order certain labs to see how you are responding to Inflectra and monitor your side effects. 

Receive this medication exactly as prescribed by your doctor. 

The dose your doctor recommends may be based on the following:

• the condition being treated
• how you respond to this medication
• your side effects
• your weight

The recommended dose of Inflectra (infliximab-dyyb) for each of the indications are:

Crohn’s Disease: 5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks. In some situations, some may benefit from 10 mg/kg. 

Pediatric Crohn’s Disease: 5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks.

Ulcerative Colitis: 5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks.

Rheumatoid Arthritis: In combination with methotrexate, 3 mg/kg at 0, 2 and 6 weeks, then every 8 weeks. In some situations, some may benefit from 10 mg/kg. 

Ankylosing Spondylitis: 5 mg/kg at 0, 2 and 6 weeks, then every 6 weeks.

Psoriatic Arthritis and Plaque Psoriasis: 5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks.

If Inflectra is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

Make sure to discuss with your doctor when you will receive infusions and to come in for all your infusions and follow-up appointments.

WARNING: SERIOUS INFECTIONS and MALIGNANCY. 

• Increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis) and infections due to other opportunistic pathogens.
• Discontinue INFLECTRA if a patient develops a serious infection.
• Perform test for latent TB; if positive, start treatment for TB prior to starting INFLECTRA. 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 products.
• 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 cases were reported in patients with Crohn’s disease or ulcerative colitis, most of whom were adolescent or young adult males.