Ixifi is a prescription medication used to treat certain inflammatory bowel diseases, arthritis, and psoriasis in patients over 6 years of age.

Ixifi belongs to a group of drugs called tumor necrosis factor (TNF) blocker medications. Ixifi blocks the action of a protein in your body called tumor necrosis factor-alpha (TNF-alpha). TNF-alpha is made by your body's immune system. People with certain diseases have too much TNF-alpha that can cause the immune system to attack normal healthy parts of the body. Ixifi can block the damage caused by too much TNF-alpha.

This medication is available in an injectable form to be given directly into a vein by a healthcare professional. It is given over a period of about 2 hours.
 
Common side effects of Ixifi include upper respiratory infections, infusion-related reactions, headache, and stomach pain.

Ixifi is a prescription medicine that is approved for patients with:

• Rheumatoid Arthritis - adults with moderately to severely active rheumatoid arthritis, along with the medicine methotrexate.
• Crohn's Disease - children 6 years and older and adults with Crohn's disease who have not responded well to other medicines.
• Ankylosing Spondylitis
• Psoriatic Arthritis
• Plaque Psoriasis - adult patients with plaque psoriasis that is chronic (does not go away), severe, extensive, and or disabling.
• Ulcerative Colitis - adults with moderately to severely active ulcerative colitis who have not responded well to other medicines.

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

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

Common side effects of Ixifi include the following:

• respiratory infections such as sinus infections and sore throat
• headache
• coughing
• stomach pain

Infusion reactions can happen up to 2 hours after your infusion of Ixifi. Symptoms of infusion reactions may include:

• fever
• chills
• chest pain
• low blood pressure or high blood pressure
• shortness of breath
• rash
• itching

Children with Crohn’s disease showed some differences in side effects compared with adults with Crohn’s disease. The side effects that happened more in children were: anemia (low red blood cells), leukopenia (low white blood cells), flushing (redness or blushing), viral infections, neutropenia (low neutrophils, the white blood cells that fight infection), bone fracture, bacterial infection and allergic reactions of the breathing tract.

This is not a complete list of Ixifi side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effects that bother you or that do not go away.
 
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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:

• Kineret (anakinra)
• Orencia (abatacept)
• Actemra (tocilizumab)
• other biological therapies
• methotrexate
• any substrate that makes use of CYP450 enzymes
• medications that suppress the immune system
• live vaccines

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

Serious side effects have been reported with Ixifi including the following:

• serious infections. This medication can increase the risk of developing infections such as tuberculosis or fungal infections. Patients should be closely monitored for infectious signs and stopped if a serious infection develops.
• malignancies. Lymphomas (lymphatic cancers), skin cancers, cerivcal cancers, and other malignancies can occur while on this medication. 
• hepatitis B reactivation. This medication can cause hepatitis B virus infections. Patients who are put on Ixifi should be screened to test for hepatitis B antigen. Ixifi should be stopped if a hepatitis B infection occurs.
• hepatotoxicity (liver toxicity). This medication can cause elevation in abnormal liver function tests. Patiens should be closely monitored for liver injury while on this medication.
• heart failure. Patients with pre-existing heart failure may be at high risk of fatal events while on this medication. Patients with heart failure should be closely watched. Ixifi should be stopped at any sign of heart failure worsening.
• hematologic (blood) reactions. Patients can experience abnormal blood cell counts while on this medication. Patients should seek medication attention with any signs or symptoms of blood dyscrasia or infection, such as a persistent fever.
• hypersensitivity. Infusion reactions can occur with this medication. Tell your doctor or get medical help right away if you get any of these symptoms during or after an infusion this medication:
  • hives (red itchy welts) or rash
  • itching
  • swelling of your lips, tongue, throat or face
  • sudden cough
  • weakness
  • dizziness or feel faint
  • palpitations (feel like your heart is racing or fluttering)
  • chest pain
• cardiovascular and cerebrovascular (heart and brain) reactions. Serious injury to the brain, heart attack, changes in blood pressure, or changes in heart rhythm can occur with this medication. Patients on Ixifi should be monitored for this and should stop if any of these occur.
• neurologic reactions. Diseases of the central nervous system such as multiple sclerosis, optic neuritis, or Guillain-Barré syndrome can occur with this medication. Patients with a pre-existing nervous system condition should be cautious about starting Ixifi. Ixifi should be stopped if any of these develop.
• use with Anakinra. Use of this medication with anakinra (Kineret) has lead to serious infections or decreased white blood cell count. Using Ixifi with anakinra is not recommended.
• use with Abatacept. Use of this medication with abatacept (Orencia) has lead to serious infections. Using Ixifi with abatacept is not recommended.
• concurrent use with other biologics. Use of this medication with other biological medications has not been well-studied. Using Ixifi with other biologics is not recommended for the potential of higher infection risk.
• switching between biological DMARDs. Switching between biologics should be done with care, as a higher risk of infection can occur.
• autoimmunity.  Lupus-like syndrome can occur with prolonged use of this medication. Treatment should be discontinued if a patient shows any symptoms of lupus-like syndrome. This can include:
  • muscle pain
  • joint pain
  • fever
  • swelling
  • tired feeing
  • weight loss
  • any discomfort around the lungs or heart
• live vaccines. There is limited data for patients receiving live vaccine swhile on Ixifi. Infections can occur with live vaccines. Receiving live vaccines is not recommended while on Ixifi. Vaccines should be up-to-date before starting Ixifi.

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 Ixifi, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Ixifi, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Ixifi or to any of its ingredients
• have an infection
• live near areas where fungal infections are common
• have a history of Crohn's disease, ulcerative colitis, or cancer
• have liver problems
• have had phototherapy for psoriasis
• have COPD or lung disease
• have any conditions that affect the nervous system
• have pre-existing heart failure
• are not fully up-to-date on vaccines
• are pregnant or plan on becoming 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.

There are no well-done studies that have been done in humans with Ixifi. In animal studies, pregnant animals were given this medication, and the babies did not show any medical issues related to this medication. It has been shown that medications similar to Ixifi can cross the placenta. This can make the developing baby susceptible to infections. Live vaccines are not recommended for patients who are currently on Ixifi.

• It is not known if Ixifi harms your unborn baby. IxifiI should be given to a pregnant woman only if clearly needed. Talk to your doctor about stopping Ixifi if you are pregnant or plan to become pregnant.

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

It is not known if Ixifi 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 the benefits outweigh the risk of using Ixifi.

• You will be given Ixifi through a needle placed in a vein (IV or intravenous infusion) in your arm.

• Your doctor may decide to give you medicine before starting the Ixifi infusion to prevent or lessen side effects.

• Only a healthcare professional should prepare the medicine and administer it to you.

• Ixifi will be given to you over a period of about 2 hours.

• If you have side effects from Ixifi, the infusion may need to be adjusted or stopped. In addition, your healthcare professional may decide to treat your symptoms.

• A healthcare professional will monitor you during the Ixifi infusion and for a period of time afterward for side effects. Your doctor may do certain tests while you are receiving Ixifi to monitor you for side effects and to see how well you respond to the treatment.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

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

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age
• your gender

The recommended dose/dose range of Ixifi is calculated by weight. Your doctor will develop a dose of the medication that is right for you. It is given at 0, 2, and 6 weeks. It will then be given every 6 or 8 weeks thereafter. How often you receive the medication is based on what you are using it for.

Crohn’s Disease: 5 mg/kg at 0, 2, and 6 weeks, then every 8 weeks. Some adult patients who initially respond to treatment may benefit from increasing the dose to 10 mg/kg if they later lose their response. 

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 conjunction with methotrexate, 3 mg/kg at 0, 2, and 6 weeks, then every 8 weeks. Some patients may benefit from increasing the dose up to 10 mg/kg or treating as often as every 4 weeks. 

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.

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

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 Ixifi if a patient develops a serious infection.
• Perform test for latent TB; if positive, start treatment for TB prior to starting IXIFI. 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 IXIFI cases were reported in patients with Crohn’s disease or ulcerative colitis, most of whom were adolescent or young adult males.