Tuesday, January 24, 2023

Remicade Treatment For Ulcerative Colitis

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What Is Remicade Used For

Infliximab for Patients with Severe Ulcerative Colitis – IBD in the News

If you have a certain type of arthritis or disease related to inflammation, your doctor may recommend Remicade. Doctors may prescribe Remicade to treat the conditions below. Remicade doesnt cure these conditions, but it does help manage them by easing the symptoms they cause.

Remicade works by blocking the activity of a type of immune system protein called tumor necrosis factor . This protein helps your body fight infections. But with some diseases, such as arthritis and Crohns disease, the body makes too much TNF, or TNF is too active. Blocking TNFs activity may help treat these diseases.

Your doctor will explain how Remicade will be given to you. Theyll also explain how much youll be given and how often. Below are commonly used dosages, but the dosage you receive will be determined by your doctor.

What Can Remicade Do For You

So your GI doctor says to you, I think we should use Remicade to treat your IBD. We can set you up to do convenient in-office infusions. Your brain suddenly goes into overdrive. You have so many questions! What is Remicade? How is it given? What is an in-office infusion? What are the side effects? Dont fret. Read on and you will find the answers to all of these questions, and more.

Remicade is an immunosuppressive prescription drug used to treat autoimmune diseases, such as Crohns Disease, Ulcerative Colitis, Rheumatoid Arthritis, Psoriatic Arthritis and Anklylosing Spondylitis. This autoimmune response is caused by too much of a protein called tumor necrosis factor-alpha circulating in the body. High levels of this protein cause the bodys immune system to mistakenly attack and destroy cells in the body.

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The Time Commitment Of Infusions

In addition, the more I needed treatments, the longer they seemed to take at the hospital. At first, the sessions lasted about two hours. Then, it seemed the hospital pharmacy got slower and slower in delivering the medication to the IV therapy center.

My appointments quickly evolved to sitting in place for 3-4 hours. As a teacher, Im used to being up and moving around. Sitting still for so long created its own sort of hurt on my body.

Not to mention, the longer I sat, the more I contemplated the costs.

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Report A Janssen Product Adverse Event

You may contact the Medical Information Center by calling 1-800-JANSSEN to speak to a clinical expert regarding your question or to report a possible adverse event.

Report a Janssen COVID-19 Vaccine Adverse Event

Report a Adverse Event to FDA VAERS at www.vaers.hhs.gov/reportevent.html or call the FDA at 1-800-822-7967.Report a Adverse Event to Janssen at 1-800-565-4008 or 1-908-455-8822 .

Crohns Disease And Ulcerative Colitis Infusion Treatment

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When living with Crohns disease or ulcerative colitis, one of the first things you may want to know is how the disease is treated. Treatment often consists of one or more prescription medications, which help to suppress the immune response that is causing inflammation to the gastrointestinal tract. In addition to biologic agents, people with Crohns disease and ulcerative colitis often have low levels of iron in the blood, and therefore may benefit from intravenous iron infusions.

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Key Points About Stelara

  • Stelara is approved to treat Crohns disease.
  • The loading dose of Stelara is given by infusion and thereafter is given by injections at home.
  • People taking shots for allergies should talk to their doctor about possible allergic reactions and Stelara.
  • Common side effects include infections, injection site reactions, and vomiting.
  • If you are pregnant or plan to become pregnant, you and your doctor should decide if you should take Stelara.
  • Its thought that Stelara does pass into breastmilk.
  • Stelara must be refrigerated.

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Remicade Infusion Side Effects

Remicade is a very potent drug that has potential side effects. These can occur during or after the infusion. Severe infections, including tuberculosis, pneumonia and sepsis, have been reported in patients taking Remicade. Tell your doctor if you have had or have been exposed to tuberculosis. Testing for tuberculosis generally is done before starting treatment with Remicade.

Patients with heart failure generally should not be treated with Remicade. Tell your physician if you have shortness of breath or new swelling of your ankles or feet. Rare reports of liver injury, blood disorders, lymphoma and other cancers, as well as neurologic disease, have occurred in patients receiving Remicade.

Allergic reactions to the protein in Remicade also can occur. Read important safety information at remicade.com.

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Will I Have Withdrawal Symptoms If I Stop Taking Remicade

No, you wont have actual withdrawal symptoms. But you may have more symptoms of your condition or they may worsen if you stop taking Remicade.

In a small study, researchers tested the outcomes of stopping Remicade treatment. They found that 72.1% of people needed medication to treat their condition after they stopped taking Remicade.

This study included people with Crohns disease. They were in clinical remission at the time they stopped using Remicade. People stayed symptom free for an average of 1 year after they stopped taking Remicade.

If you have questions about what to expect when your doctor ends your Remicade treatment, talk with them.

Administration Instructions Regarding Infusion Reactions:

Bad Experience with Remicade (Infliximab) Infusion | My IBD Journey with Ulcerative Colitis

Prior to treatment, ensure appropriate personnel and medication are available to treat reactions that occur during infusion and shortly after infusion. Prior to infusion with Infliximab, patients may be premedicated with histamine-1 receptor antagonists, histamine-2 receptor antagonists, acetaminophen, and/or corticosteroids.

For mild to moderate reactions during the infusion, consider slowing or stopping the infusion. Upon resolution of these reactions, may reinitiate at a lower infusion rate and/or with histamine-1 receptor antagonists, histamine-2 receptor antagonists, acetaminophen, and/or corticosteroids. Discontinue the infusion if the mild to moderate reactions reoccur.

Discontinue the infusion if severe hypersensitivity reactions occur during the infusion.

Reference:1. Infliximab . Horsham, PA: Janssen Biotech, Inc.

SERIOUS INFECTIONS

Patients treated with either REMICADE® or Infliximab are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Discontinue either REMICADE® or Infliximab if a patient develops a serious infection or sepsis.

Reported infections include:

MALIGNANCIES
CONTRAINDICATIONS
HEPATITIS B REACTIVATION
HEPATOTOXICITY
HEART FAILURE
HEMATOLOGIC EVENTS
HYPERSENSITIVITY
CARDIOVASCULAR AND CEREBROVASCULAR REACTIONS DURING AND AFTER INFUSION
NEUROLOGIC EVENTS
AUTOIMMUNITY

cp-253861v1

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Could Remicade Stop Working For Me

Yes. Remicade may become less effective for you over time. This can occur if your bodys immune system starts to recognize Remicade as a foreign invader and makes antibodies to Remicade. Antibodies are immune system proteins that fight foreign substances, including medications such as Remicade.

If your body makes anti-Remicade antibodies, the drug will clear from your system faster and wont be as effective.

Remicade may also stop working for a time because of stress, dietary choices, or other health conditions.

If youre concerned about how effective Remicade is in treating your condition, talk with your doctor.

How Is Remicade Given

Before you start treatment with Remicade, your doctor may perform tests to make sure you do not have tuberculosis or other infections.

Remicade is given as an infusion into a vein. A healthcare provider will give you this injection.

This medicine must be given slowly, and the infusion can take at least 2 hours to complete.

You may be watched closely after receiving infliximab, to make sure the medicine has not caused any serious side effects.

Infliximab affects your immune system. You may get infections more easily, even serious or fatal infections. Your doctor will need to examine you on a regular basis, and you may need frequent TB tests.

Serious infections may be more likely in older adults.

If you need surgery, tell the surgeon ahead of time that you are using Remicade.

If you’ve ever had hepatitis B, using infliximab can cause this virus to become active or get worse. You may need frequent liver function tests while using this medicine and for several months after you stop.

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What Are The Side Effects And Risks Of Remicade

Remicade affects your immune system and can lower its ability to fight infections.

The most common side effect of Remicade include:

  • Respiratory infections
  • Stroke within 24 hours of infusion
  • Allergic reaction during or after the infusion
  • Delayed allergic reactions
  • Lupus-like syndrome

People taking Simponi shouldnt receive live vaccines or treatment with a weakened bacteria .

How Does Infliximab Work

REMICADE®

Crohns disease and ulcerative colitis have been linked to an increase in certain proteins – including one called tumor necrosis factor . Your bodys immune system naturally produces TNF.

An increase in TNF is linked to an increase in inflammation in the bodys digestive system – which can lead to a worsening of inflammatory bowel disease symptoms.

Remicade is one of a group of medications which target TNF proteins, bind to them and block them. This helps to prevent inflammation in the body which is hoped will reduce IBD symptoms. The immune system is also suppressed. This can mean that people taking Remicade are more prone to picking up illnesses and infections.

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Questions About Receiving Remicade

Heres a list of questions and answers related to receiving Remicade.

  • What if I miss a dose of Remicade? Youll receive doses of Remicade from a healthcare professional. If you miss an appointment to receive your next dose of Remicade, reschedule immediately. Missing doses of Remicade may affect how well the medication works.
  • Will I need to use Remicade long term? You might. Ask your doctor how long youll need to use Remicade to treat your condition. Your doctor will assess how well the medication is working for you. Sometimes Remicade can stop working, in which case your doctor may need to switch your medication.
  • Should I receive Remicade with food? Remicade is injected directly into your vein. Receiving Remicade with or without food wont affect its absorption.
  • How long does Remicade take to work? Depending on the condition youre using Remicade for, it may take several weeks to several months before you feel the drug easing your symptoms. Talk with your doctor to find out how long it might be before the medication starts working.

Report A Janssen Product Quality Complaint

You may contact the Medical Information Center by calling 1-800-JANSSEN to speak to a clinical expert regarding your question or to report a product quality complaint.

Report a Janssen COVID-19 Vaccine Product Quality Complaint

Report a Product Quality Complaint to Janssen at 1-800-565-4008 or 1-908-455-9922 .

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Remicade Generic Or Biosimilar

Remicade is available only as a brand-name medication. It contains the active drug ingredient infliximab.

The Food and Drug Administration has approved four biosimilar versions of Remicade: Avsola, Inflectra, Ixifi, and Renflexis.

A biosimilar is a medication thats similar to a brand-name drug. A generic medication, on the other hand, is an exact copy of the active ingredient in a brand-name drug. Biosimilars are based on biologic medications, which are created from parts of living organisms. Generics are based on regular drugs made from chemicals. Biosimilars and generics also tend to cost less than brand-name medications.

What Should I Know About Remicade Vs Entyvio

Ulcerative Colitis Medications: Prednisone, Ascol, Remicade, Etc.

A doctor may prescribe either Remicade or Entyvio for adults with Crohns disease or ulcerative colitis. Remicade works by blocking the activity of an immune system protein called tumor necrosis factor. Entyvio is an integrin receptor blocker. Integrin is another immune system protein that plays a role in ulcerative colitis and Crohns disease.

To find out whether Remicade or Entyvio may be better for treating your condition, talk with your doctor.

For more information about Remicade and Entyvio, view this detailed breakdown. And ask your doctor if youd like to know more about how these drugs compare with each other.

When considering Remicade treatment, discuss your overall health and any medical conditions you have with your doctor. And tell your doctor if youre taking any medications. Some drugs can interfere with Remicade.

These and other considerations to discuss with your doctor are described below.

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Infusion Dosing Schedule In Adults And Children

Even if you will be taking infliximab by injection, youll have your first two doses by infusion in hospital. See the previous sections on infusions.

Youll usually have your first injection in hospital or by a trained nurse at home. Youll then be trained to inject it yourself. If you prefer, it may be possible for someone else, such as a family member, to be trained to give you the injections.

Infliximab comes ready to use in either a pre-filled syringe or a pre-filled injection pen. You may not see the needle in the injection pen, as its inside. The syringes or pens come in a pack. The pack contains an alcohol pad to clean your skin before injecting.

Differences In Administration Efficacy And Conditions Treated

Robert Burakoff, MD, MPH, is board-certified in gastroentrology. He is the vice chair for ambulatory services for the department of medicine at Weill Cornell Medical College in New York, where he is also a professor. He was the founding editor and co-editor in chief of Inflammatory Bowel Diseases.

Biologics are a newer class of drugs used to treat the inflammation that is caused by inflammatory bowel disease . This is a broad range of medications that each work in slightly different ways with different standards of administration and dosing. Some are approved to treat just one form of IBD, while others are used to treat both Crohns disease and ulcerative colitis.

Because biologic drugs temper the immune response, people taking them are prone to certain infections. Its important, therefore, to take steps to reduce your vulnerability. People with IBD should receive vaccinations, ideally before starting a biologic, although many immunizations can also be given while taking a biologic.

According to 2020 guidelines, a biologic drug should be used first-line for treatment in people with moderate to severe ulcerative colitis.

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Dosing Of Infliximab For Pediatric Patients1

Infusions are administered every 8 weeks after 3 induction doses. Infliximab is administered by IV infusion over a period of not less than 2 hours.

Moderately to Severely Active Crohnâs Disease

Moderately to Severely Active Ulcerative Colitis

5 mg/kg 0, 2, and 6 weeks

5 mg/kg 0, 2, and 6 weeks

5 mg/kg every 8 weeks

5 mg/kg every 8 weeks

Side Effects And Risks

Remicade medicine 100mg Infliximab treatment of arthritis, psoriasis ...

Because Inflectra is a biosimilar of infliximab , Inflectra and Remicade have the same side effects. Examples of common and serious side effects for each drug are listed below.

More common side effects

This list contains more common side effects that can occur with both Remicade and Inflectra :

for these side effects. A boxed warning is the most serious warning from the Food and Drug Administration . For more information, see FDA warnings at the beginning of this article.

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Ifx Concentrations And Week 8 Outcomes

Serum IFX concentrations are shown in Table 2 and Figure 1. Comparing subjects in clinical remission at week 8 with non-remitters, there was no statistically significant difference in IFX concentrations at peak or week 1. There was a trend for higher IFX concentrations at pre-dose #2 and #3 for those in clinical remission at week 8 vs. non-remitters . There was a trend, but no statistically significant difference in IFX concentrations at pre-dose #2 and #3 for those in clinical response and/or remission at week 8 vs. non-responders/remitters

Figure 1. Serum infliximab concentrations by time. Box plot values include: lower adjacent value, first quartile, median, third quartile, and upper adjacent value . Lower and upper adjacent values are the most extreme values within the first quartile minus 1.5 × interquartile range and the third quartile plus 1.5 × interquartile range, respectively.

Figure 2. Serum infliximab concentrations at week 1, pre-dose #2, and pre-dose #3 by clinical remission status at Week 8. Box plot values include: lower adjacent value, first quartile, median, third quartile, and upper adjacent value . Lower and upper adjacent values are the most extreme values within the first quartile minus 1.5 × interquartile range and the third quartile plus 1.5 × interquartile range, respectively.

Can I Get Vaccines While Being Treated With Remicade

Yes and no. You can get inactive vaccines while taking Remicade. Inactive vaccines are made from germs that have been killed. Many of the vaccines that doctors recommend are inactive.

However, Remicade can weaken your immune systems ability to fight infections.* So you shouldnt get live vaccines during treatment. Live vaccines are made from weakened forms of germs. Examples of live vaccines to avoid while taking Remicade include the measles, mumps, and rubella vaccine and the yellow fever vaccine. For more information, see the Remicade interactions section above.

Before you start taking Remicade, check with your doctor to see if youre up to date on your vaccines.

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Approved Uses For Remicade

Remicade is approved by the FDA to treat several autoimmune diseases .

Remicade for Crohns disease

Crohns disease is a kind of inflammatory bowel disease in which you have inflammation in your digestive tract.

Remicade is FDA-approved to treat moderate to severe Crohns disease in adults as well as children ages 6 years and older. Its approved for use when other commonly used medications havent eased Crohns disease symptoms well enough.

Remicade for ulcerative colitis

Ulcerative colitis is also a type of IBD, but you have inflammation in your colon .

Remicade is FDA-approved to treat moderate to severe ulcerative colitis in adults as well as children ages 6 years and older. Its approved for use when other conventional medications havent eased ulcerative colitis symptoms well enough.

Remicade for plaque psoriasis

Plaque psoriasis is a type of psoriasis in which red, itchy, red patches form on your skin.

Remicade is FDA-approved to treat chronic, severe plaque psoriasis in adults who:

  • can take oral or injectable drugs that are systemic
  • cant take other conventional medications

Remicade for rheumatoid arthritis

With rheumatoid arthritis , you have pain and inflammation in your joints and other body parts.

Remicade is FDA-approved to treat moderate to severe RA in adults. Its used with the drug methotrexate.

Remicade for ankylosing spondylitis

Ankylosing spondylitis is a form of arthritis that mostly affects your spine.

Remicade for psoriatic arthritis

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